SIST EN 62366:2008/A1:2015

Medical devices - Application of usability engineering to medical devices

Medizinprodukte - Anwendung der Gebrauchstauglichkeit auf Medizinprodukte

Dispositifs médicaux - Application de l'ingénierie de l'aptitude à l'utilisation aux dispositifs médicaux

Medicinske naprave – Izvedba tehnik uporabe pri medicinskih napravah - Dopolnilo A1

General Information

• Status: Withdrawn
• Publication Date: 13-Aug-2015
• Withdrawal Date: 15-Apr-2018
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 16-Apr-2018
• Due Date: 09-May-2018
• Completion Date: 16-Apr-2018
• Directive: 2006/95/EC - Directive 2006/95/EC of the European Parliament and of the Council of 12 December 2006 on the harmonisation of the laws of Member States relating to electrical equipment designed for use within certain voltage limits (codified version)
• 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 62366:2008/A1:2015 - Medical devices - Application of usability engineering to medical devices

Relations

• Amends: SIST EN 62366:2008 - Medical devices - Application of usability engineering to medical devices
• Effective Date: 01-Sep-2015
• Replaced By: SIST EN 62366-1:2015 - Medical devices - Part 1: Application of usability engineering to medical devices
• Effective Date: 01-Sep-2015
• Amends: SIST EN 62366:2008 - Medical devices - Application of usability engineering to medical devices
• Effective Date: 28-Jan-2023
• Replaced By: SIST EN 62366-1:2015 - Medical devices - Part 1: Application of usability engineering to medical devices
• Effective Date: 28-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 62366:2008/A1:2015
01-september-2015
Medicinske naprave – Izvedba tehnik uporabe pri medicinskih napravah -
Dopolnilo A1
Medical devices - Application of usability engineering to medical devices
Medizinprodukte - Anwendung der Gebrauchstauglichkeit auf Medizinprodukte
Dispositifs médicaux - Application de l'ingénierie de l'aptitude à l'utilisation aux dispositifs
médicaux
Ta slovenski standard je istoveten z: EN 62366:2008/A1:2015
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
SIST EN 62366:2008/A1:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 62366:2008/A1:2015

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SIST EN 62366:2008/A1:2015


EUROPEAN STANDARD EN 62366:2008/A1

NORME EUROPÉENNE

EUROPÄISCHE NORM
May 2015
ICS 11.040

English Version
Medical devices - Application of usability engineering to medical
devices
(IEC 62366:2007/A1:2014)
Dispositifs médicaux - Application de l'ingénierie de Medizinprodukte - Anwendung der Gebrauchstauglichkeit
l'aptitude à l'utilisation aux dispositifs médicaux auf Medizinprodukte
(IEC 62366:2007/A1:2014) (IEC 62366:2007/A1:2014)
This amendment A1 modifies the European Standard EN 62366:2008; it was approved by CENELEC on 2015-04-14. 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, 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: Avenue Marnix 17, B-1000 Brussels
© 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
 Ref. No. EN 62366:2008/A1:2015 E

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SIST EN 62366:2008/A1:2015
EN 62366:2008/A1:2015
Foreword
The text of document 62A/889/FDIS, future IEC 62366:2007/A1, prepared by SC 62A "Common
aspects of electrical equipment used in medical practice" of IEC/TC 62 "Electrical equipment in
medical practice" and ISO/TC 210 "Quality management and corresponding general aspects for
medical devices" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
EN 62366:2008/A1:2015.

The following dates are fixed:
(dop) 2016-01-14
• latest date by which the document has to be
implemented at national level by
publication of an identical national
standard or by endorsement
• latest date by which the national (dow) 2018-04-14
standards conflicting with the
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 [and/or CEN] shall not be held responsible for identifying any or all such
patent rights.

This document has been prepared under a mandate given to CENELEC by the European Commission
and the European Free Trade Association, and supports essential requirements of EU Directive.

For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, included in
EN 62366:2008.

This standard covers the Principle Elements of the Safety Objectives for Electrical Equipment
Designed for Use within Certain Voltage Limits (LVD - 2006/95/EC).

Endorsement notice
The text of the International Standard IEC 62366:2007/A1:2014 was approved by CENELEC as a
European Standard without any modification.
2

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SIST EN 62366:2008/A1:2015



IEC 62366


Edition 1.0 2014-01




INTERNATIONAL



STANDARD




NORME



INTERNATIONALE




A MENDMENT 1

AM ENDEMENT 1





Medical devices – Application of usability engineering to medical devices



Dispositifs médicaux – Application de l'ingénierie de l'aptitude à l'utilisation aux


dispositifs médicaux

















INTERNATIONAL

ELECTROTECHNICAL

COMMISSION


COMMISSION

ELECTROTECHNIQUE

PRICE CODE
INTERNATIONALE

CODE PRIX G


ICS 11.040 ISBN 978-2-8322-1134-2



Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

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SIST EN 62366:2008/A1:2015
– 2 – 62366 Amend.1 © IEC:2014
FOREWORD
This amendment has been prepared by a joint working group of subcommittee 62A: Common
aspects of electrical medical equipment used in medical practice, of IEC technical committee
62: Electrical medical equipment in medical practice and technical committee ISO/TC 210:
Quality management and corresponding general aspects for medical devices.
The text of this amendment is based on the following documents:
FDIS Report on voting
62A/889/FDIS 62A/897/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 23
P-members out of 23 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 62366 was published in 2007. This amendment is intended to add
urgently needed requirements to deal with legacy devices for which the user interface design
is of unknown provenance. Work is continuing in parallel to develop the second edition of
IEC 62366.

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 mandatory implementation nationally not earlier than 3 years from the date of publication.

INTRODUCTION
Add after the last paragraph of the introduction the following paragraph:

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SIST EN 62366:2008/A1:2015
62366 Amend.1 © IEC:2014 – 3 –
Amendment 1 updates the standard to add urgently needed requirements to deal with legacy
devices where the USER INTERFACE design is of unknown provenance.
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.
3 Terms and definitions
Add the following new definition:
3.27
USER INTERFACE OF UNKNOWN PROVENANCE
UOUP
USER INTERFACE or part of a USER INTERFACE of a MEDICAL DEVICE previously developed for
which adequate RECORDS of the USABILITY ENGINEERING PROCESS of this standard are not
available
5 USABILITY ENGINEERING PROCESS
Add the following new subclause:
5.10 * USER INTERFACE OF UNKNOWN PROVENANCE (UOUP)
Instead of all of the requirements of 5.1 through 5.9, UOUP may be evaluated according to
Annex K.
Compliance is checked by application of Annex K.
Annex A – General guidance and rationale
A.2 Rationale for requirements in particular
...