EN ISO 14971:2019

Medical devices - Application of risk management to medical devices (ISO 14971:2019)

This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process described in this document intends to assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
The requirements of this document are applicable to all phases of the life cycle of a medical device. The process described in this document applies to risks associated with a medical device, such as risks related to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability.
The process described in this document can also be applied to products that are not necessarily medical devices in some jurisdictions and can also be used by others involved in the medical device life cycle.
This document does not apply to:
—          decisions on the use of a medical device in the context of any particular clinical procedure; or
—          business risk management.
This document requires manufacturers to establish objective criteria for risk acceptability but does not specify acceptable risk levels.
Risk management can be an integral part of a quality management system. However, this document does not require the manufacturer to have a quality management system in place.
NOTE       Guidance on the application of this document can be found in ISO/TR 24971[9].

Medizinprodukte - Anwendung des Risikomanagements auf Medizinprodukte (ISO 14971:2019)

Dispositifs médicaux - Application de la gestion des risques aux dispositifs médicaux (ISO 14971:2019)

Le présent document spécifie la terminologie, les principes et un processus de gestion des risques relatifs aux dispositifs médicaux, y compris les logiciels utilisés en tant que dispositifs médicaux et les dispositifs médicaux de diagnostic in vitro. Le processus décrit dans le présent document vise à aider les fabricants de dispositifs médicaux à identifier les dangers associés au dispositif médical, à estimer et évaluer les risques correspondants, à maîtriser ces risques et à surveiller l'efficacité des moyens de maîtrise.
Les exigences du présent document s'appliquent à tous les stades du cycle de vie d'un dispositif médical. Le processus décrit dans le présent document s'applique aux risques associés à un dispositif médical, tels que les risques concernant la biocompatibilité, la sécurité des données et des systèmes, l'électricité, les parties en mouvement, le rayonnement et l'aptitude à l'utilisation.
Le processus décrit dans le présent document peut aussi s'appliquer aux produits qui ne sont pas nécessairement des dispositifs médicaux dans certaines juridictions et peut être utilisé par d'autres personnes impliquées dans le cycle de vie de dispositifs médicaux.
Le présent document ne s'applique pas à ce qui suit:
—          les décisions relatives à l'utilisation d'un dispositif médical au cours d'une procédure clinique particulière; ou
—          la gestion des risques commerciaux.
Le présent document impose aux fabricants d'établir des critères objectifs d'acceptabilité des risques, mais ne spécifie pas de niveaux de risque acceptables.
La gestion des risques peut faire partie intégrante d'un système de management de la qualité. Cependant, le présent document n'exige pas du fabricant qu'il mette en place un système de management de la qualité.
NOTE       Des recommandations relatives à l'application du présent document sont données dans l'ISO/TR 24971[9].

Medicinski pripomočki - Uporaba obvladovanja tveganja pri medicinskih pripomočkih (ISO 14971:2019)

General Information

• Status: Published
• Publication Date: 17-Dec-2019
• Withdrawal Date: 29-Jun-2020
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: CEN/CLC/TC 3 - Quality management and corresponding general aspects for medical devices
• Drafting Committee: CEN/CLC/TC 3 - Quality management and corresponding general aspects for medical devices
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 18-Dec-2019
• Completion Date: 18-Dec-2019
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Directive: 2017/746 - Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
• 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
• 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/252 - Standardization Mandate to CEN/CENELEC concerning the development of European standards relating to in vitro diagnostic medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Mandate: M/565 - Medical devices and in vitro diagnostic medical devices in support of Regulation (EU) 2017/745 of the European Parliament and of the Council and Regulation (EU) 2017/746
• Mandate: M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• Ref Project: SIST EN ISO 14971:2020 - Medical devices - Application of risk management to medical devices (ISO 14971:2019)

Relations

• Replaces: EN ISO 14971:2012 - Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
• Effective Date: 30-Nov-2016
• Amended By: EN ISO 14971:2019/A11:2021 - Medical devices - Application of risk management to medical devices (ISO 14971:2019)
• Effective Date: 10-Nov-2021

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 14971:2020
01-maj-2020
Nadomešča:
SIST EN ISO 14971:2012
Medicinski pripomočki - Uporaba obvladovanja tveganja pri medicinskih
pripomočkih (ISO 14971:2019)
Medical devices - Application of risk management to medical devices (ISO 14971:2019)
Medizinprodukte - Anwendung des Risikomanagements auf Medizinprodukte (ISO
14971:2019)
Dispositifs médicaux - Application de la gestion des risques aux dispositifs médicaux
(ISO 14971:2019)
Ta slovenski standard je istoveten z: EN ISO 14971:2019
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
SIST EN ISO 14971:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 14971:2020

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SIST EN ISO 14971:2020


EUROPEAN STANDARD
EN ISO 14971

NORME EUROPÉENNE

EUROPÄISCHE NORM
December 2019
ICS 11.040.01
Supersedes EN ISO 14971:2012
English version

Medical devices - Application of risk management to
medical devices (ISO 14971:2019)
Dispositifs médicaux - Application de la gestion des Medizinprodukte - Anwendung des
risques aux dispositifs médicaux (ISO 14971:2019) Risikomanagements auf Medizinprodukte (ISO
14971:2019)
This European Standard was approved by CEN on 5 August 2019.

CEN and 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 CEN and 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 CEN and CENELEC member into its own language and notified to the CEN-CENELEC
Management Centre has the same status as the official versions.

CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium,
Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia,
Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.






















CEN-CENELEC Management Centre:
Rue de la Science 23, B-1040 Brussels
© 2019 CEN/CENELEC All rights of exploitation in any form and by any means Ref. No. EN ISO 14971:2019 E
reserved worldwide for CEN national Members and for
CENELEC Members.

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SIST EN ISO 14971:2020
EN ISO 14971:2019 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 14971:2020
EN ISO 14971:2019 (E)
European foreword
This document (EN ISO 14971:2019) has been prepared by Technical Committee ISO/TC 210 "Quality
management and corresponding general aspects for medical devices" in collaboration with Technical
Committee CEN/CLC/JTC 3 “Quality management and corresponding general aspects for medical
devices” the secretariat of which is held by NEN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by June 2020, and conflicting national standards shall be
withdrawn at the latest by June 2020.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 14971:2012.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 14971:2019 has been approved by CEN as EN ISO 14971:2019 without any modification.


3

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SIST EN ISO 14971:2020

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SIST EN ISO 14971:2020
INTERNATIONAL ISO
STANDARD 14971
Third edition
2019-12
Medical devices — Application
...

SLOVENSKI SIST EN ISO 14971



STANDARD
maj 2020









Medicinski pripomočki – Uporaba obvladovanja tveganja pri medicinskih
pripomočkih (ISO 14971:2019)

Medical devices – Application of risk management to medical devices
(ISO 14971:2019)

Medizinprodukte – Anwendung des Risikomanagements auf Medizinprodukte
(ISO 14971:2019)

Dispositifs médicaux – Application de la gestion des risques aux dispositifs
médicaux (ISO 14971:2019)






















Referenčna oznaka
ICS 11.040.01 SIST EN ISO 14971:2020 (sl)

      Nadaljevanje na straneh II in od 1 do 43

2021-11. Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 14971 : 2020
NACIONALNI UVOD

Standard SIST EN ISO 14971 (sl), Medicinski pripomočki – Uporaba obvladovanja tveganja pri
medicinskih pripomočkih (ISO 14971:2019), 2020, ima status slovenskega standarda in je istoveten
evropskemu standardu EN ISO 14971 (en, de, fr), Medical devices – Application of risk management to
medical devices (ISO 14971:2019), 2019.

Ta standard nadomešča SIST EN ISO 14971:2012.

NACIONALNI PREDGOVOR

Evropski standard EN ISO 14971:2019 je pripravil tehnični odbor Evropskega komiteja za
standardizacijo CEN/CLC/TC 3 Vodenje kakovosti in ustrezni splošni vidiki medicinskih pripomočkov
(Quality management and corresponding general aspects for medical devices). Slovenski standard
SIST EN ISO 14971:2020 je prevod evropskega standarda EN ISO 14971:2019. V primeru spora glede
besedila slovenskega prevoda v tem standardu je odločilen izvirni evropski standard v enem od treh
uradnih jezikov CEN. Slovensko izdajo standarda je pripravil tehnični odbor SIST/TC VAZ Varovanje
zdravja.

Odločitev za privzem tega standarda je dne 24. aprila 2020 sprejel SIST/TC VAZ Varovanje zdravja.

ZVEZA Z NACIONALNIMI STANDARDI

Ta dokument se ne sklicuje na druge standarde.

OSNOVA ZA IZDAJO STANDARDA

– privzem standarda EN ISO 14971:2019

PREDHODNA IZDAJA

– standard SIST EN ISO 14971:2012

OPOMBE

– Povsod, kjer se v besedilu standarda uporablja izraz “evropski standard”, v SIST EN ISO 14971:2020
to pomeni “slovenski standard”.

– Uvod in nacionalni predgovor nista sestavni del standarda.

– Ta nacionalni dokument je istoveten EN ISO 14971:2019 in je objavljen z dovoljenjem

Upravni center
CEN-CENELEC
Rue de la Science 23
B-1040 Bruselj

This national document is identical with EN ISO 14971:2019 and is published with the permission of

CEN-CENELEC
Management Centre
Rue de la Science 23
B-1040 Brussels




II

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EVROPSKI STANDARD  EN ISO 14971
EUROPEAN STANDARD

NORME EUROPÉENNE
december 2019
EUROPÄISCHE NORM

ICS 11.940.01 Nadomešča EN ISO 14971:2012




Slovenska izdaja

Medicinski pripomočki – Uporaba obvladovanja tveganja pri
medicinskih pripomočkih (ISO 14971:2019)

Medical devices – Application of Dispositifs médicaux – Application Medizinprodukte – Anwendung
risk management to medical de la gestion des risques aux des Risikomanagements auf
devices (ISO 14971:2019) dispositifs médicaux Medizinprodukte (ISO 14971:2019)
(ISO 14971:2019)



Ta evropski standard je CEN odobril 5. avgusta 2019.

Člani CEN in CENELEC morajo izpolnjevati določila notranjih predpisov CEN/CENELEC, s katerimi
je predpisano, da mora biti ta evropski standard brez kakršnih koli sprememb sprejet kot nacionalni
standard. Seznami najnovejših izdaj teh nacionalnih standardov in njihovi bibliografski podatki so
na voljo pri Upravnem centru CEN-CENELEC ali članih CEN in CENELEC.

Ta evropski standard obstaja v treh uradnih izdajah (angleški, francoski in nemški). Izdaje v drugih
jezikih, ki jih člani CEN in CENELEC na lastno odgovornost prevedejo in izdajo ter prijavijo pri
Upravnem centru CEN-CENELEC, veljajo kot uradne izdaje.

Člani CEN in CENELEC so nacionalni organi za standarde in nacionalni elektrotehniški odbori
Avstrije, Belgije, Bolgarije, Cipra, Češke republike, Danske, Estonije, Finske, Francije, Grčije,
Hrvaške, Irske, Islandije, Italije, Latvije, Litve, Luksemburga, Madžarske, Malte, Nemčije,
Nizozemske, Norveške, Poljske, Portugalske, Republike Severna Makedonija, Romunije,
Slovaške, Slovenije, Srbije, Španije, Švedske, Švice, Turčije in Združenega kraljestva.













CEN-CENELEC
Evropski komite za standardizacijo
European Committee for Standardization
Comité Européen de Normalisation
Europäisches Komitee für Normung

Upravni center CEN-CENELEC
Rue de la Science 23, B-1040 Bruselj

© 2019 CEN/CENELEC Lastnice avtorskih pravic so vse države članice CEN in Ref. št. EN ISO 14971:2019 E
CENELEC.

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SIST EN ISO 14971 : 2020
VSEBINA Stran

Evropski predgovor .
...