IEC 60601-1:2005/AMD1:2012

IEC 60601-1 ®
Edition 3.0 2012-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
AMENDMENT 1
AMENDEMENT 1
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
IEC 60601-1:2005/A1:2012
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IEC 60601-1 ®
Edition 3.0 2012-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
AMENDMENT 1
AMENDEMENT 1
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 XE
ICS 11.040 ISBN 978-2-83220-227-2

– 2 – 60601-1 Amend.1 © IEC:2012
FOREWORD
This amendment 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 amendment is based on the following documents:
FDIS Report on voting
62A/805/FDIS 62A/820/RVD
Full information on the voting for the approval of this amendment can be found in the report
on voting indicated in the above table.
The committee has decided that the contents of this amendment and the base 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• withdrawn,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.
The contents of the corrigendum of July 2014 have been included in this copy.
IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct
understanding of its contents. Users should therefore print this document using a
colour printer.
_____________
60601-1 Amend.1 © IEC:2012 – 3 –
INTRODUCTION TO THE AMENDMENT
The third edition of IEC 60601-1 was published in 2005. At the time of publication, there were
nd
94 National Committee comments on the 2 CDV and the FDIS that were deferred to a future
amendment/revision. Each of their deferred comments was captured in an Issue Sheet by the
SC 62A secretariat. By the time of the Auckland meeting in April 2008, the Subcommittees
had developed two Interpretation Sheets and the SC 62A secretariat has received an
additional 15 issues from National Committees and other interested parties.
st
At the Auckland meeting, IEC/TC 62 approved a project to develop the 1 amendment to
IEC 60601-1:2005 based on the issues outstanding at the time. The TC approved developing
st
the 1 amendment with a view to addressing outstanding issues, including but not limited to:
– those listed in 62A/593/DC and 62A/602/INF;
– the way in which risk management has been introduced into IEC 60601-1:2005; and
– the way the concept of essential performance is used in IEC 60601-1:2005.
Since the Auckland meeting, the secretariat has received 73 additional issues from National
Committees or other interested parties for a total of 182 Issues Sheets. This amendment is
intended to address those issues.

– 4 – 60601-1 Amend.1 © IEC:2012
FOREWORD
Replace the paragraph beginning "This third edition cancels…" with the following:
This third edition cancels and replaces the second edition published in 1988, its Amendment 1
(1991) and Amendment 2 (1995), the second edition of IEC 60601-1-1 published in 2000 and
the first edition of IEC 60601-1-4 published in 1996 and its Amendment 1 (1999). This edition
constitutes a technical revision. This edition has been significantly restructured. Requirements
in the electrical section have been further aligned with those for information technology
equipment covered by IEC 60950-1 and a requirement for including a RISK MANAGEMENT
PROCESS has been added. For an expanded description of this revision, see Annex A.3.
Add the following note at the end of the Foreword:
NOTE The attention of National Committees is drawn to the fact that equipment manufacturers and testing
organizations may need a transitional period following publication of a new, amended or revised IEC or ISO
publication in which to make products in accordance with the new requirements and to equip themselves for
conducting new or revised tests. It is the recommendation of the committee that the content of this publication be
adopted for mandatory implementation nationally not earlier than 3 years from the date of publication.
INTRODUCTION
In the second dash of the existing ninth paragraph, replace the final sentence with:
Compliance with this edition of IEC 60601-1 requires that the MANUFACTURER have in place a
RISK MANAGEMENT PROCESS complying with parts of ISO 14971 (see 4.2).
After the last paragraph of the introduction, insert the following new paragraph:
Amendment 1 to this standard is intended to address:
– issues identified by National Committees and other interested parties since the publication
of IEC 60601-1:2005;
– the way in which RISK MANAGEMENT has been introduced into IEC 60601-1:2005; and
– the way the concept of ESSENTIAL PERFORMANCE is used in IEC 60601-1:2005.
1 Scope, object and related standards
1.1 * Scope
Renumber the note as Note 1.
Delete the fourth paragraph.
Replace the fifth paragraph with:
The IEC 60601 series does not apply to:
– in vitro diagnostic equipment that does not fall within the definition of ME EQUIPMENT, which
is covered by the IEC 61010 series [61];
– implantable parts of active implantable medical devices covered by the ISO 14708
series [69]; or
– medical gas pipeline systems covered by ISO 7396-1 [68].
NOTE 2 ISO 7396-1 applies the requirement of IEC 60601-1-8 to certain monitoring and ALARM SIGNALS.

60601-1 Amend.1 © IEC:2012 – 5 –
1.3 * Collateral standards
Replace Note 3 with:
NOTE 3 Collateral standards in the IEC 60601 family are numbered IEC 60601-1-xx. The IEC maintains a
catalogue of valid International Standards. Users of this standard should consult this catalogue at
"http://webstore.iec.ch" to determine which collateral standards have been published.
1.4 * Particular standards
Replace the note with:
NOTE Particular standards in the IEC 60601 family that are developed by IEC committees are numbered
IEC 60601-2-xx. In addition, particular standards developed by joint projects between ISO and IEC can be
numbered either IEC 80601-2-xx or ISO 80601-2-xx depending on which committee administered the project. IEC
and ISO maintain catalogues of valid International Standards. Users of this standard should consult these
catalogues at "http://webstore.iec.ch" and "http://www.iso.org/iso/store.htm" to determine which particular
standards have been published.
2 * Normative references
Update the following normative references:
)
IEC 60065:2001, Audio, video and similar electronic apparatus – Safety requirements
Amendment 1:2005
Amendment 2:2010
IEC 60068-2-2:2007, Environmental testing – Part 2-2: Tests – Test B: Dry heat
IEC 60227-1:2007, Polyvinyl chloride insulated cables of rated voltages up to and including
450/750 V – Part 1: General requirements
IEC 60245-1:2003, Rubber insulated cables – Rated voltages up to and including 450/750 V –
Part 1: General requirements
Amendment 1:2007
IEC 60335-1:2010, Household and similar electrical appliances – Safety – Part 1: General
requirements
IEC 60417, Graphical symbols for use on equipment. Available from:
symbols.info/equipment>
IEC 60601-1-3, Medical electrical equipment – Part 1-3: General requirements for basic safety
and essential performance: Collateral standard: Radiation protection in diagnostic X-ray
equipment
IEC 60664-1:2007, Insulation coordination for equipment within low-voltage systems – Part 1:

Principles, requirements and tests
IEC 60730-1:2010, Automatic electrical controls for household and similar use – Part 1:
General requirements
IEC 60825-1:2007, Safety of laser products – Part 1: Equipment classification and
requirements
___________
1)
There exists a consolidated edition 7.2 including IEC 60065:2001 and its Amendment 1 (2005) and
Amendment 2 (2010).
2)
There exists a consolidated edition 4.1 including IEC 60245-1:2003 and its Amendment 1 (2007).

– 6 – 60601-1 Amend.1 © IEC:2012
IEC 60851-3:2009, Winding wires – Test methods – Part 3: Mechanical properties
IEC 60851-5:2008, Winding wires – Test methods – Part 5: Electrical properties
)
IEC 61058-1:2000, Switches for appliances – Part 1: General requirements
Amendment 1:2001
Amendment 2:2007
ISO 7010:2011, Graphical symbols – Safety colours and safety signs –Registered safety signs
ISO 14971:2007, Medical devices – Application of risk management to medical devices
Replace the existing references to ISO 11135, ISO 11137, ISO 13852 and ISO 15223 by the
following:
ISO 11135-1:2007, Sterilization of health care products – Ethylene oxide – Part 1:
Requirements for development, validation and routine control of a sterilization process for
medical devices
ISO 11137-1:2006, Sterilization of health care products – Radiation – Part 1: Requirements
for development, validation and routine control of a sterilization process for medical devices
ISO 13857:2008, Safety of machinery – Safety distances to prevent hazard zones being
reached by the upper and lower limbs
ISO 15223-1:2012, Medical devices – Symbols to be used with medical device labels,
labelling and information to be supplied – Part 1: General requirements
Delete the following normative references:
IEC 60878:2003, Graphical symbols for electrical equipment in medical practice
IEC 61558-1:1997, Safety of power transformers, power supply units and similar –
Part 1: General requirements and tests
Amendment 1:1998
ISO 31 (all parts), Quantities and units
ISO 1000, SI units and recommendations for the use of their multiples and of certain other
units
ISO 11134, Sterilization of health care products – Requirements for validation and routine
control – Industrial moist heat sterilization
Add the following new normative references:
IEC 62133, Secondary cells and batteries containing alkaline or other non-acid electrolytes –
Safety requirements for portable sealed secondary cells, and for batteries made from them,
for use in portable applications
IEC 62304:2006, Medical device software – Software lifecycle processes
___________
3)
There exists a consolidated edition 3.2, including IEC 61058-1:2000 and its Amendment 1 (2001) and
Amendment 2 (2007)
60601-1 Amend.1 © IEC:2012 – 7 –
ISO 17665-1:2006, Sterilization of health care products – Moist heat – Part 1: Requirements
for the development, validation and routine control of a sterilization process for medical
devices
ISO 80000-1:2009, Quantities and units – Part 1: General
3 * Terminology and definitions
Add a new Note 3 and renumber the existing Note 3 to Note 4:
NOTE 3 When the term "safety" is used in this document in roman or italic type, it does not mean "safety" as
defined in ISO 14971, but rather is used to mean "the state of being protected from or guarded against hurt or
injury; freedom from danger”.
3.5
AIR CLEARANCE
Replace the existing note with the following:
NOTE Adapted from IEC 60664-1:2007, definition 3.2.
Figure 2 – Example of the defined terminals and conductors
In the key, replace " MAINS CONDUCTOR" by " MAINS CONNECTOR".
3.15
CLEARLY LEGIBLE
Add an asterisk before the term and replace the existing note by the following:
NOTE See the test in 7.1.2.
3.25
EARTH LEAKAGE CURRENT
Replace the existing definition with the following:
current flowing from the MAINS PART through or across the insulation into the PROTECTIVE
EARTH CONDUCTOR or a functional earthed connection according to 8.6.9
3.27
* ESSENTIAL PERFORMANCE
Replace the existing definition with the following:
performance of a clinical function, other than that related to BASIC SAFETY, where loss or
degradation beyond the limits specified by the MANUFACTURER results in an unacceptable RISK
3.28
EXPECTED SERVICE LIFE
Replace the existing definition with the following:
time period specified by the MANUFACTURER during which the ME EQUIPMENT or ME SYSTEM is
expected to remain safe for use (i.e. maintain BASIC SAFETY and ESSENTIAL PERFORMANCE)
NOTE Maintenance can be necessary during the EXPECTED SERVICE LIFE.
3.30
FIXED
Add the following note after the examples:

– 8 – 60601-1 Amend.1 © IEC:2012
NOTE See the taxonomy in the rationale for definition 3.63.
3.37
HAND-HELD
Replace the existing definition with the following:
term referring to equipment that, once installed and placed into service, is intended to be
supported by the hand
NOTE 1 Equipment can refer to ACCESSORIES or equipment parts.
NOTE 2 See the taxonomy in the rationale for definition 3.63.
3.38
HARM
Replace the source citation with the following:
[ISO 14971:2007, definition 2.2, modified]
3.39
HAZARD
Replace the existing source citation with the following:
[ISO 14971:2007, definition 2.3]
3.40
HAZARDOUS SITUATION
Replace the existing source citation with the following:
[ISO 14971:2007, definition 2.4]
3.43
INSULATION CO-ORDINATION
Add a note to the existing definition as follows:
NOTE This includes insulation types, CREEPAGE DISTANCES, AIR CLEARANCES, distance through insulation,
coatings, encapsulation, environmental aspects, etc.
3.44
* INTENDED USE
INTENDED PURPOSE
Delete the asterisk in front of the term and replace the existing definition and note with the
following:
PROCESS or service is intended according to the specifications,
use for which a product,
instructions and information provided by the MANUFACTURER
[ISO 14971:2007, definition 2.5]
NOTE INTENDED USE should not be confused with NORMAL USE. While both include the concept of use as intended
by the MANUFACTURER, INTENDED USE focuses on the medical purpose while NORMAL USE incorporates not only the
medical purpose, but maintenance, transport, etc. as well.
3.49
* MAINS PART
Replace the existing definition and the notes with the following:
part of electrical equipment forming a circuit that is intended to be connected to the SUPPLY
MAINS
60601-1 Amend.1 © IEC:2012 – 9 –
NOTE 1 The MAINS PART includes all conductive parts that are not separated from the SUPPLY MAINS by at least
one MEANS OF PROTECTION.
NOTE 2 For the purpose of this definition, the PROTECTIVE EARTH CONDUCTOR is not regarded as a part of the
MAINS PART (see Figure 2 and Figure 3).
3.55
MANUFACTURER
Replace existing Note 4 with:
NOTE 4 Adapted from ISO 14971:2007, definition 2.8.
3.65
MOBILE
Replace the existing definition with the following:
term referring to TRANSPORTABLE equipment that, once installed and placed into service, is
intended to be moved from one location to another while supported by its own wheels or
equivalent means
NOTE See the taxonomy in the rationale for definition 3.63.
3.67
MULTIPLE SOCKET-OUTLET
MSO
In the existing definition, replace "cables or cords or ME EQUIPMENT for" with "cables, cords or

ME EQUIPMENT providing".
3.71
NORMAL USE
In the existing note, delete the term "service" in the last line of the sentence.
3.72
OBJECTIVE EVIDENCE
Replace the existing definition with the following:
data supporting the existence or verity of something
NOTE Objective evidence can be obtained through observation, measurement, testing or other means.
[ISO 14971:2007, definition 2.10]
3.76
PATIENT
Add a note to the definition as follows:
NOTE A PATIENT can be an OPERATOR.
3.81
PEAK WORKING VOLTAGE
Replace the existing source citation with the following:
[IEC 60950-1:2005, definition 1.2.9.8, modified]
3.85
PORTABLE
Replace the existing definition with the following:

– 10 – 60601-1 Amend.1 © IEC:2012
term referring to TRANSPORTABLE equipment that, once installed and placed into service, is
intended to be moved from one location to another while being carried by one or more
persons
NOTE 1 Equipment can refer to ACCESSORIES or equipment parts.
NOTE 2 See the taxonomy in the rationale for definition 3.63.
3.88
PROCEDURE
Replace the existing definition with the following:
specified way to carry out an activity or a PROCESS
[ISO 14971:2007, definition 2.12]
3.89
PROCESS
Replace the existing definition with the following:
set of interrelated or interacting activities which transforms inputs into outputs
[ISO 14971:2007, definition 2.13]
3.98
RECORD
Replace the existing definition with the following:
document stating results achieved or providing evidence of activities performed
[ISO 14971:2007, definition 2.14]
3.100
RESIDUAL RISK
Replace the existing definition with the following:
RISK remaining after RISK CONTROL measures have been taken
[ISO 14971:2007, definition 2.15]
3.102
RISK
Replace the existing source citation with the following:
[ISO 14971:2007, definition 2.16]
3.103
RISK ANALYSIS
Replace the existing source citation with the following:
[ISO 14971:2007, definition 2.17]
3.104
RISK ASSESSMENT
Replace the existing source citation with the following:
[ISO 14971:2007, definition 2.18]

60601-1 Amend.1 © IEC:2012 – 11 –
3.105
RISK CONTROL
Replace the existing definition with the following:
PROCESS in which decisions are made and measures implemented by which RISKS are reduced
to, or maintained within, specified levels
[ISO 14971:2007, definition 2.19]
3.106
RISK EVALUATION
Replace the existing definition with the following:
PROCESS of comparing the estimated RISK against given RISK criteria to determine the
acceptability of the RISK
[ISO 14971:2007, definition 2.21]
3.107
RISK MANAGEMENT
Replace the existing definition with the following:
PROCEDURES and practices to the tasks of
systematic application of management policies,
analyzing, evaluating and controlling RISK
[ISO 14971:2007, definition 2.22]
NOTE For the purposes of this standard, RISK MANAGEMENT does not include planning for or monitoring of
production and post-production information; whereas this is required for compliance with ISO 14971 (see 4.2.2).
3.108
RISK MANAGEMENT FILE
Replace the existing definition with the following:
set of RECORDS and other documents that are produced by RISK MANAGEMENT
[ISO 14971:2007, definition 2.23]
NOTE All safety related information including MANUFACTURER'S calculations, test results, etc. is considered to be
part of the RISK MANAGEMENT FILE. See also 4.2.
3.114
SEVERITY
Replace the existing source citation with the following:
[ISO 14971:2007, definition 2.25]
3.116
SINGLE FAULT CONDITION
Replace the existing definition with the following:
condition of ME EQUIPMENT in which a single means for reducing a RISK is defective or a single
abnormal condition is present
NOTE See 4.7 and 13.2.
3.118
STATIONARY
Replace the existing definition with the following:

– 12 – 60601-1 Amend.1 © IEC:2012
term referring to equipment that, once installed and placed into service, is not intended to be
moved from one place to another
NOTE See the taxonomy in the rationale for definition 3.63.
3.130
TRANSPORTABLE
Replace the existing definition with the following:
term referring to equipment that, once installed and placed into service, is intended to be
moved from one place to another whether or not connected to a supply and without an
appreciable restriction of range
EXAMPLES MOBILE equipment, PORTABLE equipment and BODY-WORN equipment
NOTE See the taxonomy in the rationale for definition 3.63.
3.132
TYPE B APPLIED PART
Delete the reference to "DB" in two places in Note 1.
3.133
TYPE BF APPLIED PART
Delete the reference to "DB" in two places in Note 1.
3.134
TYPE CF APPLIED PART
Delete the reference to "DB" in two places in Note 1 and insert Note 3 as follows:
NOTE 3 See the rationale for the definition of DIRECT CARDIAC APPLICATION (3.22) concerning the applied parts
that need to be TYPE CF APPLIED PARTS.
3.136
USABILITY
Replace the existing definition with the following:
characteristic of the OPERATOR interface that establishes effectiveness, efficiency, ease of
OPERATOR learning and OPERATOR satisfaction
[IEC 62366:2007, definition 3.17, modified]
3.137
USABILITY ENGINEERING
Replace the existing definition with the following:
application of knowledge about human behaviour, abilities, limitations, and other
characteristics to the design of tools, devices, systems, tasks, jobs, and environments to
achieve adequate USABILITY
[IEC 62366:2007, definition 3.18]
3.138
VERIFICATION
Replace the existing definition with the following:
confirmation, through the provision of OBJECTIVE EVIDENCE, that specified requirements have
been fulfilled
NOTE 1 The term “verified” is used to designate the corresponding status.

60601-1 Amend.1 © IEC:2012 – 13 –
NOTE 2 Confirmation can comprise activities such as:
– performing alternative calculations;
– comparing a new design specification with a similar proven design specification;
– undertaking tests and demonstrations;
– reviewing documents prior to issue.
[ISO 14971:2007, definition 2.28]
3.139
WORKING VOLTAGE
Replace the existing source citation with the following:
[IEC 60950-1:2005, definition 1.2.9.6]
Add the following new definitions:
3.140
AIR KERMA
K
by dm, where dE is the sum of the initial kinetic energies of all the charged
quotient of dE
tr tr
particles liberated by uncharged particles in a mass dm of air, thus
dE
tr
K =
dm
–1
Unit: J kg
The special name for the unit of AIR KERMA is gray (Gy) (ICRU 60)
[IEC 60601-1-3:2008, definition 3.4]
3.141
ALARM CONDITION
state of the ALARM SYSTEM when it has determined that a potential or actual HAZARDOUS
SITUATION exists for which OPERATOR awareness or response is required
NOTE 1 An ALARM CONDITION can be invalid, i.e. a false positive ALARM CONDITION.
NOTE 2 An ALARM CONDITION can be missed, i.e. a false negative ALARM CONDITION.
[IEC 60601-1-8:2006 / Amendment 1 (2012), definition 3.1]
3.142
ALARM SIGNAL
type of signal generated by the ALARM SYSTEM to indicate the presence (or occurrence) of an
ALARM CONDITION
[IEC 60601-1-8:2006, definition 3.9]
3.143
ALARM SYSTEM
parts of ME EQUIPMENT or a ME SYSTEM that detect ALARM CONDITIONS and, as appropriate,
generate ALARM SIGNALS
[IEC 60601-1-8:2006, definition 3.11]
3.144
BODY-WORN
term referring to TRANSPORTABLE equipment whose INTENDED USE includes operation while
being worn by a PATIENT or attached to a PATIENT’S clothing

– 14 – 60601-1 Amend.1 © IEC:2012
NOTE 1 TRANSPORTABLE equipment can be both BODY-WORN and HAND-HELD.
[IEC 60601-1-11:2010, definition 3.1]
NOTE 2 See the taxonomy in the rationale for definition 3.63.
3.145
IT-NETWORK
INFORMATION TECHNOLOGY NETWORK
a system or systems composed of communicating nodes and transmission links to provide
physically linked or wireless transmission between two or more specified communication
nodes
[IEC 80001-1:2010, definition 2.12]
3.146
PRIMARY OPERATING FUNCTION
function that involves OPERATOR interaction that is frequently used or related to the safety of
the ME EQUIPMENT
[IEC 62366:2007, definition 3.14, modified]
3.147
USABILITY ENGINEERING FILE
set of RECORDS and other documents that are produced by the USABILITY ENGINEERING
PROCESS
[IEC 62366:2007, definition 3.19]
4 General requirements
4.2 * RISK MANAGEMENT PROCESS for ME EQUIPMENT or ME SYSTEMS
Replace the existing text of the subclause with the following:
4.2.1 Introduction to RISK MANAGEMENT
RISK MANAGEMENT PROCESS that is required for compliance with
Subclause 4.2 specifies the
this standard. This RISK MANAGEMENT PROCESS is intended to serve the following purposes:
a) To identify whether the normative requirements specified in Clauses 5 to 17 of this
standard, together with the requirements of applicable collateral and particular standards,
address all the HAZARDS associated with the particular ME EQUIPMENT or ME SYSTEM under
consideration.
b) To identify the way in which some particular tests specified in this standard should be
applied to a particular ME EQUIPMENT or ME SYSTEM.
c) To identify whether particular HAZARDS or HAZARDOUS SITUATIONS for which this standard
does not provide specific acceptance criteria result in any RISKS for a particular
ME EQUIPMENT or ME SYSTEM, and, if so, to establish acceptable RISK levels and evaluate
the RESIDUAL RISKS.
d) To evaluate the acceptability of alternative RISK CONTROL strategies by comparing
RESIDUAL RISK with that achieved by applying the full requirements of this standard.
Although the RISK MANAGEMENT PROCESS specified in this standard is required to comply with
the relevant requirements of ISO 14971, it is not as extensive as and does not include all of
RISK MANAGEMENT
the elements required for compliance with ISO 14971. For example, the
PROCESS required for compliance with this standard does not include the production and post-
production monitoring required in ISO 14971. Furthermore, verification of compliance with the
RISK MANAGEMENT requirements of this standard can be accomplished by examination of the

60601-1 Amend.1 © IEC:2012 – 15 –
RECORDS and other documentation required by this standard and assessment of the
processes cited in this standard and does not require auditing of the RISK MANAGEMENT
PROCESS.
4.2.2 General requirement for RISK MANAGEMENT
A RISK MANAGEMENT PROCESS complying with ISO 14971 shall be performed. For compliance
with this standard, all elements of the ISO 14971:2007 RISK MANAGEMENT PROCESS shall be
applied except:
– the planning for and execution of production and post-production monitoring (subclause
3.1, fourth dash, subclause 3.4, item f), and Clause 9 of ISO 14971:2007), and
RISK MANAGEMENT PROCESS (subclause 3.2, fourth
– periodic reviews of the suitability of the
dash, of ISO 14971:2007).
When applying any of the requirements of ISO 14971:
– the term “medical device” shall assume the same meaning as ME EQUIPMENT or ME SYSTEM;
and
– the term “fault conditions” referred to in ISO 14971 shall include, but shall not be limited
to, SINGLE FAULT CONDITIONS identified in this standard.
NOTE 1 This standard specifies requirements that are generally applicable to RISKS associated with the
ME EQUIPMENT or ME SYSTEMS. Those requirements are intended to facilitate the RISK MANAGEMENT PROCESS. The
RISK MANAGEMENT PROCESS is aimed at identifying not only those HAZARDS addressed by this standard, but all
HAZARDS, their associated RISKS and RISK CONTROL measures.
NOTE 2 Conditions or faults that can give rise to HAZARDOUS SITUATIONS are identified in the clauses of this
standard. In these cases, it will often be necessary to carry out a RISK MANAGEMENT PROCESS to determine what the
actual HAZARDOUS SITUATIONS are and the tests that need to be done to show that the identified HAZARDOUS
SITUATIONS do not arise in the specified circumstances.
NOTE 3 It is recognized that the MANUFACTURER might not be able to follow all the PROCESSES identified in this
standard for each constituent component of the ME EQUIPMENT or ME SYSTEM, such as proprietary components,
subsystems of non-medical origin, and legacy devices. In this case, the MANUFACTURER would need to take special
account of the need for additional RISK CONTROL measures.
NOTE 4 Where requirements of this standard refer to freedom from unacceptable RISK, acceptability or
unacceptability of this RISK is determined by the MANUFACTURER in accordance with the MANUFACTURER’S policy for
determining acceptable RISK.
NOTE 5 Not all the RISKS associated with the ME EQUIPMENT or ME SYSTEM are subject to specific requirements of
this standard (see 1.1).
Compliance is checked by:
– inspection of the MANUFACTURER'S policy for determining criteria for RISK acceptability;
– inspection of the RISK MANAGEMENT plan for the particular ME EQUIPMENT or ME SYSTEM
under consideration; and
– confirming the MANUFACTURER has prepared a RISK MANAGEMENT FILE containing the RISK
MANAGEMENT RECORDS and other documentation required by this standard for the particular
ME EQUIPMENT or ME SYSTEM under consideration.
NOTE 6 It is helpful to keep an index containing references or pointers to the RISK MANAGEMENT RECORDS and
other documentation required by this standard.
4.2.3 Evaluating RISK
4.2.3.1 HAZARDS identified in the IEC 60601-series
The requirements of this standard shall be applied in the following way when evaluating RISK:
a) Where this standard or its collateral or particular standards specify requirements
addressing particular HAZARDS or HAZARDOUS SITUATIONS, together with specific acceptance
criteria, compliance with these requirements is presumed to establish that the RESIDUAL

– 16 – 60601-1 Amend.1 © IEC:2012
RISKS have been reduced to acceptable levels unless there is OBJECTIVE EVIDENCE to the
contrary.
EXAMPLE 1 Subclause 8.5.1.2, MEANS OF PATIENT PROTECTION (MOPP)
EXAMPLE 2 Subclause 9.4.2.1, Instability in transport position
Compliance is checked by satisfying the relevant requirements of this standard and its
collateral and particular standards.
b) Where this standard or its collateral or particular standards specify requirements
addressing particular HAZARDS or HAZARDOUS SITUATIONS but do not provide specific
acceptance criteria, the MANUFACTURER shall provide the acceptance criteria defined in the
RISK MANAGEMENT plan. These acceptance criteria shall ensure that the RESIDUAL RISK is
acceptable according to the criteria for RISK acceptability recorded in the RISK MANAGEMENT
plan.
EXAMPLE 3 Subclause 9.8.3.3, Dynamic forces due to loading from persons
EXAMPLE 4 Subclause 11.6.3, Spillage on ME EQUIPMENT and ME SYSTEMS
Compliance is checked by confirming that the RECORDS in the RISK MANAGEMENT FILE
demonstrate that, after applying the specific requirements of this standard, the acceptance
criteria determined by the MANUFACTURER are satisfied. Only the relevant parts of the RISK
MANAGEMENT FILE need to be reviewed, e.g. the MANUFACTURER'S calculations or test
results, or the determination of RISK acceptability.
c) Where this standard or its collateral or particular standards identify particular HAZARDS or
HAZARDOUS SITUATIONS that have to be investigated without providing specific technical
requirements:
– the MANUFACTURER shall determine whether such HAZARDS or HAZARDOUS SITUATIONS
exist for the particular ME EQUIPMENT or ME SYSTEM, and
– where such HAZARDS or HAZARDOUS SITUATIONS exist for the particular ME EQUIPMENT or
ME SYSTEM, the MANUFACTURER shall evaluate and (if necessary) control these RISKS
following the RISK MANAGEMENT PROCESS specified in 4.2.2.
EXAMPLE 5 Subclause 10.2, Alpha, beta, gamma, neutron and other particle radiation
Compliance is checked by confirming that the RECORDS in the RISK MANAGEMENT FILE
demonstrate that the RESIDUAL RISK is acceptable using the criteria for RISK acceptability
recorded in the RISK MANAGEMENT plan, i.e. no unacceptable RISK remains. Only the
relevant parts of the RISK MANAGEMENT FILE need to be reviewed, e.g. the MANUFACTURER'S
calculations or test results, or the determination of RISK acceptability.
NOTE When ME EQUIPMENT or an ME SYSTEM has been designed in such way that for a certain type of HAZARDS no
HAZARDOUS SITUATION exists, no further RISK ASSESSMENT for that HAZARD is necessary. This can be verified by
tests or inspections.
4.2.3.2 HAZARDS not identified in the IEC 60601 series
For HAZARDS or HAZARDOUS SITUATIONS that are identified for the particular ME EQUIPMENT or
ME SYSTEM but are not specifically addressed in this standard or its collateral or particular
standards, the MANUFACTURER shall address those HAZARDS in the RISK MANAGEMENT PROCESS
as specified in 4.2.2.
EXAMPLE ME EQUIPMENT or an ME SYSTEM for which there are particular RISKS but no particular standard.
Compliance is checked by inspection of the RISK MANAGEMENT FILE.
4.3 * ESSENTIAL PERFORMANCE
Replace the existing text of the subclause with the following:

60601-1 Amend.1 © IEC:2012 – 17 –
During RISK ANALYSIS, the MANUFACTURER shall identify the performance of the clinical
function(s) of the ME EQUIPMENT or ME SYSTEM, other than that related to BASIC SAFETY, that is
necessary to achieve its INTENDED USE or that could affect the safety of the ME EQUIPMENT or
ME SYSTEM.
The MANUFACTURER shall then specify performance limits between fully functional and total
loss of the identified performance in both NORMAL CONDITION and SINGLE FAULT CONDITION.
The MANUFACTURER shall then evaluate the RISK from the loss or degradation of the identified
performance beyond the limits specified by the MANUFACTURER. If the resulting RISK is
unacceptable, then the identified performance constitutes an ESSENTIAL PERFORMANCE of the
ME EQUIPMENT or ME SYSTEM.
The MANUFACTURER shall implement RISK CONTROL measures to reduce the RISK from the loss
performance to an acceptable level.
or degradation of the identified
NOTE 1 The performance of the RISK CONTROL measure might well become an aspect of the ESSENTIAL
PERFORMANCE of the ME EQUIPMENT or ME SYSTEM. For example, the generation of the ALARM SIGNAL to indicate the
interruption of the SUPPLY MAINS could be “essential” if an interruption of the SUPPLY MAINS could result in an
unacceptable RISK if it went unattended.
The MANUFACTURER shall specify the methods used to verify the effectiveness of the RISK
CONTROL measures. This shall include any assessment made to determine whether
verification is needed.
NOTE 2 Following the principles of RISK MANAGEMENT, the MANUFACTURER is required to verify the effectiveness of
each RISK CONTROL measure. This can involve demonstrating that the RISK CONTROL measure will operate in the
presence of the conditions that result in the loss or degradation of the identified performance.
EXAMPLE 1 If ESSENTIAL PERFORMANCE is lost because of an interruption of the SUPPLY MAINS, an ALARM SYSTEM
intended to notify the OPERATOR that the SUPPLY MAINS has been interrupted would need to have a backup power
source so that the generation of the ALARM SIGNAL would not depend on the SUPPLY MAINS.
EXAMPLE 2 If the failure of a component results in the loss of ESSENTIAL PERFORMANCE, the design of the ME
EQUIPMENT or ME SYSTEM would need to be such that the component failure does not compromise the effectiveness
of any RISK CONTROL measures put in place to mitigate the RISK from the loss of the ESSENTIAL PERFORMANCE.
NOTE 3 Each collateral standard or particular standard in the IEC 60601 or the IEC/ISO 80601 series can list
potential ESSENTIAL PERFORMANCES to guide the MANUFACTURER to identify particular ESSENTIAL PERFORMANCE in
accordance with 4.3.
Compliance is checked by inspection of the RISK MANAGEMENT FILE.
Where this standard requires that ESSENTIAL PERFORMANCE is to be maintained following a
particular test, compliance is checked by inspection and, if necessary, by functional test(s)
that demonstrate the MANUFACTURER'S specified limits are maintained or the ME EQUIPMENT or

ME SYSTEM transitions to a safe state as defined by the MANUFACTURER.
4.5 * Equivalent safety for ME EQUIPMENT or ME SYSTEMS
Replace the heading and the text of the subclause with the following:
4.5 * Alternative RISK CONTROL measures or test methods for ME EQUIPMENT or
ME SYSTEMS
Where this standard specifies a particular RISK CONTROL measure or test method, an
alternative RISK CONTROL measure or test method is acceptable, provided that the
MANUFACTURER can demonstrate through scientific data or clinical opinion or comparative
studies that the RESIDUAL RISK that results from applying the alternative RISK CONTROL
measure or test method remains acceptable and is comparable to the RESIDUAL RISK that
results from applying the requirements of this standard.
Comparative studies in this context mean studies comparing the effect of the alternative RISK
CONTROL measure or test method with the RISK CONTROL measure or test method specified in
this standard.
– 18 – 60601-1 Amend.1 © IEC:2012
NOTE Alternative RISK CONTROL measures can allow for exceeding limits specified in this standard or in its
collateral or particular standards if additional measures for compensation are provided.
Compliance is checked by inspection of the RISK MANAGEMENT FILE.
4.6 * ME EQUIPMENT or ME SYSTEM parts that contact the PATIENT
Replace the text of the subclause with the following:
The RISK MANAGEMENT PROCESS shall include an assessment of whether parts that can come
into contact with the PATIENT but fall outside of the definition of APPLIED PARTS need to be
subject to the requirements for APPLIED PARTS. For the parts concerned, the requirements for
TYPE B APPLIED PART shall be applied unless the assessment identifies a need for the
requirements for a TYPE BF APPLIED PART or TYPE CF APPLIED PART to apply.
If the RISK MANAGEMENT PROCESS determines that such parts are subject to the requirements
for APPLIED PARTS, then all the relevant requirements and tests of this standard and of relevant
collateral and particular standards shall apply, except that 7.2.10 does not apply to such
parts.
Compliance is checked by inspection of the RISK MANAGEMENT FILE.
4.8 Components of ME EQUIPMENT
Add an asterisk to the title.
4.11 Power input
After the third dashed item, insert the following note:
NOTE 1 Technical details of a true r.m.s. meter can be found in IEC 62354 [66].
Replace the existing final paragraph with the following note:

NOTE 2 Supplier information can be used to supplement the above measurement as a power input specification.
5 * General requirements for testing ME EQUIPMENT
5.1 * Type tests
Replace the existing third paragraph and the note with the following:
The combination of simultaneous independent faults that could result in a HAZARDOUS
SITUATION shall be documented in the RISK MANAGEMENT FILE (see also 4.7). When testing is
necessary to demonstrate that BASIC SAFETY and ESSENTIAL PERFORMANCE are maintained
under such simultaneous independent faults, the related testing may be limited to worst case
situations.
NOTE 1 The test results might necessitate a revision of the RISK ANALYSIS.
NOTE 2 When considering use of tests described in this standard as routine tests, see Annex K of IEC/TR 62354
(production line tests) or see IEC 62353 (recurrent tests).
5.4 Other conditions
Replace existing list item a) with the following:
a) Unless otherwise specified in this standard, ME EQUIPMENT is to be tested under the least
favourable working conditions. The working conditions are specified in the ACCOMPANYING
. The least favourable working conditi
...