IEC 60601-1-8:2006/AMD2:2020
(Amendment)Amendment 2 - Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
Amendment 2 - Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
Amendement 2 - Appareils électromédicaux - Partie 1-8 : Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale : exigences générales, essais et guide pour les systèmes d'alarme des appareils et des systèmes électromédicaux
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IEC 60601-1-8
Edition 2.0 2020-07
INTERNATIONAL
STANDARD
colour
inside
AMENDMENT 2
Medical electrical equipment –
Part 1-8: General requirements for basic safety and essential performance –
Collateral standard: General requirements, tests and guidance for alarm
systems in medical electrical equipment and medical electrical systems
IEC 60601-1-8:2006-10/AMD2:2020-07(en)
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
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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.
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latest edition, a corrigendum or an amendment might have been published.
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IEC 60601-1-8
Edition 2.0 2020-07
INTERNATIONAL
STANDARD
colour
inside
AMENDMENT 2
Medical electrical equipment –
Part 1-8: General requirements for basic safety and essential performance –
Collateral standard: General requirements, tests and guidance for alarm
systems in medical electrical equipment and medical electrical systems
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.01 ISBN 978-2-8322-8631-9
– 2 – IEC 60601-1-8:2006/AMD2:2020
© IEC 2020
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, and ISO subcommittee 3: Respiratory devices and related equipment used for
patient care, of ISO technical committee 121: Anaesthetic and respiratory equipment.
It is published as a double logo amendment.
The text of this amendment is based on the following documents of IEC:
FDIS Report on voting
62A/1392/FDIS 62A/1407/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. In ISO, the amendment has been approved by 15 P
members out of 15 having cast a vote.
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.
NOTE The attention of users of this document 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.
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.
_____________
© IEC 2020
INTRODUCTION TO AMENDMENT 2
The second edition of IEC 60601-1-8 was published in 2006 and amended in 2012. Since the
publication of IEC 60601-1-8:2006+A1:2012, the IEC Subcommittee (SC) 62A Secretariat has
been collecting issues from a variety of sources including comments from National Committees.
At the November 2015 meeting of IEC/SC 62A in Kobe, Japan, the subcommittee initiated a
process to identify high-priority issues that need to be considered in an amendment and should
not wait until the third edition of IEC 60601-1-8, which is presently targeted for publication
sometime after 2024.
Those issues selected for inclusion on the final "short list" to be addressed in Amendment 2
were those approved by a 2/3 majority of the National Committees present and voting at the
Frankfurt meeting of SC 62A. At the meeting held on 10 October 2016, 20 items were presented
to the National Committees present. All 20 items received the required 2/3 majority of the
National Committees present and voting and have been included in the "short list" for
consideration in preparing Amendment 2. All remaining issues have been placed on a "long list"
for consideration in the third edition of IEC 60601-1-8.
The "short list" of issues was documented in the design specification for Amendment 2. As
IEC 60601-1-8 was jointly developed with ISO/TC 121/SC 3, the work was assigned to
IEC/SC 62A-ISO/TC 121/SC 3 Joint Working Group (JWG) 2. JWG 2 was directed to consider
each issue described in Clause 6 of the design specification and develop an appropriate
solution for the identified problem. That final solution in this amendment can encompass any
technical solution proposed by the author of the issue or it can involve a different solution
developed by the expert group. The expert group can also have recommended that no change
to the standard was justified by the problem statement.
Because this is an amendment to IEC 60601-1-8:2006, the style in force at the time of
publication of IEC 60601-1-8 has been applied to this amendment. The style specified in
ISO/IEC Directives Part 2:2018 has only been applied when implementing the new style
guidance would not result in additional editorial changes. For example, notes to definitions are
designated as "NOTE" rather than "Note to entry" in Clause 3.
Users of this document should note that when constructing the dated references to specific
elements in a standard, such as definitions, amendments are only referenced if they modified
the text being cited. For example, if a reference is made to a definition that has not been
modified by an amendment, then the reference to the amendment is not included in the dated
reference.
– 4 – IEC 60601-1-8:2006/AMD2:2020
© IEC 2020
INTRODUCTION
Replace, in the second sentence of the existing second paragraph, "source" with "origin".
1.3.1 IEC 60601-1
Replace the first two existing dashes with the following new dashes:
– "the general standard" designates IEC 60601-1 alone, including any amendments;
– "this collateral standard" designates IEC 60601-1-8 alone, including any amendments;
2 Normative references
Replace the existing references to IEC 60601-1, IEC 61672-1 and IEC 62366-1 by the following
new references:
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety
and essential performance
Amendment 1:2012
Amendment 2:2020
IEC 61672-1:2013, Electroacoustics – Sound level meters – Part 1: Specifications
IEC 62366-1:2015, Medical devices – Part 1: Application of usability engineering to medical
devices
Amendment 1:2020
3 Terms and definitions
Replace the existing first paragraph with the following new paragraph:
For the purposes of this document, the terms and definitions given in
IEC 60601-1:2005+A1:2012+A2:2020, IEC 62366-1:2015+A1:2020, and the following
definitions apply.
3.17
* DISTRIBUTED ALARM SYSTEM
Replace the existing term and definition with the following new entry:
3.17
* DISTRIBUTED ALARM SYSTEM
DAS
ALARM SYSTEM that involves more than one item of equipment in a ME SYSTEM intended for delivery
of ALARM CONDITIONS with technical confirmation
NOTE 1 The parts of a DISTRIBUTED ALARM SYSTEM can be widely separated in distance.
NOTE 2 A DISTRIBUTED ALARM SYSTEM is intended to notify OPERATORS of the existence of an ALARM CONDITION.
NOTE 3 For the purposes of this document, technical confirmation means that each element of a DISTRIBUTED ALARM
SYSTEM confirms or guarantees the successful delivery of the ALARM CONDITION to the next element or appropriate
TECHNICAL ALARM CONDITIONS are created as described in 6.11.2.2.1.
3.20
FALSE NEGATIVE ALARM CONDITION
Replace, in the existing note, "the equipment itself" with "the ALARM SYSTEM itself".
© IEC 2020
3.22
HIGH PRIORITY
Replace the existing note with the following new notes:
NOTE 1 The priority is assigned through RISK ANALYSIS. See 6.1.2 for the assignment of priority.
NOTE 2 Immediate implies the interruption of current workflow is expected [59], [60].
3.23
*INFORMAL SIGNAL
Add, after the existing Example 3, the following new note:
NOTE An ADVISORY is a type of INFORMATION SIGNAL.
3.25
INTERBURST INTERVAL
Replace, in the existing parenthetical, "Figure 1" with "Figure 1 and Figure G.1".
Add the following new note:
NOTE For the purposes of this document, when an AUDITORY ICON is used, the INTERBURST INTERVAL begins at the
end of the AUDITORY ICON.
3.27
LOW PRIORITY
Replace the existing term, definition and note with the following new entry:
3.27
LOW PRIORITY
indicating that OPERATOR awareness is required and future action might be needed
NOTE 1 The priority is assigned through RISK ANALYSIS. See 6.1.2 for the assignment of priority.
NOTE 2 Awareness implies the planning of future workflow is expected [59], [60].
3.28
MEDIUM PRIORITY
Replace the existing note with the following new notes:
NOTE 1 The priority is assigned through RISK ANALYSIS. See 6.1.2 for the assignment of priority.
NOTE 2 Prompt implies the re-planning of current workflow is expected [59], [60].
3.37
* ACKNOWLEDGED
Replace the existing term, definition and notes, added by Amendment 1, with the following new
entry:
3.37
* ACKNOWLEDGED
state of an ALARM SYSTEM initiated by OPERATOR action, where the auditory ALARM SIGNAL
associated with a currently active ALARM CONDITION is inactivated until the ALARM CONDITION no
longer exists or until a predetermined time interval has elapsed
NOTE ACKNOWLEDGED only affects ALARM SIGNALS that are active at the time of the OPERATOR action.
Add, after 3.37, the following new terms and definitions:
– 6 – IEC 60601-1-8:2006/AMD2:2020
© IEC 2020
3.38
* ADVISORY
ADVISORY SIGNAL
INFORMATION SIGNAL notifying the OPERATOR of a condition of the PATIENT or ME EQUIPMENT
providing contextual awareness that is intended to improve the clinical workflow or
PATIENT condition, the awareness not being intended as a means of RISK
understanding of the
CONTROL
NOTE 1 A notification that a lab result is available, where the lab result requires immediate clinical action is not an
ADVISORY. It is an ALARM CONDITION.
NOTE 2 A signal associated with an ADVISORY, which is an INFORMATION SIGNAL, is required by this document to be
designed so that an OPERATOR does not confuse it with an ALARM SIGNAL. See 6.3.2.2.2 and 6.3.3.2.
EXAMPLE 1 A notification that it is time to draw the next blood sample.
EXAMPLE 2 A battery status notification that replacement will be needed in a day.
EXAMPLE 3 A notification that it is time to bathe the PATIENT.
EXAMPLE 4 A notification that a lab result is available, where the lab results are normal.
3.39
ALARM FATIGUE
*
situation wherein the presence of frequent ALARM SIGNALS desensitizes an OPERATOR to an
ALARM SIGNAL
NOTE 1 A desensitized OPERATOR can fail to perceive, recognize or act on an ALARM SIGNAL.
NOTE 2 The response of a desensitized OPERATOR can be inadequate, delayed or non-existent.
NOTE 3 ALARM FLOOD can cause ALARM FATIGUE.
3.40
ALARM FLOOD
situation wherein OPERATORS receive more ALARM SIGNALS in a time period than they can
manage appropriately
NOTE See [56], [57].
3.41
* ALERT
synonym for the combination of PHYSIOLOGICAL ALARM CONDITIONS, TECHNICAL ALARM CONDITIONS
and ADVISORIES
[SOURCE: ISO/IEEE 11073-10201:2020 [76], 3.3, modified – Replaced "alarms" with "ALARM
CONDITIONS", "equipment-user advisory signals" with "ADVISORIES" and deleted "patient
related".]
3.42
AUDITORY ICON
sound that creates a strong semantic link to the category it represents
NOTE 1 An AUDITORY ICON is typically a real-world sound or mimics a real-world sound.
NOTE 2 An AUDITORY ICON can aid in locating the COMMUNICATOR and the SOURCE type.
3.43
AUDITORY POINTER
sound that attracts attention, denotes the priority and aids in localization of the COMMUNICATOR
© IE
...
IEC 60601-1-8
Edition 2.0 2020-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
AMENDMENT 2
AMENDEMENT 2
Medical electrical equipment –
Part 1-8: General requirements for basic safety and essential performance –
Collateral standard: General requirements, tests and guidance for alarm
systems in medical electrical equipment and medical electrical systems
Appareils électromédicaux –
Partie 1-8: Exigences générales pour la sécurité de base et les performances
essentielles – Norme collatérale: exigences générales, essais et guide pour les
systèmes d'alarme des appareils et des systèmes électromédicaux
IEC 60601-1-8:2006-10/AMD2:2020-07(en-fr)
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
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copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
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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.
IEC publications search - webstore.iec.ch/advsearchform IEC online collection - oc.iec.ch
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IEC 60601-1-8
Edition 2.0 2020-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
A MENDMENT 2
AM ENDEMENT 2
Medical electrical equipment –
Part 1-8: General requirements for basic safety and essential performance –
Collateral standard: General requirements, tests and guidance for alarm
systems in medical electrical equipment and medical electrical systems
Appareils électromédicaux –
Partie 1-8: Exigences générales pour la sécurité de base et les performances
essentielles – Norme collatérale: exigences générales, essais et guide pour les
systèmes d'alarme des appareils et des systèmes électromédicaux
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.01 ISBN 978-2-8322-1014-3
– 2 – IEC 60601-1-8:2006/AMD2:2020
© IEC 2020
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, and ISO subcommittee 3: Respiratory devices and related equipment used for
patient care, of ISO technical committee 121: Anaesthetic and respiratory equipment.
It is published as a double logo amendment.
The text of this amendment is based on the following documents of IEC:
FDIS Report on voting
62A/1392/FDIS 62A/1407/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. In ISO, the amendment has been approved by 15 P
members out of 15 having cast a vote.
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.
NOTE The attention of users of this document 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.
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.
_____________
© IEC 2020
INTRODUCTION TO AMENDMENT 2
The second edition of IEC 60601-1-8 was published in 2006 and amended in 2012. Since the
publication of IEC 60601-1-8:2006+A1:2012, the IEC Subcommittee (SC) 62A Secretariat has
been collecting issues from a variety of sources including comments from National Committees.
At the November 2015 meeting of IEC/SC 62A in Kobe, Japan, the subcommittee initiated a
process to identify high-priority issues that need to be considered in an amendment and should
not wait until the third edition of IEC 60601-1-8, which is presently targeted for publication
sometime after 2024.
Those issues selected for inclusion on the final "short list" to be addressed in Amendment 2
were those approved by a 2/3 majority of the National Committees present and voting at the
Frankfurt meeting of SC 62A. At the meeting held on 10 October 2016, 20 items were presented
to the National Committees present. All 20 items received the required 2/3 majority of the
National Committees present and voting and have been included in the "short list" for
consideration in preparing Amendment 2. All remaining issues have been placed on a "long list"
for consideration in the third edition of IEC 60601-1-8.
The "short list" of issues was documented in the design specification for Amendment 2. As
IEC 60601-1-8 was jointly developed with ISO/TC 121/SC 3, the work was assigned to
IEC/SC 62A-ISO/TC 121/SC 3 Joint Working Group (JWG) 2. JWG 2 was directed to consider
each issue described in Clause 6 of the design specification and develop an appropriate
solution for the identified problem. That final solution in this amendment can encompass any
technical solution proposed by the author of the issue or it can involve a different solution
developed by the expert group. The expert group can also have recommended that no change
to the standard was justified by the problem statement.
Because this is an amendment to IEC 60601-1-8:2006, the style in force at the time of
publication of IEC 60601-1-8 has been applied to this amendment. The style specified in
ISO/IEC Directives Part 2:2018 has only been applied when implementing the new style
guidance would not result in additional editorial changes. For example, notes to definitions are
designated as "NOTE" rather than "Note to entry" in Clause 3.
Users of this document should note that when constructing the dated references to specific
elements in a standard, such as definitions, amendments are only referenced if they modified
the text being cited. For example, if a reference is made to a definition that has not been
modified by an amendment, then the reference to the amendment is not included in the dated
reference.
– 4 – IEC 60601-1-8:2006/AMD2:2020
© IEC 2020
INTRODUCTION
Replace, in the second sentence of the existing second paragraph, "source" with "origin".
1.3.1 IEC 60601-1
Replace the first two existing dashes with the following new dashes:
– "the general standard" designates IEC 60601-1 alone, including any amendments;
– "this collateral standard" designates IEC 60601-1-8 alone, including any amendments;
2 Normative references
Replace the existing references to IEC 60601-1, IEC 61672-1 and IEC 62366-1 by the following
new references:
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety
and essential performance
Amendment 1:2012
Amendment 2:2020
IEC 61672-1:2013, Electroacoustics – Sound level meters – Part 1: Specifications
IEC 62366-1:2015, Medical devices – Part 1: Application of usability engineering to medical
devices
Amendment 1:2020
3 Terms and definitions
Replace the existing first paragraph with the following new paragraph:
For the purposes of this document, the terms and definitions given in
IEC 60601-1:2005+A1:2012+A2:2020, IEC 62366-1:2015+A1:2020, and the following
definitions apply.
3.17
* DISTRIBUTED ALARM SYSTEM
Replace the existing term and definition with the following new entry:
3.17
* DISTRIBUTED ALARM SYSTEM
DAS
ALARM SYSTEM that involves more than one item of equipment in a ME SYSTEM intended for delivery
of ALARM CONDITIONS with technical confirmation
NOTE 1 The parts of a DISTRIBUTED ALARM SYSTEM can be widely separated in distance.
NOTE 2 A DISTRIBUTED ALARM SYSTEM is intended to notify OPERATORS of the existence of an ALARM CONDITION.
NOTE 3 For the purposes of this document, technical confirmation means that each element of a DISTRIBUTED ALARM
SYSTEM confirms or guarantees the successful delivery of the ALARM CONDITION to the next element or appropriate
TECHNICAL ALARM CONDITIONS are created as described in 6.11.2.2.1.
3.20
FALSE NEGATIVE ALARM CONDITION
Replace, in the existing note, "the equipment itself" with "the ALARM SYSTEM itself".
© IEC 2020
3.22
HIGH PRIORITY
Replace the existing note with the following new notes:
NOTE 1 The priority is assigned through RISK ANALYSIS. See 6.1.2 for the assignment of priority.
NOTE 2 Immediate implies the interruption of current workflow is expected [59], [60].
3.23
*INFORMAL SIGNAL
Add, after the existing Example 3, the following new note:
NOTE An ADVISORY is a type of INFORMATION SIGNAL.
3.25
INTERBURST INTERVAL
Replace, in the existing parenthetical, "Figure 1" with "Figure 1 and Figure G.1".
Add the following new note:
NOTE For the purposes of this document, when an AUDITORY ICON is used, the INTERBURST INTERVAL begins at the
end of the AUDITORY ICON.
3.27
LOW PRIORITY
Replace the existing term, definition and note with the following new entry:
3.27
LOW PRIORITY
indicating that OPERATOR awareness is required and future action might be needed
NOTE 1 The priority is assigned through RISK ANALYSIS. See 6.1.2 for the assignment of priority.
NOTE 2 Awareness implies the planning of future workflow is expected [59], [60].
3.28
MEDIUM PRIORITY
Replace the existing note with the following new notes:
NOTE 1 The priority is assigned through RISK ANALYSIS. See 6.1.2 for the assignment of priority.
NOTE 2 Prompt implies the re-planning of current workflow is expected [59], [60].
3.37
* ACK
...
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