IEC 60601-1-10:2007/AMD1:2013

IEC 60601-1-10 ®
Edition 1.0 2013-11
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AMENDMENT 1
AMENDEMENT 1
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/A1:2013
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IEC 60601-1-10 ®
Edition 1.0 2013-11
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AMENDMENT 1
AMENDEMENT 1
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
E
CODE PRIX
ICS 11.040 ISBN 978-2-83221-133-5

– 2 – 60601-1-10 Amend. 1 © IEC:2013
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 subcommittees SC1: Breathing attachments and anaesthetic
machines, and SC3: Lung ventilators and related devices of ISO technical committee 121:
Anaesthetic and respiratory equipment.
The text of this amendment is based on the following documents:
FDIS Report on voting
62A/888/FDIS 62A/896/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 standard 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• withdrawn,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.
_____________
INTRODUCTION TO THE AMENDMENT
The first edition of IEC 60601-1-10 was published in 2007. This amendment is intended to
update the references to IEC 60601-1:2005 to include Amendment 1:2012,
to update IEC 60601-1-6:2006 to IEC 60601-1-6:2010, including its Amendment 1 and
to update references to IEC 60601-1-8:2006 to include its Amendment 1:2012. This
amendment also removes the normative reference to IEC 62304:2006. This collateral
standard made reference to IEC 62304 because elements of the software process were not
fully covered by Clause 14 of IEC 60601-1:2005. Amendment 1 to IEC 60601-1:2005
incorporates the needed software process requirement into Clause 14. Therefore, it is
redundant and potentially confusing to have IEC 62304 explicitly called out in this collateral
standard.
FOREWORD
Add the following note at the end of the Foreword:
NOTE The attention of National Committees 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 implementation nationally not earlier than 3 years from the date of publication.

60601-1-10 Amend. 1 © IEC:2013 – 3 –
1 Scope, object and related standards
1.3.1 IEC 60601-1
Replace the existing first dashed item with:
– "the general standard" designates IEC 60601-1 alone (IEC 60601-1:2005+A1:2012);
Replace the existing second dashed item with:
– "this collateral standard" designates IEC 60601-1-10 alone (IEC 60601-1-
10:2007+A1:2013)
2 Normative references
In the existing introductory paragraph, replace the first sentence with:
The following documents, in whole or in part, are normatively referenced in this document and
are indispensable for its application.
Replace the existing references to IEC 60601-1, IEC 60601-1-6 and IEC 60601-1-8 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
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
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
Delete the following normative reference:
IEC 62304:2006, Medical device software – Software life cycle processes
Add the following normative reference:
IEC 62366:2007, Medical devices – Application of usability engineering to medical devices
3 Terms and definitions
Replace the existing introductory paragraph with:
For the purposes of this document, the terms and definitions given in
IEC 60601-1:2005+A1:2012, IEC 60601-1-6:2010+ A1:2013, IEC 60601-1-8:2006+A1:2012,
IEC 62366:2007 and the following apply.
7 * PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
Replace the existing text of the clause with the following:

– 4 – 60601-1-10 Amend. 1 © IEC:2013
For ME EQUIPMENT and ME SYSTEMS that incorporate a PCLC and incorporate PEMS, the
requirements of Clause 14 of the general standard apply.
Annex A – General guidance and rationale
A.2 Rationale for particular clauses and subclauses
Subclause 5.1 – Instructions for use
In the existing first paragraph, replace "TRAINING (see IEC 60601-1-6)" with "training (see
IEC 62366)".
Subclause 6.1 – Usability
In the existing first paragraph, in the first sentence replace "IEC 60601-1-6" with "IEC 62366",
and in the penultimate sentence place "TRAINING" in normal font.
Clause 7 – PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
Replace the existing text of the rationale with the following:
Clause 7 of the first edition of this collateral standard applied the requirements of
IEC 62304:2006 to the software elements of the PEMS. This was in addition to the requirement
of Clause 14 of the general standard. Amendment 1 to the general standard incorporates the
software PROCESS requirements into Clause 14. Therefore, the additional requirements in
Clause 7 of this collateral standard are redundant and can, in effect, be deleted.
Subclause 8.1 – General
In the existing first paragraph, in the third sentence replace IEC 60601-1" with "the general
standard", and in the last sentence replace "IEC 60601-1" with "general standard", and delete
"or IEC 62304".
Subclause 8.2.2.4 – Specification of operating conditions
In the existing second dashed item, place "TRAINING" in normal font.
Index of defined terms used with this collateral standard
Replace the references to the following defined terms with:
ALARM CONDITION . IEC 60601-1-8:2006+A1:2012, 3.1
ESSENTIAL PERFORMANCE . IEC 60601-1:2005+A1:2012, 3.27
HAZARD. IEC 60601-1:2005+A1:2012, 3.39
INTENDED USE . IEC 60601-1:2005+A1:2012, 3.44
MANUFACTURER . IEC 60601-1:2005+A1:2012, 3.55
NORMAL USE . IEC 60601-1:2005+A1:2012, 3.71
OBJECTIVE EVIDENCE . IEC 60601-1:2005+A1:2012, 3.72
PATIENT . IEC 60601-1:2005+A1:2012, 3.76
PROCESS . IEC 60601-1:2005+A1:2012, 3.89
RECORD . IEC 60601-1:2005+A1:2012, 3.98
RESIDUAL RISK . IEC 60601-1:2005+A1:2012, 3.100
RISK . IEC 60601-1:2005+A1:2012, 3.102

60601-1-10 Amend. 1 © IEC:2013 – 5 –
RISK ANALYSIS . IEC 60601-1:2005+A1:2012, 3.103
RISK MANAGEMENT . IEC 60601-1:2005+A1:2012, 3.107
RISK MANAGEMENT FILE . IEC 60601-1:2005+A1:2012, 3.108
SINGLE FAULT CONDITION . IEC 60601-1:2005+A1:2012, 3.116
USABILITY . IEC 62366:2007, 3.17
USABILITY ENGINEERING . IEC 62366:2007, 3.18
USABILITY ENGINEERING FILE . IEC 62366:2007, 3.19
USE ERROR . IEC 62366:2007, 3.21
VALIDATION .
...