SIST EN 60601-1-10:2008/A2:2021

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 (IEC 60601-1-10:2007/A2:2020)

2020-11-16_JO_BT167/DG11868/DV to remove the link to (MDD 93/42/EEC) and M/432

Medizinische elektrische Geräte - Teil 1-10: Allgemeine Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm: Anforderungen an die Entwicklung von physiologischen geschlossenen Regelkreisen (IEC 60601-1-10:2007/A2:2020)

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/A2:2020)

Medicinska električna oprema - 1-10. del: Splošne zahteve za osnovno varnost in bistvene lastnosti - Spremljevalni standard: Zahteve za razvoj fizioloških krmilnikov s sklenjeno zanko - Dopolnilo A2 (IEC 60601-1-10:2007/A2:2020)

General Information

• Status: Published
• Publication Date: 22-Aug-2021
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 27-Jul-2021
• Due Date: 01-Oct-2021
• Completion Date: 23-Aug-2021
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/432 - Standardisation Mandate addressed to CEN and CENELEC within the framework of Directive 2007/47/EC amending Directive 90/385/EEC and Directive 93/42/EEC relating to Medical Devices
• Ref Project: EN 60601-1-10:2008/A2:2021 - 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

Relations

• Amends: SIST EN 60601-1-10:2008 - 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
• Effective Date: 29-Aug-2017

Overview

EN 60601-1-10:2008/A2:2021 (adoption of IEC 60601-1-10:2007/A2:2020) is a European collateral standard for medical electrical equipment that defines requirements for the development of physiologic closed‑loop controllers (PCLC) and physiologic closed‑loop control systems (PCLCS). The amendment clarifies scope, updates normative references, and adds technical and documentation requirements for design, verification and validation of controllers that automatically regulate one or more patient variables (e.g., blood glucose, body temperature, hemodynamic quantities, drug concentration).

Key topics and requirements

• Scope and definitions: Specifies that a PCLC is part of a PCLCS and controls at least one patient (physiologic) variable. Adds definitions for PATIENT VARIABLE, COMMAND VARIABLE, CONTROLLER OUTPUT VARIABLE and related terms.
• Development lifecycle: Requires systematic analysis, design, verification and validation (V&V) of PCLCs consistent with the general IEC 60601‑1 framework.
• Technical description: Manufacturer must include a PCLCS block diagram and theory of operation in the technical documentation; compliance is verified by inspection.
• Logging and data: ME equipment incorporating a PCLC shall log at least the command/reference variable, controller output/manipulated variable, physiologic/feedback variable, and any patient variables used by the controller. Logging resolution and duration must be based on hazards identified.
• Risk and uncertainty: Requires evaluation of patient transfer element characteristics, including model uncertainty and hysteresis, as part of hazard analysis.
• Usability and use specification: The manufacturer must prepare a USE SPECIFICATION (per IEC 62366‑1) and include a summary in the instructions for use; compliance checked via usability engineering file and instructions.
• Records and process scaling: References general standard requirements for software lifecycle and records (Clause 14 of IEC 60601‑1).

Applications and users

Who uses this standard:

• Medical device manufacturers designing closed‑loop systems (e.g., automated infusion controllers, ventilator control loops, glucose regulators).
• Clinical engineers and systems integrators validating physiologic controllers.
• Regulatory affairs and conformity assessors evaluating essential performance and safety.
• Test laboratories, usability engineers and risk managers performing V&V, hazard analysis and usability assessments.

Practical value:

• Ensures safer design and validated performance of automated physiologic controllers.
• Provides required documentation and logging practices to support troubleshooting, post‑market analysis and regulatory submissions.

Related standards

• IEC 60601‑1: General requirements for basic safety and essential performance (with A1:2012, A2:2020)
• IEC 60601‑1‑6: Usability (with amendments)
• IEC 60601‑1‑8: Alarm systems
• IEC 62366‑1: Usability engineering for medical devices
• ISO 14971:2019: Risk management for medical devices
• ISO 9000:2015: Quality management fundamentals

Keywords: EN 60601-1-10:2008/A2:2021, IEC 60601-1-10, physiologic closed-loop controller, PCLC, medical electrical equipment, patient variable, verification and validation, medical device standards.

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2021
Medicinska električna oprema - 1-10. del: Splošne zahteve za osnovno varnost in
bistvene lastnosti - Spremljevalni standard: Zahteve za razvoj fizioloških
krmilnikov s sklenjeno zanko - Dopolnilo A2 (IEC 60601-1-10:2007/A2:2020)
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 (IEC 60601-1-10:2007/A2:2020)
Medizinische elektrische Geräte - Teil 1-10: Allgemeine Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm: Anforderungen
an die Entwicklung von physiologischen geschlossenen Regelkreisen (IEC 60601-1-
10:2007/A2:2020)
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/A2:2020)
Ta slovenski standard je istoveten z: EN 60601-1-10:2008/A2:2021
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN 60601-1-10:2008/A2

NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2021
ICS 11.040.01
English Version
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
(IEC 60601-1-10:2007/A2:2020)
Appareils électromédicaux - Partie 1-10: Exigences Medizinische elektrische Geräte - Teil 1-10: Allgemeine
générales pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich des
essentielles - Norme collatérale: Exigences pour le wesentlichen Leistungsmerkmale - Ergänzungsnorm:
développement des régulateurs physiologiques en boucle Anforderungen an die Entwicklung von physiologischen
fermée geschlossenen Regelkreisen
(IEC 60601-1-10:2007/A2:2020) (IEC 60601-1-10:2007/A2:2020)
This amendment A2 modifies the European Standard EN 60601-1-10:2008; it was approved by CENELEC on 2020-08-26. CENELEC
members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this amendment the
status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This amendment exists in three official versions (English, French, German). A version in any other language made by translation under the
responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the same status as
the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 60601-1-10:2008/A2:2021 E

European foreword
The text of document 62A/1394/FDIS, future IEC 60601-1-10/A2, prepared by SC 62A "Common
aspects of electrical equipment used in medical practice" of IEC/TC 62 "Electrical equipment in
medical practice" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2022-01-16
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2024-07-16
document have to be withdrawn
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 60601-1-10:2007/A2:2020 was approved by CENELEC as
a European Standard without any modification.

Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments)
applies.
NOTE 1 Where an International Publication has been modified by common modifications, indicated by (mod),
the relevant EN/HD applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is
available here: www.cenelec.eu.
Replace Annex ZA by the following one:
Publication Year Title EN/HD Year
IEC 60601-1 2005 Medical electrical equipment - Part 1: General EN 60601-1 2006
requirements for basic safety and essential
performance
- -  + corrigendum Mar. 2010
+ A1 2012  + A1 2013
- -  + A12 2014
+ A2 2020  + A2 2021
IEC 60601-1-6 2010 Medical electrical equipment - Part 1-6: General EN 60601-1-6 2010
requirements for basic safety and essential
performance - Collateral standard: Usability
+ A1 2013  + A1 2015
+ A2 2020  + A2 2021
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
+ A1 2012  + A1 2013
- -  + AC 2014
+ A2 2020  + A2 2021
IEC 62366-1 2015 Medical devices - Part 1: Application of usability EN 62366-1 2015
engineering to medical devices
- -  + AC 2015
+ A1 2020  + A1 2020
ISO 14971 2019 Medical devices – Application of risk EN ISO 14971 2019
management to medical devices
ISO 9000 - Quality management systems – Fundamentals EN ISO 9000 2015
and vocabulary
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 60601-1-10:2007/AMD2:2020 – 3 –
© 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 60601-1-10:2007/AMD2:2020 – 5 –
© 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 FEE
...