IEC 60601-1-8:2006
(Main)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
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
Specifies basic safety and essential performance requirements and tests for alarm systems in medical electrical equipment and medical electrical systems and to provide guidance for their application. This is accomplished by defining alarm categories (priorities) by degree of urgency, consistent alarm signals and consistent control states and their marking for all alarm 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
Spécifie les exigences de sécurité de base et les exigences en matière de performances essentielles ainsi que les essais des systèmes d'alarme des appareils et des systèmes électromédicaux et de donner des lignes directrices pour leur application. Cela est réalisé en définissant des catégories d'alarmes (priorités) par degré d'urgence, des signaux d'alarme et des états de commande cohérents et leur marquage pour tous les systèmes d'alarme.
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IEC 60601-1-8
Edition 2.2 2020-07
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
colour
inside
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
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
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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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IEC 60601-1-8
Edition 2.2 2020-07
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
colour
inside
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 978-2-8322-8720-0
IEC 60601-1-8
Edition 2.2 2020-07
REDLINE VERSION
colour
inside
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
– 2 – IEC 60601-1-8:2006+AMD1:2012
+AMD2:2020 CSV IEC 2020
CONTENTS
FOREWORD . 4
INTRODUCTION . 7
INTRODUCTION to Amendment 1 . 7
INTRODUCTION to Amendment 2 . 8
1 * Scope, object and related standards . 9
1.1 Scope . 9
1.2 Object . 9
1.3 Related standards . 9
2 Normative references . 10
3 Terms and definitions . 11
4 General requirements . 18
5 ME EQUIPMENT identification marking and documents . 18
5.1 Indicator lights and controls . 18
5.2 ACCOMPANYING DOCUMENTS . 19
6 ALARM SYSTEMS . 19
6.1 ALARM CONDITION . 19
6.2 * Disclosures for INTELLIGENT ALARM SYSTEM . 21
6.3 Generation of ALARM SIGNALS . 21
6.4 * Disclosure of delays . 29
6.5 ALARM PRESETS . 30
6.6 ALARM LIMIT . 32
6.7 * ALARM SYSTEM security . 33
6.8 * ALARM SIGNAL inactivation states . 33
6.9 * ALARM RESET . 37
6.10 * NON-LATCHING and LATCHING ALARM SIGNALS . 37
6.11 * DISTRIBUTED ALARM SYSTEM AND DISTRIBUTED INFORMATION SYSTEMS ABOUT
ALARM CONDITIONS . 37
6.12 * ALARM CONDITION SYSTEM logging . 42
6.13 ALARM SYSTEM functions . 44
Annex A (informative) General guidance and rationale . 47
Annex B (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 97
Annex C (normative) Symbols on marking . 100
Annex D (informative) Guidance for auditory ALARM SIGNALS . 109
Annex E (informative) Verbal ALARM SIGNALS . 111
Annex F (normative) * Reserved melodies for ALARM SIGNALS . 113
Annex G (normative) * Auditory ALARM SIGNALS . 114
Annex H (informative) VALIDATION of AUDITORY ICONS . 119
Bibliography . 125
Index of defined terms used in this collateral standard . 131
Figure 1 – Illustration of temporal characteristics of auditory ALARM SIGNALS . 26
Figure 2 – Functions of a DISTRIBUTED ALARM SYSTEM utilizing a MEDICAL IT NETWORK . 39
+AMD2:2020 CSV IEC 2020
Figure 3 – Functions of an ALARM SYSTEM . 45
Figure A.1 – Graphical representation of components of ALARM SYSTEM delay . 70
Figure G.1 – Illustration of spacing of AUDITORY POINTER . 116
Figure G.2 – Illustration of temporal characteristics of an AUDITORY POINTER . 117
Table 1 – Determination of ALARM CONDITION and assignment of priorities . 20
Table 2 – Characteristics of alarm indicator lights . 22
Table 3 – * Characteristics of the BURST of auditory ALARM SIGNALS . 24
Table 4 – * Characteristics of the PULSE of auditory ALARM SIGNALS. 25
Table 5 – ALARM SIGNAL inactivation states . 36
Table A.1 – Reference interpretation of Table F.1 .
Table A.2 – Reference interpretation of Table F.2 .
Table A.1 – ALARM SYSTEM output to perceived OPERATOR action . 55
Table A.2 – Examples of ME EQUIPMENT for each category of the SOURCE of an ALARM
CONDITION . 96
Table B.1 – Cross-reference of marking . 97
Table B.2 – Cross-reference of ACCOMPANYING DOCUMENTS . 98
Table B.3 – Cross-reference of instructions for use . 98
Table B.4 – Cross-reference of technical description . 99
Table C.1 – Graphical symbols for ALARM SYSTEMS . 100
Table C.1 – Graphical symbols for ALARM SYSTEMS (continued) . 101
Table C.1 – Graphical symbols for ALARM SYSTEMS (continued) . 102
Table C.2 – Alternative ALARM SYSTEM related markings . 108
Table D.1 – Attributes of perceived urgency . 109
Table F.1 – * Equipment encoded auditory ALARM SIGNALS categorized by ALARM
CONDITION and priority complying with Table 3 and Table 4 .
Table F.2 – * Auditory LOW PRIORITY ALARM SIGNAL complying with Table 3 and Table 4 .
Table G.1 – Characteristics of the BURST of the AUDITORY POINTER . 115
Table G.2 – Characteristics of the PULSE of the AUDITORY POINTER . 116
Table G.3 – Characteristics of the AUDITORY POINTER . 117
Table G.4 – * Characteristics of the AUDITORY ICON . 118
Table G.5 – Characteristics of the auditory ALARM SIGNAL . 118
Table H.1 – Performance levels of three AUDITORY POINTERS and seven AUDITORY ICONS
based on available data . 120
– 4 – IEC 60601-1-8:2006+AMD1:2012
+AMD2:2020 CSV IEC 2020
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
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
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensu
...
IEC 60601-1-8
Edition 2.0 2006-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
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
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.
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IEC 60601-1-8
Edition 2.0 2006-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
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
PRICE CODE
INTERNATIONALE
XC
CODE PRIX
ICS 11.040.01 ISBN 2-8318-8826-3
60601-1-8 © IEC:2006 –– 2 – 3 – 60601-1-8 © IEC:2006
CONTENTS
FOREWORD.4
INTRODUCTION.7
1 * Scope, object and related standards .8
1.1 Scope.8
1.2 Object .8
1.3 Related standards .8
2 Normative references .9
3 Terms and definitions .9
4 General requirements .13
5 ME EQUIPMENT identification marking and documents.14
5.1 Indicator lights and controls.14
5.2 ACCOMPANYING DOCUMENTS.14
6 ALARM SYSTEMS.14
6.1 ALARM CONDITION .14
6.2 * Disclosures for INTELLIGENT ALARM SYSTEM .15
6.3 Generation of ALARM SIGNALS .16
6.4 * Disclosure of delays.21
6.5 ALARM PRESETS.21
6.6 ALARM LIMIT .24
6.7 * ALARM SYSTEM security.25
6.8 * ALARM SIGNAL inactivation states .25
6.9 * ALARM RESET .27
6.10 * NON-LATCHING and LATCHING ALARM SIGNALS .27
6.11 * DISTRIBUTED ALARM SYSTEM .28
6.12 * ALARM CONDITION logging .29
Annex A (informative) General guidance and rationale.30
Annex B (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS.64
Annex C (normative) Symbols on marking.67
ANNEX D (informative) Guidance for auditory ALARM SIGNALS .71
ANNEX E (informative) Verbal ALARM SIGNALS.72
ANNEX F (normative) * Reserved melodies for ALARM SIGNALS.75
Bibliography.76
Index of defined terms used in this collateral standard.78
Figure 1 – Illustration of temporal characteristics of auditory ALARM SIGNALS .19
Figure A.1 – Graphical representation of components of ALARM SYSTEM delay .49
60601-1-8 © IEC:200660601-1-8 © IEC:2006 –– 3 – 5 –
Table 1 – ALARM CONDITION priorities.15
Table 2 – Characteristics of alarm indicator lights .16
Table 3 – * Characteristics of the BURST of auditory ALARM SIGNALS .18
Table 4 – * Characteristics of the PULSE of auditory ALARM SIGNALS.18
Table 5 – ALARM SIGNAL inactivation states.27
Table A.1 – Reference interpretation of Table F.1.62
Table A.2 – Reference interpretation of Table F.2.63
Table B.1 – Cross-reference of marking.64
Table B.2 – Cross-reference of ACCOMPANYING DOCUMENTS .65
Table B.3 – Cross-reference of instructions for use.65
Table B.4 – Cross-reference of technical description .66
Table C.1 – Graphical symbols for ALARM SYSTEMS .67
Table C.2 – Alternative ALARM SYSTEM related markings.70
Table D.1 – Attributes of perceived urgency.71
Table F.1 – * Equipment encoded auditory ALARM SIGNALS categorized by ALARM
CONDITION and priority complying with Table 3 and Table 4 .75
Table F.2 – * Auditory LOW PRIORITY ALARM SIGNAL complying with Table 3 and Table 4 .75
60601-1-8 © IEC:2006 –– 4 – 7 – 60601-1-8 © IEC:2006
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
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
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with an IEC Publication.
6) All users should ensure t
...
IEC 60601-1-8
Edition 2.1 2012-11
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
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
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 Secretariat Tel.: +41 22 919 02 11
3, rue de Varembé info@iec.ch
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 Products & Services Portal - products.iec.ch
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variety of criteria (reference number, text, technical publications previews. With a subscription you will always
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and withdrawn publications.
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Stay up to date on all new IEC publications. Just Published
containing more than 22 300 terminological entries in English
details all new publications released. Available online and
and French, with equivalent terms in 19 additional languages.
once a month by email.
Also known as the International Electrotechnical Vocabulary
(IEV) online.
IEC Customer Service Centre - webstore.iec.ch/csc
If you wish to give us your feedback on this publication or
need further assistance, please contact the Customer Service
Centre: sales@iec.ch.
A propos de l'IEC
La Commission Electrotechnique Internationale (IEC) est la première organisation mondiale qui élabore et publie des
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 60601-1-8
Edition 2.1 2012-11
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
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 978-2-8322-0492-4
– 2 – 60601-1-8 IEC:2006+A1:2012
CONTENTS
FOREWORD . 4
INTRODUCTION TO THE AMENDMENT . 7
INTRODUCTION . 7
1 * Scope, object and related standards . 9
1.1 Scope . 9
1.2 Object . 9
1.3 Related standards . 9
2 Normative references . 10
3 Terms and definitions . 10
4 General requirements . 15
5 ME EQUIPMENT identification marking and documents . 15
5.1 Indicator lights and controls . 15
5.2 ACCOMPANYING DOCUMENTS . 15
6 ALARM SYSTEMS . 15
6.1 ALARM CONDITION . 15
6.2 * Disclosures for INTELLIGENT ALARM SYSTEM . 16
6.3 Generation of ALARM SIGNALS . 17
6.4 * Disclosure of delays . 24
6.5 ALARM PRESETS . 24
6.6 ALARM LIMIT . 27
6.7 * ALARM SYSTEM security . 28
6.8 * ALARM SIGNAL inactivation states . 28
6.9 * ALARM RESET . 31
6.10 * NON-LATCHING and LATCHING ALARM SIGNALS . 31
6.11 * DISTRIBUTED ALARM SYSTEM . 32
6.12 * ALARM CONDITION SYSTEM logging . 33
Annex A (informative) General guidance and rationale . 35
Annex B (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 72
Annex C (normative) Symbols on marking . 75
ANNEX D (informative) Guidance for auditory ALARM SIGNALS . 81
ANNEX E (informative) Verbal ALARM SIGNALS . 83
ANNEX F (normative) * Reserved melodies for ALARM SIGNALS . 85
Bibliography . 86
Index of defined terms used in this collateral standard . 88
Figure 1 – Illustration of temporal characteristics of auditory ALARM SIGNALS . 21
Figure A.1 – Graphical representation of components of ALARM SYSTEM delay . 53
60601-1-8 IEC:2006+A1:2012 – 3 –
Table 1 – ALARM CONDITION priorities Determination of ALARM CONDITIONS and
assignment of priorities . 16
Table 2 – Characteristics of alarm indicator lights . 18
Table 3 – * Characteristics of the BURST of auditory ALARM SIGNALS . 20
Table 4 – * Characteristics of the PULSE of auditory ALARM SIGNALS. 20
Table 5 – ALARM SIGNAL inactivation states . 30
Table A.1 – Reference interpretation of Table F.1 . 71
Table A.2 – Reference interpretation of Table F.2 . 71
Table B.1 – Cross-reference of marking . 72
Table B.2 – Cross-reference of ACCOMPANYING DOCUMENTS . 73
Table B.3 – Cross-reference of instructions for use . 73
Table B.4 – Cross-reference of technical description . 74
Table C.1 – Graphical symbols for ALARM SYSTEMS . 75
Table C.2 – Alternative ALARM SYSTEM related markings . 80
Table D.1 – Attributes of perceived urgency . 81
Table F.1 – * Equipment encoded auditory ALARM SIGNALS categorized by ALARM
CONDITION and priority complying with Table 3 and Table 4 . 85
Table F.2 – * Auditory LOW PRIORITY ALARM SIGNAL complying with Table 3 and Table 4 . 85
– 4 – 60601-1-8 IEC:2006+A1:2012
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
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
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IEC 60601-1-8
Edition 2.2 2020-07
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
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
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IEC 60601-1-8
Edition 2.2 2020-07
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
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 978-2-8322-4272-8
IEC 60601-1-8
Edition 2.2 2020-07
CONSOLIDATED VERSION
REDLINE VERSION
VERSION REDLINE
colour
inside
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
– 2 – IEC 60601-1-8:2006+AMD1:2012
+AMD2:2020 CSV IEC 2020
CONTENTS
FOREWORD . 4
INTRODUCTION . 7
INTRODUCTION to Amendment 1 . 7
INTRODUCTION to Amendment 2 . 8
1 * Scope, object and related standards . 9
1.1 Scope . 9
1.2 Object . 9
1.3 Related standards . 9
2 Normative references . 10
3 Terms and definitions . 11
4 General requirements . 18
5 ME EQUIPMENT identification marking and documents . 18
5.1 Indicator lights and controls . 18
5.2 ACCOMPANYING DOCUMENTS . 19
6 ALARM SYSTEMS . 19
6.1 ALARM CONDITION . 19
6.2 * Disclosures for INTELLIGENT ALARM SYSTEM . 21
6.3 Generation of ALARM SIGNALS . 21
6.4 * Disclosure of delays . 29
6.5 ALARM PRESETS . 30
6.6 ALARM LIMIT . 32
6.7 * ALARM SYSTEM security . 33
6.8 * ALARM SIGNAL inactivation states . 33
6.9 * ALARM RESET . 37
6.10 * NON-LATCHING and LATCHING ALARM SIGNALS . 37
6.11 * DISTRIBUTED ALARM SYSTEM AND DISTRIBUTED INFORMATION SYSTEMS ABOUT
ALARM CONDITIONS . 37
6.12 * ALARM CONDITION SYSTEM logging . 42
6.13 ALARM SYSTEM functions . 44
Annex A (informative) General guidance and rationale . 47
Annex B (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 96
Annex C (normative) Symbols on marking . 99
Annex D (informative) Guidance for auditory ALARM SIGNALS . 108
Annex E (informative) Verbal ALARM SIGNALS . 110
Annex F (normative) * Reserved melodies for ALARM SIGNALS . 112
Annex G (normative) * Auditory ALARM SIGNALS . 113
Annex H (informative) VALIDATION of AUDITORY ICONS . 118
Bibliography . 124
Index of defined terms used in this collateral standard . 130
Figure 1 – Illustration of temporal characteristics of auditory ALARM SIGNALS . 26
Figure 2 – Functions of a DISTRIBUTED ALARM SYSTEM utilizing a MEDICAL IT NETWORK . 39
Figure 3 – Functions of an ALARM SYSTEM . 45
+AMD2:2020 CSV IEC 2020
Figure A.1 – Graphical representation of components of ALARM SYSTEM delay . 70
Figure G.1 – Illustration of spacing of AUDITORY POINTER . 115
Figure G.2 – Illustration of temporal characteristics of an AUDITORY POINTER . 116
Table 1 – Determination of ALARM CONDITION and assignment of priorities . 20
Table 2 – Characteristics of alarm indicator lights . 22
Table 3 – * Characteristics of the BURST of auditory ALARM SIGNALS . 24
Table 4 – * Characteristics of the PULSE of auditory ALARM SIGNALS. 25
Table 5 – ALARM SIGNAL inactivation states . 36
Table A.1 – Reference interpretation of Table F.1 .
Table A.2 – Reference interpretation of Table F.2 .
Table A.1 – ALARM SYSTEM output to perceived OPERATOR action . 55
Table A.2 – Examples of ME EQUIPMENT for each category of the SOURCE of an ALARM
CONDITION . 95
Table B.1 – Cross-reference of marking . 96
Table B.2 – Cross-reference of ACCOMPANYING DOCUMENTS . 97
Table B.3 – Cross-reference of instructions for use . 97
Table B.4 – Cross-reference of technical description . 98
Table C.1 – Graphical symbols for ALARM SYSTEMS . 99
Table C.1 – Graphical symbols for ALARM SYSTEMS (continued) . 100
Table C.1 – Graphical symbols for ALARM SYSTEMS (continued) . 101
Table C.2 – Alternative ALARM SYSTEM related markings . 107
Table D.1 – Attributes of perceived
...
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