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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4
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 any modification.
Annex ZA
(informative)
Relationship between this European Standard and
the Essential Requirements of EU Directive 93/42/EEC
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC on medical devices.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes
European Standard of Directive 93/42/EEC
4 1, 2nd indent
4, 5, 8 and 10 5
7.1 and 7.2 6a
5 a), 5 l), 6 a) and 6 b) 7.1, 1st indent
5 a), 6 a) and 6 b) 7.1, 2nd indent
7.2 c) 7.1, 3rd indent
5 f), 5 r), 7, 8 and 10 7.2
5 h) and 6 7.3
6 7.4
5 d), 5 e) and 6 7.5
5 b), 5 f), 5 m) and 6 7.6
5 q), 6, 8, 9.1 and 10.1 8.1
6 8.2
10.2 8.3
9.2 8.4
5 g), 8 and 9.3 8.5
9.1 and 10.1 8.6
11.2 f) and 11.3 j) 8.7
5 i), 5 j) and 11.4 9.1
5 b), 5 k), 6 and 7.1 9.2, 1st indent
5 n), 6 and 7.1 9.2, 2nd indent
5 n) 9.2, 3rd indent
5 c), 5 d) and 6 9.2, 4th indent
11.1, 11.2, 11.3 b), g), h) and 11.5 13.1
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes
European Standard of Directive 93/42/EEC
11.1 13.2
11.2 b) 13.3 a)
11.2 c) and 11.2 d) 13.3 b)
11.2 e) 13.3 c)
11.2 c) 13.3 d)
11.2 g) 13.3 e)
11.2 h) 13.3 f)
11.6 13.3 g)
11.6 13.3 h)
10.1 and 11.2 j) 13.3 i)
11.2 j) 13.3 j)
11.2 k) 13.3 k)
11.2 e) 13.3 m)
11.2 d) and 11.3 d) 13.4
4 and 11.2 c) 13.5
11.3 b), c), d), i), m), n) and 11.6 13.6 a)
11.3 e) 13.6 b)
11.3 f) and 11.4 13.6 c)
11.3 h) 13.3 d)
11.3 g) and o) 13.6 e)
11.3 q), r) and t), Indent 5 13.6 f)
9.3.2, 10.2 and 11.3 l) 13.6 g)
9.3 and 11.2 k) 13.6 i)
11.3 a) 13.6 j)
11.3 b) and t), Indent 3 13.6 k)
11.3 t), Indents 1, 2 and 4 13.6 l)
11.3 t), Indent 6 13.6 m)
11.3 s) 13.6 n)
11.3 u) 13.6 q)
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
INTERNATIONAL ISO
STANDARD 14630
Fourth edition
2012-12-01
Non-active surgical implants — General
requirements
Implants chirurgicaux non actifs — Exigences générales
Reference number
ISO 14630:2012(E)
©
ISO 2012
ISO 14630:2012(E)
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO’s
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ii © ISO 2012 – All rights reserved
ISO 14630:2012(E)
Contents Page
Foreword .iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Intended performance . 3
5 Design attributes . 3
6 Materials . 4
7 Design evaluation . 5
7.1 General . 5
7.2 Pre-clinical evaluation . 5
7.3 Clinical evaluation . 6
7.4 Post-market surveillance . 6
8 Manufacture . 6
9 Sterilization . 6
9.1 General . 6
9.2 Products supplied sterile . 6
9.3 Sterilization by the user . 7
9.4 Sterilization residuals . 7
10 Packaging . 7
10.1 Protection from damage in storage and transport . 7
10.2 Maintenance of sterility in transit . 7
11 Information supplied by the manufacturer . 8
11.1 General . 8
11.2 Labelling . 8
11.3 Instructions for use . 9
11.4 Restrictions on combinations .10
11.5 Marking on implants .10
11.6 Marking for special purposes . 11
Bibliography .12
ISO 14630:2012(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International
Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical co
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