EN ISO 14630:2008

SLOVENSKI STANDARD
01-marec-2008
1DGRPHãþD
SIST EN ISO 14630:2005
Neaktivni kirurški vsadki (implantati) - Splošne zahteve (ISO 14630:2008)
Non-active surgical implants - General requirements (ISO 14630:2008)
Nichtaktive chirurgische Implantate - Allgemeine Anforderungen (ISO 14630:2008)
Implants chirurgicaux non actifs - Exigences générales (ISO 14630:2008)
Ta slovenski standard je istoveten z: EN ISO 14630:2008
ICS:
11.040.40
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 14630
NORME EUROPÉENNE
EUROPÄISCHE NORM
January 2008
ICS 11.040.40 Supersedes EN ISO 14630:2005
English Version
Non-active surgical implants - General requirements (ISO
14630:2008)
Implants chirurgicaux non actifs - Exigences générales Nichtaktive chirurgische Implantate - Allgemeine
(ISO 14630:2008) Anforderungen (ISO 14630:2008)
This European Standard was approved by CEN on 12 January 2008.
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 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 Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2008 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14630:2008: 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 14630:2008) 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 July 2008, and conflicting national standards shall be withdrawn at the
latest by July 2008.
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 14630:2005.
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 EC Directive(s).
For relationship with EC Directive(s), see informative Annex ZA, which is an integral part of this document.
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, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 14630:2008 has been approved by CEN as a EN ISO 14630:2008 without any modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential Requirements
of EU Directive 93/42/EEC
This International Standard has been prepared under a mandate given to CEN by the European Commission
to provide one means of conforming to Essential Requirements of the EU Directive 93/42/EEC of 14 June
1993 concerning medical devices.

Once this standard is cited in the Official Journal of the European Communities 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 International Standard and Directive 93/42/EEC

Clause(s)/sub-clause(s) of Essential Requirements (ERs) of Directive 93/42/EEC Qualifying
this International Standard remarks/Notes
4 1, 2, 3, 4, 5, 7.1
5 1 - 2 - 3 - 4 - 5 - 7.1 - 7.2 - 7.3 - 7.5 - 7.6 - 8 - 9.1 - 9.2
6 1 - 2 - 7.1 - 7.2 - 7.3 - 7.4 - 7.5 - 8.2 - 9.2
7 1 - 2 - 3 - 4 - 6 - 7.1 - 7.2 - 7.3 - 7.5 - 7.6 - 8 - 9.1 - 9.2 - 14
8 1 - 2 - 3 - 5 - 7.1 - 7.2
9 1 - 2 - 7.2 - 8.1 - 8.3 - 8.4
10 1 - 2 - 3 - 5 - 7.2 - 8.3 - 8.6
11 1 - 2 - 8.7 - 13
WARNING — Other requirements and other EU Directives may be applicable to the products falling within the
scope of this standard.
INTERNATIONAL ISO
STANDARD 14630
Third edition
2008-01-15
Non-active surgical implants — General
requirements
Implants chirurgicaux non actifs — Exigences générales

Reference number
ISO 14630:2008(E)
©
ISO 2008
ISO 14630:2008(E)
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ii © ISO 2008 – All rights reserved

ISO 14630:2008(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.4
6 Materials .5
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.8
11 Information supplied by the manufacturer .8
11.1 General.8
11.2 Labelling .9
11.3 Instructions for use .9
11.4 Restrictions on combinations .11
11.5 Marking on implants.11
11.6 Marking for special purposes.11
Annex A (informative) Correspondence between this International Standard and
ISO/TR 14283:2004.12
Bibliography .13

ISO 14630:2008(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 committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 14630 was prepared by Technical Committee ISO/TC 150, Implants for surgery.
This third edition cancels and replaces the second edition (ISO 14630:2005), which has been technically
revised.
iv © ISO 2008 – All rights reserved

ISO 14630:2008(E)
Introduction
This International Standard provides a method of addressing the fundamental principles outlined in
ISO/TR 14283, as they apply to non-active surgical implants. It also provides a method to demonstrate
compliance with the relevant essential requirements as outlined in general terms in An
...