IEC 60601-1-10:2007
(Main)Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers
Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers
Specifies requirements for the development (analysis, design, verification and validation) of a physiologic closed-loop controller (PCLC) as part of a physiologic closed-loop control system (PCLCS) in medical electrical equipment and medical electrical systems to control a physiologic variable. This collateral standard applies to various types of PCLC, e.g. linear and non-linear, adaptive, fuzzy, neural networks. This collateral standard applies to a closed-loop controller that sets the controller output variable in order to adjust (i.e., change or maintain) the measured physiologic variable by relating it to the reference variable.
Appareils électromédicaux - Partie 1-10: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Exigences pour le développement des régulateurs physiologiques en boucle fermée
Spécifie les exigences pour le développement (analyse, conception, vérification et validation) d'un régulateur physiologique en boucle fermée (RPBF) en tant que partie d'un système physiologique de commande en boucle fermée (SPCBF) dans les appareils em et les systèmes em pour la commande d'une variable physiologique. La présente norme collatérale s'applique aux différents types de RPBF, par exemple linéaire et non-linéaire, adaptatifs, fuzzy, réseaux de neurones. La présente norme collatérale s'applique à un régulateur en boucle fermée qui règle la variable de sortie du régulateur afin d'ajuster (c'est-à-dire, changer ou maintenir) la variable physiologique mesurée en effectuant une comparaison avec la variable de référence.
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IEC 60601-1-10
Edition 1.0 2007-11
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 1-10: General requirements for basic safety and essential performance –
Collateral Standard: Requirements for the development of physiologic
closed-loop controllers
Appareils électromédicaux –
Partie 1-10: Exigences générales pour la sécurité de base et les performances
essentielles – Norme collatérale: Exigences pour le développement des
régulateurs physiologiques en boucle fermée
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 60601-1-10
Edition 1.0 2007-11
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 1-10: General requirements for basic safety and essential performance –
Collateral Standard: Requirements for the development of physiologic
closed-loop controllers
Appareils électromédicaux –
Partie 1-10: Exigences générales pour la sécurité de base et les performances
essentielles – Norme collatérale: Exigences pour le développement des
régulateurs physiologiques en boucle fermée
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
W
CODE PRIX
ICS 11.040 ISBN 2-8318-9448-4
– 2 – 60601-1-10 © IEC:2007
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
1.3.1 IEC 60601-1 .8
1.3.2 Particular standards .9
2 Normative references .9
3 Terms and definitions .9
4 * General requirements .14
5 ME EQUIPMENT identification, marking and documents .14
5.1 * Instructions for use .14
5.2 Technical description.15
6 Accuracy of controls and instruments and protection against hazardous outputs .15
6.1 * USABILITY .15
6.2 ALARM SYSTEMS .15
6.3 * PCLCS VARIABLE logging .15
6.4 * DISTRIBUTED PCLCS .16
7 * PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .16
8 Requirements for PHYSIOLOGIC CLOSED-LOOP CONTROLLER (PCLC) development.16
8.1 * General.16
8.2 Attributes/activities of the PCLC development PROCESS .17
8.2.1 RECORDS and PROCESS scaling .17
8.2.2 Equipment specifications .17
8.2.3 * Disturbance management.20
8.2.4 * PCLC VERIFICATION.21
8.2.5 * PCLCS VALIDATION .21
Annex A (informative) General guidance and rationale.22
Annex B (informative) Description of dynamic performance of a PCLCS .32
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS.36
Bibliography.37
Index of defined terms used in this collateral standard.38
Figure 1 – Functional diagram indicating typical components of a PHYSIOLOGIC CLOSED-
LOOP CONTROL SYSTEM (PCLCS) utilizing a PCLC .10
Figure B.1 – Example of PCLCS dynamic performance with no STEADY-STATE DEVIATION.33
Figure B.2 – Example of PCLCS dynamic performance with STEADY-STATE DEVIATION.34
Figure B.3 – Example of PCLCS dynamic performance transient COMMAND VARIABLE.35
60601-1-10 © IEC:2007 – 3 –
Table A.1 – Examples of ME EQUIPMENT or ME SYSTEMS that incorporate a PCLCS .22
Table C.2 – ACCOMPANYING DOCUMENTS, instructions for use.36
Table C.3 – ACCOMPANYING DOCUMENTS, technical description .36
– 4 – 60601-1-10 © IEC:2007
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 1-10: General requirements for basic safety
and essential performance –
Collateral Standard:
Requirements for the development of
physiologic closed-loop controllers
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 that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International standard IEC 60601-1-10 has been prepared by IEC subcommittee 62A:
Common aspects of electrical equipment used in medical practice, of IEC technical committee
62: Electrical equipment in medical practice, and ISO subcommittees SC1: Breathing
attachments and anaesthetic machines, and SC3: Lung ventilators and related devices of ISO
technical committee 121: Anaesthetic and respiratory equipment.
It is published as double logo standard.
This first edition constitutes a collateral standard to IEC 60601-1: Medical electrical
equipment – Part 1: General requirements for safety and essential performance hereafter
referred to as the general standard.
60601-1-10 © IEC:2007 – 5 –
The text of
...
IEC 60601-1-10 ®
Edition 1.1 2013-11
CONSOLIDATED
VERSION
VERSION
CONSOLIDÉE
colour
inside
Medical electrical equipment –
Part 1-10: General requirements for basic safety and essential performance –
Collateral Standard: Requirements for the development of physiologic
closed-loop controllers
Appareils électromédicaux –
Partie 1-10: Exigences générales pour la sécurité de base et les performances
essentielles – Norme collatérale: Exigences pour le développement des
régulateurs physiologiques en boucle fermée
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 la CEI ou du Comité national de la CEI du pays du demandeur.
Si vous avez des questions sur le copyright de la CEI ou si vous désirez obtenir des droits supplémentaires sur cette
publication, utilisez les coordonnées ci-après ou contactez le Comité national de la CEI de votre pays de résidence.
IEC Central Office Tel.: +41 22 919 02 11
3, rue de Varembé Fax: +41 22 919 03 00
CH-1211 Geneva 20 info@iec.ch
Switzerland www.iec.ch
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 corrigenda or an amendment might have been published.
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by a variety of criteria (reference number, text, technical electrical terms containing more than 30 000 terms and
committee,…). definitions in English and French, with equivalent terms in
It also gives information on projects, replaced and additional languages. Also known as the International
withdrawn publications. Electrotechnical Vocabulary (IEV) on-line.
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A propos de la CEI
La Commission Electrotechnique Internationale (CEI) 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 CEI
Le contenu technique des publications de la CEI est constamment revu. Veuillez vous assurer que vous possédez
l’édition la plus récente, un corrigendum ou amendement peut avoir été publié.
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référence, texte, comité d’études,…). termes et définitions en anglais et en français, ainsi que
Elle donne aussi des informations sur les projets et les les termes équivalents dans les langues additionnelles.
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contactez-nous: csc@iec.ch.
IEC 60601-1-10 ®
Edition 1.1 2013-11
INTERNATIONAL
STANDARD
VERSION
CONSOLIDÉE
colour
inside
Medical electrical equipment –
Part 1-10: General requirements for basic safety and essential performance –
Collateral Standard: Requirements for the development of physiologic
closed-loop controllers
Appareils électromédicaux –
Partie 1-10: Exigences générales pour la sécurité de base et les performances
essentielles – Norme collatérale: Exigences pour le développement des
régulateurs physiologiques en boucle fermée
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040 ISBN 978-2-8322-1286-8
IEC 60601-1-10 ®
Edition 1.1 2013-11
REDLINE VERSION
VERSION REDLINE
colour
inside
Medical electrical equipment –
Part 1-10: General requirements for basic safety and essential performance –
Collateral Standard: Requirements for the development of physiologic
closed-loop controllers
Appareils électromédicaux –
Partie 1-10: Exigences générales pour la sécurité de base et les performances
essentielles – Norme collatérale: Exigences pour le développement des
régulateurs physiologiques en boucle fermée
– 2 – 60601-1-10 © IEC:2007+A1:2013
CONTENTS
FOREWORD . 4
INTRODUCTION . 7
INTRODUCTION TO THE AMENDMENT . 8
1 Scope, object and related standards . 9
1.1 * Scope . 9
1.2 Object . 9
1.3 Related standards . 9
1.3.1 IEC 60601-1 . 9
1.3.2 Particular standards . 10
2 Normative references . 10
3 Terms and definitions . 10
4 * General requirements . 15
5 ME EQUIPMENT identification, marking and documents . 16
5.1 * Instructions for use . 16
5.2 Technical description. 16
6 Accuracy of controls and instruments and protection against hazardous outputs . 16
6.1 * USABILITY . 16
6.2 ALARM SYSTEMS . 16
6.3 * PCLCS VARIABLE logging . 17
6.4 * DISTRIBUTED PCLCS . 17
7 * PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 17
8 Requirements for PHYSIOLOGIC CLOSED-LOOP CONTROLLER (PCLC) development . 17
8.1 * General . 17
8.2 Attributes/activities of the PCLC development PROCESS . 18
8.2.1 RECORDS and PROCESS scaling . 18
8.2.2 Equipment specifications . 18
8.2.3 * Disturbance management . 21
8.2.4 * PCLC VERIFICATION . 22
8.2.5 * PCLCS VALIDATION . 22
Annex A (informative) General guidance and rationale . 23
Annex B (informative) Description of dynamic performance of a PCLCS . 33
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 37
Bibliography . 38
Index of defined terms used in this collateral standard . 39
Figure 1 – Functional diagram indicating typical components of a PHYSIOLOGIC CLOSED-
LOOP CONTROL SYSTEM (PCLCS) utilizing a PCLC . 11
Figure B.1 – Example of PCLCS dynamic performance with no STEADY-STATE DEVIATION . 34
Figure B.2 – Example of PCLCS dynamic performance with STEADY-STATE DEVIATION . 35
60601-1-10 © IEC:2007+A1:2013 – 3 –
Figure B.3 – Example of PCLCS dynamic performance transient COMMAND VARIABLE . 36
Table A.1 – Examples of ME EQUIPMENT or ME SYSTEMS that incorporate a PCLCS . 23
Table C.2 – ACCOMPANYING DOCUMENTS, instructions for use . 37
Table C.3 – ACCOMPANYING DOCUMENTS, technical description . 37
– 4 – 60601-1-10 © IEC:2007+A1:2013
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 1-10: General requirements for basic safety
and essential performance –
Collateral Standard:
Requirements for the development of
physiologic closed-loop controllers
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 that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the
...
IEC 60601-1-10
Edition 1.2 2020-07
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 1-10: General requirements for basic safety and essential performance –
Collateral Standard: Requirements for the development of physiologic
closed-loop controllers
Appareils électromédicaux –
Partie 1-10: Exigences générales pour la sécurité de base et les performances
essentielles – Norme collatérale: Exigences pour le développement des
régulateurs physiologiques en boucle fermée
IEC IEC 60601-1-10:2007-11+AMD1:2013-11+AMD2:2020-07 CSV(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
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.: +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 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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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
plus récente, un corrigendum ou amendement peut avoir été publié.
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webstore.iec.ch/advsearchform Le premier dictionnaire d'électrotechnologie en ligne au
La recherche avancée permet de trouver des publications IEC monde, avec plus de 22 000 articles terminologiques en
en utilisant différents critères (numéro de référence, texte, anglais et en français, ainsi que les termes équivalents dans
comité d’études,…). Elle donne aussi des informations sur les 16 langues additionnelles. Egalement appelé Vocabulaire
projets et les publications remplacées ou retirées. Electrotechnique International (IEV) en ligne.
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IEC 60601-1-10
Edition 1.2 2020-07
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 1-10: General requirements for basic safety and essential performance –
Collateral Standard: Requirements for the development of physiologic
closed-loop controllers
Appareils électromédicaux –
Partie 1-10: Exigences générales pour la sécurité de base et les performances
essentielles – Norme collatérale: Exigences pour le développement des
régulateurs physiologiques en boucle fermée
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.01 ISBN 978-2-8322-8710-1
IEC 60601-1-10
Edition 1.2 2020-07
REDLINE VERSION
VERSION REDLINE
colour
inside
Medical electrical equipment –
Part 1-10: General requirements for basic safety and essential performance –
Collateral Standard: Requirements for the development of physiologic
closed-loop controllers
Appareils électromédicaux –
Partie 1-10: Exigences générales pour la sécurité de base et les performances
essentielles – Norme collatérale: Exigences pour le développement des
régulateurs physiologiques en boucle fermée
IEC IEC 60601-1-10:2007-11+AMD1:2013-11+AMD2:2020-07 CSV(en-fr)
– 2 – IEC 60601-1-10.2007+AMD1:2013
+AMD2:2020 CSV © IEC 2020
CONTENTS
FOREWORD . 4
INTRODUCTION . 7
INTRODUCTION to Amendment 1 . 7
INTRODUCTION to Amendment 2 . 7
1 Scope, object and related standards . 9
1.1 * Scope . 9
1.2 Object . 9
1.3 Related standards . 9
1.3.1 IEC 60601-1 . 9
1.3.2 Particular standards . 10
2 Normative references . 10
3 Terms and definitions . 10
4 * General requirements . 15
5 ME EQUIPMENT identification, marking and documents . 16
5.1 * Instructions for use . 16
5.2 Technical description. 16
6 Accuracy of controls and instruments and protection against hazardous outputs . 17
6.1 * USABILITY . 17
6.2 ALARM SYSTEMS . 17
6.3 * PCLCS VARIABLE logging . 17
6.4 * DISTRIBUTED PCLCS . 18
7 * PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 18
8 Requirements for PHYSIOLOGIC CLOSED-LOOP CONTROLLER (PCLC) development . 18
8.1 * General . 18
8.2 Attributes/activities of the PCLC development PROCESS . 19
8.2.1 RECORDS and PROCESS scaling . 19
8.2.2 Equipment specifications . 19
8.2.3 * Disturbance management . 22
8.2.4 * PCLC VERIFICATION . 23
8.2.5 * PCLCS VALIDATION . 23
Annex A (informative) General guidance and rationale . 25
Annex B (informative) Description of dynamic performance of a PCLCS . 36
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 40
Bibliography . 41
Index of defined terms used in this collateral standard . 42
Figure 1 – Functional diagram indicating typical components of a PHYSIOLOGIC CLOSED-
LOOP CONTROL SYSTEM (PCLCS) utilizing a PCLC . 11
Figure B.1 – Example of PCLCS dynamic performance with no STEADY-STATE DEVIATION . 37
Figure B.2 – Example of PCLCS dynamic performance with STEADY-STATE DEVIATION . 38
Figure B.3 – Example of PCLCS dynamic performance transient COMMAND VARIABLE . 39
Table A.1 – Examples of ME EQUIPMENT or ME SYSTEMS that incorporate a PCLCS . 25
IEC 60601-1-10.2007+AMD1:2013 – 3 –
+AMD2:2020 CSV © IEC 2020
Table C.21 – ACCOMPANYING DOCUMENTS, instructions for use . 40
Table C.32 – ACCOMPANYING DOCUMENTS, technical description . 40
– 4 – IEC 60601-1-10.2007+AMD1:2013
+AMD2:2020 CSV © IEC 2020
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 1-10: General requirements for basic safety
and essential performance –
Collateral Standard:
Requirements for the development of
physiologic closed-loop controllers
FOREWORD
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