EN 62366-1:2015/A1:2020

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

2019-04-04-JO-: link to legislation to the MDD 93/42/EEC and mandate M/432 removed following CLC/BT decision D162/C076

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

Medicinske naprave - 1. del: Izvedba tehnik uporabe pri medicinskih napravah - Dopolnilo A1 (IEC 62366-1:2015/A1:2020)

General Information

• Status: Published
• Publication Date: 06-Aug-2020
• ICS: 11.040 - Medical equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62A - IEC_SC_62A
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 07-Aug-2020
• Completion Date: 07-Aug-2020
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Directive: 98/79/EC - Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic 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: SIST EN 62366-1:2015/A1:2020 - Medical devices - Part 1: Application of usability engineering to medical devices (IEC 62366-1:2015/A1:2020)

Relations

• Amends: EN 62366-1:2015 - Medical devices - Part 1: Application of usability engineering to medical devices
• Effective Date: 26-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 62366-1:2015/A1:2020
01-november-2020
Medicinske naprave - 1. del: Izvedba tehnik uporabe pri medicinskih napravah -
Dopolnilo A1 (IEC 62366-1:2015/A1:2020)
Medical devices - Part 1: Application of usability engineering to medical devices (IEC
62366-1:2015/A1:2020)
Medizinprodukte - Teil 1: Anwendung der Gebrauchstauglichkeit auf Medizinprodukte
(IEC 62366-1:2015/A1:2020)
Dispositifs médicaux - Partie 1: Application de l'ingénierie de l'aptitude à l'utilisation aux
dispositifs médicaux (IEC 62366-1:2015/A1:2020)
Ta slovenski standard je istoveten z: EN 62366-1:2015/A1:2020
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
SIST EN 62366-1:2015/A1:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 62366-1:2015/A1:2020

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SIST EN 62366-1:2015/A1:2020


EUROPEAN STANDARD EN 62366-1:2015/A1

NORME EUROPÉENNE

EUROPÄISCHE NORM
August 2020
ICS 11.040

English Version
Medical devices - Part 1: Application of usability engineering to
medical devices
(IEC 62366-1:2015/A1:2020)
Dispositifs médicaux - Partie 1: Application de l'ingénierie Medizinprodukte - Teil 1: Anwendung der
de l'aptitude à l'utilisation aux dispositifs médicaux Gebrauchstauglichkeit auf Medizinprodukte
(IEC 62366-1:2015/A1:2020) (IEC 62366-1:2015/A1:2020)
This amendment A1 modifies the European Standard EN 62366-1:2015; it was approved by CENELEC on 2020-07-22. 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
© 2020 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
 Ref. No. EN 62366-1:2015/A1:2020 E

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SIST EN 62366-1:2015/A1:2020
EN 62366-1:2015/A1:2020 (E)
European foreword
The text of document 62A/1386/FDIS, future IEC 62366-1/A1, 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/A1:2020.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2021-04-22
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2023-07-22
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.
Endorsement notice
The text of the International Standard IEC 62366-1:2015/A1:2020 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 60601-1-11:2015 NOTE Harmonized as EN 60601-1-11:2015 (not modified)
ISO 9000:2015 NOTE Harmonized as EN ISO 9000:2015 (not modified)
ISO 9001:2015 NOTE Harmonized as EN ISO 9001:2015 (not modified)
ISO 13485:2016 NOTE Harmonized as EN ISO 13485:2016 (not modified)


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SIST EN 62366-1:2015/A1:2020
EN 62366-1:2015/A1:2020 (E)
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 referen
...