Medical devices - Part 1: Application of usability engineering to medical devices

IEC 62366-1:2015 specifies a PROCESS for a MANUFACTURER to analyse, specify, develop and evaluate the USABILITY of a MEDICAL DEVICE as it relates to SAFETY. This USABILITY ENGINEERING (HUMAN FACTORS ENGINEERING) PROCESS permits the MANUFACTURER to assess and mitigate RISKS associated with CORRECT USE and USE ERRORS, i.e., NORMAL USE. It can be used to identify but does not assess or mitigate RISKS associated with ABNORMAL USE. This first edition of IEC 62366-1, together with the first edition of IEC 62366-2, cancels and replaces the first edition of IEC 62366 published in 2007 and its Amendment 1 (2014). Part 1 has been updated to include contemporary concepts of usability engineering, while also streamlining the process. It strengthens links to ISO 14971:2007 and the related methods of risk management as applied to safety related aspects of medical device user interfaces. Part 2 contains tutorial information to assist manufactures in complying with Part 1, as well as offering more detailed descriptions of usability engineering methods that can be applied more generally to medical devices that go beyond safety-related aspects of medical device user interfaces.

Medizinprodukte - Teil 1: Anwendung der Gebrauchstauglichkeit auf Medizinprodukte

Dispositifs médicaux - Partie 1: Application de l'ingénierie de l'aptitude à l'utilisation aux dispositifs médicaux

L'IEC 62366-1:2015 spécifie un PROCESSUS permettant à un FABRICANT d'analyser, de spécifier, de développer et d'évaluer l'APTITUDE A l'UTILISATION d'un DISPOSITIF MEDICAL, concernant la SECURITE. Ce PROCESSUS D'INGENIERIE DE L'APTITUDE A L'UTILISATION (INGENIERIE DES FACTEURS HUMAINS) permet au FABRICANT d'évaluer et de réduire les RISQUES associés à une UTILISATION CORRECTE et à des ERREURS d'UTILISATION, c'est-à-dire une UTILISATION NORMALE. Il peut être utilisé pour identifier les RISQUES associés à une UTILISATION ANORMALE mais ne les évalue pas et ne les réduit pas. La première édition de l'IEC 62366-1, ainsi que la première édition de l'IEC 62366-2, annule et remplace la première édition de l'IEC 62366 parue en 2007 et son Amendement 1 (2014). La Partie 1 a été mise à jour afin d'inclure des concepts contemporains d'INGENIERIE DE L'APTITUDE A L'UTILISATION, tout en rationalisant le processus. Elle renforce aussi les liens avec l'ISO 14971:2007 et les méthodes connexes de GESTION DES RISQUES appliquées aux aspects relatifs à la sécurité des INTERFACES UTILISATEUR des DISPOSITIFS MEDICAUX. La Partie 2 contient des informations didactiques pour aider les fabricants à se conformer à la Partie 1 et fournit des descriptions plus détaillées des méthodes d'INGENIERIE DE L'APTITUDE A L'UTILISATION QUI PEUVENT ETRE APPLIQUEES D'UNE FAÇON PLUS GENERALE AUX DISPOSITIFS MEDICAUX et qui vont au-delà des aspects relatifs à la sécurité des INTERFACES UTILISATEUR des DISPOSITIFS MEDICAUX.

Medicinske naprave - 1. del: Izvedba tehnik uporabe pri medicinskih napravah

Ta del standarda IEC 62366 določa POSTOPEK, s pomočjo katerega PROIZVAJALEC analizira, določi, razvije in oceni UPORABNOST MEDICINSKE NAPRAVE, saj se nanaša na VARNOST. Ta POSTOPEK IZVEDBE TEHNIK UPORABE (NAČRTOVANJE ČLOVEŠKIH DEJAVNIKOV) omogoča PROIZVAJALCU, da oceni in blaži TVEGANJA, povezana z NEPRAVILNO UPORABO IN NAPAKAMI PRI UPORABI, tj. pri NORMALNI UPORABI. Uporablja se lahko za opredelitev, vendar ne ocenjuje ali blaži TVEGANJ, povezanih z NENORMALNO UPORABO.
OPOMBA 1: VARNOST je svoboda pred nesprejemljivim TVEGANJEM. Nesprejemljivo TVEGANJE lahko izhaja iz NAPAKE PRI UPORABI, kar lahko vodi v izpostavljenost neposrednim fizičnim NEVARNOSTIM ali izgubo ali degradacijo klinične uporabnosti.
OPOMBA 2: Navodila za izvedbo TEHNIK UPORABE za MEDICINSKE NAPRAVE so na voljo v standardu IEC 62366-22, ki ne obravnava samo VARNOSTI, ampak tudi vidike UPORABNOSTI, ki se ne nanašajo na VARNOST. Če je bil upoštevan POSTOPEK IZVEDBE TEHNIK UPORABE v tem mednarodnem standardu, se UPORABNOST MEDICINSKE NAPRAVE v zvezi z VARNOSTJO šteje za sprejemljivo, če ni OBJEKTIVNIH DOKAZOV o nasprotnem.
OPOMBA 3: Taki OBJEKTIVNI DOKAZI lahko posledično izvirajo iz POPROIZVODNEGA nadzora.

General Information

Status
Published
Publication Date
23-Apr-2015
Withdrawal Date
30-Mar-2018
Current Stage
6060 - Document made available - Publishing
Start Date
24-Apr-2015
Completion Date
24-Apr-2015

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 62366-1:2015
01-september-2015
1DGRPHãþD
SIST EN 62366:2008
SIST EN 62366:2008/A1:2015
Medicinske naprave - 1. del: Izvedba tehnik uporabe pri medicinskih napravah
Medical devices - Part 1: Application of usability engineering to medical devices
Medizinprodukte - Anwendung der Gebrauchstauglichkeit auf Medizinprodukte
Dispositifs médicaux - Partie 1: Application de l'ingénierie de l'aptitude à l'utilisation aux
dispositifs médicaux
Ta slovenski standard je istoveten z: EN 62366-1:2015
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
SIST EN 62366-1:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 62366-1:2015

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SIST EN 62366-1:2015


EUROPEAN STANDARD EN 62366-1

NORME EUROPÉENNE

EUROPÄISCHE NORM
April 2015
ICS 11.040

English Version
Medical devices - Part 1: Application of usability engineering to
medical devices
(IEC 62366-1:2015)
Dispositifs médicaux - Partie 1: Application de l'ingénierie Medizinprodukte - Anwendung der Gebrauchstauglichkeit
de l'aptitude à l'utilisation aux dispositifs médicaux auf Medizinprodukte
(IEC 62366-1:2015) (IEC 62366-1:2015)
This European Standard was approved by CENELEC on 2015-03-31. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard 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 European Standard 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 62366-1:2015 E

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SIST EN 62366-1:2015
EN 62366-1:2015 - 2 -
Foreword
The text of document 62A/977/FDIS, future edition 1 of IEC 62366-1, 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 EN 62366-
1:2015.
The following dates are fixed:
• latest date by which the document has (dop) 2015-12-31
to be implemented at national level by
publication of an identical national
standard or by endorsement
(dow) 2018-03-31
• latest date by which the national
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.
Endorsement notice
The text of the International Standard IEC 62366-1:2015 was approved by CENELEC as a European
Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards indicated:
IEC 60601-1:2005 NOTE Harmonized as EN 60601-1:2006.
IEC 60601-1:2005/A1:2012 NOTE Harmonized as EN 60601-1:2006/A1:2013.
IEC 60601-1-6:2010 NOTE Harmonized as EN 60601-1-6:2010.
IEC 60601-1-6:2010/A1:2013 NOTE Harmonized as EN 60601-1-6:2010/A1:2013.
IEC 60601-1-8:2006 NOTE Harmonized as EN 60601-1-8:2007.
IEC 60601-1-8:2006/A1:2012 NOTE Harmonized as EN 60601-1-8:2007/A1:2013.
IEC 60601-1-11 NOTE Harmonized as EN 60601-1-11.
ISO 7010:2011 NOTE Harmonized as EN ISO 7010:2012.
ISO 9000:2005 NOTE Harmonized as EN ISO 9000:2005.
ISO 9001:2008 NOTE Harmonized as EN ISO 9001:2008.
ISO 9241-11:1998 NOTE Harmonized as EN ISO 9241-11:1998.
ISO 13485:2003 NOTE Harmonized as EN ISO 13485:2012.

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SIST EN 62366-1:2015
- 3 - EN 62366-1:2015

Annex ZA
(normative)
Normative references to international publicatio
...

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