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EN ISO 14630:2012

(Main)

Non-active surgical implants - General requirements (ISO 14630:2012)

Non-active surgical implants - General requirements (ISO 14630:2012)

ISO 14630:2012 specifies general requirements for non-active surgical implants. ISO 14630:2012 is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants, intra-ocular lenses and implants utilizing viable animal tissue.
With regard to safety, ISO 14630:2012 specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests to demonstrate compliance with these requirements.

Nichtaktive chirurgische Implantate - Allgemeine Anforderungen (ISO 14630:2012)

Implants chirurgicaux non actifs - Exigences générales (ISO 14630:2012)

L'ISO 14630:2012 spécifie des exigences générales relatives aux implants chirurgicaux non actifs, ci-après appelés implants. Elle ne s'applique ni aux implants dentaires, ni aux produits utilisés en médecine dentaire restauratrice, ni aux implants transendodontiques et transradiculaires, ni aux lentilles intraoculaires, ni aux implants utilisant des tissus animaux viables.
En matière de sécurité, l'ISO 14630:2012 donne des exigences relatives aux performances prévues, aux caractéristiques de conception, aux matériaux, à l'évaluation de la conception, à la fabrication, à la stérilisation, à l'emballage et aux informations fournies par le fabricant, de même qu'aux essais destinés à faire la preuve de la conformité à ces exigences.

Neaktivni kirurški vsadki (implantati) - Splošne zahteve (ISO 14630:2012)

Ta mednarodni standard določa splošne zahteve za neaktivne kirurške vsadke, v nadaljnjem besedilu: vsadki. Ta mednarodni standard se ne uporablja za dentalne vsadke, dentalne obnovitvene materiale, transendodontske in transradikularne vsadke, intraokularne leče in vsadke z živim živalskim tkivom. V zvezi z varnostjo ta mednarodni standard določa zahteve za predvidene lastnosti, obliko, materiale, vrednotenje oblike, izdelavo, sterilizacijo, pakiranje in informacije, ki jih zagotovi proizvajalec, ter preskuse za dokazovanje skladnosti s temi zahtevami. Dodatni preskusi so navedeni ali omenjeni v standardih ravni 2 in ravni 3.

General Information

Status
Published
Publication Date
30-Nov-2012
Withdrawal Date
29-Jun-2013
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
CEN/TC 285 - Non-active surgical implants
Drafting Committee
CEN/TC 285 - Non-active surgical implants
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
01-Dec-2012
Completion Date
01-Dec-2012
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
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Mandate
M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
Ref Project
SIST EN ISO 14630:2013 - Non-active surgical implants - General requirements (ISO 14630:2012)

Relations

Replaces
EN ISO 14630:2009 - Non-active surgical implants - General requirements (ISO 14630:2008)
Effective Date
03-Apr-2010
Revised
prEN ISO 14630 - Non-active surgical implants - General requirements (ISO/DIS 14630:2022)
Effective Date
10-Oct-2018

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 14630:2013
01-marec-2013
1DGRPHãþD
SIST EN ISO 14630:2009
Neaktivni kirurški vsadki (implantati) - Splošne zahteve (ISO 14630:2012)
Non-active surgical implants - General requirements (ISO 14630:2012)
Nichtaktive chirurgische Implantate - Allgemeine Anforderungen (ISO 14630:2012)
Implants chirurgicaux non actifs - Exigences générales (ISO 14630:2012)
Ta slovenski standard je istoveten z: EN ISO 14630:2012
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
SIST EN ISO 14630:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 14630:2013

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SIST EN ISO 14630:2013


EUROPEAN STANDARD
EN ISO 14630

NORME EUROPÉENNE

EUROPÄISCHE NORM
December 2012
ICS 11.040.40 Supersedes EN ISO 14630:2009
English Version
Non-active surgical implants - General requirements (ISO
14630:2012)
Implants chirurgicaux non actifs - Exigences générales Nichtaktive chirurgische Implantate - Allgemeine
(ISO 14630:2012) Anforderungen (ISO 14630:2012)
This European Standard was approved by CEN on 30 November 2012.

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

CEN members are the national standards bodies 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.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14630:2012: E
worldwide for CEN national Members.

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SIST EN ISO 14630:2013
EN ISO 14630:2012 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4

2

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SIST EN ISO 14630:2013
EN ISO 14630:2012 (E)
Foreword
This document (EN ISO 14630:2012) has been prepared by Technical Committee ISO/TC 150 "Implants for
surgery" in collaboration with Technical Committee CEN/TC 285 “Non-active surgical implants” the secretariat
of which is held by DIN.
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 2013, and conflicting national standards shall be withdrawn at
the latest by June 2013.
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 supersedes EN ISO 14630:2009.
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 Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is 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
The text of ISO 14630:2012 has been approved by CEN as a EN ISO 14630:2012 without
...

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