EN ISO 14602:2010

SLOVENSKI STANDARD
01-junij-2010
1DGRPHãþD
SIST EN ISO 14602:2009
Neaktivni kirurški vsadki (implantati) - Vsadki za osteosintezo - Posebne zahteve
(ISO 14602:2010)
Non-active surgical implants - Implants for osteosynthesis - Particular requirements (ISO
14602:2010)
Nichtaktive chirurgische Implantate - Implantate zur Osteosynthese - Besondere
Anforderungen (ISO 14602:2010)
Implants chirurgicaux non actifs - Implants pour ostéosynthèse - Exigences particulières
(ISO 14602:2010)
Ta slovenski standard je istoveten z: EN ISO 14602:2010
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 14602
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2010
ICS 11.040.40 Supersedes EN ISO 14602:2009
English Version
Non-active surgical implants - Implants for osteosynthesis -
Particular requirements (ISO 14602:2010)
Implants chirurgicaux non actifs - Implants pour Nichtaktive chirurgische Implantate - Implantate zur
ostéosynthèse - Exigences particulières (ISO 14602:2010) Osteosynthese - Besondere Anforderungen (ISO
14602:2010)
This European Standard was approved by CEN on 14 April 2010.

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, Croatia, 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: Avenue Marnix 17, B-1000 Brussels
© 2010 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14602:2010: E
worldwide for CEN national Members.

Contents Page
Foreword .3
Annex ZA (informative)  Relationship between this International Standard and the Essential
Requirements of EU Directive 93/42/EEC as amended by EU Directive 2007/47/EC .4

Foreword
This document (EN ISO 14602:2010) 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 October 2010, and conflicting national standards shall be withdrawn at
the latest by October 2010.
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 14602:2009.
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.
For relationship with EU Directive, 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, Croatia, 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 14602:2010 has been approved by CEN as a EN ISO 14602:2010 without any modification.

Annex ZA
(informative)
Relationship between this International Standard and the Essential
Requirements of EU Directive 93/42/EEC as amended by EU Directive
2007/47/EC
This International 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 as amended by Directive 2007/47/EC.

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 International Standard and Directive 93/42/EEC as
amended by Directive 2007/47/EC

Clause(s)/sub-clause(s) Essential Requirements (ERs) of Qualifying remarks/Notes
of this International Directive 93/42/EEC as amended
Standard by Directive 2007/47/EC
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
1 – 2 – 3 – 4 – 6 –6.a – 7.1 – 7.2 –
7.3 – 7.5 – 7.6 – 8 – 9.1 – 9.2
8 1 – 2 – 3 – 5 – 7.1 – 7.2
9 1 – 2 – 7.2 – 8.1 – 8.3 – 8.4 – 8.5
10 1 – 2 – 3 – 5 – 7.2 – 8.3 – 8.6
The part of ER 13.3 a) concerning the
11 1 – 2 – 8.7 – 13
information on the manufacturer's authorized
representative in the European Community is
not addressed in this International Standard.

ER: 13.3 f) is only partially addressed in this
International Standard. The safety issue is
addressed, but not the regulatory requirement
that the manufacturer's indication of single
use must be consistent across the European
community.
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.
INTERNATIONAL ISO
STANDARD 14602
Second edition
2010-04-15
Non-active surgical implants — Implants
for osteosynthesis — Particular
requirements
Implants chirurgicaux non actifs — Implants pour ostéosynthèse —
Exigences particulières
Reference number
ISO 14602:2010(E)
©
ISO 2010
ISO 14602:2010(E)
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ISO 14602:2010(E)
Contents Page
Foreword .iv
Introduction.v
1 Scope.1
2 Normative references.1
3 Terms and definitions .1
4 Intended performance.1
4.1 General .1
4.2 Intended purpose .2
4.3 Functional characteristics.2
4.4 Intended conditions of use.3
5 Design attributes .3
6 Materials .4
7 Design evaluation.4
7.1 General .4
7.2 Pre-clinical evaluation.4
7.3 Clinical evaluation .4
7.4 Post-market surveillance.4
8 Manufacturing.5
9 Sterilization .5
10 Packaging.5
11 Information supplied by manufacturer.5
11.1 General .5
11.2 Labelling.5
11.3 Instructions for use .5
11.4 Restrictions on combinations.5
11.5 Marking on implant.5
11.6 Marking for special purposes .5
Annex A (informative) Correspondence of the clauses of this International Standard to the
fundamental principles outlined in ISO/TR 14283.6
Annex B (informative) ISO standards referring to implants and associated instruments found
acceptable through clinical use for given applications in osteosynthesis.7
Annex C (informative) ISO Standards referring to materials found acceptable through proven
clinical use .10
Annex D (informative) Standards related to testing and design evaluation .12
Bibliography.13

ISO 14602:2010(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 wh
...