SIST EN ISO 14602:2012

SLOVENSKI STANDARD
SIST EN ISO 14602:2012
01-januar-2012
1DGRPHãþD
SIST EN ISO 14602:2010
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 14602:2011
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
SIST EN ISO 14602:2012 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 14602:2012

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SIST EN ISO 14602:2012


EUROPEAN STANDARD
EN ISO 14602

NORME EUROPÉENNE

EUROPÄISCHE NORM
October 2011
ICS 11.040.40 Supersedes EN ISO 14602:2010
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 20 September 2011.

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, 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
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14602:2011: E
worldwide for CEN national Members.

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SIST EN ISO 14602:2012
EN ISO 14602:2011 (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 14602:2012
EN ISO 14602:2011 (E)
Foreword
This document (EN ISO 14602:2011) 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 April 2012, and conflicting national standards shall be withdrawn at the
latest by April 2012.
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 14602:2010.
This new edition contains a revised Annex ZA.
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 EN ISO 14602:2011 without any modification.

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SIST EN ISO 14602:2012
EN ISO 14602:2011 (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 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 Directive 93/42/EEC and this European Standard
Clause(s)/sub-clause(s) of Essential Requirements (ERs) of Qualifying remarks/Notes
this European Standard Directive 93/42/EEC
7.2
5, 7, 8 and 10
7.3
6
st
7.5 1 sentence
5
7.6
5 and 6
8.3
10
8.4
9
8.5
9
8.6
10
8.7
11.2
9.1
11.4
nd
9.2 2 indent
5 and 6
13.2
11.1
st
13.3 a) 1 sentence
11.2
13.3 b)
11.2
13.3 c)
11.2
13.3 d)
11.2
13.3 e)
11.2
13.3 f)
11.2
13.3 g)
11.6
13.3 h)
11.6
13.3 i)
10 and 11.2
13.3 j)
11.2
4

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SIST EN ISO 14602:2012
EN ISO 14602:2011 (E)
Clause(s)/sub-clause(s) of Essential Requirements (ERs) of Qualifying remarks/Notes
this European Standard Directive 93/42/EEC
13.3 k)
11.2
13.3 m)
11.2
13.4
11.2 and 11.3
13.5
4.3
11.3 13.6 a)
11.3 and 11.4 13.6 c)
11.3 13.6 e)
9 13.6 g)
9 13.6 i)
11.3 b) 13.6 k)
11.3 13.6 n)
11.3 b) 13.6 q)

WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.

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SIST EN ISO 14602:2012

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SIST EN ISO 14602:2012

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

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SIST EN ISO 14602:2012
ISO 14602:2010(E)
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ii © ISO 2010 – All rights reserved

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SIST EN ISO 14602:2012
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 2010 – All rights reserved iii

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SIST EN ISO 14602:2012
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 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 14602 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 5,
Osteosynthesis and spinal devices.
This second edition cancels and replaces the first edition (ISO 14602:1998), which has been technically
revised.
iv © ISO 2010 – All rights reserved

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SIST EN ISO 14602:2012
ISO 14602:2010(E)
Introduction
In general, non-active surgical implants for osteosynthesis are used in trauma treatment or corrective surgery.
They maintain the reduction of fractured bones and stabilize bony (or adjacent) structures to allow bone
healing or fusion and/or to provide support or correction. When they have achieved their objective, the
implants are either retrieved or left in situ.
This International Standard, in addition to the requirements in ISO 14630, provides a method for addressing
the fundamental principles in ISO/TR 14283 as they apply to non-active surgical implants for osteosynthesis.
Annex A shows the correspondence between the clauses of this International Standard and those of
ISO/TR 14283:2004.
This International Standard also provides a method of demonstrating compliance with the relevant essential
requirements (ERs) as outlined in general terms in Annex 1 of European Council Directive 93/42/EEC of
14 June 1993 concerning medical devices, amended by Directive 2007/47/EC of 5 September 2007, as they
apply to non-active surgical implants for osteosynthesis. It might also assist manufacturers to comply with the
requirements of other regulatory bodies.
Alternative methods of demonstrating compliance might be acceptable, in particular with respect to implants
which have demonstrated satisfactory long-term clinical performance.
There are three levels of standard concerned with non-active surgical implants and related instrumentation.
For the implants themselves, there are the following levels, 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.
Level 1 standards contain requirements that apply to all non-active surgical implants. They also indicate that
additional requirements are given in the level 2 and level 3 standards.
Level 2 standards, such as this International Standard, contain requirements that apply to a more restricted
set or family of non-active surgical implants. This International Standard is a Level 2 standard that lays down
particular requirements for non-active surgical implants for osteosynthesis that are in addition to those general
requirements stated in ISO 14630 for non-active surgical implants. It is to be applied in conjunction with
ISO 14630.
Level 3 standards, such as those listed in the annexes, apply to specific types of implant within a family of
non-active surgical implants, in this case particular types of non-active surgical implant for osteosynthesis.
To address all requirements for a specific implant, it is advisable that the standard of the lowest available level
be consulted first.
NOTE The requirements in this International Standard correspond to international consensus. Individual or national
standards or regulatory bodies can prescribe other requirements.

© ISO 2010 – All rights reserved v

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SIST EN ISO 14602:2012

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SIST EN ISO 14602:2012
INTERNATIONAL STANDARD ISO 14602:2010(E)

Non-active surgical implants — Implants for osteosynthesis —
Particular requirements
1 Scope
This International Standard specifies particular requirements for non-active surgical implants for
osteosynthesis, hereafter referred to as implants.
In addition to ISO 14630, this International Standard gives particular requirements for intended performance,
design attributes, materials, design evaluation, manufacturing, s
...