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EN 82304-1:2017

(Main)

Health Software - Part 1: General requirements for product safety

Health Software - Part 1: General requirements for product safety

IEC 82304-1:2016 applies to the safety and security of health software products designed to operate on general computing platforms and intended to be placed on the market without dedicated hardware, and its primary focus is on the requirements for manufacturers. It covers the entire lifecycle including design, development, validation, installation, maintenance, and disposal of health software products.

Gesundheitssoftware - Teil 1: Allgemeine Anforderungen für die Produktsicherheit

Logiciels de santé - Partie 1: Exigences générales pour la sécurité des produits

L'IEC 82304-1:2016 s'applique à la sécurité et à la sureté des produits logiciels de santé conçus pour fonctionner sur des plates-formes informatiques générales et destinés à être commercialisés sans matériel dédié. Ce document se concentre principalement sur les exigences destinées aux fabricants. Il couvre le cycle de vie complet y compris la conception, le développement, la validation, l'installation, la maintenance et l'élimination des produits logiciels de santé.

Programska oprema v zdravstvu - 1. del: Splošne zahteve za varnost proizvodov (IEC 82304-1:2016)

Ta del 82304 se uporablja za VARNOST in ZAŠČITOZDRAVSTVENE PROGRAMSKE OPREME, ki je zasnovana za delovanje na splošnih računalniških platformah in namenjena za dajanje na trg brez namenske strojne opreme, pri čemer se osredotoča predvsem na zahteve za IZDELOVALCE.

General Information

Status
Published
Publication Date
31-Aug-2017
ICS
35.240.80 - IT applications in health care technology
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
01-Sep-2017
Completion Date
01-Sep-2017
Directive
90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
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/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
M/252 - Standardization Mandate to CEN/CENELEC concerning the development of European standards relating to in vitro diagnostic medical devices
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 82304-1:2017 - Health Software - Part 1: General requirements for product safety (IEC 82304-1:2016)

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SLOVENSKI STANDARD
SIST EN 82304-1:2017
01-oktober-2017
Programska oprema v zdravstvu - 1. del: Splošne zahteve za varnost proizvodov
(IEC 82304-1:2016)
Health Software - Part 1: General requirements for product safety (IEC 82304-1:2016)
Ta slovenski standard je istoveten z: EN 82304-1:2017
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST EN 82304-1:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 82304-1:2017

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SIST EN 82304-1:2017


EUROPEAN STANDARD EN 82304-1

NORME EUROPÉENNE

EUROPÄISCHE NORM
September 2017
ICS 35.240.80

English Version
Health Software - Part 1: General requirements for product
safety
(IEC 82304-1:2016)
Logiciels de santé - Partie 1: Exigences générales pour la Gesundheitssoftware - Teil 1: Allgemeine Anforderungen für
sécurité des produits die Produktsicherheit
(IEC 82304-1:2016) (IEC 82304-1:2016)
This European Standard was approved by CENELEC on 2016-12-01. 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, 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: Avenue Marnix 17, B-1000 Brussels
© 2017 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
 Ref. No. EN 82304-1:2017 E

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SIST EN 82304-1:2017
EN 82304-1:2017
European foreword
The text of document 62A/1140/FDIS, future edition 1 of IEC 82304-1, prepared by IEC/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 82304-1:2017.

The following dates are fixed:
• latest date by which the document has (dop) 2018-03-01
to be implemented at national level by
publication of an identical national
standard or by endorsement
(dow) 2020-09-01
• 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 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.
Endorsement notice
The text of the International Standard IEC 82304-1:2016 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 (series) NOTE Harmonized as EN 60601 (series).
IEC 60601-1:2005 NOTE Harmonized as EN 60601-1:2006.
IEC 61907:2009 NOTE Harmonized as EN 61907:2010.
IEC 62366-1:2015 NOTE Harmonized as EN 62366-1:2015.
IEC 80001-1:2010 NOTE Harmonized as EN 80001-1:2011.
ISO 9000:2015 NOTE Harmonized as EN ISO 9000:2015.
ISO 13485:2015 NOTE Harmonized as EN ISO 13485:2016.
ISO 14971:2007 NOTE Harmonized as EN ISO 14971:2012.
2

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SIST EN 82304-1:2017
EN 82304-1:2017

Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents, in whole or in part, are normatively referenced in this document and are

indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
NOTE 1 When an Internation
...

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