Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

ISO 14971:2007 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
The requirements of ISO 14971:2007 are applicable to all stages of the life-cycle of a medical device.

Medizinprodukte - Anwendung des Risikomanagements auf Medizinprodukte (ISO 14971:2007, korrigierte Fassung 2007-10-01)

Diese Internationale Norm legt einen Prozess für einen Medizinproduktehersteller fest zur Identifizierung der mit Medizinprodukten verbundenen Gefährdungen, einschließlich Produkte für die In-vitro-Diagnostik (IVD). Er dient der Einschätzung und der Bewertung zugehöriger Risiken, zur Beherrschung dieser Risiken und der Überwachung der Wirksamkeit von Maßnahmen zur Risikobeherrschung.
Die Anforderungen dieser Internationalen Norm gelten für alle Phasen des Lebenszyklus eines Medizinprodukts.
Diese Internationale Norm gilt nicht für die klinische Entscheidungsfindung.
In dieser Norm werden keine vertretbaren Risikobereiche festgelegt.
Diese Norm fordert nicht, dass der Hersteller über ein Qualitätsmanagementsystem verfügt. Das Risiko-management kann jedoch ein Bestandteil eines Qualitätsmanagementsystems sein.

Dispositifs médicaux - Application de la gestion des risques aux dispositifs médicaux (ISO 14971:2007, Version corrigée de 2007-10-01)

L'ISO 14971:2007 spécifie un processus pour permettre au fabricant d'identifier les phénomènes dangereux et les situations dangereuses associés aux dispositifs médicaux, y compris les dispositifs médicaux de diagnostic in vitro (DIV), d'estimer et d'évaluer les risques, de maîtriser ces risques et de surveiller l'efficacité de cette maîtrise.
Les exigences de l'ISO 14971:2007 s'appliquent à tous les stades du cycle de vie d'un dispositif médical.

Medicinski pripomočki - Uporaba obvladovanja tveganja pri medicinskih pripomočkih (ISO 14971:2007, popravljena verzija 2007-10-01)

Standard ISO 14971 določa postopek proizvajalca za opredelitev nevarnosti v zvezi z medicinskimi pripomočki, vključno z in vitro diagnostičnimi (IVD) medicinskimi pripomočki, za oceno z njimi povezanih tveganj, izvajanje nadzora nad tveganji in spremljanje učinkovitosti nadzora. Zahteve standarda ISO 14971:2007 veljajo za vse faze življenjskega cikla medicinskega pripomočka.

General Information

Status
Withdrawn
Publication Date
03-Jul-2012
Withdrawal Date
17-Dec-2019
Current Stage
9960 - Withdrawal effective - Withdrawal
Completion Date
18-Dec-2019

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 14971:2012
01-september-2012
1DGRPHãþD
SIST EN ISO 14971:2009
0HGLFLQVNLSULSRPRþNL8SRUDEDREYODGRYDQMDWYHJDQMDSULPHGLFLQVNLK
SULSRPRþNLK ,62SRSUDYOMHQDYHU]LMD
Medical devices - Application of risk management to medical devices (ISO 14971:2007,
Corrected version 2007-10-01)
Medizinprodukte - Anwendung des Risikomanagements auf Medizinprodukte (ISO
14971:2007, korrigierte Fassung 2007-10-01)
Dispositifs médicaux - Application de la gestion des risques aux dispositifs médicaux
(ISO 14971:2007, Version corrigée de 2007-10-01)
Ta slovenski standard je istoveten z: EN ISO 14971:2012
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
SIST EN ISO 14971:2012 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 14971:2012

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SIST EN ISO 14971:2012


EUROPEAN STANDARD
EN ISO 14971

NORME EUROPÉENNE

EUROPÄISCHE NORM
July 2012
ICS 11.040.01 Supersedes EN ISO 14971:2009
English version
Medical devices - Application of risk management to medical
devices (ISO 14971:2007, Corrected version 2007-10-01)
Dispositifs médicaux - Application de la gestion des risques Medizinprodukte - Anwendung des Risikomanagements auf
aux dispositifs médicaux (ISO 14971:2007, Version Medizinprodukte (ISO 14971:2007, korrigierte Fassung
corrigée de 2007-10-01) 2007-10-01)
This European Standard was approved by CEN on 16 May 2012.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia,
Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.






CEN-CENELEC Management Centre:
Avenue Marnix 17, B-1000 Brussels
© 2012 CEN/CENELEC Ref. No. EN ISO 14971:2012 E

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SIST EN ISO 14971:2012
EN ISO 14971:2012 (E)
Foreword

The text of ISO 14971:2007, Corrected version 2007-10-01, has been prepared by Technical
Committee ISO/TC 210 “Quality management and corresponding general aspects for medical devices”
of the International Organization for Standardization (ISO) and has been taken over as
EN ISO 14971:2012 by Technical Committee CEN-CLC/TC 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 January 2013, and conflicting national standards shall
be withdrawn at the latest by January 2013.

This document supersedes EN ISO 14971:2009.

Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such
patent rights.

This document has been prepared under a mandate given to CEN by the European Commission and
the European Free Trade Association, and supports essential requirements of EU Directives
93/42/EEC on Medical Devices, 90/385/EEC on Active Implantable Medical Devices and 98/79/EC on
In Vitro Diagnostic Devices.

For relationship with EU Directives, see informative Annexes ZA, ZB and ZC, which are an integral
part of this document.

According to the CEN/CENELEC Internal Regulations, the national standards organisations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of
Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland, Turkey and the United Kingdom.

Endorsement notice

...

SLOVENSKI SIST EN ISO 14971

STANDARD
september 2012












Medicinski pripomočki – Uporaba obvladovanja tveganja pri medicinskih

pripomočkih (ISO 14971:2007, popravljena verzija 2007-10-01)



Medical devices – Application of risk management to medical devices (ISO

14971:2007, Corrected version 2007-10-01)


Dispositifs médicaux – Application de la gestion des risques aux dispositifs

médicaux (ISO 14971:2007, Version corrigée de 2007-10-01)


Medizinprodukte – Anwendung des Risikomanagements auf Medizinprodukte

(ISO 14971:2007, korrigierte Fassung 2007-10-01)





















Referenčna oznaka

ICS 11.040.01 SIST EN ISO 14971:2012 (sl)


Nadaljevanje na strani II in od 1 do 94



© 2016-09. Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 14971 : 2012
NACIONALNI UVOD

Standard SIST EN ISO 14971 (sl), Medicinski pripomočki – Uporaba obvladovanja tveganja pri
medicinskih pripomočkih (ISO 14971:2007, popravljena verzija 2007-10-01), 2012, 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 14971:2007, Corrected version
2007-10-01), 2012.

Ta standard nadomešča SIST EN ISO 14971:2009.

NACIONALNI PREDGOVOR

Evropski standard EN ISO 14971:2012 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 14971:2012 je prevod evropskega standarda EN ISO 14971:2012. V primeru spora glede
besedila slovenskega prevoda v tem standardu je odločilen izvirni evropski standard v enem izmed treh
uradnih jezikov CEN. Slovensko izdajo standarda je pripravil tehnični odbor SIST/TC VAZ Varovanje
zdravja.

Odločitev za izdajo tega standarda je dne 21. maja 2012 sprejel SIST/TC VAZ Varovanje zdravja.

OSNOVA ZA IZDAJO STANDARDA

– privzem standarda EN ISO 14971:2012

PREDHODNA IZDAJA

– standard SIST EN ISO 14971:2004

OPOMBE

– Povsod, kjer se v besedilu standarda uporablja izraz “evropski standard”, v SIST EN ISO
14971:2012 to pomeni “slovenski standard”.

– Nacionalni uvod in nacionalni predgovor nista sestavni del standarda.

– Ta nacionalni dokument je istoveten EN ISO 14971:2012 in je objavljen z dovoljenjem

Upravni Center
CEN-CENELEC
Avenue Marnix 17
B-1000 Bruselj

This national document is identical with EN ISO 14971:2012 and is published with the permission of

CEN-CENELEC
Management Centre
Avenue Marnix 17
B-1000 Brussels


II

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EVROPSKI STANDARD EN ISO 14971
EUROPEAN STANDARD
NORME EUROPÉENNE
EUROPÄISCHE NORM julij 2012


ICS 11.040.01 Nadomešča EN ISO 14971:2009




Slovenska izdaja

Medicinski pripomočki – Uporaba obvladovanja tveganja pri medicinskih
pripomočkih (ISO 14971:2007, popravljena verzija 2007-10-01)

Medical devices – Application of Dispositifs médicaux – Application de Medizinprodukte – Anwendung des
risk management to medical la gestion des risques aux dispositifs Risikomanagements auf
devices (ISO 14971:2007, médicaux (ISO 14971:2007, Version Medizinprodukte (ISO 14971:2007,
Corrected version 2007-10-01) corrigée de 2007-10-01) korrigierte Fassung 2007-10-01)




Ta evropski standard je CEN sprejel dne 16. maja 2012.

Člani CEN in CENELEC morajo izpolnjevati notranje predpise CEN/CENELEC, ki predpisujejo pogoje,
pod katerimi mora biti ta standard brez kakršnihkoli sprememb sprejet kot nacionalni standard. Seznami
najnovejših izdaj teh nacionalnih standardov in njihovi bibliografski podatki se na zahtevo lahko dobijo
pri Upravnem centru CEN-CENELEC ali kateremkoli članu 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, Nekdanje jugoslovanske
republike Makedonije, Nizozemske, Norveške, Poljske, Portugalske, Romunije, Slovaške, Slovenije,
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: Avenue Marnix 17, B-1000 Brussels

...

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