IEC 60601-1:2005

IEC 60601-1 ®
Edition 3.2 2020-08
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
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inside
Medical electrical equipment –
Part 1: General requirements for basic safety and essential performance

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IEC 60601-1 ®
Edition 3.2 2020-08
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
colour
inside
Medical electrical equipment –

Part 1: General requirements for basic safety and essential performance

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.01 ISBN 978-2-8322-8799-6

IEC 60601-1 ®
Edition 3.2 2020-08
CONSOLIDATED VERSION
REDLINE VERSION
colour
inside
Medical electrical equipment –
Part 1: General requirements for basic safety and essential performance
Publication IEC 60601-1 (Third edition – 2005) I-SH 01

MEDICAL ELECTRICAL EQUIPMENT –
Part 1: General requirements for basic safety
and essential performance
INTERPRETATION SHEET 1
This interpretation sheet has been prepared by SC 62A: Common aspects of electrical
equipment used in medical practice
The text of this interpretation sheet is based on the following documents:
ISH Report on voting
62A/599/ISH 62A/613/RVD
Full information on the voting for the approval of this interpretation sheet can be found in the
report on voting indicated in the above table.
___________
Subclause 1.1
This subclause is clarified by the following:
IEC 60601-1 does not apply to medical gas pipeline systems covered by ISO 7396-1, Medical
gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum.
NOTE Subclause 6.3 of ISO 7396-1 applies the requirement of IEC 60601-1-8 to certain monitoring and alarm
signals.
This clarification will remain valid until a new version of IEC 60601-1 is published.

___________
April 2008
– 1 –
Publication IEC 60601-1 (Third edition – 2005) I-SH 02

MEDICAL ELECTRICAL EQUIPMENT –

Part 1: General requirements for basic safety
and essential performance
INTERPRETATION SHEET 2
This interpretation sheet has been prepared by subcomittee 62A: Common aspects of
electrical equipment used in medical practice, of IEC technical committee 62: Electrical
equipment in medical practice.
The text of this interpretation sheet is based on the following documents:
ISH Report on voting
62A/634/ISH 62A/640/RVD
Full information on the voting for the approval of this interpretation sheet can be found in the
report on voting indicated in the above table.
_____________
Subclause 11.3
This subclause is clarified by the following:
As stated in the rationale for this subclause, fire ENCLOSURES are intended to be used only
where there is a significant likelihood of fire due to the presence of a source of ignition (as
described in the subclause) and a significant source of fuel. Most materials used in the
construction of ME EQUIPMENT are not considered to be such a source of fuel unless they are
in the presence of an OXYGEN RICH ENVIRONMENT. MANUFACTURERS should determine, through
analyses documented in the RISK MANAGEMENT FILE, whether the ME EQUIPMENT contains
combustible materials (fuel) in sufficient quantities to support combustion in conjunction with
ignition sources (capable of releasing greater than 900 J).
Subclause 13.1.2
This subclause is clarified by the following:
As stated in subclause 4.7, it is the MANUFACTURER’S RISK ANALYSIS that determines which
components are subject to failure testing based on the associated RISK. Where the associated
RISK of fire exceeds the MANUFACTURER’S criteria for RISK acceptability, the MANUFACTURER’S
simulation analysis (such as FMEAs) should be accepted in lieu of physical testing. As also
stated in 4.7, component reliability and ratings are to be considered in such failure simulation
analyses. Common electronic components that have a history of use without causing
equipment fires should not be considered a likely source of ignition.
Where the subclause identifies “emission of flames, molten metal, poisonous or ignitable
substance in hazardous quantities;” as a hazardous situation, this refers to emissions from
the ENCLOSURE not from components themselves. Where it identifies “exceeding the allowable
values for ‘other components and materials’ identified in Table 22 times 1,5 minus 12,5 °C”,
this applies only where doing so would result in an unacceptable RISK (as identified in the
MANUFACTURER’S RISK ANALYSIS according to 4.7). Typically, this would be cases where
January 2009 ICS 11.040 French text overleaf

– 2 –
ESSENTIAL PERFORMANCE would not be maintained or where greater than 900 J of energy
would be released in the presence of flammable materials that could sustain combustion.
The first exemption to fault analysis or testing identified in subclause 13.1.2 (“The
construction or the supply circuit limits the power dissipation in SINGLE FAULT CONDITION to less
than 15 W or the energy dissipation to less than 900 J.”) is intended to apply where the
component design itself (“The construction”) or fusing (or other current limiting devices) in the
supply circuit (“or the supply circuit”) assure the energy released during failures will not
exceed the limits. For most common signal level components rated for operation below
5 Watts, the energy released by short-circuiting of outputs will not exceed the 900 J limit.
This clarification will remain valid until a new version of IEC 60601-1 is published.
___________
January 2009 ICS 11.040 French text overleaf

SC 62A/Publication IEC 60601-1:2005, including Amendment 1:2012, Third edition/I-SH 03
MEDICAL ELECTRICAL EQUIPMENT –
Part 1: General requirements for basic safety and essential performance

INTERPRETATION SHEET 3
This interpretation sheet has been prepared by subcommittee 62A: Common aspects of
electrical equipment used in medical practice, of IEC technical committee 62: Electrical
equipment in medical practice.
The text of this interpretation sheet is based on the following documents:
ISH Report on voting
62A/858/ISH 62A/875/RVD
Full information on the voting for the approval of this interpretation sheet can be found in the
report on voting indicated in the above table.
___________
Subclause 13.1.2 fourth dash (Emissions, deformation of ENCLOSURE or exceeding
maximum temperature)
This subclause states the following:
The following HAZARDOUS SITUATIONS shall not occur:
− ….
− temperatures of ME EQUIPMENT parts that are not APPLIED PARTS but are likely to be
touched, exceeding the allowable values in Table 23 when measured and adjusted as
described in 11.1.3;
This is clarified by the following:
The above requirement is regarded as fulfilled in accordance with Subclause 4.5 for
temperatures at the surfaces of the enclosure, if the following conditions are fulfilled:
− The maximum allowed temperature on OPERATOR accessible surfaces in SINGLE FAULT
CONDITION is 105 °C; and
− the instructions for use contain a warning that, under some SINGLE FAULT CONDITIONS, the
temperature of: (indicate the surface of concern) could get hot and there is a possible RISK
of a burn if touched, and
− if the RISK ANALYSIS demonstrates a need for a warning symbol on the ENCLOSURE, safety
sign ISO 7010-W018 ( ) shall be used on or adjacent to the hot spot on the
ENCLOSURE; and
− the RISK ASSESSMENT demonstrates that the temperature attained in the SINGLE FAULT
CONDITION is acceptable, and
− the RISK ASSESSMENT demonstrates that applying the alternative RISK CONTROL measures
in this Interpretation Sheet results in a RESIDUAL RISK that is comparable to the RESIDUAL
RISK resulting from applying the requirement of the standard.
NOTE 1 This Interpretation Sheet is intended to be used with both Edition 3.0 and Edition 3.1 of IEC 60601-1.
NOTE 2 An example of an analysis that demonstrates an adequately low probability of occurrence of HARM is
shown below.
May 2013 ICS 11.040 French text overleaf

Example RISK ASSESSMENT:
The sum failure rate for parts that could increase the surface temperature of parts of the
enclosure of XYZ device touchable only by the OPERATOR to values above those of Table 23
calculates to be 60 FIT (1 FIT = 1E-9/h) according to the standard MIL-HDBK-217F where FIT
stands for "failure in time". In case of such failures, the device would emit an odour and would
no longer function properly. It is estimated, that only in one of 3 cases the device would not
be switched off immediately and the hot surface would be resulting in a burn.
The resulting overall probability of such HARM where adequate warning is provided in the
instructions for use in combination with warning sign ISO 7010 W018 would be: probability
= 1/3 * 60 FIT = 2 E-8/h =approx. 0,0002 per year.
In this example, the WXW Company's RISK acceptance criteria require that a HARM of that
severity must have a probability of less than 0,0003 per year for the associated RISK to be
considered acceptable. Based on that RISK acceptance criterion, the RISK associated with
overtemperature of the ENCLOSURE caused by single faults in the circuitry is acceptable.

May 2013 ICS 11.040 French text overleaf

 IEC 2021
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
IEC 60601-1
Edition 3.0  2005-12
Amendement 1  2012-07
MEDICAL ELECTRICAL EQUIPMENT –

Part 1: General requirements for basic safety and essential performance

INTERPRETATION SHEET 1
This interpretation sheet has been prepared by subcommittee 62A: Common aspects of
electrical equipment used in medical practice, of IEC technical committee 62: Electrical
equipment in medical practice.
The text of this interpretation sheet is based on the following documents:
DISH Report on voting
62A/1403/DISH 62A/1414/RVDISH
Full information on the voting for the approval of this interpretation sheet can be found in the
report on voting indicated in the above table.

___________
Interpretation of Subclauses 4.3 of IEC 60601-1:2005/AMD1:2012 and 4.7 of
This interpretation sheet is intended to clarify the requirements which are needed to maintain
ESSENTIAL PERFORMANCE in SINGLE FAULT CONDITION.
Subclause 4.3 * ESSENTIAL PERFORMANCE
The requirements in this subclause of IEC 60601-1:2005/AMD1:2012 are clarified by the
following.
aa) IEC 60601-1:2005/AMD1:2012 requires that both the NORMAL CONDITION and the SINGLE
FAULT CONDITIONS are to be considered in the identification of ESSENTIAL PERFORMANCE,
because:
ICS 11.040.01
– 2 – IEC 60601-1:2005/AMD1:2012/ISH1:2021
 IEC 2021
1) ESSENTIAL PERFORMANCE is defined in terms of the performance of a clinical function
(see 3.27);
NOTE 1 ESSENTIAL PERFORMANCE can have multiple aspects.
2) in particular, SINGLE FAULT CONDITIONS can cause or contribute to the loss or
degradation of such a clinical function that results in unacceptable RISK; and
3) according to IEC 60601-1:2005, 4.7, ME EQUIPMENT is required to remain SINGLE FAULT
SAFE or the RISK remains acceptable and this also applies to ESSENTIAL PERFORMANCE.
bb) The subclause requires the MANUFACTURER to:
NOTE 2 Many particular standards specify performance limits, RISK CONTROL measures and VERIFICATION
methods for some aspects of ESSENTIAL PERFORMANCE.
1) identify performance of clinical functions, other than that related to BASIC SAFETY, that
is necessary to achieve the INTENDED USE or that could affect safety;
2) specify performance limits between fully functional and total loss of the identified
performance in both
i) NORMAL CONDITION, and
ii) SINGLE FAULT CONDITION;
NOTE 3 The specified performance limits can be different in NORMAL CONDITION and SINGLE FAULT
.
CONDITION
3) evaluate the RISK from loss or degradation of the identified performance beyond the
specified limits;
i) Where the resulting RISK is unacceptable, the identified performance is
ESSENTIAL PERFORMANCE.
RISK CONTROL measures to reduce these RISKS to an acceptable level for
4) implement
both
i) NORMAL CONDITION, and
ii) SINGLE FAULT CONDITION;
5) assess and determine which RISK CONTROL measures need VERIFICATION of
effectiveness; and
6) specify methods for the VERIFICATION of the effectiveness of the RISK CONTROL
measures.
cc) The requirements of IEC 60601-1:2005/AMD1:2012 4.3 as clarified in items 4.3 bb) 1) to
4.3 bb) 6) above include documentation of the relevant results in the RISK MANAGEMENT
FILE. The documentation is intended to serve as OBJECTIVE EVIDENCE that the required
activities have been performed.
dd) The compliance statement refers to “inspection of the RISK MANAGEMENT FILE”. Inspection
means the careful examination or scrutiny of the contents of the RISK MANAGEMENT FILE.
Only confirming the existence of a RISK MANAGEMENT FILE is insufficient. Inspection can
include functional tests as clarified in IEC 60601-1:2005/AMD1:2012/ISH1 items 4.3 bb) 5)
and 4.3 bb) 6). This is similar to the other uses of “inspection” throughout this standard.
Subclause 4.7 * SINGLE FAULT CONDITION for ME EQUIPMENT
The requirements in this subclause of IEC 60601-1:2005 are clarified by the following.
aa) IEC 60601-1:2005 requires that ME EQUIPMENT remains SINGLE FAULT SAFE or the RISK
remains acceptable according to 4.2 during the EXPECTED SERVICE LIFE and this also
applies to ESSENTIAL PERFORMANCE.
bb) SINGLE FAULT CONDITION (as defined in 3.116) describes the condition where “a single
means for reducing a RISK is defective or a single abnormal condition is present”. Either
condition anticipates the failure or fault of one component [other than those indicated in
4.7 a), e.g. a COMPONENT WITH HIGH-INTEGRITY CHARACTERISTICS].

 IEC 2021
Component failure or fault can relate to:
1) a single part (e.g. resistor, capacitor, wire, mechanical part),
2) a subassembly (e.g. battery block, power supply unit, line filter, PESS), or
3) a device with a specified function (e.g. protective unit, control unit, monitoring unit).
Any SINGLE FAULT CONDITION that could result in a HAZARDOUS SITUATION, including those
mentioned in 13.1, needs to be simulated, physically or theoretically. Care needs to be
taken to adequately determine the worst case situation when analysing failure or fault of
subassemblies and functional units.
cc) It can be necessary to investigate the consequences of a second independent fault or
failure. This is relevant when the initial fault or failure remains undetected during NORMAL
USE for the EXPECTED SERVICE LIFE or when the fault or failure is so likely that it is
considered to be a NORMAL CONDITION. See 4.7 b) and 5.1 and their rationales in Annex A.
dd) The RISK ASSESSMENT is used to determine which SINGLE FAULT CONDITIONS are to be tested
in agreement with 4.3, 4.7 and 5.1. This includes consideration of a second independent
fault or failure following an initial SINGLE FAULT CONDITION that remains undetected during
NORMAL USE for the EXPECTED SERVICE LIFE. This also applies to the VERIFICATION of the
effectiveness of the RISK CONTROL measures needed to maintain ESSENTIAL PERFORMANCE
[see IEC 60601-1/AMD1:2012/ISH1 4.3 bb) 5) and 4.3 bb) 6)].
ee) The requirements of 4.7 include documentation of the relevant tests in the RISK MANAGEMENT
FILE. The documentation is intended to serve as OBJECTIVE EVIDENCE that the required
activities have been performed.

– 2 – IEC 60601-1:2005+AMD1:2012
+AMD2:2020 CSV  IEC 2020
CONTENTS
FOREWORD . 11
INTRODUCTION . 14
INTRODUCTION TO AMENDMENT 1 . 16
INTRODUCTION TO AMENDMENT 2 . 16
1 Scope, object and related standards . 18
1.1 * Scope . 18
1.2 Object . 18
1.3 * Collateral standards . 18
1.4 * Particular standards . 19
2 * Normative references . 19
3 * Terminology and definitions . 24
4 General requirements . 45
4.1 * Conditions for application to ME EQUIPMENT or ME SYSTEMS . 45
4.2 * RISK MANAGEMENT PROCESS for ME EQUIPMENT or ME SYSTEMS . 45
4.3 * ESSENTIAL PERFORMANCE . 48
4.4 * EXPECTED SERVICE LIFE . 49
4.5 * Equivalent safety for ME EQUIPMENT or ME SYSTEMS
* Alternative RISK CONTROL measures or test methods for ME EQUIPMENT or
ME SYSTEMS . 50
4.6 * ME EQUIPMENT or ME SYSTEM parts that contact the PATIENT . 50
4.7 * SINGLE FAULT CONDITION for ME EQUIPMENT . 50
4.8 * Components of ME EQUIPMENT . 51
4.9 * Use of COMPONENTS WITH HIGH-INTEGRITY CHARACTERISTICS in
ME EQUIPMENT . 52
4.10 * Power supply . 53
4.11 Power input . 53
5 * General requirements for testing ME EQUIPMENT . 54
5.1 * TYPE TESTS . 54
5.2 * Number of samples . 54
5.3 Ambient temperature, humidity, atmospheric pressure . 54
5.4 Other conditions . 54
5.5 Supply voltages, type of current, nature of supply, frequency . 55
5.6 Repairs and modifications . 55
5.7 * Humidity preconditioning treatment . 55
5.8 Sequence of tests . 56
5.9 * Determination of APPLIED PARTS and ACCESSIBLE PARTS . 56
6 * Classification of ME EQUIPMENT and ME SYSTEMS . 59
6.1 General . 59
6.2 * Protection against electric shock . 59
6.3  Protection against harmful ingress of water or particulate matter . 59
6.4 Method(s) of sterilization . 59
6.5 Suitability for use in an OXYGEN RICH ENVIRONMENT . 59
6.6 * Mode of operation . 59
7 ME EQUIPMENT identification, marking and documents . 60
7.1 General . 60

+AMD2:2020 CSV  IEC 2020
7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts (see also
Table C.1) . 61
7.3 Marking on the inside of ME EQUIPMENT or ME EQUIPMENT parts (see also
Table C.2) . 66
7.4 Marking of controls and instruments (see also Table C.3) . 67
7.5 Safety signs SAFETY SIGNS . 69
7.6 Symbols . 70
7.7 Colours of the insulation of conductors . 70
7.8 * Indicator lights and controls . 71
7.9 ACCOMPANYING DOCUMENTS . 72
8 * Protection against electrical HAZARDS from ME EQUIPMENT . 79
8.1 Fundamental rule of protection against electric shock. 79
8.2 Requirements related to power sources . 80
8.3 Classification of APPLIED PARTS . 80
8.4 Limitation of voltage, current or energy. 81
8.5 Separation of parts . 84
8.6 * Protective earthing, functional earthing and potential equalization of
ME EQUIPMENT . 97
8.7 LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS . 100
8.8 Insulation . 122
8.9 * CREEPAGE DISTANCES and AIR CLEARANCES . 129
8.10 Components and wiring . 147
8.11 MAINS PARTS, components and layout . 149
9 * Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 155
9.1 MECHANICAL HAZARDS of ME EQUIPMENT . 155
9.2 * MECHANICAL HAZARDS associated with moving parts. 155
9.3 * MECHANICAL HAZARD associated with surfaces, corners and edges. 161
9.4 * Instability HAZARDS . 161
9.5 * Expelled parts HAZARD . 166
9.6 Acoustic energy (including infra- and ultrasound) and vibration . 167
9.7 * Pressure vessels and parts subject to pneumatic and hydraulic pressure . 168
9.8 * MECHANICAL HAZARDS associated with support systems . 171
10 * Protection against unwanted and excessive radiation HAZARDS . 177
10.1 X-Radiation . 177
10.2 Alpha, beta, gamma, neutron and other particle radiation . 178
10.3 Microwave radiation . 178
10.4 * Lasers and light emitting diodes (LEDs) . 179
10.5 * Other visible electromagnetic radiation . 179
10.6 * Infrared radiation . 179
10.7 * Ultraviolet radiation . 179
11 Protection against excessive temperatures and other HAZARDS . 179
11.1 * Excessive temperatures in ME EQUIPMENT . 179
11.2 * Fire prevention . 184
11.3 * Constructional requirements for fire ENCLOSURES of ME EQUIPMENT . 188
11.4 * ME EQUIPMENT and ME SYSTEMS intended for use with flammable

anaesthetics . 191
11.5 * ME EQUIPMENT and ME SYSTEMS intended for use in conjunction with
flammable agents . 191

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+AMD2:2020 CSV  IEC 2020
11.6 Overflow, spillage, leakage, ingress of water or particulate matter, cleaning,
disinfection, sterilization and compatibility with substances used with the
ME EQUIPMENT . 191
11.7 Biocompatibility of ME EQUIPMENT and ME SYSTEMS . 194
11.8 * Interruption of the power supply / SUPPLY MAINS to ME EQUIPMENT . 194
12 * Accuracy of controls and instruments and protection against hazardous outputs . 194
12.1 Accuracy of controls and instruments . 194
12.2 USABILITY of ME EQUIPMENT . 194
12.3 ALARM SYSTEMS . 194
12.4 Protection against hazardous output. 194
13 * HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 196
13.1 Specific HAZARDOUS SITUATIONS . 196
13.2 SINGLE FAULT CONDITIONS . 198
14 * PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 203
14.1 * General . 203
14.2 * Documentation . 204
14.3 * RISK MANAGEMENT plan . 204
14.4 * PEMS DEVELOPMENT LIFE-CYCLE . 204
14.5 * Problem resolution . 204
14.6 RISK MANAGEMENT PROCESS . 205
14.7 * Requirement specification . 205
14.8 * Architecture . 205
14.9 * Design and implementation . 206
14.10 * VERIFICATION . 206
14.11 * PEMS VALIDATION . 206
14.12 * Modification . 207
14.13 * Connection of PEMS by NETWORK/DATA COUPLING to other equipment
* PEMS intended to be incorporated into an IT-NETWORK . 207
15 Construction of ME EQUIPMENT . 208
15.1 * Arrangements of controls and indicators of ME EQUIPMENT . 208
15.2 * Serviceability . 208
15.3 Mechanical strength . 209
15.4 ME EQUIPMENT components and general assembly . 212
15.5 * MAINS SUPPLY TRANSFORMERS of ME EQUIPMENT and transformers providing
separation in accordance with 8.5 . 218
16 * ME SYSTEMS . 222
16.1 * General requirements for the ME SYSTEMS . 222
16.2 * ACCOMPANYING DOCUMENTS of an ME SYSTEM . 223
16.3 * Power supply . 224
16.4 ENCLOSURES . 224
16.5 * SEPARATION DEVICES . 224
16.6 * LEAKAGE CURRENTS . 224
16.7 * Protection against MECHANICAL HAZARDS . 225
16.8 Interruption of the power supply to parts of an ME SYSTEM . 226
16.9 ME SYSTEM connections and wiring . 226
17 * Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 228
Annex A (informative) General guidance and rationale . 229
Annex B (informative) Sequence of testing . 351

+AMD2:2020 CSV  IEC 2020
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 355
Annex D (informative) Symbols on marking (see Clause 7) . 358
Annex E (informative) Examples of the connection of the measuring device (MD) for
measurement of the PATIENT LEAKAGE CURRENT and PATIENT AUXILIARY CURRENT (see
8.7) . 367
Annex F (informative) Suitable measuring supply circuits . 369
Annex G (normative) Protection against HAZARDS of ignition of flammable anaesthetic
mixtures . 372
Annex H (informative) PEMS structure, PEMS DEVELOPMENT LIFE-CYCLE and
documentation . 388
Annex I (informative) ME SYSTEMS aspects . 401
Annex J (informative) Survey of insulation paths . 407
Annex K (informative) Simplified PATIENT LEAKAGE CURRENT diagrams . 410
Annex L (normative) Insulated winding wires for use without interleaved insulation . 413
Annex M (normative) Reduction of pollution degrees . 416
Bibliography . 417
INDEX OF ABBREVIATIONS AND ACRONYMS . 422
INDEX . 424
Figure 1 – Detachable mains connection . 25
Figure 2 – Example of the defined terminals and conductors. 26
Figure 3 – Example of a CLASS I ME EQUIPMENT . 27
Figure 4 – Example of a metal-enclosed CLASS II ME EQUIPMENT . 27
Figure 5 – Schematic flow chart for component qualification (see 4.8) . 52
Figure 6 – Standard test finger (see 5.9.2.1) . 57
Figure 7 – Test hook (see 5.9.2.2) . 58
Figure 8 – Test pin (see 8.4.2 d) . 83
Figure 9 – Application of test voltage to bridged PATIENT CONNECTIONS for
DEFIBRILLATION-PROOF APPLIED PARTS (see 8.5.5.1) . 93
Figure 10 – Application of test voltage to individual PATIENT CONNECTIONS for
DEFIBRILLATION-PROOF APPLIED PARTS (see 8.5.5.1) . 95
Figure 11 – Application of test voltage to test the delivered defibrillation energy . 97
Figure 12 – Example of a measuring device and its frequency characteristics . 102
Figure 13 – Measuring circuit for the EARTH LEAKAGE CURRENT of CLASS I ME EQUIPMENT,
with or without APPLIED PART . 105
Figure 14 – Measuring circuit for the TOUCH CURRENT . 107
Figure 15 – Measuring circuit for the PATIENT LEAKAGE CURRENT from the PATIENT
CONNECTION to earth. 109
Figure 16 – Measuring circuit for the PATIENT LEAKAGE CURRENT via the PATIENT
CONNECTION(S) of an F-TYPE APPLIED PART to earth caused by an external voltage on the
PATIENT CONNECTION(S) . 111
Figure 17 – Measuring circuit for the PATIENT LEAKAGE CURRENT from PATIENT
CONNECTION(S) to earth caused by an external voltage on a SIGNAL INPUT/OUTPUT PART . 113
Figure 18 – Measuring circuit for the PATIENT LEAKAGE CURRENT from PATIENT
CONNECTION(S) to earth caused by an external voltage on a metal ACCESSIBLE PART that
is not PROTECTIVELY EARTHED . 115

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+AMD2:2020 CSV  IEC 2020
Figure 19 – Measuring circuit for the PATIENT AUXILIARY CURRENT . 116
Figure 20 – Measuring circuit for the total PATIENT LEAKAGE CURRENT with all PATIENT
CONNECTIONS of all APPLIED PARTS of the same type (TYPE B APPLIED PARTS, TYPE BF
APPLIED PARTS or TYPE CF APPLIED PARTS) connected together . 117
Figure 21 – Ball-pressure test apparatus . 129
Figure 22 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 1 . 142
Figure 23 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 2 . 142
Figure 24 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 3 . 142
Figure 25 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 4 . 143
Figure 26 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 5 . 143
Figure 27 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 6 . 144
Figure 28 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 7 . 144
Figure 29 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 8 . 145
Figure 30 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 9 . 146
Figure 31 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 10 . 147
Figure 32 – Ratio between HYDRAULIC TEST PRESSURE and MAXIMUM PERMISSIBLE
WORKING EQUIPMENT PRESSURE . 170
Figure 33 – Human body test mass (see 9.8.3.3) Body upper-carriage module . 176
Figure 34 – Spark ignition test apparatus . 185
Figure 35 – Maximum allowable current I as a function of the maximum allowable
voltage U measured in a purely resistive circuit in an OXYGEN RICH ENVIRONMENT . 186
Figure 36 – Maximum allowable voltage U as a function of the capacitance C
measured in a capacitive circuit used in an OXYGEN RICH ENVIRONMENT . 186
Figure 37 – Maximum allowable current I as a function of the inductance L measured
in an inductive circuit in an OXYGEN RICH ENVIRONMENT . 187
Figure 38 – Baffle . 190
Figure 39 – Area of the bottom of an ENCLOSURE as specified in 11.3 b) 1) . 191
Figure 40 – Identification of MEANS OF PATIENT PROTECTION and MEANS OF OPERATOR
PROTECTION . 85
Figure 41 – WORKING VOLTAGE measurement . 90
Figure A.1 – Identification of ME EQUIPMENT, APPLIED PARTS and PATIENT CONNECTIONS
in an ECG monitor . 235
Figure A.2 – Example of the insulation of an F-TYPE APPLIED PART with the insulation
incorporated in the ME EQUIPMENT . 235
Figure A.3 – Identification of ME EQUIPMENT, APPLIED PARTS and PATIENT CONNECTIONS
in a PATIENT monitor with invasive pressure monitoring facility . 236
Figure A.4 – Identification of ME EQUIPMENT, APPLIED PARTS and PATIENT CONNECTIONS
in a multifunction PATIENT monitor with invasive pressure monitoring facilities . 237
Figure A.5 – Identification of APPLIED PARTS and PATIENT CONNECTIONS in an X-ray ME
SYSTEM . 238
Figure A.6 – Identification of ME EQUIPMENT, APPLIED PARTS and PATIENT CONNECTIONS in
a transcutaneous electronic nerve stimulator (TENS) intended to be worn on the
PATIENT’S belt and connected to electrodes applied to the PATIENT’S upper arm . 239
Figure A.7 – Identification of ME EQUIPMENT or ME SYSTEM, APPLIED PARTS and PATIENT
CONNECTIONS in a
...

IEC 60601-1 ®
Edition 3.1 2012-08
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
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inside
Medical electrical equipment –
Part 1: General requirements for basic safety and essential performance

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IEC 60601-1 ®
Edition 3.1 2012-08
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
colour
inside
Medical electrical equipment –

Part 1: General requirements for basic safety and essential performance

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040 ISBN 978-2-8322-0331-6

IEC 60601-1 ®
Edition 3.1 2012-08
CONSOLIDATED VERSION
REDLINE VERSION
colour
inside
Medical electrical equipment –
Part 1: General requirements for basic safety and essential performance

Publication IEC 60601-1 (Third edition – 2005) I-SH 01

MEDICAL ELECTRICAL EQUIPMENT –
Part 1: General requirements for basic safety
and essential performance
INTERPRETATION SHEET 1
This interpretation sheet has been prepared by SC 62A: Common aspects of electrical
equipment used in medical practice
The text of this interpretation sheet is based on the following documents:
ISH Report on voting
62A/599/ISH 62A/613/RVD
Full information on the voting for the approval of this interpretation sheet can be found in the
report on voting indicated in the above table.
___________
Subclause 1.1
This subclause is clarified by the following:
IEC 60601-1 does not apply to medical gas pipeline systems covered by ISO 7396-1, Medical
gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum.
NOTE Subclause 6.3 of ISO 7396-1 applies the requirement of IEC 60601-1-8 to certain monitoring and alarm
signals.
This clarification will remain valid until a new version of IEC 60601-1 is published.

___________
April 2008
– 1 –
Publication IEC 60601-1 (Third edition – 2005) I-SH 02

MEDICAL ELECTRICAL EQUIPMENT –

Part 1: General requirements for basic safety
and essential performance
INTERPRETATION SHEET 2
This interpretation sheet has been prepared by subcomittee 62A: Common aspects of
electrical equipment used in medical practice, of IEC technical committee 62: Electrical
equipment in medical practice.
The text of this interpretation sheet is based on the following documents:
ISH Report on voting
62A/634/ISH 62A/640/RVD
Full information on the voting for the approval of this interpretation sheet can be found in the
report on voting indicated in the above table.
_____________
Subclause 11.3
This subclause is clarified by the following:
As stated in the rationale for this subclause, fire ENCLOSURES are intended to be used only
where there is a significant likelihood of fire due to the presence of a source of ignition (as
described in the subclause) and a significant source of fuel. Most materials used in the
construction of ME EQUIPMENT are not considered to be such a source of fuel unless they are
in the presence of an OXYGEN RICH ENVIRONMENT. MANUFACTURERS should determine, through
analyses documented in the RISK MANAGEMENT FILE, whether the ME EQUIPMENT contains
combustible materials (fuel) in sufficient quantities to support combustion in conjunction with
ignition sources (capable of releasing greater than 900 J).
Subclause 13.1.2
This subclause is clarified by the following:
As stated in subclause 4.7, it is the MANUFACTURER’S RISK ANALYSIS that determines which
components are subject to failure testing based on the associated RISK. Where the associated
RISK of fire exceeds the MANUFACTURER’S criteria for RISK acceptability, the MANUFACTURER’S
simulation analysis (such as FMEAs) should be accepted in lieu of physical testing. As also
stated in 4.7, component reliability and ratings are to be considered in such failure simulation
analyses. Common electronic components that have a history of use without causing
equipment fires should not be considered a likely source of ignition.
Where the subclause identifies “emission of flames, molten metal, poisonous or ignitable
substance in hazardous quantities;” as a hazardous situation, this refers to emissions from
the ENCLOSURE not from components themselves. Where it identifies “exceeding the allowable
values for ‘other components and materials’ identified in Table 22 times 1,5 minus 12,5 °C”,
this applies only where doing so would result in an unacceptable RISK (as identified in the
MANUFACTURER’S RISK ANALYSIS according to 4.7). Typically, this would be cases where
January 2009 ICS 11.040 French text overleaf

– 2 –
ESSENTIAL PERFORMANCE would not be maintained or where greater than 900 J of energy
would be released in the presence of flammable materials that could sustain combustion.
The first exemption to fault analysis or testing identified in subclause 13.1.2 (“The
construction or the supply circuit limits the power dissipation in SINGLE FAULT CONDITION to less
than 15 W or the energy dissipation to less than 900 J.”) is intended to apply where the
component design itself (“The construction”) or fusing (or other current limiting devices) in the
supply circuit (“or the supply circuit”) assure the energy released during failures will not
exceed the limits. For most common signal level components rated for operation below
5 Watts, the energy released by short-circuiting of outputs will not exceed the 900 J limit.
This clarification will remain valid until a new version of IEC 60601-1 is published.

___________
January 2009 ICS 11.040 French text overleaf

SC 62A/Publication IEC 60601-1:2005, including Amendment 1:2012, Third edition/I-SH 03
MEDICAL ELECTRICAL EQUIPMENT –
Part 1: General requirements for basic safety and essential performance

INTERPRETATION SHEET 3
This interpretation sheet has been prepared by subcommittee 62A: Common aspects of
electrical equipment used in medical practice, of IEC technical committee 62: Electrical
equipment in medical practice.
The text of this interpretation sheet is based on the following documents:
ISH Report on voting
62A/858/ISH 62A/875/RVD
Full information on the voting for the approval of this interpretation sheet can be found in the
report on voting indicated in the above table.
___________
Subclause 13.1.2 fourth dash (Emissions, deformation of ENCLOSURE or exceeding
maximum temperature)
This subclause states the following:
The following HAZARDOUS SITUATIONS shall not occur:
− ….
− temperatures of ME EQUIPMENT parts that are not APPLIED PARTS but are likely to be
touched, exceeding the allowable values in Table 23 when measured and adjusted as
described in 11.1.3;
This is clarified by the following:
The above requirement is regarded as fulfilled in accordance with Subclause 4.5 for
temperatures at the surfaces of the enclosure, if the following conditions are fulfilled:
− The maximum allowed temperature on OPERATOR accessible surfaces in SINGLE FAULT
CONDITION is 105 °C; and
− the instructions for use contain a warning that, under some SINGLE FAULT CONDITIONS, the
temperature of: (indicate the surface of concern) could get hot and there is a possible RISK
of a burn if touched, and
− if the RISK ANALYSIS demonstrates a need for a warning symbol on the ENCLOSURE, safety
sign ISO 7010-W018 ( ) shall be used on or adjacent to the hot spot on the
ENCLOSURE; and
− the RISK ASSESSMENT demonstrates that the temperature attained in the SINGLE FAULT
CONDITION is acceptable, and
− the RISK ASSESSMENT demonstrates that applying the alternative RISK CONTROL measures
in this Interpretation Sheet results in a RESIDUAL RISK that is comparable to the RESIDUAL
RISK resulting from applying the requirement of the standard.
NOTE 1 This Interpretation Sheet is intended to be used with both Edition 3.0 and Edition 3.1 of IEC 60601-1.
NOTE 2 An example of an analysis that demonstrates an adequately low probability of occurrence of HARM is
shown below.
May 2013 ICS 11.040 French text overleaf

Example RISK ASSESSMENT:
The sum failure rate for parts that could increase the surface temperature of parts of the
enclosure of XYZ device touchable only by the OPERATOR to values above those of Table 23
calculates to be 60 FIT (1 FIT = 1E-9/h) according to the standard MIL-HDBK-217F where FIT
stands for "failure in time". In case of such failures, the device would emit an odour and would
no longer function properly. It is estimated, that only in one of 3 cases the device would not
be switched off immediately and the hot surface would be resulting in a burn.
The resulting overall probability of such HARM where adequate warning is provided in the
instructions for use in combination with warning sign ISO 7010 W018 would be: probability
= 1/3 * 60 FIT = 2 E-8/h =approx. 0,0002 per year.
In this example, the WXW Company's RISK acceptance criteria require that a HARM of that
severity must have a probability of less than 0,0003 per year for the associated RISK to be
considered acceptable. Based on that RISK acceptance criterion, the RISK associated with
overtemperature of the ENCLOSURE caused by single faults in the circuitry is acceptable.

May 2013 ICS 11.040 French text overleaf

 IEC 2021
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
IEC 60601-1
Edition 3.0  2005-12
Amendement 1  2012-07
MEDICAL ELECTRICAL EQUIPMENT –

Part 1: General requirements for basic safety and essential performance

INTERPRETATION SHEET 1
This interpretation sheet has been prepared by subcommittee 62A: Common aspects of
electrical equipment used in medical practice, of IEC technical committee 62: Electrical
equipment in medical practice.
The text of this interpretation sheet is based on the following documents:
DISH Report on voting
62A/1403/DISH 62A/1414/RVDISH
Full information on the voting for the approval of this interpretation sheet can be found in the
report on voting indicated in the above table.

___________
Interpretation of Subclauses 4.3 of IEC 60601-1:2005/AMD1:2012 and 4.7 of
This interpretation sheet is intended to clarify the requirements which are needed to maintain
ESSENTIAL PERFORMANCE in SINGLE FAULT CONDITION.
Subclause 4.3 * ESSENTIAL PERFORMANCE
The requirements in this subclause of IEC 60601-1:2005/AMD1:2012 are clarified by the
following.
aa) IEC 60601-1:2005/AMD1:2012 requires that both the NORMAL CONDITION and the SINGLE
FAULT CONDITIONS are to be considered in the identification of ESSENTIAL PERFORMANCE,
because:
ICS 11.040.01
– 2 – IEC 60601-1:2005/AMD1:2012/ISH1:2021
 IEC 2021
1) ESSENTIAL PERFORMANCE is defined in terms of the performance of a clinical function
(see 3.27);
NOTE 1 ESSENTIAL PERFORMANCE can have multiple aspects.
2) in particular, SINGLE FAULT CONDITIONS can cause or contribute to the loss or
degradation of such a clinical function that results in unacceptable RISK; and
3) according to IEC 60601-1:2005, 4.7, ME EQUIPMENT is required to remain SINGLE FAULT
SAFE or the RISK remains acceptable and this also applies to ESSENTIAL PERFORMANCE.
bb) The subclause requires the MANUFACTURER to:
NOTE 2 Many particular standards specify performance limits, RISK CONTROL measures and VERIFICATION
methods for some aspects of ESSENTIAL PERFORMANCE.
1) identify performance of clinical functions, other than that related to BASIC SAFETY, that
is necessary to achieve the INTENDED USE or that could affect safety;
2) specify performance limits between fully functional and total loss of the identified
performance in both
i) NORMAL CONDITION, and
ii) SINGLE FAULT CONDITION;
NOTE 3 The specified performance limits can be different in NORMAL CONDITION and SINGLE FAULT
.
CONDITION
3) evaluate the RISK from loss or degradation of the identified performance beyond the
specified limits;
i) Where the resulting RISK is unacceptable, the identified performance is
ESSENTIAL PERFORMANCE.
RISK CONTROL measures to reduce these RISKS to an acceptable level for
4) implement
both
i) NORMAL CONDITION, and
ii) SINGLE FAULT CONDITION;
5) assess and determine which RISK CONTROL measures need VERIFICATION of
effectiveness; and
6) specify methods for the VERIFICATION of the effectiveness of the RISK CONTROL
measures.
cc) The requirements of IEC 60601-1:2005/AMD1:2012 4.3 as clarified in items 4.3 bb) 1) to
4.3 bb) 6) above include documentation of the relevant results in the RISK MANAGEMENT
FILE. The documentation is intended to serve as OBJECTIVE EVIDENCE that the required
activities have been performed.
dd) The compliance statement refers to “inspection of the RISK MANAGEMENT FILE”. Inspection
means the careful examination or scrutiny of the contents of the RISK MANAGEMENT FILE.
Only confirming the existence of a RISK MANAGEMENT FILE is insufficient. Inspection can
include functional tests as clarified in IEC 60601-1:2005/AMD1:2012/ISH1 items 4.3 bb) 5)
and 4.3 bb) 6). This is similar to the other uses of “inspection” throughout this standard.
Subclause 4.7 * SINGLE FAULT CONDITION for ME EQUIPMENT
The requirements in this subclause of IEC 60601-1:2005 are clarified by the following.
aa) IEC 60601-1:2005 requires that ME EQUIPMENT remains SINGLE FAULT SAFE or the RISK
remains acceptable according to 4.2 during the EXPECTED SERVICE LIFE and this also
applies to ESSENTIAL PERFORMANCE.
bb) SINGLE FAULT CONDITION (as defined in 3.116) describes the condition where “a single
means for reducing a RISK is defective or a single abnormal condition is present”. Either
condition anticipates the failure or fault of one component [other than those indicated in
4.7 a), e.g. a COMPONENT WITH HIGH-INTEGRITY CHARACTERISTICS].

 IEC 2021
Component failure or fault can relate to:
1) a single part (e.g. resistor, capacitor, wire, mechanical part),
2) a subassembly (e.g. battery block, power supply unit, line filter, PESS), or
3) a device with a specified function (e.g. protective unit, control unit, monitoring unit).
Any SINGLE FAULT CONDITION that could result in a HAZARDOUS SITUATION, including those
mentioned in 13.1, needs to be simulated, physically or theoretically. Care needs to be
taken to adequately determine the worst case situation when analysing failure or fault of
subassemblies and functional units.
cc) It can be necessary to investigate the consequences of a second independent fault or
failure. This is relevant when the initial fault or failure remains undetected during NORMAL
USE for the EXPECTED SERVICE LIFE or when the fault or failure is so likely that it is
considered to be a NORMAL CONDITION. See 4.7 b) and 5.1 and their rationales in Annex A.
dd) The RISK ASSESSMENT is used to determine which SINGLE FAULT CONDITIONS are to be tested
in agreement with 4.3, 4.7 and 5.1. This includes consideration of a second independent
fault or failure following an initial SINGLE FAULT CONDITION that remains undetected during
NORMAL USE for the EXPECTED SERVICE LIFE. This also applies to the VERIFICATION of the
effectiveness of the RISK CONTROL measures needed to maintain ESSENTIAL PERFORMANCE
[see IEC 60601-1/AMD1:2012/ISH1 4.3 bb) 5) and 4.3 bb) 6)].
ee) The requirements of 4.7 include documentation of the relevant tests in the RISK MANAGEMENT
FILE. The documentation is intended to serve as OBJECTIVE EVIDENCE that the required
activities have been performed.

– 2 – 60601-1  IEC:2005+A1:2012(E)
CONTENTS
FOREWORD . 11
INTRODUCTION . 14
INTRODUCTION TO THE AMENDMENT . 16

1 Scope, object and related standards . 17
1.1 * Scope . 17
1.2 Object . 17
1.3 * Collateral standards . 17
1.4 * Particular standards . 18
2 * Normative references . 18
3 * Terminology and definitions . 22
4 General requirements . 42
4.1 * Conditions for application to ME EQUIPMENT or ME SYSTEMS . 42
4.2 * RISK MANAGEMENT PROCESS for ME EQUIPMENT or ME SYSTEMS . 43
4.3 * ESSENTIAL PERFORMANCE . 46
4.4 * EXPECTED SERVICE LIFE . 46
4.5 * Equivalent safety for ME EQUIPMENT or ME SYSTEMS Alternative RISK
CONTROL measures or test methods for ME EQUIPMENT or ME SYSTEMS . 47
4.6 * ME EQUIPMENT or ME SYSTEM parts that contact the PATIENT . 47
4.7 * SINGLE FAULT CONDITION for ME EQUIPMENT . 47
4.8 * Components of ME EQUIPMENT . 48
4.9 * Use of COMPONENTS WITH HIGH-INTEGRITY CHARACTERISTICS in ME EQUIPMENT . 49
4.10 * Power supply . 50
4.11 Power input . 50
5 * General requirements for testing ME EQUIPMENT . 51
5.1 * TYPE TESTS . 51
5.2 * Number of samples . 51
5.3 Ambient temperature, humidity, atmospheric pressure . 51
5.4 Other conditions . 51
5.5 Supply voltages, type of current, nature of supply, frequency . 52
5.6 Repairs and modifications . 52
5.7 * Humidity preconditioning treatment . 52
5.8 Sequence of tests . 53
5.9 * Determination of APPLIED PARTS and ACCESSIBLE PARTS . 53
6 * Classification of ME EQUIPMENT and ME SYSTEMS . 56
6.1 General . 56
6.2 * Protection against electric shock . 56
6.3 * Protection against harmful ingress of water or particulate matter . 56
6.4 Method(s) of sterilization . 56
6.5 Suitability for use in an OXYGEN RICH ENVIRONMENT . 56
6.6 * Mode of operation . 56
7 ME EQUIPMENT identification, marking and documents . 57
7.1 General . 57
7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts (see also
Table C.1) . 58

60601-1  IEC:2005+A1:2012(E) – 3 –
7.3 Marking on the inside of ME EQUIPMENT or ME EQUIPMENT parts (see also
Table C.2) . 63
7.4 Marking of controls and instruments (see also Table C.3) . 64
7.5 Safety signs . 66
7.6 Symbols . 66
7.7 Colours of the insulation of conductors . 67
7.8 * Indicator lights and controls . 67
7.9 ACCOMPANYING DOCUMENTS . 68
8 * Protection against electrical HAZARDS from ME EQUIPMENT . 74
8.1 Fundamental rule of protection against electric shock. 74
8.2 Requirements related to power sources . 75
8.3 Classification of APPLIED PARTS . 76
8.4 Limitation of voltage, current or energy. 76
8.5 Separation of parts . 79
8.6 * Protective earthing, functional earthing and potential equalization of
ME EQUIPMENT . 89
8.7 LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS . 92
8.8 Insulation . 114
8.9 * CREEPAGE DISTANCES and AIR CLEARANCES . 120
8.10 Components and wiring . 138
8.11 MAINS PARTS, components and layout . 140
9 * Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 146
9.1 MECHANICAL HAZARDS of ME EQUIPMENT . 146
9.2 * MECHANICAL HAZARDS associated with moving parts. 146
9.3 * MECHANICAL HAZARD associated with surfaces, corners and edges. 152
9.4 * Instability HAZARDS . 152
9.5 * Expelled parts HAZARD . 157
9.6 Acoustic energy (including infra- and ultrasound) and vibration . 158
9.7 * Pressure vessels and parts subject to pneumatic and hydraulic pressure . 159
9.8 * MECHANICAL HAZARDS associated with support systems . 162
10 * Protection against unwanted and excessive radiation HAZARDS . 168
10.1 X-Radiation . 168
10.2 Alpha, beta, gamma, neutron and other particle radiation . 169
10.3 Microwave radiation . 169
10.4 * Lasers and light emitting diodes (LEDs) . 170
10.5 Other visible electromagnetic radiation . 170
10.6 Infrared radiation . 170
10.7 Ultraviolet radiation . 170
11 Protection against excessive temperatures and other HAZARDS . 170
11.1 * Excessive temperatures in ME EQUIPMENT . 170
11.2 * Fire prevention . 175
11.3 * Constructional requirements for fire ENCLOSURES of ME EQUIPMENT . 179
11.4 * ME EQUIPMENT and ME SYSTEMS intended for use with flammable
anaesthetics . 181
11.5 * ME EQUIPMENT and ME SYSTEMS intended for use in conjunction with
flammable agents . 182
11.6 Overflow, spillage, leakage, ingress of water or particulate matter, cleaning,
disinfection, sterilization and compatibility with substances used with the
ME EQUIPMENT . 182

– 4 – 60601-1  IEC:2005+A1:2012(E)
11.7 Biocompatibility of ME EQUIPMENT and ME SYSTEMS . 184
11.8 * Interruption of the power supply / SUPPLY MAINS to ME EQUIPMENT . 184
12 * Accuracy of controls and instruments and protection against hazardous outputs . 184
12.1 Accuracy of controls and instruments . 184
12.2 USABILITY of ME EQUIPMENT . 184
12.3 ALARM SYSTEMS . 185
12.4 Protection against hazardous output. 185
13 * HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 186
13.1 Specific HAZARDOUS SITUATIONS . 186
13.2 SINGLE FAULT CONDITIONS . 187
14 * PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 192
14.1 * General . 192
14.2 * Documentation . 193
14.3 * RISK MANAGEMENT plan . 193
14.4 * PEMS DEVELOPMENT LIFE-CYCLE . 193
14.5 * Problem resolution . 194
14.6 RISK MANAGEMENT PROCESS . 194
14.7 * Requirement specification . 195
14.8 * Architecture . 195
14.9 * Design and implementation . 195
14.10 * VERIFICATION . 195
14.11 * PEMS VALIDATION . 196
14.12 * Modification . 196
14.13 * Connection of PEMS by NETWORK/DATA COUPLING to other equipment
PEMS intended to be incorporated into an IT-NETWORK . 196
15 Construction of ME EQUIPMENT . 198
15.1 * Arrangements of controls and indicators of ME EQUIPMENT . 198
15.2 * Serviceability . 198
15.3 Mechanical strength . 198
15.4 ME EQUIPMENT components and general assembly . 202
15.5 * MAINS SUPPLY TRANSFORMERS of ME EQUIPMENT and transformers providing
separation in accordance with 8.5 . 207
16 * ME SYSTEMS . 211
16.1 * General requirements for the ME SYSTEMS . 211
16.2 * ACCOMPANYING DOCUMENTS of an ME SYSTEM . 212
16.3 * Power supply . 213
16.4 ENCLOSURES . 213
16.5 * SEPARATION DEVICES . 213
16.6 * LEAKAGE CURRENTS . 214
16.7 * Protection against MECHANICAL HAZARDS . 215
16.8 Interruption of the power supply to parts of an ME SYSTEM . 215
16.9 ME SYSTEM connections and wiring . 215
17 * Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 217

Annex A (informative) General guidance and rationale . 218
Annex B (informative) Sequence of testing . 329
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 333

60601-1  IEC:2005+A1:2012(E) – 5 –
Annex D (informative) Symbols on marking (see Clause 7) . 336
Annex E (informative) Examples of the connection of the measuring device (MD) for
measurement of the PATIENT LEAKAGE CURRENT and PATIENT AUXILIARY CURRENT (see
8.7) . 345
Annex F (informative) Suitable measuring supply circuits . 347
Annex G (normative) Protection against HAZARDS of ignition of flammable anaesthetic
mixtures . 350
Annex H (informative) Pems structure, PEMS DEVELOPMENT LIFE-CYCLE and
documentation . 365
Annex I (informative) ME SYSTEMS aspects . 378
Annex J (informative) Survey of insulation paths . 384
Annex K (informative) Simplified PATIENT LEAKAGE CURRENT diagrams . 387
Annex L (normative) Insulated winding wires for use without interleaved insulation . 390
Annex M (normative) Reduction of pollution degrees . 393

Bibliography . 394

INDEX OF ABBREVIATIONS AND ACRONYMS . 398

INDEX . 400

Figure 1 – Detachable mains connection . 23
Figure 2 – Example of the defined terminals and conductors. 25
Figure 3 – Example of a CLASS I ME EQUIPMENT . 26
Figure 4 – Example of a metal-enclosed CLASS II ME EQUIPMENT . 26
Figure 5 – Schematic flow chart for component qualification (see 4.8) . 49
Figure 6 – Standard test finger (see 5.9.2.1) . 54
Figure 7 – Test hook (see 5.9.2.2) . 55
Figure 8 – Test pin (see 8.4.2 d) . 78
Figure 9 – Application of test voltage to bridged PATIENT CONNECTIONS for
DEFIBRILLATION-PROOF APPLIED PARTS (see 8.5.5.1) . 85
Figure 10 – Application of test voltage to individual PATIENT CONNECTIONS for
DEFIBRILLATION-PROOF APPLIED PARTS (see 8.5.5.1) . 87
Figure 11 – Application of test voltage to test the delivered defibrillation energy . 89
Figure 12 – Example of a measuring device and its frequency characteristics . 94
Figure 13 – Measuring circuit for the EARTH LEAKAGE CURRENT of CLASS I ME EQUIPMENT,
with or without APPLIED PART . 97
Figure 14 – Measuring circuit for the TOUCH CURRENT . 99
Figure 15 – Measuring circuit for the PATIENT LEAKAGE CURRENT from the PATIENT
CONNECTION to earth. 101
Figure 16 – Measuring circuit for the PATIENT LEAKAGE current via the PATIENT
CONNECTION(s) of an F-TYPE APPLIED PART to earth caused by an external voltage on the
PATIENT CONNECTION(s) . 103
Figure 17 – Measuring circuit for the PATIENT LEAKAGE CURRENT from PATIENT
CONNECTION(s) to earth caused by an external voltage on a SIGNAL INPUT/OUTPUT PART . 105

– 6 – 60601-1  IEC:2005+A1:2012(E)
Figure 18 – Measuring circuit for the PATIENT LEAKAGE CURRENT from PATIENT
CONNECTION(s) to earth caused by an external voltage on a metal ACCESSIBLE PART that
is not PROTECTIVELY EARTHED . 107
Figure 19 – Measuring circuit for the PATIENT AUXILIARY CURRENT . 108
Figure 20 – Measuring circuit for the total PATIENT LEAKAGE CURRENT with all PATIENT
CONNECTIONS of all APPLIED PARTS of the same type (TYPE B APPLIED PARTS, TYPE BF
APPLIED PARTS or TYPE CF APPLIED PARTS) connected together . 109
Figure 21 – Ball-pressure test apparatus . 120
Figure 22 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 1 . 133
Figure 23 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 2 . 133
Figure 24 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 3 . 133
Figure 25 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 4 . 134
Figure 26 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 5 . 134
Figure 27 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 6 . 135
Figure 28 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 7 . 135
Figure 29 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 8 . 136
Figure 30 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 9 . 137
Figure 31 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 10 . 138
Figure 32 – Ratio between hydraulic test pressure and maximum permissible working
pressure . 161
Figure 33 – Human body test mass (see 9.8.3.3) Body upper-carriage module . 167
Figure 34 – Spark ignition test apparatus . 176
Figure 35 – Maximum allowable current I as a function of the maximum allowable
voltage U measured in a purely resistive circuit in an OXYGEN RICH ENVIRONMENT . 177
Figure 36 – Maximum allowable voltage U as a function of the capacitance C
measured in a capacitive circuit used in an OXYGEN RICH ENVIRONMENT . 177
Figure 37 – Maximum allowable current I as a function of the inductance L measured
in an inductive circuit in an OXYGEN RICH ENVIRONMENT . 178
Figure 38 – Baffle . 181
Figure 39 – Area of the bottom of an ENCLOSURE as specified in 11.3 b) 1) . 181
Figure A.1 – Identification of ME EQUIPMENT, APPLIED PARTS and PATIENT CONNECTIONS
in an ECG monitor . 224
Figure A.2 – Example of the insulation of an F-TYPE APPLIED PART with the insulation
incorporated in the ME EQUIPMENT . 224
Figure A.3 – Identification of ME EQUIPMENT, APPLIED PARTS and PATIENT CONNECTIONS
in a PATIENT monitor with invasive pressure monitoring facility . 225
Figure A.4 – Identification of ME EQUIPMENT, APPLIED PARTS and PATIENT CONNECTIONS
in a multifunction PATIENT monitor with invasive pressure monitoring facilities . 226
Figure A.5 – Identification of APPLIED PARTS and PATIENT CONNECTIONS in an X-ray me
system . 227
Figure A.6 – Identification of ME EQUIPMENT, APPLIED PARTS and PATIENT CONNECTIONS
in a transcutaneous electronic nerve stimulator (TENS) intended to be worn on the
patient’s belt and connected to electrodes applied to the PATIENT’S upper arm . 228
Figure A.7 – Identification of ME EQUIPMENT or ME SYSTEM, APPLIED PARTS and PATIENT
CONNECTIONS in a personal computer with an ECG module . 229
Figure A.8 – Pictorial representation of the relationship of HAZARD, sequence of events,
HAZARDOUS SITUATION and HARM . 232
Figure A.9 – Example of PATIENT ENVIRONMENT. 237

60601-1  IEC:2005+A1:2012(E) – 7 –
Figure A.10 – Floating circuit . 256
Figure A.11 – Interruption of a po
...

IEC 60601-1
Edition 3.0 2005-12
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 1: General requirements for basic safety and essential performance
Appareils électromédicaux –
Partie 1: Exigences générales pour la sécurité de base et les performances
essentielles
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IEC 60601-1
Edition 3.0 2005-12
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 1: General requirements for basic safety and essential performance

Appareils électromédicaux –
Partie 1: Exigences générales pour la sécurité de base et les performances
essentielles
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX XH
ICS 11.040 ISBN 2-8318-8400-4
Publication IEC 60601-1 (Third edition – 2005) I-SH 01

MEDICAL ELECTRICAL EQUIPMENT –
Part 1: General requirements for basic safety
and essential performance
INTERPRETATION SHEET 1
This interpretation sheet has been prepared by SC 62A: Common aspects of electrical
equipment used in medical practice
The text of this interpretation sheet is based on the following documents:
ISH Report on voting
62A/599/ISH 62A/613/RVD
Full information on the voting for the approval of this interpretation sheet can be found in the
report on voting indicated in the above table.
___________
Subclause 1.1
This subclause is clarified by the following:
IEC 60601-1 does not apply to medical gas pipeline systems covered by ISO 7396-1, Medical
gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum.
NOTE Subclause 6.3 of ISO 7396-1 applies the requirement of IEC 60601-1-8 to certain monitoring and alarm
signals.
This clarification will remain valid until a new version of IEC 60601-1 is published.

___________
April 2008
– 1 –
Publication IEC 60601-1 (Third edition – 2005) I-SH 02

MEDICAL ELECTRICAL EQUIPMENT –

Part 1: General requirements for basic safety
and essential performance
INTERPRETATION SHEET 2
This interpretation sheet has been prepared by subcomittee 62A: Common aspects of
electrical equipment used in medical practice, of IEC technical committee 62: Electrical
equipment in medical practice.
The text of this interpretation sheet is based on the following documents:
ISH Report on voting
62A/634/ISH 62A/640/RVD
Full information on the voting for the approval of this interpretation sheet can be found in the
report on voting indicated in the above table.
_____________
Subclause 11.3
This subclause is clarified by the following:
As stated in the rationale for this subclause, fire ENCLOSURES are intended to be used only
where there is a significant likelihood of fire due to the presence of a source of ignition (as
described in the subclause) and a significant source of fuel. Most materials used in the
construction of ME EQUIPMENT are not considered to be such a source of fuel unless they are
in the presence of an OXYGEN RICH ENVIRONMENT. MANUFACTURERS should determine, through
analyses documented in the RISK MANAGEMENT FILE, whether the ME EQUIPMENT contains
combustible materials (fuel) in sufficient quantities to support combustion in conjunction with
ignition sources (capable of releasing greater than 900 J).
Subclause 13.1.2
This subclause is clarified by the following:
As stated in subclause 4.7, it is the MANUFACTURER’S RISK ANALYSIS that determines which
components are subject to failure testing based on the associated RISK. Where the associated
RISK of fire exceeds the MANUFACTURER’S criteria for RISK acceptability, the MANUFACTURER’S
simulation analysis (such as FMEAs) should be accepted in lieu of physical testing. As also
stated in 4.7, component reliability and ratings are to be considered in such failure simulation
analyses. Common electronic components that have a history of use without causing
equipment fires should not be considered a likely source of ignition.
Where the subclause identifies “emission of flames, molten metal, poisonous or ignitable
substance in hazardous quantities;” as a hazardous situation, this refers to emissions from
the ENCLOSURE not from components themselves. Where it identifies “exceeding the allowable
values for ‘other components and materials’ identified in Table 22 times 1,5 minus 12,5 °C”,
this applies only where doing so would result in an unacceptable RISK (as identified in the
MANUFACTURER’S RISK ANALYSIS according to 4.7). Typically, this would be cases where
January 2009 ICS 11.040 French text overleaf

– 2 –
ESSENTIAL PERFORMANCE would not be maintained or where greater than 900 J of energy
would be released in the presence of flammable materials that could sustain combustion.
The first exemption to fault analysis or testing identified in subclause 13.1.2 (“The
construction or the supply circuit limits the power dissipation in SINGLE FAULT CONDITION to less
than 15 W or the energy dissipation to less than 900 J.”) is intended to apply where the
component design itself (“The construction”) or fusing (or other current limiting devices) in the
supply circuit (“or the supply circuit”) assure the energy released during failures will not
exceed the limits. For most common signal level components rated for operation below
5 Watts, the energy released by short-circuiting of outputs will not exceed the 900 J limit.
This clarification will remain valid until a new version of IEC 60601-1 is published.

___________
January 2009 ICS 11.040 French text overleaf

SC 62A/Publication IEC 60601-1:2005, including Amendment 1:2012, Third edition/I-SH 03
MEDICAL ELECTRICAL EQUIPMENT –
Part 1: General requirements for basic safety and essential performance

INTERPRETATION SHEET 3
This interpretation sheet has been prepared by subcommittee 62A: Common aspects of
electrical equipment used in medical practice, of IEC technical committee 62: Electrical
equipment in medical practice.
The text of this interpretation sheet is based on the following documents:
ISH Report on voting
62A/858/ISH 62A/875/RVD
Full information on the voting for the approval of this interpretation sheet can be found in the
report on voting indicated in the above table.
___________
Subclause 13.1.2 fourth dash (Emissions, deformation of ENCLOSURE or exceeding
maximum temperature)
This subclause states the following:
The following HAZARDOUS SITUATIONS shall not occur:
− ….
− temperatures of ME EQUIPMENT parts that are not APPLIED PARTS but are likely to be
touched, exceeding the allowable values in Table 23 when measured and adjusted as
described in 11.1.3;
This is clarified by the following:
The above requirement is regarded as fulfilled in accordance with Subclause 4.5 for
temperatures at the surfaces of the enclosure, if the following conditions are fulfilled:
− The maximum allowed temperature on OPERATOR accessible surfaces in SINGLE FAULT
CONDITION is 105 °C; and
− the instructions for use contain a warning that, under some SINGLE FAULT CONDITIONS, the
temperature of: (indicate the surface of concern) could get hot and there is a possible RISK
of a burn if touched, and
− if the RISK ANALYSIS demonstrates a need for a warning symbol on the ENCLOSURE, safety
sign ISO 7010-W018 ( ) shall be used on or adjacent to the hot spot on the
ENCLOSURE; and
− the RISK ASSESSMENT demonstrates that the temperature attained in the SINGLE FAULT
CONDITION is acceptable, and
− the RISK ASSESSMENT demonstrates that applying the alternative RISK CONTROL measures
in this Interpretation Sheet results in a RESIDUAL RISK that is comparable to the RESIDUAL
RISK resulting from applying the requirement of the standard.
NOTE 1 This Interpretation Sheet is intended to be used with both Edition 3.0 and Edition 3.1 of IEC 60601-1.
NOTE 2 An example of an analysis that demonstrates an adequately low probability of occurrence of HARM is
shown below.
May 2013 ICS 11.040 French text overleaf

Example RISK ASSESSMENT:
The sum failure rate for parts that could increase the surface temperature of parts of the
enclosure of XYZ device touchable only by the OPERATOR to values above those of Table 23
calculates to be 60 FIT (1 FIT = 1E-9/h) according to the standard MIL-HDBK-217F where FIT
stands for "failure in time". In case of such failures, the device would emit an odour and would
no longer function properly. It is estimated, that only in one of 3 cases the device would not
be switched off immediately and the hot surface would be resulting in a burn.
The resulting overall probability of such HARM where adequate warning is provided in the
instructions for use in combination with warning sign ISO 7010 W018 would be: probability
= 1/3 * 60 FIT = 2 E-8/h =approx. 0,0002 per year.
In this example, the WXW Company's RISK acceptance criteria require that a HARM of that
severity must have a probability of less than 0,0003 per year for the associated RISK to be
considered acceptable. Based on that RISK acceptance criterion, the RISK associated with
overtemperature of the ENCLOSURE caused by single faults in the circuitry is acceptable.

May 2013 ICS 11.040 French text overleaf

60601-1 © IEC:2005 – 3 – – 2 – 60601-1 © IEC:2005
CONTENTS
FOREWORD.11
INTRODUCTION.13
1 Scope, object and related standards.15
1.1 * Scope .15
1.2 Object .15
1.3 * Collateral standards.15
1.4 * Particular standards .16
2 * Normative references.16
3 * Terminology and definitions .20
4 General requirements .40
4.1 * Conditions for application to ME EQUIPMENT or ME SYSTEMS.40
4.2 * RISK MANAGEMENT PROCESS for ME EQUIPMENT or ME SYSTEMS .40
4.3 * ESSENTIAL PERFORMANCE .41
4.4 * EXPECTED SERVICE LIFE .41
4.5 * Equivalent safety for ME EQUIPMENT or ME SYSTEMS .42
4.6 * MEEQUIPMENT or ME SYSTEM parts that contact the PATIENT .42
4.7 * SINGLE FAULT CONDITION for ME EQUIPMENT.42
4.8 Components of ME EQUIPMENT .43
4.9 * Use of COMPONENTS WITH HIGH-INTEGRITY CHARACTERISTICS in ME EQUIPMENT .43
4.10 * Power supply .44
4.11 Power input .45
5 * General requirements for testing ME EQUIPMENT .46
5.1 * TYPE TESTS.46
5.2 * Number of samples .46
5.3 Ambient temperature, humidity, atmospheric pressure.46
5.4 Other conditions .46
5.5 Supply voltages, type of current, nature of supply, frequency .47
5.6 Repairs and modifications .47
5.7 * Humidity preconditioning treatment .47
5.8 Sequence of tests .48
5.9 * Determination of APPLIED PARTS and ACCESSIBLE PARTS .48
6 * Classification of ME EQUIPMENT and ME SYSTEMS.50
6.1 General .50
6.2 * Protection against electric shock.50
6.3 * Protection against harmful ingress of water or particulate matter . 51
6.4 Method(s) of sterilization . 51
6.5 Suitability for use in an OXYGEN RICH ENVIRONMENT . 51
6.6 * Mode of operation. 51

60601-1 © IEC:200560601-1 © IEC:2005 – 5 – – 3 –
7MEEQUIPMENT identification, marking and documents .51
7.1 General .51
7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts .53
7.3 Marking on the inside of ME EQUIPMENT or ME EQUIPMENT parts .57
7.4 Marking of controls and instruments .59
7.5 Safety signs .60
7.6 Symbols .61
7.7 Colours of the insulation of conductors.61
7.8 * Indicator lights and controls .62
7.9 ACCOMPANYING DOCUMENTS.62
8 * Protection against electrical HAZARDS from ME EQUIPMENT.68
8.1 Fundamental rule of protection against electric shock.68
8.2 Requirements related to power sources.69
8.3 Classification of APPLIED PARTS .69
8.4 Limitation of voltage, current or energy.70
8.5 Separation of parts.73
8.6 * Protective earthing, functional earthing and potential equalization of
ME EQUIPMENT.81
8.7 LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS .84
8.8 Insulation .101
8.9 * CREEPAGE DISTANCES and AIR CLEARANCES.107
8.10 Components and wiring .122
8.11 MAINS PARTS, components and layout .124
9 * Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS .130
9.1 MECHANICAL HAZARDS of ME EQUIPMENT .130
9.2 * HAZARDS associated with moving parts.131
9.3 * HAZARD associated with surfaces, corners and edges.136
9.4 * Instability HAZARDS .136
9.5 * Expelled parts HAZARD .141
9.6 Acoustic energy (including infra- and ultrasound) and vibration .141
9.7 * Pressure vessels and parts subject to pneumatic and hydraulic pressure.143
9.8 * HAZARDS associated with support systems .146
10 * Protection against unwanted and excessive radiation HAZARDS .151
10.1 X-Radiation .151
10.2 Alpha, beta, gamma, neutron and other particle radiation .152
10.3 Microwave radiation .152
10.4 * Lasers and light emitting diodes (LEDs) .152
10.5 Other visible electromagnetic radiation.152
10.6 Infrared radiation.153
10.7 Ultraviolet radiation .153
11 * Protection against excessive temperatures and other HAZARDS.153
11.1 * Excessive temperatures in ME EQUIPMENT.153
11.2 * Fire prevention.157
11.3 * Constructional requirements for fire ENCLOSURES of ME EQUIPMENT.162

60601-1 © IEC:2005 – 7 – – 4 – 60601-1 © IEC:2005
11.4 * MEEQUIPMENT and ME SYSTEMS intended for use with flammable
anaesthetics.165
11.5 * MEEQUIPMENT and ME SYSTEMS intended for use in conjunction with
flammable agents .165
11.6 Overflow, spillage, leakage, ingress of water or particulate matter, cleaning,
disinfection, sterilization and compatibility with substances used with the
ME EQUIPMENT.165
11.7 Biocompatibility of ME EQUIPMENT and ME SYSTEMS.167
11.8 * Interruption of the power supply / SUPPLY MAINS to ME EQUIPMENT .167
12 * Accuracy of controls and instruments and protection against hazardous outputs .167
12.1 Accuracy of controls and instruments .167
12.2 USABILITY.167
12.3 Alarm systems.167
12.4 Protection against hazardous output.167
13 * HAZARDOUS SITUATIONS and fault conditions.169
13.1 Specific HAZARDOUS SITUATIONS .169
13.2 SINGLE FAULT CONDITIONS .170
14 * PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .176
14.1 * General.176
14.2 * Documentation.176
14.3 * RISK MANAGEMENT plan .177
14.4 * PEMS DEVELOPMENT LIFE-CYCLE .177
14.5 * Problem resolution .177
14.6 RISK MANAGEMENT PROCESS.177
14.7 * Requirement specification .178
14.8 * Architecture .178
14.9 * Design and implementation.179
14.10 * VERIFICATION .179
14.11 * PEMS VALIDATION .179
14.12 * Modification .180
14.13 * Connection of PEMS by NETWORK/DATA COUPLING to other equipment .180
15 Construction of ME EQUIPMENT .180
15.1 * Arrangements of controls and indicators of ME EQUIPMENT.180
15.2 * Serviceability .180
15.3 Mechanical strength .181
15.4 MEEQUIPMENT components and general assembly.185
15.5 * MAINS SUPPLY TRANSFORMERS of ME EQUIPMENT and transformers providing
separation in accordance with 8.5 .190
16 * ME SYSTEMS .194
16.1 * General requirements for the ME SYSTEMS .194
16.2 * ACCOMPANYING DOCUMENTS of an ME SYSTEM .195
16.3 * Power supply .196
16.4 ENCLOSURES .196
16.5 * SEPARATION DEVICES.196
16.6 * LEAKAGE CURRENTS.197
16.7 * Protection against MECHANICAL HAZARDS .198

60601-1 © IEC:200560601-1 © IEC:2005 – 9 – – 5 –
16.8 Interruption of the power supply to parts of an ME SYSTEM .198
16.9 ME SYSTEM connections and wiring .198
17 * Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS .200
Annex A (informative) General guidance and rationale.201
Annex B (informative) Sequence of testing .307
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS.311
Annex D (informative) Symbols on marking.315
Annex E (informative) Examples of the connection of the measuring device (MD) for
measurement of the PATIENT LEAKAGE CURRENT and PATIENT AUXILIARY CURRENT .324
Annex F (informative) Suitable measuring supply circuits.326
Annex G (normative) Protection against HAZARDS of ignition of flammable anaesthetic
mixtures.329
Annex H (informative) PEMS structure, PEMS DEVELOPMENT LIFE-CYCLE and
documentation .344
Annex I (informative) ME SYSTEMS aspects.357
Annex J (informative) Survey of insulation paths.363
Annex K (informative) Simplified PATIENT LEAKAGE CURRENT diagrams .366
Annex L (normative) Insulated winding wires for use without interleaved insulation.369
Bibliography.372
INDEX .375
INDEX OF ABBREVIATIONS AND ACRONYMS .388
Figure 1 – Detachable mains connection.22
Figure 2 – Example of the defined terminals and conductors.23
Figure 3 – Example of a CLASS I ME EQUIPMENT.24
Figure 4 – Example of a metal-enclosed CLASS II ME EQUIPMENT .24
Figure 5 – Schematic flow chart for component qualification .44
Figure 6 – Standard test finger.49
Figure 7 – Test hook.50
Figure 8 – Test pin. 7 1
Figure 9 – Application of test voltage to bridged PATIENT CONNECTIONS for
DEFIBRILLATION-PROOF APPLIED PARTS. 78
Figure 10 – Application of test voltage to individual PATIENT CONNECTIONS for
DEFIBRILLATION-PROOF APPLIED PARTS. 80
Figure 11 – Application of test voltage to test the delivered defibrillation energy . 81

– 6 – 60601-1 © IEC:2005
Figure 12 – Example of a measuring device and its frequency characteristics.85
Figure 13 – Measuring circuit for the EARTH LEAKAGE CURRENT of CLASS I ME EQUIPMENT,
with or without APPLIED PART .88
Figure 14 – Measuring circuit for the TOUCH CURRENT.89
Figure 15 – Measuring circuit for the PATIENT LEAKAGE CURRENT from the PATIENT
CONNECTION to earth.90
Figure 16 – Measuring circuit for the PATIENT LEAKAGE CURRENT via the PATIENT
CONNECTION(S) of an F-TYPE APPLIED PART to earth caused by an external voltage on the
PATIENT CONNECTION(S) .91
Figure 17 – Measuring circuit for the PATIENT LEAKAGE CURRENT from PATIENT
CONNECTION(S) to earth caused by an external voltage on a SIGNAL INPUT/OUTPUT PART .92
Figure 18 – Measuring circuit for the PATIENT LEAKAGE CURRENT from PATIENT
CONNECTION(S) to earth caused by an external voltage on a metal ACCESSIBLE PART that
is not PROTECTIVELY EARTHED .93
Figure 19 – Measuring circuit for the PATIENT AUXILIARY CURRENT .94
Figure 20 – Measuring circuit for the total PATIENT LEAKAGE CURRENT with all PATIENT
CONNECTIONS of all APPLIED PARTS of the same type (TYPE B APPLIED PARTS, TYPE BF
APPLIED PARTS or TYPE CF APPLIED PARTS) connected together.95
Figure 21 – Ball-pressure test apparatus .107
Figure 22 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 1 .120
Figure 23 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 2 .120
Figure 24 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 3 .120
Figure 25 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 4 .120
Figure 26 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 5 .120
Figure 27 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 6 .121
Figure 28 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 7 .121
Figure 29 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 8 .121
Figure 30 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 9 .121
Figure 31 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 10 .122
Figure 32 – Ratio between HYDRAULIC TEST PRESSURE and MAXIMUM PERMISSIBLE
WORKING PRESSURE .145
Figure 33 – Human body test mass.150
Figure 34 – Spark ignition test apparatus.159
Figure 35 – Maximum allowable current I as a function of the maximum allowable
voltage U measured in a purely resistive circuit in an OXYGEN RICH ENVIRONMENT .159
Figure 36 – Maximum allowable voltage U as a function of the capacitance C
measured in a capacitive circuit used in an OXYGEN RICH ENVIRONMENT .160
Figure 37 – Maximum allowable current I as a function of the inductance L measured
in an inductive circuit in an OXYGEN RICH ENVIRONMENT .160
Figure 38 – Baffle .164
Figure 39 – Area of the bottom of an ENCLOSURE as specified in 11.3 b) 1) .164
Figure A.1 – Identification of ME EQUIPMENT, APPLIED PARTS and PATIENT CONNECTIONS
in an ECG monitor .207

60601-1 © IEC:200560601-1 © IEC:2005 –– 13 7 – –
Figure A.2 – Example of the insulation of an F-TYPE APPLIED PART with the insulation
incorporated in the ME EQUIPMENT .208
Figure A.3 – Identification of ME EQUIPMENT, APPLIED PARTS and PATIENT CONNECTIONS
in a PATIENT monitor with invasive pressure monitoring facility .209
Figure A.4 – Identification of ME EQUIPMENT, APPLIED PARTS and PATIENT CONNECTIONS
in a multifunction PATIENT monitor with invasive pressure monitoring facilities.210
Figure A.5 – Identification of APPLIED PARTS and PATIENT CONNECTIONS in an X-ray ME
SYSTEM .211
Figure A.6 – Identification of ME EQUIPMENT, APPLIED PARTS and PATIENT CONNECTIONS in
a transcutaneous electronic nerve stimulator (TENS) intended to be worn on the
PATIENT’S belt and connected to electrodes applied to the PATIENT’S upper arm.211
Figure A.7 – Identification of ME EQUIPMENT or ME SYSTEM, APPLIED PARTS and PATIENT
CONNECTIONS in a personal computer with an ECG module .212
Figure A.8 – Pictorial representation of the relationship of HAZARD, sequence of events,
HAZARDOUS SITUATION and HARM .215
Figure A.9 – Example of PATIENT ENVIRONMENT.221
Figure A.10 – Floating circuit .235
Figure A.11 – Interruption of a power-carrying conductor between ME EQUIPMENT parts
in separate ENCLOSURES.238
Figure A.12 – Identification of MEANS OF PATIENT PROTECTION and MEANS OF OPERATOR
PROTECTION.242
Figure A.13 – Allowable protective earth impedance where the fault current is limited .249
Figure A.14 – Probability of ventricular fibrillation .255
Figure A.15 – Example of a measuring circuit for the PATIENT LEAKAGE CURRENT from a
PATIENT CONNECTION to earth for ME EQUIPMENT with multiple PATIENT CONNECTIONS .260
Figure A.16 – Instability test conditions.272
Figure A.17 – Example of determining TENSILE SAFETY FACTOR using Table 21 .278
Figure A.18 – Example of determining design and test loads .279
Figure A.19 – Example of human body mass distribution .279
Figure E.1 – TYPE B APPLIED PART.324
Figure E.2 – TYPE BF APPLIED PART .324
Figure E.3 – TYPE CF APPLIED PART .325
Figure E.4 – PATIENT AUXILIARY CURRENT .325
Figure E.5 – Loading of the PATIENT CONNECTIONS if specified by the MANUFACTURER .325
Figure F.1 – Measuring supply circuit with one side of the SUPPLY MAINS at
approximately earth potential .326
Figure F.2 – Measuring supply circuit with SUPPLY MAINS approximately symmetrical to
earth potential.326
Figure F.3 – Measuring supply circuit for polyphase ME EQUIPMENT specified for
connection to a polyphase SUPPLY MAINS.327
Figure F.4 – Measuring supply circuit for single-phase ME EQUIPMENT specified for
connection to a polyphase SUPPLY MAINS.327

60601-1 © IEC:2005 –– 15 8 – – 60601-1 © IEC:2005
Figure F.5 – Measuring supply circuit for ME EQUIPMENT having a separate power
supply unit or intended to receive its power from another equipment in an ME SYSTEM.328
Figure G.1– Maximum allowable current I as a function of the maximum allowable
ZR
voltage U measured in a purely resistive circuit with the most flammable mixture of
ZR
ether vapour with air .335
Figure G.2 – Maximum allowable voltage U as a function of the capacitance C
ZC max
measured in a capacitive circuit with the most flammable mixture of ether vapour with air .336
Figure G.3 – Maximum allowable current I as a function of the inductance L
ZL max
measured in an inductive circuit with the most flammable mixture of ether vapour with air .336
Figure G.4 – Maximum allowable current I as a function of the maximum allowable
ZR
voltage U measured in a purely resistive circuit with the most flammable mixture of
ZR
ether vapour with oxygen .340
Figure G.5 – Maximum allowable voltage U as a function of the capacitance C
ZC max
measured in a capacitive circuit with the most flammable mixture of ether vapour with
oxygen.341
Figure G.6 – Maximum allowable current I as a function of the inductance L
ZL max
measured in an inductive circuit with the most flammable mixture of ether vapour with
oxygen.341
Figure G.7 – Test apparatus .343
Figure H.1 – Examples of PEMS/ PESS structures .345
Figure H.2 – A PEMS DEVELOPMENT LIFE-CYCLE model .346
Figure H.3 – PEMS documentation requirements from Clause 14 and ISO 14971:2000 .350
Figure H.4 – Example of potential parameters required to be specified for
NETWORK/DATA COUPLING .356
Figure I.1 – Example of the construction of a MULTIPLE SOCKET-OUTLET (MSO).361
Figure I.2 – Examples of application of MULTIPLE SOCKET-OUTLETS (MSO) .362
Figure J.1 – Insulation example 1 .363
Figure J.2 – Insulation example 2 .363
Figure J.3 – Insulation example 3 .363
Figure J.4 – Insulation example 4 .364
Figure J.5 – Insulation example 5 .364
Figure J.6 – Insul
...

IEC 60601-1 ®
Edition 3.2 2020-08
CONSOLIDATED VERSION
INTERNATIONAL
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Medical electrical equipment –
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Appareils électromédicaux –
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IEC 60601-1 ®
Edition 3.2 2020-08
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 1: General requirements for basic safety and essential performance
Appareils électromédicaux –
Partie 1: Exigences générales pour la sécurité de base et les performances
essentielles
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.01 ISBN 978-2-8322-4262-9

IEC 60601-1 ®
Edition 3.2 2020-08
CONSOLIDATED VERSION
REDLINE VERSION
VERSION REDLINE
colour
inside
Medical electrical equipment –
Part 1: General requirements for basic safety and essential performance

Appareils électromédicaux –
Partie 1: Exigences générales pour la sécurité de base et les performances
essentielles
Publication IEC 60601-1 (Third edition – 2005) I-SH 01

MEDICAL ELECTRICAL EQUIPMENT –
Part 1: General requirements for basic safety
and essential performance
INTERPRETATION SHEET 1
This interpretation sheet has been prepared by SC 62A: Common aspects of electrical
equipment used in medical practice
The text of this interpretation sheet is based on the following documents:
ISH Report on voting
62A/599/ISH 62A/613/RVD
Full information on the voting for the approval of this interpretation sheet can be found in the
report on voting indicated in the above table.
___________
Subclause 1.1
This subclause is clarified by the following:
IEC 60601-1 does not apply to medical gas pipeline systems covered by ISO 7396-1, Medical
gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum.
NOTE Subclause 6.3 of ISO 7396-1 applies the requirement of IEC 60601-1-8 to certain monitoring and alarm
signals.
This clarification will remain valid until a new version of IEC 60601-1 is published.

___________
April 2008
– 1 –
Publication IEC 60601-1 (Third edition – 2005) I-SH 02

MEDICAL ELECTRICAL EQUIPMENT –

Part 1: General requirements for basic safety
and essential performance
INTERPRETATION SHEET 2
This interpretation sheet has been prepared by subcomittee 62A: Common aspects of
electrical equipment used in medical practice, of IEC technical committee 62: Electrical
equipment in medical practice.
The text of this interpretation sheet is based on the following documents:
ISH Report on voting
62A/634/ISH 62A/640/RVD
Full information on the voting for the approval of this interpretation sheet can be found in the
report on voting indicated in the above table.
_____________
Subclause 11.3
This subclause is clarified by the following:
As stated in the rationale for this subclause, fire ENCLOSURES are intended to be used only
where there is a significant likelihood of fire due to the presence of a source of ignition (as
described in the subclause) and a significant source of fuel. Most materials used in the
construction of ME EQUIPMENT are not considered to be such a source of fuel unless they are
in the presence of an OXYGEN RICH ENVIRONMENT. MANUFACTURERS should determine, through
analyses documented in the RISK MANAGEMENT FILE, whether the ME EQUIPMENT contains
combustible materials (fuel) in sufficient quantities to support combustion in conjunction with
ignition sources (capable of releasing greater than 900 J).
Subclause 13.1.2
This subclause is clarified by the following:
As stated in subclause 4.7, it is the MANUFACTURER’S RISK ANALYSIS that determines which
components are subject to failure testing based on the associated RISK. Where the associated
RISK of fire exceeds the MANUFACTURER’S criteria for RISK acceptability, the MANUFACTURER’S
simulation analysis (such as FMEAs) should be accepted in lieu of physical testing. As also
stated in 4.7, component reliability and ratings are to be considered in such failure simulation
analyses. Common electronic components that have a history of use without causing
equipment fires should not be considered a likely source of ignition.
Where the subclause identifies “emission of flames, molten metal, poisonous or ignitable
substance in hazardous quantities;” as a hazardous situation, this refers to emissions from
the ENCLOSURE not from components themselves. Where it identifies “exceeding the allowable
values for ‘other components and materials’ identified in Table 22 times 1,5 minus 12,5 °C”,
this applies only where doing so would result in an unacceptable RISK (as identified in the
MANUFACTURER’S RISK ANALYSIS according to 4.7). Typically, this would be cases where
January 2009 ICS 11.040 French text overleaf

– 2 –
ESSENTIAL PERFORMANCE would not be maintained or where greater than 900 J of energy
would be released in the presence of flammable materials that could sustain combustion.
The first exemption to fault analysis or testing identified in subclause 13.1.2 (“The
construction or the supply circuit limits the power dissipation in SINGLE FAULT CONDITION to less
than 15 W or the energy dissipation to less than 900 J.”) is intended to apply where the
component design itself (“The construction”) or fusing (or other current limiting devices) in the
supply circuit (“or the supply circuit”) assure the energy released during failures will not
exceed the limits. For most common signal level components rated for operation below
5 Watts, the energy released by short-circuiting of outputs will not exceed the 900 J limit.
This clarification will remain valid until a new version of IEC 60601-1 is published.

___________
January 2009 ICS 11.040 French text overleaf

SC 62A/Publication IEC 60601-1:2005, including Amendment 1:2012, Third edition/I-SH 03
MEDICAL ELECTRICAL EQUIPMENT –
Part 1: General requirements for basic safety and essential performance

INTERPRETATION SHEET 3
This interpretation sheet has been prepared by subcommittee 62A: Common aspects of
electrical equipment used in medical practice, of IEC technical committee 62: Electrical
equipment in medical practice.
The text of this interpretation sheet is based on the following documents:
ISH Report on voting
62A/858/ISH 62A/875/RVD
Full information on the voting for the approval of this interpretation sheet can be found in the
report on voting indicated in the above table.
___________
Subclause 13.1.2 fourth dash (Emissions, deformation of ENCLOSURE or exceeding
maximum temperature)
This subclause states the following:
The following HAZARDOUS SITUATIONS shall not occur:
− ….
− temperatures of ME EQUIPMENT parts that are not APPLIED PARTS but are likely to be
touched, exceeding the allowable values in Table 23 when measured and adjusted as
described in 11.1.3;
This is clarified by the following:
The above requirement is regarded as fulfilled in accordance with Subclause 4.5 for
temperatures at the surfaces of the enclosure, if the following conditions are fulfilled:
− The maximum allowed temperature on OPERATOR accessible surfaces in SINGLE FAULT
CONDITION is 105 °C; and
− the instructions for use contain a warning that, under some SINGLE FAULT CONDITIONS, the
temperature of: (indicate the surface of concern) could get hot and there is a possible RISK
of a burn if touched, and
− if the RISK ANALYSIS demonstrates a need for a warning symbol on the ENCLOSURE, safety
sign ISO 7010-W018 ( ) shall be used on or adjacent to the hot spot on the
ENCLOSURE; and
− the RISK ASSESSMENT demonstrates that the temperature attained in the SINGLE FAULT
CONDITION is acceptable, and
− the RISK ASSESSMENT demonstrates that applying the alternative RISK CONTROL measures
in this Interpretation Sheet results in a RESIDUAL RISK that is comparable to the RESIDUAL
RISK resulting from applying the requirement of the standard.
NOTE 1 This Interpretation Sheet is intended to be used with both Edition 3.0 and Edition 3.1 of IEC 60601-1.
NOTE 2 An example of an analysis that demonstrates an adequately low probability of occurrence of HARM is
shown below.
May 2013 ICS 11.040 French text overleaf

Example RISK ASSESSMENT:
The sum failure rate for parts that could increase the surface temperature of parts of the
enclosure of XYZ device touchable only by the OPERATOR to values above those of Table 23
calculates to be 60 FIT (1 FIT = 1E-9/h) according to the standard MIL-HDBK-217F where FIT
stands for "failure in time". In case of such failures, the device would emit an odour and would
no longer function properly. It is estimated, that only in one of 3 cases the device would not
be switched off immediately and the hot surface would be resulting in a burn.
The resulting overall probability of such HARM where adequate warning is provided in the
instructions for use in combination with warning sign ISO 7010 W018 would be: probability
= 1/3 * 60 FIT = 2 E-8/h =approx. 0,0002 per year.
In this example, the WXW Company's RISK acceptance criteria require that a HARM of that
severity must have a probability of less than 0,0003 per year for the associated RISK to be
considered acceptable. Based on that RISK acceptance criterion, the RISK associated with
overtemperature of the ENCLOSURE caused by single faults in the circuitry is acceptable.

May 2013 ICS 11.040 French text overleaf

 IEC 2021
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
IEC 60601-1
Edition 3.0  2005-12
Amendement 1  2012-07
MEDICAL ELECTRICAL EQUIPMENT –

Part 1: General requirements for basic safety and essential performance

INTERPRETATION SHEET 1
This interpretation sheet has been prepared by subcommittee 62A: Common aspects of
electrical equipment used in medical practice, of IEC technical committee 62: Electrical
equipment in medical practice.
The text of this interpretation sheet is based on the following documents:
DISH Report on voting
62A/1403/DISH 62A/1414/RVDISH
Full information on the voting for the approval of this interpretation sheet can be found in the
report on voting indicated in the above table.

___________
Interpretation of Subclauses 4.3 of IEC 60601-1:2005/AMD1:2012 and 4.7 of
This interpretation sheet is intended to clarify the requirements which are needed to maintain
ESSENTIAL PERFORMANCE in SINGLE FAULT CONDITION.
Subclause 4.3 * ESSENTIAL PERFORMANCE
The requirements in this subclause of IEC 60601-1:2005/AMD1:2012 are clarified by the
following.
aa) IEC 60601-1:2005/AMD1:2012 requires that both the NORMAL CONDITION and the SINGLE
FAULT CONDITIONS are to be considered in the identification of ESSENTIAL PERFORMANCE,
because:
ICS 11.040.01
– 2 – IEC 60601-1:2005/AMD1:2012/ISH1:2021
 IEC 2021
1) ESSENTIAL PERFORMANCE is defined in terms of the performance of a clinical function
(see 3.27);
NOTE 1 ESSENTIAL PERFORMANCE can have multiple aspects.
2) in particular, SINGLE FAULT CONDITIONS can cause or contribute to the loss or
degradation of such a clinical function that results in unacceptable RISK; and
3) according to IEC 60601-1:2005, 4.7, ME EQUIPMENT is required to remain SINGLE FAULT
SAFE or the RISK remains acceptable and this also applies to ESSENTIAL PERFORMANCE.
bb) The subclause requires the MANUFACTURER to:
NOTE 2 Many particular standards specify performance limits, RISK CONTROL measures and VERIFICATION
methods for some aspects of ESSENTIAL PERFORMANCE.
1) identify performance of clinical functions, other than that related to BASIC SAFETY, that
is necessary to achieve the INTENDED USE or that could affect safety;
2) specify performance limits between fully functional and total loss of the identified
performance in both
i) NORMAL CONDITION, and
ii) SINGLE FAULT CONDITION;
NOTE 3 The specified performance limits can be different in NORMAL CONDITION and SINGLE FAULT
.
CONDITION
3) evaluate the RISK from loss or degradation of the identified performance beyond the
specified limits;
i) Where the resulting RISK is unacceptable, the identified performance is
ESSENTIAL PERFORMANCE.
RISK CONTROL measures to reduce these RISKS to an acceptable level for
4) implement
both
i) NORMAL CONDITION, and
ii) SINGLE FAULT CONDITION;
5) assess and determine which RISK CONTROL measures need VERIFICATION of
effectiveness; and
6) specify methods for the VERIFICATION of the effectiveness of the RISK CONTROL
measures.
cc) The requirements of IEC 60601-1:2005/AMD1:2012 4.3 as clarified in items 4.3 bb) 1) to
4.3 bb) 6) above include documentation of the relevant results in the RISK MANAGEMENT
FILE. The documentation is intended to serve as OBJECTIVE EVIDENCE that the required
activities have been performed.
dd) The compliance statement refers to “inspection of the RISK MANAGEMENT FILE”. Inspection
means the careful examination or scrutiny of the contents of the RISK MANAGEMENT FILE.
Only confirming the existence of a RISK MANAGEMENT FILE is insufficient. Inspection can
include functional tests as clarified in IEC 60601-1:2005/AMD1:2012/ISH1 items 4.3 bb) 5)
and 4.3 bb) 6). This is similar to the other uses of “inspection” throughout this standard.
Subclause 4.7 * SINGLE FAULT CONDITION for ME EQUIPMENT
The requirements in this subclause of IEC 60601-1:2005 are clarified by the following.
aa) IEC 60601-1:2005 requires that ME EQUIPMENT remains SINGLE FAULT SAFE or the RISK
remains acceptable according to 4.2 during the EXPECTED SERVICE LIFE and this also
applies to ESSENTIAL PERFORMANCE.
bb) SINGLE FAULT CONDITION (as defined in 3.116) describes the condition where “a single
means for reducing a RISK is defective or a single abnormal condition is present”. Either
condition anticipates the failure or fault of one component [other than those indicated in
4.7 a), e.g. a COMPONENT WITH HIGH-INTEGRITY CHARACTERISTICS].

 IEC 2021
Component failure or fault can relate to:
1) a single part (e.g. resistor, capacitor, wire, mechanical part),
2) a subassembly (e.g. battery block, power supply unit, line filter, PESS), or
3) a device with a specified function (e.g. protective unit, control unit, monitoring unit).
Any SINGLE FAULT CONDITION that could result in a HAZARDOUS SITUATION, including those
mentioned in 13.1, needs to be simulated, physically or theoretically. Care needs to be
taken to adequately determine the worst case situation when analysing failure or fault of
subassemblies and functional units.
cc) It can be necessary to investigate the consequences of a second independent fault or
failure. This is relevant when the initial fault or failure remains undetected during NORMAL
USE for the EXPECTED SERVICE LIFE or when the fault or failure is so likely that it is
considered to be a NORMAL CONDITION. See 4.7 b) and 5.1 and their rationales in Annex A.
dd) The RISK ASSESSMENT is used to determine which SINGLE FAULT CONDITIONS are to be tested
in agreement with 4.3, 4.7 and 5.1. This includes consideration of a second independent
fault or failure following an initial SINGLE FAULT CONDITION that remains undetected during
NORMAL USE for the EXPECTED SERVICE LIFE. This also applies to the VERIFICATION of the
effectiveness of the RISK CONTROL measures needed to maintain ESSENTIAL PERFORMANCE
[see IEC 60601-1/AMD1:2012/ISH1 4.3 bb) 5) and 4.3 bb) 6)].
ee) The requirements of 4.7 include documentation of the relevant tests in the RISK MANAGEMENT
FILE. The documentation is intended to serve as OBJECTIVE EVIDENCE that the required
activities have been performed.

– 2 – IEC 60601-1:2005+AMD1:2012
+AMD2:2020 CSV  IEC 2020
CONTENTS
FOREWORD . 11
INTRODUCTION . 14
INTRODUCTION TO AMENDMENT 1 . 16
INTRODUCTION TO AMENDMENT 2 . 16
1 Scope, object and related standards . 18
1.1 * Scope . 18
1.2 Object . 18
1.3 * Collateral standards . 18
1.4 * Particular standards . 19
2 * Normative references . 19
3 * Terminology and definitions . 24
4 General requirements . 45
4.1 * Conditions for application to ME EQUIPMENT or ME SYSTEMS . 45
4.2 * RISK MANAGEMENT PROCESS for ME EQUIPMENT or ME SYSTEMS . 45
4.3 * ESSENTIAL PERFORMANCE . 48
4.4 * EXPECTED SERVICE LIFE . 49
4.5 * Equivalent safety for ME EQUIPMENT or ME SYSTEMS
* Alternative RISK CONTROL measures or test methods for ME EQUIPMENT or
ME SYSTEMS . 50
4.6 * ME EQUIPMENT or ME SYSTEM parts that contact the PATIENT . 50
4.7 * SINGLE FAULT CONDITION for ME EQUIPMENT . 50
4.8 * Components of ME EQUIPMENT . 51
4.9 * Use of COMPONENTS WITH HIGH-INTEGRITY CHARACTERISTICS in
ME EQUIPMENT . 52
4.10 * Power supply . 53
4.11 Power input . 53
5 * General requirements for testing ME EQUIPMENT . 54
5.1 * TYPE TESTS . 54
5.2 * Number of samples . 54
5.3 Ambient temperature, humidity, atmospheric pressure . 54
5.4 Other conditions . 54
5.5 Supply voltages, type of current, nature of supply, frequency . 55
5.6 Repairs and modifications . 55
5.7 * Humidity preconditioning treatment . 55
5.8 Sequence of tests . 56
5.9 * Determination of APPLIED PARTS and ACCESSIBLE PARTS . 56
6 * Classification of ME EQUIPMENT and ME SYSTEMS . 59
6.1 General . 59
6.2 * Protection against electric shock . 59
6.3 Protection against harmful ingress of water or particulate matter . 59
6.4 Method(s) of sterilization . 59
6.5 Suitability for use in an OXYGEN RICH ENVIRONMENT . 59
6.6 * Mode of operation . 59
7 ME EQUIPMENT identification, marking and documents . 60
7.1 General . 60

+AMD2:2020 CSV  IEC 2020
7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts (see also
Table C.1) . 61
7.3 Marking on the inside of ME EQUIPMENT or ME EQUIPMENT parts (see also
Table C.2) . 66
7.4 Marking of controls and instruments (see also Table C.3) . 67
7.5 Safety signs SAFETY SIGNS . 69
7.6 Symbols . 70
7.7 Colours of the insulation of conductors . 70
7.8 * Indicator lights and controls . 71
7.9 ACCOMPANYING DOCUMENTS . 72
8 * Protection against electrical HAZARDS from ME EQUIPMENT . 79
8.1 Fundamental rule of protection against electric shock. 79
8.2 Requirements related to power sources . 80
8.3 Classification of APPLIED PARTS . 80
8.4 Limitation of voltage, current or energy. 81
8.5 Separation of parts . 84
8.6 * Protective earthing, functional earthing and potential equalization of
ME EQUIPMENT . 97
8.7 LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS . 100
8.8 Insulation . 122
8.9 * CREEPAGE DISTANCES and AIR CLEARANCES . 129
8.10 Components and wiring . 147
8.11 MAINS PARTS, components and layout . 149
9 * Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 155
9.1 MECHANICAL HAZARDS of ME EQUIPMENT . 155
9.2 * MECHANICAL HAZARDS associated with moving parts. 155
9.3 * MECHANICAL HAZARD associated with surfaces, corners and edges. 161
9.4 * Instability HAZARDS . 161
9.5 * Expelled parts HAZARD . 166
9.6 Acoustic energy (including infra- and ultrasound) and vibration . 167
9.7 * Pressure vessels and parts subject to pneumatic and hydraulic pressure . 168
9.8 * MECHANICAL HAZARDS associated with support systems . 171
10 * Protection against unwanted and excessive radiation HAZARDS . 177
10.1 X-Radiation . 177
10.2 Alpha, beta, gamma, neutron and other particle radiation . 178
10.3 Microwave radiation . 178
10.4 * Lasers and light emitting diodes (LEDs) . 179
10.5 * Other visible electromagnetic radiation . 179
10.6 * Infrared radiation . 179
10.7 * Ultraviolet radiation . 179
11 Protection against excessive temperatures and other HAZARDS . 179
11.1 * Excessive temperatures in ME EQUIPMENT . 179
11.2 * Fire prevention . 184
11.3 * Constructional requirements for fire ENCLOSURES of ME EQUIPMENT . 188
11.4 * ME EQUIPMENT and ME SYSTEMS intended for use with flammable

anaesthetics . 191
11.5 * ME EQUIPMENT and ME SYSTEMS intended for use in conjunction with
flammable agents . 191

– 4 – IEC 60601-1:2005+AMD1:2012
+AMD2:2020 CSV  IEC 2020
11.6 Overflow, spillage, leakage, ingress of water or particulate matter, cleaning,
disinfection, sterilization and compatibility with substances used with the
ME EQUIPMENT . 191
11.7 Biocompatibility of ME EQUIPMENT and ME SYSTEMS . 194
11.8 * Interruption of the power supply / SUPPLY MAINS to ME EQUIPMENT . 194
12 * Accuracy of controls and instruments and protection against hazardous outputs . 194
12.1 Accuracy of controls and instruments . 194
12.2 USABILITY of ME EQUIPMENT . 194
12.3 ALARM SYSTEMS . 194
12.4 Protection against hazardous output. 194
13 * HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 196
13.1 Specific HAZARDOUS SITUATIONS . 196
13.2 SINGLE FAULT CONDITIONS . 198
14 * PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 203
14.1 * General . 203
14.2 * Documentation . 204
14.3 * RISK MANAGEMENT plan . 204
14.4 * PEMS DEVELOPMENT LIFE-CYCLE . 204
14.5 * Problem resolution . 204
14.6 RISK MANAGEMENT PROCESS . 205
14.7 * Requirement specification . 205
14.8 * Architecture . 205
14.9 * Design and implementation . 206
14.10 * VERIFICATION . 206
14.11 * PEMS VALIDATION . 206
14.12 * Modification . 207
14.13 * Connection of PEMS by NETWORK/DATA COUPLING to other equipment
* PEMS intended to be incorporated into an IT-NETWORK . 207
15 Construction of ME EQUIPMENT . 208
15.1 * Arrangements of controls and indicators of ME EQUIPMENT . 208
15.2 * Serviceability . 208
15.3 Mechanical strength . 209
15.4 ME EQUIPMENT components and general assembly . 212
15.5 * MAINS SUPPLY TRANSFORMERS of ME EQUIPMENT and transformers providing
separation in accordance with 8.5 . 218
16 * ME SYSTEMS . 222
16.1 * General requirements for the ME SYSTEMS . 222
16.2 * ACCOMPANYING DOCUMENTS of an ME SYSTEM . 223
16.3 * Power supply . 224
16.4 ENCLOSURES . 224
16.5 * SEPARATION DEVICES . 224
16.6 * LEAKAGE CURRENTS . 224
16.7 * Protection against MECHANICAL HAZARDS . 225
16.8 Interruption of the power supply to parts of an ME SYSTEM . 226
16.9 ME SYSTEM connections and wiring . 226
17 * Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 228
Annex A (informative) General guidance and rationale . 229
Annex B (informative) Sequence of testing . 351

+AMD2:2020 CSV  IEC 2020
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 355
Annex D (informative) Symbols on marking (see Clause 7) . 358
Annex E (informative) Examples of the connection of the measuring device (MD) for
measurement of the PATIENT LEAKAGE CURRENT and PATIENT AUXILIARY CURRENT (see
8.7) . 367
Annex F (informative) Suitable measuring supply circuits . 369
Annex G (normative) Protection against HAZARDS of ignition of flammable anaesthetic
mixtures . 372
Annex H (informative) PEMS structure, PEMS DEVELOPMENT LIFE-CYCLE and
documentation . 388
Annex I (informative) ME SYSTEMS aspects . 401
Annex J (informative) Survey of insulation paths . 407
Annex K (informative) Simplified PATIENT LEAKAGE CURRENT diagrams . 410
Annex L (normative) Insulated winding wires for use without interleaved insulation . 413
Annex M (normative) Reduction of pollution degrees . 416
Bibliography . 417
INDEX OF ABBREVIATIONS AND ACRONYMS . 422
INDEX . 424

Figure 1 – Detachable mains connection . 25
Figure 2 – Example of the defined terminals and conductors. 26
Figure 3 – Example of a CLASS I ME EQUIPMENT . 27
Figure 4 – Example of a metal-enclosed CLASS II ME EQUIPMENT . 27
Figure 5 – Schematic flow chart for component qualification (see 4.8) . 52
Figure 6 – Standard test finger (see 5.9.2.1) . 57
Figure 7 – Test hook (see 5.9.2.2) . 58
Figure 8 – Test pin (see 8.4.2 d) . 83
Figure 9 – Application of test voltage to bridged PATIENT CONNECTIONS for
DEFIBRILLATION-PROOF APPLIED PARTS (see 8.5.5.1) . 93
Figure 10 – Application of test voltage to individual PATIENT CONNECTIONS for
DEFIBRILLATION-PROOF APPLIED PARTS (see 8.5.5.1) . 95
Figure 11 – Application of test voltage to test the delivered defibrillation energy . 97
Figure 12 – Example of a measuring device and its frequency characteristics . 102
Figure 13 – Measuring circuit for the EARTH LEAKAGE CURRENT of CLASS I ME EQUIPMENT,
with or without APPLIED PART . 105
Figure 14 – Measuring circuit for the TOUCH CURRENT . 107
Figure 15 – Measuring circuit for the PATIENT LEAKAGE CURRENT from the PATIENT
CONNECTION to earth. 109
Figure 16 – Measuring circuit for the PATIENT LEAKAGE CURRENT via the PATIENT
CONNECTION(S) of an F-TYPE APPLIED PART to earth caused by an external voltage on the
PATIENT CONNECTION(S) . 111
Figure 17 – Measuring circuit for the PATIENT LEAKAGE CURRENT from PATIENT
CONNECTION(S) to earth caused by an external voltage on a SIGNAL INPUT/OUTPUT PART . 113
Figure 18 – Measuring circuit for the PATIENT LEAKAGE CURRENT from PATIENT
CONNECTION(S) to earth caused by an external voltage on a metal ACCESSIBLE PART that
is not PROTECTIVELY EARTHED . 115

– 6 – IEC 60601-1:2005+AMD1:2012
+AMD2:2020 CSV  IEC 2020
Figure 19 – Measuring circuit for the PATIENT AUXILIARY CURRENT . 116
Figure 20 – Measuring circuit for the total PATIENT LEAKAGE CURRENT with all PATIENT
CONNECTIONS of all APPLIED PARTS of the same type (TYPE B APPLIED PARTS, TYPE BF
APPLIED PARTS or TYPE CF APPLIED PARTS) connected together . 117
Figure 21 – Ball-pressure test apparatus . 129
Figure 22 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 1 . 142
Figure 23 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 2 . 142
Figure 24 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 3 . 142
Figure 25 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 4 . 143
Figure 26 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 5 . 143
Figure 27 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 6 . 144
Figure 28 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 7 . 144
Figure 29 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 8 . 145
Figure 30 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 9 . 146
Figure 31 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 10 . 147
Figure 32 – Ratio between HYDRAULIC TEST PRESSURE and MAXIMUM PERMISSIBLE
WORKING EQUIPMENT PRESSURE . 170
Figure
...

IEC 60601-1 ®
Edition 3.1 2012-08
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
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Medical electrical equipment –
Part 1: General requirements for basic safety and essential performance

Appareils électromédicaux –
Partie 1: Exigences générales pour la sécurité de base et les performances
essentielles
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IEC 60601-1 ®
Edition 3.1 2012-08
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –

Part 1: General requirements for basic safety and essential performance

Appareils électromédicaux –
Partie 1: Exigences générales pour la sécurité de base et les performances

essentielles
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040 ISBN 978-2-8322-0331-6

IEC 60601-1 ®
Edition 3.1 2012-08
CONSOLIDATED VERSION
REDLINE VERSION
VERSION REDLINE
colour
inside
Medical electrical equipment –
Part 1: General requirements for basic safety and essential performance

Appareils électromédicaux –
Partie 1: Exigences générales pour la sécurité de base et les performances
essentielles
Publication IEC 60601-1 (Third edition – 2005) I-SH 01

MEDICAL ELECTRICAL EQUIPMENT –
Part 1: General requirements for basic safety
and essential performance
INTERPRETATION SHEET 1
This interpretation sheet has been prepared by SC 62A: Common aspects of electrical
equipment used in medical practice
The text of this interpretation sheet is based on the following documents:
ISH Report on voting
62A/599/ISH 62A/613/RVD
Full information on the voting for the approval of this interpretation sheet can be found in the
report on voting indicated in the above table.
___________
Subclause 1.1
This subclause is clarified by the following:
IEC 60601-1 does not apply to medical gas pipeline systems covered by ISO 7396-1, Medical
gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum.
NOTE Subclause 6.3 of ISO 7396-1 applies the requirement of IEC 60601-1-8 to certain monitoring and alarm
signals.
This clarification will remain valid until a new version of IEC 60601-1 is published.

___________
April 2008
– 1 –
Publication IEC 60601-1 (Third edition – 2005) I-SH 02

MEDICAL ELECTRICAL EQUIPMENT –

Part 1: General requirements for basic safety
and essential performance
INTERPRETATION SHEET 2
This interpretation sheet has been prepared by subcomittee 62A: Common aspects of
electrical equipment used in medical practice, of IEC technical committee 62: Electrical
equipment in medical practice.
The text of this interpretation sheet is based on the following documents:
ISH Report on voting
62A/634/ISH 62A/640/RVD
Full information on the voting for the approval of this interpretation sheet can be found in the
report on voting indicated in the above table.
_____________
Subclause 11.3
This subclause is clarified by the following:
As stated in the rationale for this subclause, fire ENCLOSURES are intended to be used only
where there is a significant likelihood of fire due to the presence of a source of ignition (as
described in the subclause) and a significant source of fuel. Most materials used in the
construction of ME EQUIPMENT are not considered to be such a source of fuel unless they are
in the presence of an OXYGEN RICH ENVIRONMENT. MANUFACTURERS should determine, through
analyses documented in the RISK MANAGEMENT FILE, whether the ME EQUIPMENT contains
combustible materials (fuel) in sufficient quantities to support combustion in conjunction with
ignition sources (capable of releasing greater than 900 J).
Subclause 13.1.2
This subclause is clarified by the following:
As stated in subclause 4.7, it is the MANUFACTURER’S RISK ANALYSIS that determines which
components are subject to failure testing based on the associated RISK. Where the associated
RISK of fire exceeds the MANUFACTURER’S criteria for RISK acceptability, the MANUFACTURER’S
simulation analysis (such as FMEAs) should be accepted in lieu of physical testing. As also
stated in 4.7, component reliability and ratings are to be considered in such failure simulation
analyses. Common electronic components that have a history of use without causing
equipment fires should not be considered a likely source of ignition.
Where the subclause identifies “emission of flames, molten metal, poisonous or ignitable
substance in hazardous quantities;” as a hazardous situation, this refers to emissions from
the ENCLOSURE not from components themselves. Where it identifies “exceeding the allowable
values for ‘other components and materials’ identified in Table 22 times 1,5 minus 12,5 °C”,
this applies only where doing so would result in an unacceptable RISK (as identified in the
MANUFACTURER’S RISK ANALYSIS according to 4.7). Typically, this would be cases where
January 2009 ICS 11.040 French text overleaf

– 2 –
ESSENTIAL PERFORMANCE would not be maintained or where greater than 900 J of energy
would be released in the presence of flammable materials that could sustain combustion.
The first exemption to fault analysis or testing identified in subclause 13.1.2 (“The
construction or the supply circuit limits the power dissipation in SINGLE FAULT CONDITION to less
than 15 W or the energy dissipation to less than 900 J.”) is intended to apply where the
component design itself (“The construction”) or fusing (or other current limiting devices) in the
supply circuit (“or the supply circuit”) assure the energy released during failures will not
exceed the limits. For most common signal level components rated for operation below
5 Watts, the energy released by short-circuiting of outputs will not exceed the 900 J limit.
This clarification will remain valid until a new version of IEC 60601-1 is published.

___________
January 2009 ICS 11.040 French text overleaf

SC 62A/Publication IEC 60601-1:2005, including Amendment 1:2012, Third edition/I-SH 03
MEDICAL ELECTRICAL EQUIPMENT –
Part 1: General requirements for basic safety and essential performance

INTERPRETATION SHEET 3
This interpretation sheet has been prepared by subcommittee 62A: Common aspects of
electrical equipment used in medical practice, of IEC technical committee 62: Electrical
equipment in medical practice.
The text of this interpretation sheet is based on the following documents:
ISH Report on voting
62A/858/ISH 62A/875/RVD
Full information on the voting for the approval of this interpretation sheet can be found in the
report on voting indicated in the above table.
___________
Subclause 13.1.2 fourth dash (Emissions, deformation of ENCLOSURE or exceeding
maximum temperature)
This subclause states the following:
The following HAZARDOUS SITUATIONS shall not occur:
− ….
− temperatures of ME EQUIPMENT parts that are not APPLIED PARTS but are likely to be
touched, exceeding the allowable values in Table 23 when measured and adjusted as
described in 11.1.3;
This is clarified by the following:
The above requirement is regarded as fulfilled in accordance with Subclause 4.5 for
temperatures at the surfaces of the enclosure, if the following conditions are fulfilled:
− The maximum allowed temperature on OPERATOR accessible surfaces in SINGLE FAULT
CONDITION is 105 °C; and
− the instructions for use contain a warning that, under some SINGLE FAULT CONDITIONS, the
temperature of: (indicate the surface of concern) could get hot and there is a possible RISK
of a burn if touched, and
− if the RISK ANALYSIS demonstrates a need for a warning symbol on the ENCLOSURE, safety
sign ISO 7010-W018 ( ) shall be used on or adjacent to the hot spot on the
ENCLOSURE; and
− the RISK ASSESSMENT demonstrates that the temperature attained in the SINGLE FAULT
CONDITION is acceptable, and
− the RISK ASSESSMENT demonstrates that applying the alternative RISK CONTROL measures
in this Interpretation Sheet results in a RESIDUAL RISK that is comparable to the RESIDUAL
RISK resulting from applying the requirement of the standard.
NOTE 1 This Interpretation Sheet is intended to be used with both Edition 3.0 and Edition 3.1 of IEC 60601-1.
NOTE 2 An example of an analysis that demonstrates an adequately low probability of occurrence of HARM is
shown below.
May 2013 ICS 11.040 French text overleaf

Example RISK ASSESSMENT:
The sum failure rate for parts that could increase the surface temperature of parts of the
enclosure of XYZ device touchable only by the OPERATOR to values above those of Table 23
calculates to be 60 FIT (1 FIT = 1E-9/h) according to the standard MIL-HDBK-217F where FIT
stands for "failure in time". In case of such failures, the device would emit an odour and would
no longer function properly. It is estimated, that only in one of 3 cases the device would not
be switched off immediately and the hot surface would be resulting in a burn.
The resulting overall probability of such HARM where adequate warning is provided in the
instructions for use in combination with warning sign ISO 7010 W018 would be: probability
= 1/3 * 60 FIT = 2 E-8/h =approx. 0,0002 per year.
In this example, the WXW Company's RISK acceptance criteria require that a HARM of that
severity must have a probability of less than 0,0003 per year for the associated RISK to be
considered acceptable. Based on that RISK acceptance criterion, the RISK associated with
overtemperature of the ENCLOSURE caused by single faults in the circuitry is acceptable.

May 2013 ICS 11.040 French text overleaf

 IEC 2021
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
IEC 60601-1
Edition 3.0  2005-12
Amendement 1  2012-07
MEDICAL ELECTRICAL EQUIPMENT –

Part 1: General requirements for basic safety and essential performance

INTERPRETATION SHEET 1
This interpretation sheet has been prepared by subcommittee 62A: Common aspects of
electrical equipment used in medical practice, of IEC technical committee 62: Electrical
equipment in medical practice.
The text of this interpretation sheet is based on the following documents:
DISH Report on voting
62A/1403/DISH 62A/1414/RVDISH
Full information on the voting for the approval of this interpretation sheet can be found in the
report on voting indicated in the above table.

___________
Interpretation of Subclauses 4.3 of IEC 60601-1:2005/AMD1:2012 and 4.7 of
This interpretation sheet is intended to clarify the requirements which are needed to maintain
ESSENTIAL PERFORMANCE in SINGLE FAULT CONDITION.
Subclause 4.3 * ESSENTIAL PERFORMANCE
The requirements in this subclause of IEC 60601-1:2005/AMD1:2012 are clarified by the
following.
aa) IEC 60601-1:2005/AMD1:2012 requires that both the NORMAL CONDITION and the SINGLE
FAULT CONDITIONS are to be considered in the identification of ESSENTIAL PERFORMANCE,
because:
ICS 11.040.01
– 2 – IEC 60601-1:2005/AMD1:2012/ISH1:2021
 IEC 2021
1) ESSENTIAL PERFORMANCE is defined in terms of the performance of a clinical function
(see 3.27);
NOTE 1 ESSENTIAL PERFORMANCE can have multiple aspects.
2) in particular, SINGLE FAULT CONDITIONS can cause or contribute to the loss or
degradation of such a clinical function that results in unacceptable RISK; and
3) according to IEC 60601-1:2005, 4.7, ME EQUIPMENT is required to remain SINGLE FAULT
SAFE or the RISK remains acceptable and this also applies to ESSENTIAL PERFORMANCE.
bb) The subclause requires the MANUFACTURER to:
NOTE 2 Many particular standards specify performance limits, RISK CONTROL measures and VERIFICATION
methods for some aspects of ESSENTIAL PERFORMANCE.
1) identify performance of clinical functions, other than that related to BASIC SAFETY, that
is necessary to achieve the INTENDED USE or that could affect safety;
2) specify performance limits between fully functional and total loss of the identified
performance in both
i) NORMAL CONDITION, and
ii) SINGLE FAULT CONDITION;
NOTE 3 The specified performance limits can be different in NORMAL CONDITION and SINGLE FAULT
.
CONDITION
3) evaluate the RISK from loss or degradation of the identified performance beyond the
specified limits;
i) Where the resulting RISK is unacceptable, the identified performance is
ESSENTIAL PERFORMANCE.
RISK CONTROL measures to reduce these RISKS to an acceptable level for
4) implement
both
i) NORMAL CONDITION, and
ii) SINGLE FAULT CONDITION;
5) assess and determine which RISK CONTROL measures need VERIFICATION of
effectiveness; and
6) specify methods for the VERIFICATION of the effectiveness of the RISK CONTROL
measures.
cc) The requirements of IEC 60601-1:2005/AMD1:2012 4.3 as clarified in items 4.3 bb) 1) to
4.3 bb) 6) above include documentation of the relevant results in the RISK MANAGEMENT
FILE. The documentation is intended to serve as OBJECTIVE EVIDENCE that the required
activities have been performed.
dd) The compliance statement refers to “inspection of the RISK MANAGEMENT FILE”. Inspection
means the careful examination or scrutiny of the contents of the RISK MANAGEMENT FILE.
Only confirming the existence of a RISK MANAGEMENT FILE is insufficient. Inspection can
include functional tests as clarified in IEC 60601-1:2005/AMD1:2012/ISH1 items 4.3 bb) 5)
and 4.3 bb) 6). This is similar to the other uses of “inspection” throughout this standard.
Subclause 4.7 * SINGLE FAULT CONDITION for ME EQUIPMENT
The requirements in this subclause of IEC 60601-1:2005 are clarified by the following.
aa) IEC 60601-1:2005 requires that ME EQUIPMENT remains SINGLE FAULT SAFE or the RISK
remains acceptable according to 4.2 during the EXPECTED SERVICE LIFE and this also
applies to ESSENTIAL PERFORMANCE.
bb) SINGLE FAULT CONDITION (as defined in 3.116) describes the condition where “a single
means for reducing a RISK is defective or a single abnormal condition is present”. Either
condition anticipates the failure or fault of one component [other than those indicated in
4.7 a), e.g. a COMPONENT WITH HIGH-INTEGRITY CHARACTERISTICS].

 IEC 2021
Component failure or fault can relate to:
1) a single part (e.g. resistor, capacitor, wire, mechanical part),
2) a subassembly (e.g. battery block, power supply unit, line filter, PESS), or
3) a device with a specified function (e.g. protective unit, control unit, monitoring unit).
Any SINGLE FAULT CONDITION that could result in a HAZARDOUS SITUATION, including those
mentioned in 13.1, needs to be simulated, physically or theoretically. Care needs to be
taken to adequately determine the worst case situation when analysing failure or fault of
subassemblies and functional units.
cc) It can be necessary to investigate the consequences of a second independent fault or
failure. This is relevant when the initial fault or failure remains undetected during NORMAL
USE for the EXPECTED SERVICE LIFE or when the fault or failure is so likely that it is
considered to be a NORMAL CONDITION. See 4.7 b) and 5.1 and their rationales in Annex A.
dd) The RISK ASSESSMENT is used to determine which SINGLE FAULT CONDITIONS are to be tested
in agreement with 4.3, 4.7 and 5.1. This includes consideration of a second independent
fault or failure following an initial SINGLE FAULT CONDITION that remains undetected during
NORMAL USE for the EXPECTED SERVICE LIFE. This also applies to the VERIFICATION of the
effectiveness of the RISK CONTROL measures needed to maintain ESSENTIAL PERFORMANCE
[see IEC 60601-1/AMD1:2012/ISH1 4.3 bb) 5) and 4.3 bb) 6)].
ee) The requirements of 4.7 include documentation of the relevant tests in the RISK MANAGEMENT
FILE. The documentation is intended to serve as OBJECTIVE EVIDENCE that the required
activities have been performed.

– 2 – IEC 60601-1:2005+AMD1:2012 CSV
 IEC 2012
CONTENTS
FOREWORD . 10
INTRODUCTION . 13
INTRODUCTION TO THE AMENDMENT . 15
1 Scope, object and related standards . 16
1.1 * Scope . 16
1.2 Object . 16
1.3 * Collateral standards . 16
1.4 * Particular standards . 17
2 * Normative references . 17
3 * Terminology and definitions . 21
4 General requirements . 42
4.1 * Conditions for application to ME EQUIPMENT or ME SYSTEMS . 42
4.2 * RISK MANAGEMENT PROCESS for ME EQUIPMENT or ME SYSTEMS . 42
4.3 * ESSENTIAL PERFORMANCE . 45
4.4 * EXPECTED SERVICE LIFE . 46
4.5 * Equivalent safety Alternative RISK CONTROL measures or test methods for
ME EQUIPMENT or ME SYSTEMS . 46
4.6 * ME EQUIPMENT or ME SYSTEM parts that contact the PATIENT . 47
4.7 * SINGLE FAULT CONDITION for ME EQUIPMENT . 47
4.8 * Components of ME EQUIPMENT . 48
4.9 * Use of COMPONENTS WITH HIGH-INTEGRITY CHARACTERISTICS in ME EQUIPMENT . 48
4.10 * Power supply . 49
4.11 Power input . 50
5 * General requirements for testing ME EQUIPMENT . 50
5.1 * TYPE TESTS . 50
5.2 * Number of samples . 51
5.3 Ambient temperature, humidity, atmospheric pressure . 51
5.4 Other conditions . 51
5.5 Supply voltages, type of current, nature of supply, frequency . 51
5.6 Repairs and modifications . 52
5.7 * Humidity preconditioning treatment . 52
5.8 Sequence of tests . 53
5.9 * Determination of APPLIED PARTS and ACCESSIBLE PARTS . 53
6 * Classification of ME EQUIPMENT and ME SYSTEMS . 56
6.1 General . 56
6.2 * Protection against electric shock . 56
6.3 * Protection against harmful ingress of water or particulate matter . 56
6.4 Method(s) of sterilization . 56
6.5 Suitability for use in an OXYGEN RICH ENVIRONMENT . 56
6.6 * Mode of operation . 56
7 ME EQUIPMENT identification, marking and documents . 57
7.1 General . 57
7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts (see also
Table C.1) . 58
7.3 Marking on the inside of ME EQUIPMENT or ME EQUIPMENT parts (see also
Table C.2) . 63

 IEC 2012
7.4 Marking of controls and instruments (see also Table C.3) . 64
7.5 Safety signs . 66
7.6 Symbols . 66
7.7 Colours of the insulation of conductors . 67
7.8 * Indicator lights and controls . 67
7.9 ACCOMPANYING DOCUMENTS . 68
8 * Protection against electrical HAZARDS from ME EQUIPMENT . 74
8.1 Fundamental rule of protection against electric shock. 74
8.2 Requirements related to power sources . 75
8.3 Classification of APPLIED PARTS . 76
8.4 Limitation of voltage, current or energy. 76
8.5 Separation of parts . 79
8.6 * Protective earthing, functional earthing and potential equalization of
ME EQUIPMENT . 89
8.7 LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS . 92
8.8 Insulation . 114
8.9 * CREEPAGE DISTANCES and AIR CLEARANCES . 120
8.10 Components and wiring . 137
8.11 MAINS PARTS, components and layout . 139
9 * Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 145
9.1 MECHANICAL HAZARDS of ME EQUIPMENT . 145
9.2 * MECHANICAL HAZARDS associated with moving parts. 145
9.3 * MECHANICAL HAZARD associated with surfaces, corners and edges. 151
9.4 * Instability HAZARDS . 151
9.5 * Expelled parts HAZARD . 156
9.6 Acoustic energy (including infra- and ultrasound) and vibration . 157
9.7 * Pressure vessels and parts subject to pneumatic and hydraulic pressure . 158
9.8 * MECHANICAL HAZARDS associated with support systems . 161
10 * Protection against unwanted and excessive radiation HAZARDS . 167
10.1 X-Radiation . 167
10.2 Alpha, beta, gamma, neutron and other particle radiation . 168
10.3 Microwave radiation . 168
10.4 * Lasers and light emitting diodes (LEDs) . 169
10.5 Other visible electromagnetic radiation . 169
10.6 Infrared radiation . 169
10.7 Ultraviolet radiation . 169
11 Protection against excessive temperatures and other HAZARDS . 169
11.1 * Excessive temperatures in ME EQUIPMENT . 169
11.2 * Fire prevention . 174
11.3 * Constructional requirements for fire ENCLOSURES of ME EQUIPMENT . 178
11.4 * ME EQUIPMENT and ME SYSTEMS intended for use with flammable
anaesthetics . 180
11.5 * ME EQUIPMENT and ME SYSTEMS intended for use in conjunction with
flammable agents . 181
11.6 Overflow, spillage, leakage, ingress of water or particulate matter, cleaning,
disinfection, sterilization and compatibility with substances used with the
ME EQUIPMENT . 181
11.7 Biocompatibility of ME EQUIPMENT and ME SYSTEMS . 183
11.8 * Interruption of the power supply / SUPPLY MAINS to ME EQUIPMENT . 183

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12 * Accuracy of controls and instruments and protection against hazardous outputs . 183
12.1 Accuracy of controls and instruments . 183
12.2 USABILITY of ME EQUIPMENT . 183
12.3 ALARM SYSTEMS . 184
12.4 Protection against hazardous output. 184
13 * HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 185
13.1 Specific HAZARDOUS SITUATIONS . 185
13.2 SINGLE FAULT CONDITIONS . 187
14 * PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 192
14.1 * General . 192
14.2 * Documentation . 192
14.3 * RISK MANAGEMENT plan . 193
14.4 * PEMS DEVELOPMENT LIFE-CYCLE . 193
14.5 * Problem resolution . 193
14.6 RISK MANAGEMENT PROCESS . 193
14.7 * Requirement specification . 194
14.8 * Architecture . 194
14.9 * Design and implementation . 194
14.10 * VERIFICATION . 195
14.11 * PEMS VALIDATION . 195
14.12 * Modification . 195
14.13 * Connection of PEMS by NETWORK/DATA COUPLING to other equipment
PEMS intended to be incorporated into an IT-NETWORK . 196
15 Construction of ME EQUIPMENT . 197
15.1 * Arrangements of controls and indicators of ME EQUIPMENT . 197
15.2 * Serviceability . 197
15.3 Mechanical strength . 197
15.4 ME EQUIPMENT components and general assembly . 201
15.5 * MAINS SUPPLY TRANSFORMERS of ME EQUIPMENT and transformers providing
separation in accordance with 8.5 . 206
16 * ME SYSTEMS . 210
16.1 * General requirements for the ME SYSTEMS . 210
16.2 * ACCOMPANYING DOCUMENTS of an ME SYSTEM . 211
16.3 * Power supply . 212
16.4 ENCLOSURES . 212
16.5 * SEPARATION DEVICES . 212
16.6 * LEAKAGE CURRENTS . 213
16.7 * Protection against MECHANICAL HAZARDS . 214
16.8 Interruption of the power supply to parts of an ME SYSTEM . 214
16.9 ME SYSTEM connections and wiring . 214
17 * Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 216
Annex A (informative) General guidance and rationale . 217
Annex B (informative) Sequence of testing . 327
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 331
Annex D (informative) Symbols on marking (see Clause 7) . 334
Annex E (informative) Examples of the connection of the measuring device (MD) for
measurement of the PATIENT LEAKAGE CURRENT and PATIENT AUXILIARY CURRENT (see
8.7) . 343

 IEC 2012
Annex F (informative) Suitable measuring supply circuits . 345
Annex G (normative) Protection against HAZARDS of ignition of flammable anaesthetic
mixtures . 348
Annex H (informative) Pems structure, PEMS DEVELOPMENT LIFE-CYCLE and
documentation . 363
Annex I (informative) ME SYSTEMS aspects . 376
Annex J (informative) Survey of insulation paths . 382
Annex K (informative) Simplified PATIENT LEAKAGE CURRENT diagrams . 385
Annex L (normative) Insulated winding wires for use without interleaved insulation . 388
Annex M (normative) Reduction of pollution degrees . 391
Bibliography . 392
INDEX OF ABBREVIATIONS AND ACRONYMS . 396
INDEX . 398

Figure 1 – Detachable mains connection . 23
Figure 2 – Example of the defined terminals and conductors. 24
Figure 3 – Example of a CLASS I ME EQUIPMENT . 25
Figure 4 – Example of a metal-enclosed CLASS II ME EQUIPMENT . 25
Figure 5 – Schematic flow chart for component qualification . 49
Figure 6 – Standard test finger. 54
Figure 7 – Test hook . 55
Figure 8 – Test pin . 78
Figure 9 – Application of test voltage to bridged PATIENT CONNECTIONS for
DEFIBRILLATION-PROOF APPLIED PARTS . 85
Figure 10 – Application of test voltage to individual PATIENT CONNECTIONS for
DEFIBRILLATION-PROOF APPLIED PARTS . 87
Figure 11 – Application of test voltage to test the delivered defibrillation energy . 89
Figure 12 – Example of a measuring device and its frequency characteristics . 94
Figure 13 – Measuring circuit for the EARTH LEAKAGE CURRENT of CLASS I ME EQUIPMENT,
with or without APPLIED PART . 97
Figure 14 – Measuring circuit for the TOUCH CURRENT . 99
Figure 15 – Measuring circuit for the PATIENT LEAKAGE CURRENT from the PATIENT
CONNECTION to earth. 101
Figure 16 – Measuring circuit for the PATIENT LEAKAGE current via the PATIENT
CONNECTION(s) of an F-TYPE APPLIED PART to earth caused by an external voltage on the
PATIENT CONNECTION(s) . 103
Figure 17 – Measuring circuit for the PATIENT LEAKAGE CURRENT from PATIENT
CONNECTION(s) to earth caused by an external voltage on a SIGNAL INPUT/OUTPUT PART . 105
Figure 18 – Measuring circuit for the PATIENT LEAKAGE CURRENT from PATIENT
CONNECTION(s) to earth caused by an external voltage on a metal ACCESSIBLE PART that
is not PROTECTIVELY EARTHED . 107
Figure 19 – Measuring circuit for the PATIENT AUXILIARY CURRENT . 108
Figure 20 – Measuring circuit for the total PATIENT LEAKAGE CURRENT with all PATIENT
CONNECTIONS of all APPLIED PARTS of the same type (TYPE B APPLIED PARTS, TYPE BF
APPLIED PARTS or TYPE CF APPLIED PARTS) connected together . 109
Figure 21 – Ball-pressure test apparatus . 120
Figure 22 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 1 . 132

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Figure 23 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 2 . 132
Figure 24 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 3 . 133
Figure 25 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 4 . 133
Figure 26 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 5 . 133
Figure 27 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 6 . 134
Figure 28 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 7 . 134
Figure 29 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 8 . 135
Figure 30 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 9 . 136
Figure 31 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 10 . 137
Figure 32 – Ratio between hydraulic test pressure and maximum permissible working
pressure . 160
Figure 33 –
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