|
IEC 60601-1-10
Edition 1.0 2020-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AMENDMENT 2
AMENDEMENT 2
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 60601-1-10:2007-11/AMD2:2020-07(en-fr)
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
CH-1211 Geneva 20
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and withdrawn publications.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 once 67 000 electrotechnical terminology entries in English and
a month by email. French extracted from the Terms and definitions clause of IEC
publications issued between 2002 and 2015. Some entries
IEC Customer Service Centre - webstore.iec.ch/csc have been collected from earlier publications of IEC TC 37, 77,
If you wish to give us your feedback on this publication or need 86 and CISPR.
further assistance, please contact the Customer Service
.
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.
Recherche de publications IEC - Le premier dictionnaire d'électrotechnologie en ligne au monde,
webstore.iec.ch/advsearchform avec plus de 22 000 articles terminologiques en anglais et en
La recherche avancée permet de trouver des publications IEC français, ainsi que les termes équivalents dans 16 langues
en utilisant différents critères (numéro de référence, texte, additionnelles. Egalement appelé Vocabulaire
comité d’études,…). Elle donne aussi des informations sur les Electrotechnique International (IEV) en ligne.
projets et les publications remplacées ou retirées.
Glossaire IEC - std.iec.ch/glossary
IEC Just Published - webstore.iec.ch/justpublished 67 000 entrées terminologiques électrotechniques, en anglais
Restez informé sur les nouvelles publications IEC. Just et en français, extraites des articles Termes et définitions des
Published détaille les nouvelles publications parues. publications IEC parues entre 2002 et 2015. Plus certaines
Disponible en ligne et une fois par mois par email. entrées antérieures extraites des publications des CE 37, 77,
86 et CISPR de l'IEC.
Service Clients - webstore.iec.ch/csc
Si vous désirez nous donner des commentaires sur cette
publication ou si vous avez des questions contactez-nous:
[email protected] .
Electropedia - www.electropedia.org
IEC 60601-1-10
Edition 1.0 2020-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 2
AM ENDEMENT 2
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 978-2-8322-8622-7
– 2 – IEC 60601-1-10:2007/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/1394/FDIS 62A/1409/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 17 P
members out of 17 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.
_____________
© IEC 2020
INTRODUCTION TO AMENDMENT 2
The first edition of IEC 60601-1-10 was published in 2007 and amended in 2013. Since the
publication of IEC 60601-1-10:2007+A1:2013, 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 second edition of IEC 60601-1-10, 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, 13 items were presented
to the National Committees present. All 13 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 second edition of IEC 60601-1-10.
The "short list" of issues was documented in the design specification for Amendment 2. As
IEC 60601-1-10 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) 5. JWG 5 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 60601-1-10:2007, the style in force at the time of
publication of IEC 60601-1-10 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, references to
amendments take the following form: "IEC 60601-1:2005+A1:2012+A2:2020".
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 60601-1-10:2007/AMD2:2020
© IEC 2020
1.1 * Scope
Replace the existing second paragraph and note with the following new paragraph and example:
This collateral standard 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) to control at least one PATIENT VARIABLE (i.e.
a PHYSIOLOGIC VARIABLE) in ME EQUIPMENT and ME SYSTEMS.
EXAMPLE A PATIENT VARIABLE can be a measure of body chemistry (e.g. electrolytes or blood glucose value), a
physical property (e.g. body temperature, electrophysiologic characteristic, hemodynamic quantity), or a
pharmaceutical concentration.
1.3.1 IEC 60601-1
Replace, in the first two dashes of the existing second paragraph, the parentheses, added by
Amendment 1, with the words ", including any amendments".
2 Normative references
Replace the existing references to IEC 60601-1, IEC 60601-1-6, IEC 60601-1-8, IEC 62366 and
ISO 14971, modified by Amendment 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 60601-1-6:2010, Medical electrical equipment – Part 1-6: General requirements for basic
safety and essential performance – Collateral standard: Usability
Amendment 1:2013
Amendment 2:2020
IEC 60601-1-8:2006, 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 1:2012
Amendment 2:2020
IEC 62366-1:2015, Medical devices – Part 1: Application of usability engineering to medical
devices
Amendment 1:2020
ISO 14971:2019, Medical devices – Application of risk management to medical devices
Add the following new normative reference:
ISO 9000:2015, Quality management systems – Fundamentals and vocabulary
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 60601-1-6:2010+A1:2013+A2:2020, IEC 60601-1-
8:2006+A1:2012+A2:2020, IEC 62366-1:2015+A1:2020, ISO 9000:2015 and the following
apply.
© IEC 2020
Figure 1 – Functional diagram indicating typical components of a PHYSIOLOGIC CLOSED-
LOOP CONTROL SYSTEM (PCLCS) utilizing a PCLC
Add, to the definition of symbol "y" in the existing key, the word "controlled" before "PHYSIOLOGIC
VARIABLE".
3.4
* COMMAND VARIABLE
Add the following new note:
NOTE A COMMAND VARIABLE may be a range or a function (e.g. clinical protocol).
3.20
* PHYSIOLOGIC CLOSED-LOOP CONTROLLER
Add the following new notes:
NOTE 1 A PCLC may utilize multiple PHYSIOLOGIC VARIABLES and COMMAND VARIABLES as well as multiple
CONTROLLER OUTPUT VARIABLES.
NOTE 2 A PATIENT VARIABLE may be used as an input to adjust the parameters of the CONTROL TRANSFER ELEMENT.
3.21
PHYSIOLOGIC VARIABLE
Replace the existing definition with the following new definition:
PATIENT VARIABLE intended to be controlled
Delete the existing note.
3.23
RELATIVE OVERSHOOT
Add, after "PHYSIOLOGIC VARIABLE" in the existing Note 1, the words "or FEEDBACK VARIABLE".
Add the following new term and definition:
3.29
* PATIENT VARIABLE
PATIENT attribute, characteristic, quantity or condition that is measured
EXAMPLE A PATIENT VARIABLE can be a measure of body chemistry (e.g. electrolytes or blood glucose value), a
physical property (e.g. body temperature, el
...