EN ISO 14602:2009

SLOVENSKI STANDARD
01-julij-2009
1DGRPHãþD
SIST EN ISO 14602:2000
Neaktivni kirurški vsadki (implantati) - Vsadki za osteosintezo - Posebne zahteve
(ISO 14602:1998)
Non-active surgical implants - Implants for Osteosynthesis - Particular requirements (ISO
14602:1998)
Nichtaktive chirurgische Implantate - Implantate zur Osteosynthese - Besondere
Anforderungen (ISO 14602:1998)
Implants chirurgicaux non actifs - Implants pour ostéosynthèse - Exigences particulières
(ISO 14602:1998)
Ta slovenski standard je istoveten z: EN ISO 14602:2009
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
May 2009
ICS 11.040.40 Supersedes EN ISO 14602:1998
English Version
Non-active surgical implants - Implants for Osteosynthesis -
Particular requirements (ISO 14602:1998)
Implants chirurgicaux non actifs - Implants pour Nichtaktive chirurgische Implantate - Implantate zur
ostéosynthèse - Exigences particulières (ISO 14602:1998) Osteosynthese - Besondere Anforderungen (ISO
14602:1998)
This European Standard was approved by CEN on 19 April 2009.
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: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14602:2009: 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
The text of ISO 14602:1998 has been prepared by Technical Committee ISO/TC 150 “Implants for surgery” of
the International Organization for Standardization (ISO) and has been taken over as EN ISO 14602:2009 by
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 November 2009, and conflicting national standards shall be withdrawn
at the latest by March 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 14602:1998.
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.
For relationship with EC 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, 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 14602:1998 has been approved by CEN as a EN ISO 14602:2009 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 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 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 — Correspondence between this European Standard and Directive 93/42/EEC

Clause(s)/sub-clause(s) of Essential Requirements Qualifying remarks/Notes
this EN (ERs) of Directive
93/42/EEC
4, 4.1, 4.2, 4.3 1, 2, 3, 4, 5, 7.1, 7.2, 7.3, This clause 4 has been detailed in consideration of
7.4 the complexity related to osteosynthesis
Part of ER 1 relating to risk of use error is not
addressed in this European Standard.
Note: Ergonomic features are an important issue for
joint replacement implants and should be addressed
during the next revision.
The part of ER 7.1 relating to biophysical or
modelling research is partly addressed by this
European Standard.
Note: validated modelling is an important issue for
joint replacement implants and should be addressed
during the next revision.
The part of ER 7.4 relating to the regulatory
provisions for the verification of the medicinal
product is not addressed by this European Standard.
5, 5.1, 5.2 1, 2, 3, 4, 5, 7.1, 7.2, 7.3, Most of the requirements are covered in the level 1
7.6, 8, 9.1 standard EN ISO 14630:1997. The additional
requirements of this standard, clauses 5.1 and 5.2
are added to draw particular attention to
interconnecting implant systems and the
physiological environment.
The part of ER 1 relating to risk of use error is not
addressed in this European Standard.
Note: Ergonomic features are an important issue for
joint replacement implants and should be addressed
during the next revision.
The part of ER 7.1 relating to biophysical or
modelling research is partly addressed by this
European Standard.
Note: validated modelling is an important issue for
joint replacement implants and should be addressed
during the next revision.
6 1, 2, 7.1, 7.2, 7.3, 7.4, This clause 6 refers entirely to the content of the
7.5, 8.2, 9.2 level 1 standard EN ISO 14630:1997, but gives an
annex B an informative list of ISO standards related
to materials found acceptable for implants for
osteosynthesis through proven clinical use.
The part of ER 1 relating to risk of use error is not
addressed in this European Standard.
Note: Ergonomic features are an important issue for
joint replacement implants and should be addressed
during the next revision.
The part of ER 7.1 relating to biophysical or
modelling research is partly addressed by this
European Standard.
Note: validated modelling is an important issue for
joint replacement implants and should be addressed
during the next revision.
The part of ER 7.4 relating to the regulatory
provisions for the verification of the medicinal
product is not addressed by this European Standard.
7, 7.1, 7.2 1, 2, 3, 4, 6, 7.1, 7.2, 7.3, Clause 7 adds mainly features to the testing aspect
7.4, 7.6, 9.2 of implants for osteosynthesis, otherwise EN ISO
14630:1997 applies
The part of ER 1 relating to risk of use error is not
addressed in this European Standard.
Note: Ergonomic features are an important issue for
joint replacement implants and should be addressed
during the next revision.
ER 6.a) on clinical evaluation is not addressed by
this European Standard.
Note: this should be addressed during the next
revision.
The part of ER 7.1 relating to biophysical or
modelling research is partly addressed by this
European Standard.
Note: validated modelling is an important issue for
joint replacement implants and should be addressed
during the next revision.
The part of ER 7.4 relating to the regulatory
provisions for the verification of the medicinal
product is not addressed by this European Standard.
8 1, 2, 3, 5, 7.1, 7.2 The requirements of the level 1 standard EN ISO
14630:1997 apply, no requirements were added in
this level 2 standard
The part of ER 1 relating to risk of use error is not
addressed in this European Standard.
Note: Ergonomic features are an important issue for
joint replacement implants and should be addressed
during the next revision.
The part of ER 7.1 relating to biophysical or
modelling research is partly addressed by this
European Standard.
Note: validated modelling is an important issue for
joint replacement implants and should be addressed
during the next revision.
9 1, 2, 7.2, 8, 8.1, 8.3, 8.4 The requirements of the level 1 standard EN ISO
14630:1997 apply, no requirements were added in
this level 2 standard
The part of ER 1 relating to risk of use error is not
addressed in this European Standard.
Note: Ergonomic features are an important issue for
joint replacement implants and should be addressed
during the next revision.
10 1, 2, 3, 5, 7.2, 8, 8.4 The requirements of the level 1 standard EN ISO
14630:1997 apply, no requirements were added in
this level 2 standard
The part of ER 1 relating to risk of use error is not
addressed in this European Standard.
Note: Ergonomic features are an important issue for
joint replacement implants and should be addressed
during the next revision.
11 1, 2, 8.7, 9.1, 13 Part of 13 3 a relating to the authorised
representative is not covered by this European
Standard.
In clause 11 of this standard some relevant
requirements are added to the general requirements
of EN ISO 14630:1997
The part of ER 1 relating to risk of use error is not
addressed in this European Standard.
Note: Ergonomic features are an important issue for
joint replacement implants and should be addressed
during the next revision.
ER 13.6 q is not addressed by this European
Standard.
Note: It is common practice to include the date of
issue in the instructions for use for joint replacement
implants. Should be addressed at the occasion of
the next revision.
13.3f and 13.6 h: ERs concerning single use are
relevant for external fixators. They are not
addressed by this European Standard.
Note: Should be addressed at the occasion of the
next revision.
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
First edition
1998-05-15
Non-active surgical implants — Implants for
Osteosynthesis — Particular requirements
Implants chirurgicaux non actifs — Implants pour ostéosynthèse —
Exigences particulières
A
Reference number
ISO 14602:1998(E)
ISO 14602:1998(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.
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.
International Standard ISO 14602 was prepared by the European
Committee for Standardization (CEN) in collaboration with ISO Technical
Committee TC 150, Implants for surgery, SC 5, Osteosynthesis, in
accordance with the Agreement on technical cooperation between ISO and
CEN (Vienna Agreement).
Throughout the text of this standard, read “. this European Standard .” to
mean “. this International Standard .”.
Annexes A, B and C of this International Standard are for information only.
For the purposes of this International Standard, the CEN annex regarding
fulfilment of European Council Directives has been removed.
©  ISO 1998
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 the publisher.
International Organization for Standardization
Case postale 56 • CH-1211 Genève 20 • Switzerland
Internet iso@iso.ch
Printed in Switzerland
ii
©
ISO ISO 14602:1998(E)
Contents
Foreword iv
Introduction v
1 Scope 1
2 Normative references 1
3 Definitions 1
4 Intended performance 1
5 Design attributes 3
6 Materials 3
7 Design evaluation 3
8 Manufacturing 4
9 Sterilization 4
10 Packaging 4
11 Information supplied by the manufacturer 4
Annex A (informative) ISO Standards referring to implants and associated instruments
found acceptable through clinical use for given applications in
osteosynthesis 5
Annex B (informative) ISO Standards referring to materials found acceptable through
proven clinical use 7
Annex C (informative) Standards relating to testing and design evaluation 8
iii
©
ISO 14602:1998(E) ISO
Foreword
The text of EN ISO 14602:1998 has been prepared by Technical Committee CEN/TC 285 "Non- active surgical
implants", the secretariat of which is held by NNI, in collaboration with ISO/TC 150 "Implants for surgery".
This European Standard has been prepared under a mandate given to CEN by the Commission of the
European Commission and the European Free Trade Association, and supports essential requirements of EU
Directive(s).
There are three levels of European Standards concerned with non-active surgical implants. These are as
follows, with level 1 being the highest:
- level 1: General requirements for non-active surgical implants;
- level 2: Particular requirements for families of non-active surgical implants;
- level 3: Specific requirements for types of non-active surgical implants.
This standard is a level 2 standard and contains requirements that apply to all non-active surgical implants in
the family of osteosynthesis implants.
The level 1 standard contains requirements that apply to all non-active surgical implants. It also indicates that
there are additional requirements in the level 2 and level 3 standards.
The level 1 standard has been published as EN ISO 14630:1997.
Level 3 Standards apply to specific types of implants within a family such as knee and hip join
...