SIST EN ISO 14602:2009

Non-active surgical implants - Implants for Osteosynthesis - Particular requirements (ISO 14602:1998)

This European standard specifies particular requirements for non-active surgical Implants for osteosynthesis, hereafter referred to as implants. In addition to EN ISO 14630:1997, this standard gives particular requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging, and information supplied by the manufacturer.

Nichtaktive chirurgische Implantate - Implantate zur Osteosynthese - Besondere Anforderungen (ISO 14602:1998)

Diese Norm legt besondere Anforderungen für nichtaktive chirurgische Implantate zur Osteosynthese fest, die
nachstehend als Implantate bezeichnet werden.
Zusätzlich zur EN ISO 14630:1997 enthält diese Norm besondere Anforderungen für die beabsichtigte
Funktion, Konstruktionsmerkmale, Werkstoffe, Designprüfung, Herstellung, Sterilisation, Verpackung und die
Bereitstellung von Informationen durch den Hersteller.

Implants chirurgicaux non actifs - Implants pour ostéosynthèse - Exigences particulières (ISO 14602:1998)

Neaktivni kirurški vsadki (implantati) - Vsadki za osteosintezo - Posebne zahteve (ISO 14602:1998)

General Information

• Status: Withdrawn
• Public Enquiry End Date: 14-Mar-2009
• Publication Date: 14-Jun-2009
• Withdrawal Date: 02-May-2010
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 03-May-2010
• Due Date: 26-May-2010
• Completion Date: 03-May-2010
• 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
• Directive: 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: EN ISO 14602:2009 - Non-active surgical implants - Implants for Osteosynthesis - Particular requirements (ISO 14602:1998)

Relations

• Replaced By: SIST EN ISO 14602:2010 - Non-active surgical implants - Implants for osteosynthesis - Particular requirements (ISO 14602:2010)
• Effective Date: 01-Jun-2010
• Replaces: SIST EN ISO 14602:2000 - Non-active surgical implants - Implants for Osteosynthesis - Particular requirements (ISO 14602:1998)
• Effective Date: 01-Jul-2009
• Replaces: SIST EN ISO 14602:2000 - Non-active surgical implants - Implants for Osteosynthesis - Particular requirements (ISO 14602:1998)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 14602:2009
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
SIST EN ISO 14602:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 14602:2009

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SIST EN ISO 14602:2009
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.

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SIST EN ISO 14602:2009
EN ISO 14602:2009 (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 14602:2009
EN ISO 14602:2009 (E)
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.
3

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SIST EN ISO 14602:2009
EN ISO 14602:2009 (E)
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.
4

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SIST EN ISO 14602:2009
EN ISO 14602:2009 (E)
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
5

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SIST EN ISO 14602:2009
EN ISO 14602:2009 (E)
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
6

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SIST EN ISO 14602:2009
EN ISO 14602:2009 (E)
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.


7

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SIST EN ISO 14602:2009

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SIST EN ISO 14602:2009
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)

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SIST EN ISO 14602:2009
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 [e-mail]
Printed in Switzerland
ii

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SIST EN ISO 14602:2009
©
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

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SIST EN ISO 14602:2009
©
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
...

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Neaktivni kirurški vsadki (implantati) - Vsadki za osteosintezo - Posebne zahteve (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)Non-active surgical implants - Implants for Osteosynthesis - Particular requirements (ISO 14602:1998)11.040.40Implantanti za kirurgijo, protetiko in ortetikoImplants for surgery, prosthetics and orthoticsICS:Ta slovenski standard je istoveten z:prEN ISO 14602kSIST prEN ISO 14602:2009en01-marec-2009kSIST prEN ISO 14602:2009SLOVENSKI
STANDARD



kSIST prEN ISO 14602:2009



EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMFINAL DRAFTprEN ISO 14602December 2008ICS 11.040.40Will supersede EN ISO 14602:1998
English VersionNon-active surgical implants - Implants for Osteosynthesis -Particular requirements (ISO 14602:1998)Implants chirurgicaux non actifs - Implants pourostéosynthèse - Exigences particulières (ISO 14602:1998)Nichtaktive chirurgische Implantate - Implantate zurOsteosynthese - Besondere Anforderungen (ISO14602:1998)This draft European Standard is submitted to CEN members for unique acceptance procedure. It has been drawn up by the TechnicalCommittee CEN/TC 285.If this draft becomes a European Standard, CEN members are bound to comply with the CEN/CENELEC Internal Regulations whichstipulate the conditions for giving this European Standard the status of a national standard without any alteration.This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other languagemade by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has thesame 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.Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice andshall not be referred to as a European Standard.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre:
Avenue Marnix 17,
B-1000 Brussels© 2008 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. prEN ISO 14602:2008: EkSIST prEN ISO 14602:2009



prEN ISO 14602:2008 (E) 2 Contents Page Foreword .3Annex ZA (informative)
Relationship between this
European
Standard and the Essential Requirements
of EU Directive 93/42/EEC .4 kSIST prEN ISO 14602:2009



prEN ISO 14602:2008 (E) 3 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 prEN ISO 14602:2008 by Technical Committee CEN/TC 285 “Non-active surgical implants” the secretariat of which is held by DIN. This document is currently submitted to the Unique Acceptance Procedure. This document will supersede 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. Endorsement notice The text of ISO 14602:1998 has been approved by CEN as a prEN ISO 14602:2008 without any modification. kSIST prEN ISO 14602:2009



prEN ISO 14602:2008 (E) 4 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 this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 4, 4.1, 4.2, 4.3 1, 2, 3, 4, 5, 7.1, 7.2, 7.3, 7.4 This clause 4 has been detailed in consideration of 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, 7.6, 8, 9.1 Most of the requirements are covered in the level 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.
kSIST prEN ISO 14602:2009



prEN ISO 14602:2008 (E) 5 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, 7.5, 8.2, 9.2 This clause 6 refers entirely to the content of the 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, 7.4, 7.6, 9.2 Clause 7 adds mainly features to the testing aspect 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 kSIST prEN ISO 14602:2009



prEN ISO 14602:2008 (E) 6 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 kSIST prEN ISO 14602:2009



prEN ISO 14602:2008 (E) 7 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.
kSIST prEN ISO 14602:2009



kSIST prEN ISO 14602:2009



AReference numberISO 14602:1998(E)INTERNATIONALSTANDARDISO14602First edition1998-05-15Non-active surgical implants — Implants forOsteosynthesis — Particular requirementsImplants chirurgicaux non actifs — Implants pour ostéosynthèse —Exigences particulièreskSIST prEN ISO 14602:2009



ISO 14602:1998(E)©
ISO 1998All rights reserved. Unless otherwise specified, no part of this publication may be reproducedor utilized in any form or by any means, electronic or mechanical, including photocopying andmicrofilm, without permission in writing from the publisher.International Organization for StandardizationCase postale 56 · CH-1211 Genève 20 · [e-mail] in SwitzerlandiiForewordISO (the International Organization for Standardization) is a worldwidefederation of national standards bodies (ISO member bodies). The work ofpreparing International Standards is normally carried out through ISOtechnical committees. Each member body interested in a subject for whicha technical committee has been established has the right to be representedon that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISOcollaborates closely with the International Electrotechnical Commission(IEC) on all matters of electrotechnical standardization.Draft International Standards adopted by the technical committees arecirculated to the member bodies for voting. Publication as an InternationalStandard requires approval by at least 75 % of the member bodies castinga vote.International Standard ISO 14602 was prepared by the EuropeanCommittee for Standardization (CEN) in collaboration with ISO TechnicalCommittee TC 150, Implants for surgery, SC 5, Osteosynthesis, inaccordance with the Agreement on technical cooperation between ISO andCEN (Vienna Agreement).Throughout the text of this standard, read “. this European Standard .” tomean “. 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 regardingfulfilment of European Council Directives has been removed.kSIST prEN ISO 14602:2009



© ISOISO 14602:1998(E)iiiContentsForewordivIntroductionv1 Scope12 Normative references13 Definitions14 Intended performance15 Design attributes36 Materials37 Design evaluation38 Manufacturing49 Sterilization410 Packaging411 Information supplied by the manufacturer4Annex A (informative)ISO Standards referring to implants and associated instrumentsfound acceptable through clinical use for given applications inosteosynthesis5Annex B (informative)ISO Standards referring to materials found acceptable throughproven clinical use7Annex C (informative)Standards relating to testing and design evaluation8kSIST prEN ISO 14602:2009



ISO 14602:1998(E)© ISOivForewordThe text of EN ISO 14602:1998 has been prepared by Technical Committee CEN/TC 285 "Non- active surgicalimplants", 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 theEuropean Commission and the European Free Trade Association, and supports essential requirements of EUDirective(s).There are three levels of European Standards concerned with non-active surgical implants. These are asfollows, 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 inthe family of osteosynthesis implants.The level 1 standard contains requirements that apply to all non-active surgical implants. It also indicates thatthere 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 joints. To address allrequirements, it is necessary to start with a standard of lowest available level.References can also be found in the Annexes of this standard.This European Standard shall be given the status of a national standard, either by publication of an identicaltext or by endorsement, at the latest by September 1998 and conflicting national standards shall be withdrawnat the latest by September 1998.According to th
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