IEC 60601-1:2005

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

IEC 60601-1:2005 contains requirements concerning basic safety and essential performance that are generally applicable to medical electrical equipment. For certain types of medical electrical equipment, these requirements are either supplemented or modified by the special requirements of a collateral or particular standard. Where particular standards exist, this standard should not be used alone. The contents of the corrigenda of December 2006, December 2007 and December 2022, the interpretation sheets of April 2008, January 2009 and May 2013 have been included in this copy.

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

IEC 60601-1:2005 contient les exigences concernant la sécurité de base et les performances essentielles qui sont généralement applicables aux appareils électromédicaux. Pour certains types d'appareil électromédicaux, ces exigences sont soit complétées soit modifiées par des exigences spécifiques données dans une norme collatérale ou une norme particulière. Lorsqu'il existe une norme particulière, il est recommandé de ne pas utiliser la présente norme générale seule. Le contenu des corrigenda de décembre 2006, décembre 2007 et décembre 2022, les feuilles d'interprétation d'avril 2008, janvier 2009 et mai 2013 a été pris en considération dans cet exemplaire.

General Information

• Status: Published
• Publication Date: 19-Aug-2020
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: SC 62A - Common aspects of medical equipment, software, and systems
• Current Stage: PPUB - Publication issued
• Start Date: 15-Mar-2006
• Completion Date: 15-Dec-2005

Relations

• Amended By: IEC 60601-1:2005/AMD2:2020 - Amendment 2 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
• Effective Date: 05-Sep-2023
• Amended By: IEC 60601-1:2005/AMD1:2012 - Amendment 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
• Effective Date: 05-Sep-2023
• Corrected By: IEC 60601-1:2005/COR1:2006 - Corrigendum 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
• Effective Date: 05-Sep-2023
• Corrected By: IEC 60601-1:2005/COR3:2022 - Corrigendum 3 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
• Effective Date: 05-Sep-2023
• Corrected By: IEC 60601-1:2005/COR2:2007 - Corrigendum 2 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
• Effective Date: 05-Sep-2023
• Revised: IEC 60601-1:2005/ISH2:2009 - Interpretation sheet 2 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
• Effective Date: 05-Sep-2023
• Revised: IEC 60601-1:2005/ISH1:2008 - Interpretation sheet 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
• Effective Date: 05-Sep-2023
• Revises: IEC 60601-1:1988 - Medical electrical equipment - Part 1: General requirements for safety
• Effective Date: 05-Sep-2023
• Revised: IEC 60601-1:2005/ISH3:2013 - Interpretation sheet 3 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
• Effective Date: 05-Sep-2023
• Revised: IEC 60601-1:2005/AMD1:2012/ISH1:2021 - Interpretation Sheet 1 - Amendment 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
• Effective Date: 05-Sep-2023

Standards Content (Sample)

- 1 -
IEC 60601-1
(Edition 3.1 – 2012)
Consolidated version
Medical electrical equipment –
Part 1: General requirements for basic safety
and essential performance
CORRIGENDUM 1
7.9.3 Technical description
7.9.3.1 General
Delete the first bullet in the list that immediately follows the first paragraph of this subclause,
which reads:
– the information required in 7.2;
Table D.2 – Safety signs
For rows 5, 6 and 7, instead of:
...

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

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC
copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
your local IEC member National Committee for further information.

IEC Central Office Tel.: [phone]
3, rue de Varembé [e-mail]
CH-1211 Geneva 20 www.iec.ch
Switzerland
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.

About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigendum or an amendment might have been published.

IEC publications search - webstore.iec.ch/advsearchform Electropedia - www.electropedia.org
The advanced search enables to find IEC publications by a The world's leading online dictionary on electrotechnology,
variety of criteria (reference number, text, technical containing more than 22 000 terminological entries in English
committee,…). It also gives information on projects, replaced and French, with equivalent terms in 16 additional languages.
and withdrawn publications. Also known as the International Electrotechnical Vocabulary

(IEV) online.
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Stay up to date on all new IEC publications. Just Published IEC Glossary - std.iec.ch/glossary
details all new publications released. Available online and 67 000 electrotechnical terminology entries in English and
once a month by email. French extracted from the Terms and Definitions clause of
IEC publications issued since 2002. Some entries have been
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If you wish to give us your feedback on this publication or CISPR.

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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
...

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

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC
copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
your local IEC member National Committee for further information.

IEC Central Office Tel.: [phone]
3, rue de Varembé [e-mail]
CH-1211 Geneva 20 www.iec.ch
Switzerland
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.

About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigendum or an amendment might have been published.

IEC publications search - webstore.iec.ch/advsearchform Electropedia - www.electropedia.org
The advanced search enables to find IEC publications by a The world's leading online dictionary on electrotechnology,
variety of criteria (reference number, text, technical containing more than 22 000 terminological entries in English
committee,…). It also gives information on projects, replaced and French, with equivalent terms in 16 additional languages.
and withdrawn publications. Also known as the International Electrotechnical Vocabulary

(IEV) online.
IEC Just Published - webstore.iec.ch/justpublished
Stay up to date on all new IEC publications. Just Published IEC Glossary - std.iec.ch/glossary
details all new publications released. Available online and 67 000 electrotechnical terminology entries in English and
once a month by email. French extracted from the Terms and definitions clause of
IEC publications issued between 2002 and 2015. Some
IEC Customer Service Centre - webstore.iec.ch/csc entries have been collected from earlier publications of IEC
If you wish to give us your feedback on this publication or TC 37, 77, 86 and CISPR.

need further assistance, please contact the Customer Service

Centre: [e-mail].
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
...

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
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by
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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 .
...

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
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC
copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
your local IEC member National Committee for further information.

Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite
ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie
et les microfilms, sans l'accord écrit de l'IEC ou du Comité national de l'IEC du pays du demandeur. Si vous avez des
questions sur le copyright de l'IEC ou si vous désirez obtenir des droits supplémentaires sur cette publication, utilisez
les coordonnées ci-après ou contactez le Comité national de l'IEC de votre pays de résidence.

IEC Central Office Tel.: [phone]
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CH-1211 Geneva 20 www.iec.ch
Switzerland
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.

About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigendum or an amendment might have been published.

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Normes internationales pour tout ce qui a trait à l'électricité, à l'électronique et aux technologies apparentées.

A propos des publications IEC
Le contenu technique des publications IEC est constamment revu. Veuillez vous assurer que vous possédez l’édition la
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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
...

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
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC
copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
your local IEC member National Committee for further information.

Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite
ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie
et les microfilms, sans l'accord écrit de l'IEC ou du Comité national de l'IEC du pays du demandeur. Si vous avez des
questions sur le copyright de l'IEC ou si vous désirez obtenir des droits supplémentaires sur cette publication, utilisez
les coordonnées ci-après ou contactez le Comité national de l'IEC de votre pays de résidence.

IEC Central Office Tel.: [phone]
3, rue de Varembé [e-mail]
CH-1211 Geneva 20 www.iec.ch
Switzerland
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.

About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigendum or an amendment might have been published.

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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 accep
...