IEC 60601-1-6:2010/AMD1:2013

Amendment 1 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

Amendement 1 - Appareils électromédicaux - Partie 1-6: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Aptitude à l'utilisation

General Information

• Status: Published
• Publication Date: 28-Oct-2013
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: SC 62A - Common aspects of medical equipment, software, and systems
• Drafting Committee: MT 25 - TC 62/SC 62A/MT 25
• Current Stage: PPUB - Publication issued
• Start Date: 31-Oct-2013
• Completion Date: 29-Oct-2013

Relations

• Amends: IEC 60601-1-6:2010 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
• Effective Date: 05-Sep-2023

Standards Content (Sample)

IEC 60601-1-6 ®
Edition 3.0 2013-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AMENDMENT 1
AMENDEMENT 1
Medical electrical equipment –
Part 1-6: General requirements for basic safety and essential performance –
Collateral standard: Usability

Appareils électromédicaux –
Partie 1-6: Exigences générales pour la sécurité de base et les performances
essentielles – Norme collatérale: Aptitude à l'utilisation

IEC 60601-1-6:2010/A1:2013
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IEC 60601-1-6 ®
Edition 3.0 2013-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AMENDMENT 1
AMENDEMENT 1
Medical electrical equipment –

Part 1-6: General requirements for basic safety and essential performance –

Collateral standard: Usability

Appareils électromédicaux –
Partie 1-6: Exigences générales pour la sécurité de base et les performances

essentielles – Norme collatérale: Aptitude à l'utilisation

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX F
ICS 11.040 ISBN 978-2-8322-1132-8

– 2 – 60601-1-6 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.
The text of this amendment is based on the following documents:
FDIS Report on voting
62A/890/FDIS 62A/898/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.
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 third edition of IEC 60601-1-6 was published in 2010. The third edition created a bridge
that enables a MANUFACTURER to conform to the requirements in IEC 60601-1 that make
normative reference to IEC 60601-1-6 by employing a USABILITY ENGINEERING PROCESS
complying with IEC 62366:2007. However, IEC 62366 contains certain life-cycle process
elements that are inconsistent with a TYPE TEST.
This amendment is intended to clarify the elements of the USABILITY ENGINEERING PROCESS that
are required for compliance with the IEC 60601 series.

FOREWORD
In the existing paragraph beginning "This document cancels and replaces…", delete the
second sentence.
In the existing third paragraph from the end of the Foreword, beginning "To assist the user…",
1)
replace "IEC 62366:2007" with "IEC 62366:2007+A1— " in two places.
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
—————————
1)
To be published.
60601-1-6 Amend.1 © IEC:2013 – 3 –
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.
INTRODUCTION
In the first sentence of the fourth paragraph, replace "IEC 60601-1:2005" with
"IEC 60601-1:2005+A1:2012".
In the second sentence of the existing sixth paragraph, replace "IEC 62366:2007" with
"IEC 62366".
Add, after the last paragraph of the introduction, the following new paragraph:
Amendment 1 removes the reference to the complete life-cycle process (including post-
production monitoring and surveillance). IEC 60601 (the series) is confined to performing a
TYPE TEST of ME EQUIPMENT. It does not extend to the entire life cycle including post-
production monitoring and periodic maintenance of the USABILITY ENGINEERING PROCESS.
1.3.1 IEC 60601-1
Replace the existing first bullet with:
– "the general standard" designates IEC 60601-1 alone (IEC 60601-1:2005+A1:2012);
Replace the existing second bullet with:
– "this collateral standard" designates IEC 60601-1-6 alone (IEC 60601-1-6:2010+A1:2013).
2 Normative references
Replace the existing references to IEC 60601-1, IEC 60601-1-8 and IEC 62366 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 60601-1-8:2006, 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
IEC 62366:2007, Medical devices – Application of usability engineering to medical devices
2)
Amendment 1:—
3 Terms and definitions
In the existing introductory paragraph, replace "IEC 60601-1:2005" with
"IEC 60601-1:2005+A1:2012", "IEC 60601-1-8:2006" with "IEC 60601-1-8:2006+A1:2012" and
2)
"IEC 62366:2007" with "IEC 62366:2007+A1:— ".
—————————
2)
To be published.
– 4 – 60601-1-6 Amend.1 © IEC:2013
4.2 * USABILITY ENGINEERING PROCESS for ME EQUIPMENT
Replace the existing first paragraph with following:
3)
A USABILITY ENGINEERING PROCESS complying with IEC 62366:2007+A1: — shall be performed
except:
– the planning for and execution of production and post-production monitoring in the context
of applying the USABILITY ENGINEERING PROCESS within the framework of ISO 14971, and
– maintenance of the USABILITY ENGINEERING PROCESS.
In the existing second paragraph, replace "IEC 60601-1:2005" with
"IEC 60601-1:2005+A1:2012".
5 * Replacement of requirements given in IEC 62366
3)
In the existing second paragraph, replace "IEC 62366:2007" with "IEC 62366:2007+A1— .
Annex A –General guidance and rationale
A.2 Rationale for particular clauses and subclauses
Subclause 4.2 – USABILITY ENGINEERING PROCESS for ME EQUIPMENT
Replace the existing third paragraph of the rationale with the following:
While the USABILITY ENGINEERING PROCESS described in IEC 62366 is more mature and refined
than the PROCESS in the second edition of IEC 60601-1-6, it is fundamentally the same
PROCESS.
The scope of IEC 60601-1 and of this collateral standard is confined to performing a TYPE
TEST of ME EQUIPMENT; it does not extend to life-cycle monitoring. For this reason, the
monitoring of production and post-production information and the planning thereof, as
required by the ISO 14971 framework, is excluded from the USABILITY ENGINEERING PROCESS
described in this standard. The requirement in IEC 62366 for periodic maintenance of the
USABILITY ENGINEERING PROCESS is also excluded.
In the existing fourth paragraph, replace "IEC 60601-1:2005" with
"IEC 60601-1:2005+A1:2012".
Clause 5 – Replacement of requirements given in IEC 62366
In the existing first paragraph, replace "IEC 60601-1:2005" with "IEC 60601-1:2005+A1:2012".
Annex B Mapping between the elements of IEC 60601-1-6:2006 and the related
elements in IEC 62366:2007
)
In the existing first paragraph, replace "IEC 62366:2007" with "IEC 62366:2007+A1— in two
places.
Table B.1 – Mapping between the elements of IEC 60601-1-6:2006 and the related
elements in IEC 62366:2007
—————————
3)
To be published.
60601-1-6 Amend.1 © IEC:2013 – 5 –
3)
In the existing title of the table, replace "IEC 62366:2007" with "IEC 62366:2007+A1: ".
Throughout the existing table, replace all occurrences of "IEC 60601-1:2005" with
"IEC 60601-1:2005+A1:2012", all occurrences of "IEC 60601-1-8:2006" with
"IEC 60601-1-8:2006+A1:2012"and all occurrences of "IEC 62366:2007" with
)
"IEC 62366:2007+A1— ".
Insert, immediately preceding the row on " 4 General requirements", the following new row:
3.27 USER INTERFACE OF UNKNOWN
PROVENANCE
UOUP
NOTE Amendment 1 to IEC 62366
added a new term that was not in
IEC 60601-1.6:2006.
Insert, immediately following the row on "6.2.6 USABILITY VALIDATION", the following new row:
5.10 USER INTERFACE OF UNKNOWN
PROVENANCE (UOUP)
NOTE Amendment 1 to IEC 62366
added a set of requirements when dealing
WITH USER INTERFACE or part of a USER
INTERFACE of a MEDICAL DEVICE previously
developed for which RECORDS of the
USABILITY ENGINEERING PROCESS of this
standard are not available. These
requirements are found in Annex K and
replace those in subclauses 5.1 to 5.9 for
UOUP.
Insert, immediately following the row on "ANNEX J", the following new row:
Annex K Evaluation of a USER INTERFACE OF
UNKNOWN PROVENANCE (UOUP)
NOTE Amendment 1 to IEC 62366
added this annex. The annex provides a
set of normative requirements when
dealing WITH USER INTERFACE or part of a
USER INTERFACE of a MEDICAL DEVICE
previously developed for which RECORDS
of the USABILITY ENGINEERING PROCESS of
this standard are not available.

Index of defined terms used with this collateral standard
Amend the references to the following defined terms as follows:
ALARM SIGNAL . IEC 60601-1:2005+A1:2012, 3.142
ALARM SYSTEM . IEC 60601-1:2005+A1:2012, 3.143
ESSENTIAL PERFORMANCE . IEC 60601-1:2005+A1:2012, 3.27
HAND-HELD . IEC 60601-1:2005+A1:2012, 3.37
HAZARD.IEC 60601-1: 2005 + A1:2012, 3.39
INTENDED USE .
...