IEC 60601-2-49:2011

IEC 60601-2-49 ®
Edition 2.0 2011-02
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-49: Particular requirements for the basic safety and essential performance
of multifunction patient monitoring equipment

Appareils électromédicaux –
Partie 2-49: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils de surveillance multifonction des patients

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IEC 60601-2-49 ®
Edition 2.0 2011-02
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-49: Particular requirements for the basic safety and essential performance
of multifunction patient monitoring equipment

Appareils électromédicaux –
Partie 2-49: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils de surveillance multifonction des patients

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX XA
ICS 11.040.55 ISBN 978-2-88912-369-8

– 2 – 60601-2-49  IEC:2011
CONTENTS
FOREWORD . 4

INTRODUCTION . 7

201.1 Scope, object and related standards . 8

201.2 Normative references . 10

201.3 Terms and definitions . 10

201.4 General requirements . 11

201.5 General requirements for testing of ME EQUIPMENT . 12

201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 12
201.7 ME EQUIPMENT identification, marking and documents. 12
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 14
201.9 Protection against mechanical hazards of ME EQUIPMENT and ME SYSTEMS . 16
201.10 Protection against unwanted and excessive radiation HAZARDS . 16
201.11 Protection against excessive temperatures and other HAZARDS . 16
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 17
201.13 HAZARDOUS SITUATIONS and fault conditions . 18
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 18
201.15 Construction of ME EQUIPMENT . 18
201.16 ME SYSTEMS . 18
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 18
202 Electromagnetic compatibility – Requirements and tests . 18
208 General requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems . 26
Annexes . 32
Annex AA (informative) General guidance and rationale . 33
Annex BB (informative) Alarm diagrams of Clause 208/IEC 60601-1-8:2006 . 43
ANNEX CC (informative) Examples of the connection of the measuring device (MD) for
measurement of the PATIENT LEAKAGE CURRENT and PATIENT AUXILIARY CURRENT . 46
Bibliography . 49
Index of defined terms used in this particular standard. 50

Figure 202.101 – Test layout for conducted and radiated emission and radiated
immunity test with non-conductive APPLIED PART . 20
Figure 202.102 – Test layout for radiated and conducted emission test and radiated
immunity test with a PATIENT CONNECTION . 21
Figure 202.103 –Test circuit for HF surgery protection measurement according to
subclause 202.6.2.1.101 with PATIENT CONNECTIONS . 24
Figure 202.104 – Test setup for HF surgery protection measurement according to
subclause 202.6.2.1.101 . 25
Figure 202.105 – Test circuit for HF surgery protection measurement according to
subclause 202.6.2.1.101 with non-conductive APPLIED PART . 26
Figure AA.1 – Single APPLIED PART with MULTIPLE FUNCTIONS and PATIENT CONNECTIONS . 35

60601-2-49  IEC:2011 – 3 –
Figure AA.2 – Single APPLIED PART (6) with MULTIPLE FUNCTIONS and

PATIENT CONNECTIONS and multiple APPLIED PARTS (7) with SINGLE FUNCTIONS and

PATIENT CONNECTIONS . 36

Figure BB.1 – NON-LATCHING ALARM SIGNALS without ALARM RESET . 43

Figure BB.2 – NON-LATCHING ALARM SIGNALS with ALARM RESET . 44

Figure BB.3 – LATCHING ALARM SIGNALS with ALARM RESET . 44

Figure BB.4 – Two ALARM CONDITIONS with ALARM RESET . 45

Figure CC.1 – PART LEAKAGE CURRENT measurement of TYPE BF APPLIED PARTS with

MULTIPLE FUNCTIONS . 46

Figure CC.2 – PART LEAKAGE CURRENT measurement of TYPE CF APPLIED PARTS with
MULTIPLE FUNCTIONS . 47
Figure CC.3 – Total PATIENT LEAKAGE CURRENT of TYPE BF and CF APPLIED PARTS with
MULTIPLE FUNCTIONS caused by an external voltage on the PATIENT CONNECTIONS . 48

Table 201.101 – ESSENTIAL PERFORMANCE requirements . 11
Table 208.101 – ALARM CONDITION priorities . 27
Table 208.102 – Characteristics of the BURST of auditory ALARM SIGNALS . 28

– 4 – 60601-2-49  IEC:2011
INTERNATIONAL ELECTROTECHNICAL COMMISSION

____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-49: Particular requirements for the basic

safety and essential performance of multifunction

patient monitoring equipment
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
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8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of

patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International standard IEC 60601-2-49 has been prepared by IEC subcommittee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
This second edition cancels and replaces the first edition of IEC 60601-2-49, published in
2001. This edition constitutes a technical revision to the new structure of IEC 60601-1:2005
(third edition).
60601-2-49  IEC:2011 – 5 –
The text of this particular standard is based on the following documents:

FDIS Report on voting
62D/886/FDIS 62D/908/RVD
Full information on the voting for the approval of this particular standard can be found in the

report on voting indicated in the above table.

This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.

In this standard, the following print types are used:
– Requirements and definitions: roman type.
– Test specifications: italic type.
– Informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type.
– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
NOTED: SMALL CAPITALS.
In referring to the structure of this standard, the term
– “clause” means one of the seventeen numbered divisions within the table of contents,
inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
– “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
subclauses of Clause 7).
References to clauses within this standard are preceded by the term “Clause” followed by the
clause number. References to subclauses within this particular standard are by number only.
In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this standard, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance
with this standard;
– “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this standard;

– “may” is used to describe a permissible way to achieve compliance with a requirement or
test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
indicates that there is guidance or rationale related to that item in Annex AA.
A list of all parts of the IEC 60601 series, published under the general title Medical electrical
equipment, can be found on the IEC website.

– 6 – 60601-2-49  IEC:2011
The committee has decided that the contents of this publication will remain unchanged until
the stability date indicated on the IEC web site under "http://webstore.iec.ch" in the data

related to the specific publication. At this date, the publication will be

• reconfirmed,
• withdrawn,
• replaced by a revised edition, or

• amended.
60601-2-49  IEC:2011 – 7 –
INTRODUCTION
This particular standard concerns the BASIC SAFETY and ESSENTIAL PERFORMANCE of

MULTIFUNCTION PATIENT MONITORING EQUIPMENT. It amends and supplements IEC 60601-1

(third edition, 2005): Medical electrical equipment – Part 1: General requirements for basic

safety and essential performance), hereinafter referred to as the general standard.

The aim of this second edition is to bring this particular standard up to date with reference to

the third edition of the general standard through reformatting and technical changes.

The requirements of this particular standard take priority over those of the general standard.

A “General guidance and rationale” for the requirements of this particular standard is included
in Annex AA. It is considered that knowledge of the reasons for these requirements will not
only facilitate the proper application of the standard but will, in due course, expedite any
revision necessitated by changes in clinical practice or as a result of developments in
technology. However, this Annex AA does not form part of the requirements of this standard.

– 8 – 60601-2-49  IEC:2011
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-49: Particular requirements for the basic

safety and essential performance of multifunction

patient monitoring equipment
201.1 Scope, object and related standards

Clause 1 of the general standard applies, except as follows:
201.1.1 * Scope
Replacement:
This particular standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE requirements of
MULTIFUNCTION PATIENT MONITORING EQUIPMENT as defined in 201.3.63, hereafter referred to as
ME EQUIPMENT. This particular standard applies to ME EQUIPMENT used in a hospital
environment as well as when used outside the hospital environment, such as in ambulances
and air transport.
ME EQUIPMENT intended for use under extreme or uncontrolled environmental conditions
outside the hospital environment, such as in ambulances and air transport, shall comply with
this particular standard. Additional standards may apply to ME EQUIPMENT for those
environments of use.
The scope of this standard is restricted to ME EQUIPMENT intended for connection to a single
PATIENT that has either two or more APPLIED PARTS or MULTIPLE FUNCTIONS on an APPLIED PART.
This standard does not specify requirements for individual monitoring functions such as ECG,
invasive pressure and pulse oximetry. The particular standards related to these physiological
parameters specify requirements from the perspective of stand-alone ME EQUIPMENT. This
particular standard addresses the differences related to MULTIFUNCTION PATIENT MONITORING
EQUIPMENT, since such equipment has a broader INTENDED USE than this stand-alone
ME EQUIPMENT.
201.1.2 Object
Replacement:
The object of this particular standard is to establish BASIC SAFETY and
ESSENTIAL PERFORMANCE requirements for MULTIFUNCTION PATIENT MONITORING EQUIPMENT as
defined in 201.3.63.
201.1.3 Collateral standards
Addition:
This particular standard refers to those applicable collateral standards that are listed in
Clause 2 of the general standard and Clause 201.2 of this particular standard.
—————————
The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for
basic safety and essential performance.

60601-2-49  IEC:2011 – 9 –
IEC 60601-1-2 and IEC 60601-1-8 apply as modified in Clauses 202 and 208 respectively.

IEC 60601-1-3 does not apply. All other published collateral standards in the IEC 60601-1

series apply as published.
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements

contained in the general standard and collateral standards as appropriate for the particular

ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL

PERFORMANCE requirements.
A requirement of a particular standard takes priority over the general standard.
For brevity, IEC 60601-1 is referred to in this particular standard as the general standard.
Collateral standards are referred to by their document number.
The numbering of clauses and subclauses of this particular standard corresponds to that of
the general standard with the prefix “201” (e.g. 201.1 in this particular standard addresses the
content of Clause 1 of the general standard) or applicable collateral standard with the prefix
“20x”, where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in
this particular standard addresses the content of Clause 4 of the IEC 60601-1-2 collateral
standard, 203.4 in this particular standard addresses the content of Clause 4 of the
IEC 60601-1-3 collateral standard, etc.). The changes to the text of the general standard are
specified by the use of the following words:
"Replacement" means that the clause or subclause of the general standard or applicable
collateral standard is replaced completely by the text of this particular standard.
"Addition" means that the text of this particular standard is additional to the requirements of
the general standard or applicable collateral standard.
"Amendment" means that the clause or subclause of the general standard or applicable
collateral standard is amended as indicated by the text of this particular standard.
Subclauses, figures or tables which are additional to those of the general standard are
numbered starting from 201.101. However, due to the fact that definitions in the general
standard are numbered 3.1 through 3.139, additional definitions in this standard are
numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and
additional items aa), bb), etc.

Subclauses, figures or tables which are additional to those of a collateral standard are
numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for
IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
The term "this standard" is used to make reference to the general standard, any applicable
collateral standards and this particular standard taken together.
Where there is no corresponding clause or subclause in this particular standard, the clause or
subclause of the general standard or applicable collateral standard, although possibly not
relevant, applies without modification; where it is intended that any part of the general
standard or applicable collateral standard, although possibly relevant, is not to be applied, a
statement to that effect is given in this particular standard.

– 10 – 60601-2-49  IEC:2011
201.2 Normative references
Clause 2 of the general standard applies, except as follows.

Replacement:
IEC 60601-1-2:2007, Medical electrical equipment – Part 1-2: General requirements for basic

safety and essential performance – Collateral standard: Electromagnetic compatibility –

Requirements and tests
IEC 60601-1-8:2006, Medical electrical equipment – Part 1-8: General requirements for basic

safety and essential performance – Collateral standard: General requirements, tests and
guidance for alarm systems in medical electrical equipment and medical electrical systems.
ISO 15223-1:2007, Medical devices – Symbols to be used with medical device labels,
labelling and information to be supplied – Part 1: General requirements
Addition:
IEC 60601-2-2:2009, Medical electrical equipment – Part 2-2: Particular requirements for the
basic safety and essential performance of high frequency surgical equipment and high
frequency surgical accessories
IEC 60601-2-27:___ , Medical electrical equipment – Part 2-27, Particular requirements for
the basic safety and essential performance of electrocardiographic monitoring equipment
IEC 60601-2-34:___ , Medical electrical equipment – Part 2-34, Particular requirements for
the basic safety and essential performance of invasive blood pressure monitoring equipment
201.3 Terms and definitions
NOTE An index of defined terms is found beginning on page 50.
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005
apply, except as follows:
Replacement:
201.3.63
MULTIFUNCTION PATIENT MONITORING EQUIPMENT

ME EQUIPMENT
modular or pre-configured device whose primary intended use is patient monitoring provided
with not more than one connection to a particular SUPPLY MAINS, including more than one
PHYSIOLOGICAL MONITORING UNIT designed to acquire physiological signals from a single
PATIENT and to process those signals for display purposes and to generate ALARM SIGNALS
Additional definitions:
201.3.201
MULTIPLE FUNCTION
measurement of more than one physiological function on one APPLIED PART
—————————
Third edition, to be published.
Third edition, to be published.

60601-2-49  IEC:2011 – 11 –
201.3.202
PART LEAKAGE CURRENT
current flowing from all PATIENT CONNECTION of one SINGLE FUNCTION of an APPLIED PART

through the PATIENT to the remaining PATIENT CONNECTION(S) of all other SINGLE FUNCTION(S) of

that same APPLIED PART under NORMAL CONDITIONS and not intended to produce a

physiological effect
201.3.203
PHYSIOLOGICAL MONITORING UNIT
part of the ME EQUIPMENT whose purpose is to collect information relating to (a) physiological
function(s) and to process it for monitoring and possibly also diagnostic purposes

201.3.204
SINGLE FUNCTION
measurement of one physiological function on one APPLIED PART
NOTE Examples of physiological functions are body temperature, ECG, ECG/impedance respiration, invasive and
non-invasive blood pressure etc.
201.4 General requirements
Clause 4 of the general standard applies, except as follows:
201.4.3 ESSENTIAL PERFORMANCE
201.4.3.101 Additional ESSENTIAL PERFORMANCE requirements
Additional ESSENTIAL PERFORMANCE requirements for MULTIFUNCTION PATIENT MONITORING
are found in subclauses listed in Table 201.101.
EQUIPMENT
Table 201.101 – ESSENTIAL PERFORMANCE requirements
Requirement Subclause
Defibrillator protection 201.8.5.5.1
Electrosurgery interference 202.6.2.101
Delays to or from a DISTRIBUTED ALARM SYSTEM 208.6.4.2

201.4.5 * Equivalent safety for ME EQUIPMENT or ME SYSTEMS
Addition:
When several particular standards simultaneously apply to MULTI-FUNCTION PATIENT
MONITORING EQUIPMENT, all relevant requirements from those standards shall be applied. If
requirements from particular standards are in conflict, the RISK MANAGEMENT PROCESS shall be
used to identify which standard’s requirement applies. In doing this, MANUFACTURERS are
strongly urged to give this particular standard’s requirements additional weight whenever
possible.
If the alarm requirements specified in other particular standards on MULTIFUNCTION PATIENT
MONITORING EQUIPMENT conflict with those of this particular standard, the alarm requirements
of this particular standard shall take priority over the others.

– 12 – 60601-2-49  IEC:2011
201.5 General requirements for testing of ME EQUIPMENT

Clause 5 of the general standard applies, except as follows:

201.5.4 Other conditions
Addition:
Unless otherwise stated, tests shall be carried out with the ACCESSORIES listed in the

instructions for use.
For ME EQUIPMENT with an INTERNAL ELECTRICAL POWER SOURCE, if the test result is affected by
the INTERNAL ELECTRICAL POWER SOURCE voltage, then the test shall be performed using the
least favourable INTERNAL ELECTRICAL POWER SOURCE voltage specified by the MANUFACTURER.
If necessary for the purpose of conducting the test, an external battery or d.c. power supply
may be used to provide the necessary test voltage (see 201.11.8.101).
The values used in test circuits, unless otherwise specified, shall have at least an accuracy as
given below:
– resistors: ± 1 %;
– capacitors: ± 10 %;
– inductors: ± 10 %;
– test voltages: ± 1 %.
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of the general standard applies, except as follows:
201.6.2 * Protection against electric shock
Replacement of the last paragraph:
APPLIED PARTS shall be classified as TYPE BF or CF APPLIED PARTS (see 7.2.10 and 8.3 of the
general standard). APPLIED PARTS shall be classified as DEFIBRILLATION-PROOF APPLIED PARTS
(see 8.5.5 of the general standard), unless another particular standard permits non-
DEFIBRILLATION-PROOF APPLIED PARTS or technical limitations prevent the design of
DEFIBRILLATION-PROOF APPLIED PARTS.
201.6.6 Mode of operation
Replacement:
ME EQUIPMENT shall be classified for CONTINUOUS OPERATION (see 7.2.11).
201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of the general standard applies with the following addition:
201.7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts
201.7.2.2 Identification
Addition:
60601-2-49  IEC:2011 – 13 –
When detachable, each PHYSIOLOGICAL MONITORING UNIT shall be identified by the following

markings and information:
a) MANUFACTURER's name or mark;

b) designation of the model either by a name specific to the model or by reference number or

reference letters;
c) serial number;
d) for ACCESSORIES of PHYSIOLOGICAL MONITORING UNITS: lot code, symbols 5.14, 5.15 and
5.16 from ISO 15223-1:2007, if applicable.

201.7.2.10 APPLIED PARTS
Addition:
For PATIENT input connections and ACCESSORIES of MULTIFUNCTION PATIENT MONITORING
the following additional marking requirements shall apply:
EQUIPMENT
a) Each connector of a PATIENT CONNECTION on the APPLIED PART shall be marked to identify
the associated function.
NOTE Examples of associated functions are ECG, ECG/Respiration or temperature.
b) * ACCESSORIES of a ME EQUIPMENT (for example, PATIENT CABLES, TRANSDUCERS or sensors)
specified as not being protected against the effects of defibrillation shall be marked with
symbol 10 of Table D.1 in Annex D of the general standard (see also 201.7.9.2.9.101 e)).
201.7.9.2.9 Operating instructions
Addition:
201.7.9.2.9.101 Additional instructions for use
The operating instructions shall include the following:
a) the INTENDED USE of the ME EQUIPMENT including the environment of use;
b) that the use of the me equipment is restricted to one patient at a time;
c) instructions for connecting a potential equalization conductor, if applicable;
d) adequate information (and type number, if necessary) to identify the accessories such as
PATIENT CABLES or TRANSDUCERS which need to be used to provide protection against the
effect of the discharge of a cardiac defibrillator and against burns;
PATIENT; a description of how the
e) precautions to take when using a defibrillator on a
discharge of a defibrillator affects the ME EQUIPMENT; a warning that defibrillator protection
requires use of MANUFACTURER specified ACCESSORIES, including PATIENT CABLES and

TRANSDUCERS. The specification (or type-number) of such ACCESSORIES shall be disclosed.
The necessary precautions to take if ACCESSORIES that are marked according to
201.7.2.10 (specified as not being protected against the effects of defibrillation) are being
used.
f) advice to the clinical OPERATOR regarding whether the ME EQUIPMENT incorporates means
to protect the PATIENT against burns when used with HIGH-FREQUENCY (HF) SURGICAL
EQUIPMENT. Advice shall be given regarding the location of ELECTRODES and TRANSDUCERS
NEUTRAL ELECTRODE
etc. to reduce the hazards of burns in the event of a defect in the
connection of the HF SURGICAL EQUIPMENT;
NOTE ‘NEUTRAL ELECTRODE’ here refers to a term defined in IEC 60601-2-2.
g) the choice and application of the specified ACCESSORIES;
h) * advice and procedures regarding testing of the ME EQUIPMENT and ACCESSORIES on a
daily basis (by the clinical OPERATOR) and on a scheduled basis (as a service activity).
Emphasis should be placed on how the clinician may test visual and auditory
ALARM SIGNALS.
– 14 – 60601-2-49  IEC:2011
i) identification of other PHYSIOLOGICAL MONITORING UNIT(S) the ME EQUIPMENT is intended to

be used;
j) the default settings (e.g. ALARM SETTINGS, ALARM PRESETS, modes, and filter settings);

k) simple fault finding methods for troubleshooting problems by which the clinical OPERATOR

can locate problems if the ME EQUIPMENT appears to be functioning incorrectly;

NOTE This relates to simple clinical OPERATOR difficulties, not to technical malfunctions.

l) the subsequent operation of the ME EQUIPMENT after interruption of the SUPPLY MAINS

exceeding 30 s (see 201.11.8);

m) advice on the preferred ALARM SETTINGS and configurations of the ALARM SYSTEM when

INTENDED USE includes the monitoring of PATIENTS that are not continuously attended by a

clinical OPERATOR;
n) the configuration procedure that allows the ALARM SIGNAL inactivation states (ALARM
, AUDIO PAUSED, ALARM OFF, AUDIO OFF) and the function ALARM RESET to be
PAUSED
controlled remotely (see 208.6.11.101), if provided;
o) * description of how to disable ALARM SIGNALS for TECHNICAL ALARM CONDITIONS if sensors,
probes, or modules are intentionally disconnected by the clinical OPERATOR;
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
Clause 8 of the general standard applies, except as follows:
201.8.3 Classification of APPLIED PARTS
Replacement of item c):
c) An APPLIED PART not covered by a) or b) shall be a TYPE BF APPLIED PART or
TYPE CF APPLIED PART.
201.8.5 Separation of parts
201.8.5.2.3 * PATIENT leads
Addition:
Any connector for electrical connections on a PATIENT lead that is at the end of the lead
remote from the ME EQUIPMENT shall be so constructed that said part cannot be connected to
earth or possible hazardous voltage while other PATIENT CONNECTIONS of the same
SINGLE FUNCTION or of MULTIPLE FUNCTIONS on the same APPLIED PART contact the PATIENT. For
APPLIED PARTS having multiple PATIENT CONNECTIONS any connector in a lead having electrical
connections to ME EQUIPMENT shall comply with one of the following requirements:

– the air clearance between connector pins and a flat surface shall be at least 0,5 mm; or
– ME EQUIPMENT shall pass the limits of the total PATIENT LEAKAGE CURRENT caused by an
external voltage on the PATIENT CONNECTIONS (see 8.7 and Table 4 of the general
standard) when measured between different SINGLE FUNCTIONS (see Figure CC.3).
201.8.5.5 DEFIBRILLATION-PROOF APPLIED PARTS
201.8.5.5.1 * Defibrillation protection
Addition to a)
– unused PATIENT CONNECTIONS of any other MULTIPLE FUNCTION on the same APPLIED PART.
Replacement of b):
60601-2-49  IEC:2011 – 15 –
Following exposure to the defibrillation voltage, the ME EQUIPMENT shall resume normal

operation after a recovery time not exceeding 15 s without any OPERATOR interactions, unless

other recovery times are specified by applicable particular standard/s. The ME EQUIPMENT shall

resume normal operation in the previous operating mode, without loss of any OPERATOR

settings or stored data, and shall continue to provide BASIC SAFETY and ESSENTIAL

PERFORMANCE.
Addition:
aa) ME EQUIPMENT shall be energized for the common-mode test and differential mode test.

201.8.7 LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS
201.8.7.1 General requirements
Addition:
201.8.7.1.101 * PART LEAKAGE CURRENT
The PART LEAKAGE CURRENT of APPLIED PARTS shall comply with the following requirements:
a) PART LEAKAGE CURRENT of TYPE BF APPLIED PARTS
In NORMAL CONDITION the PART LEAKAGE CURRENT shall not exceed the values of
PATIENT AUXILIARY CURRENTS as specified in Table 3 of the general standard for
TYPE BF APPLIED PARTS. The SINGLE FAULT CONDITIONS specified in 8.7.2 of the general
standard do not apply for this test.
The PART LEAKAGE CURRENT of TYPE BF APPLIED PARTS shall be measured between any
SINGLE FUNCTION and the remaining SINGLE FUNCTIONS of the same APPLIED PART in turn.
The PATIENT CONNECTIONS shall be connected together.
Compliance is checked by verifying that the measured currents are below the limits
specified in Table 3 of the general standard for PATIENT AUXILIARY CURRENTS of
TYPE BF APPLIED PARTS in NORMAL CONDITION. The SINGLE FAULT CONDITIONS specified in
8.7.2 of the general standard do not apply for this test.
b) PART LEAKAGE CURRENT of TYPE CF APPLIED PARTS
In NORMAL CONDITION the PART LEAKAGE CURRENT shall not exceed the values of
PATIENT AUXILIARY CURRENTS as specified in Table 3 of the general standard for

TYPE CF APPLIED PARTS.
In TYPE CF APPLIED PARTS, the PART LEAKAGE CURRENT shall be measured in turn between
each PATIENT CONNECTION of the same SINGLE FUNCTION and the remaining
SINGLE FUNCTIONS connected together.
Compliance is checked by verifying that the measured currents are below the limits
specified in Table 3 of the general standard for PATIENT AUXILIARY CURRENTS of
TYPE CF APPLIED PARTS in NORMAL CONDITION. The SINGLE FAULT CONDITIONS specified in
8.7.2 of the general standard do not apply for this test.
NOTE See Annex CC for examples of test configurations.

– 16 – 60601-2-49  IEC:2011
201.9 Protection against mechanical hazards of ME EQUIPMENT and

ME SYSTEMS
Clause 9 of the general standard applies.

201.10 Protection against unwanted and excessive radiation HAZARDS

Clause 10 of the general standard applies.

201.11 Protection against excessive temperatures and other HAZARDS
Clause 11 of the general standard applies, except as follows:
201.11.6.5 * Ingress of water or particulate matter into ME EQUIPMENT and ME SYSTEMS
Addition:
PORTABLE/TRANSPORTABLE ME EQUIPMENT or parts of the ME EQUIPMENT separable while
remaining functioning shall be constructed so that, in the event of spillage of liquids
(accidental wetting) no HAZARDOUS SITUATION results from the ingress of liquids.
ME EQUIPMENT shall meet the dielectric strength requirements specified in 8.8.3 of the
The
general standard and shall comply with the requirements of this particular standard.
Compliance is checked by the following test:
Place the PORTABLE/TRANSPORTABLE ME EQUIPMENT or parts of the ME EQUIPMENT in the least
favourable position of NORMAL USE. Subject the ME EQUIPMENT for 30 s to an artificial rainfall of
3 mm/min falling vertically from a height of 0,5 m above the top of the ME EQUIPMENT.
A test apparatus is shown in Figure 3 of IEC 60529.
An intercepting device may be used to determine the duration of the test.
Immediately after 30 s exposure, remove any visible moisture on the ENCLOSURE.
Immediately after the above test, verify (by inspection) that any water that entered the
ME EQUIPMENT cannot adversely affect the BASIC SAFETY of the ME EQUIPMENT. Verify that the
ME EQUIPMENT meets the relevant dielectric strength test (8.8.3 of the general standard) and

HAZARDOUS SITUATION.
does not result in a
After this test, verify that the ME EQUIPMENT complies with the requirements of this particular
standard.
201.11.8 * Interruption of the power supply / SUPPLY MAINS to ME EQUIPMENT
Addition:
If the SUPPLY MAINS to the ME EQUIPMENT is interrupted for 30 s or less, no change of clinical
OPERATOR settings shall occur, including the mode of operation, and all stored PATIENT data
shall remain available.
NOTE The ME EQUIPMENT does not have to be operating during the interruption of the SUPPLY MAINS.

60601-2-49  IEC:2011 – 17 –
Compliance is checked by observing the ME EQUIPMENT operating mode, OPERATOR settings,

and stored data and interrupting the SUPPLY MAINS for a period of between 25 s and 30 s by

disconnecting the POWER SUPPLY CORD.

If the SUPPLY MAINS is interrupted for more than 30 s, the subsequent operation shall be one of

the following:
– reversion to the MANUFACTURER’s default settings,

– reversion to the previous RESPONSIBLE ORGANIZATION’S default settings or

– reversion to the last settings used.

NOTE Means may be provided to the OPERATOR to select one or more than one of the above options.
Compliance is be checked by functional test.
If ME EQUIPMENT contains an INTERNAL ELECTRICAL POWER SOURCE and the SUPPLY MAINS is
interrupted, the ME EQUIPMENT shall continue normal operation by switching automatically to
operating from its INTERNAL ELECTRICAL POWER SOURCE, and the mode of operation, all
OPERATOR settings and stored data shall not be changed. Power-saving measures may be
taken provided the ME EQUIPMENT continues to conform to this particular standard.
ME EQUIPMENT shall visually indicate when it is operating from its INTERNAL ELECTRICAL
POWER SOURCE.
Compliance is checked by interrupting the SUPPLY MAINS and observing that OPERATOR
settings and stored data are not changed, that normal operation continues, and that a visual
indication is displayed that ME EQUIPMENT is operating from its INTERNAL ELECTRICAL POWER
. The ‘on-off’ switch needs to remain in the ‘on’ position.
SOURCE
Addition:
201.11.8.101 Protection against depletion of battery
ME EQUIPMENT powered from an INTERNAL ELECTRICAL POWER SOURCE shall not cause a
HAZARDOUS SITUATION to the PATIENT
...