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EN ISO 14602:2011

(Main)

Non-active surgical implants - Implants for osteosynthesis - Particular requirements (ISO 14602:2010)

Non-active surgical implants - Implants for osteosynthesis - Particular requirements (ISO 14602:2010)

ISO 14602:2010 specifies particular requirements for non-active surgical Implants for osteosynthesis, referred to as implants.
In addition to ISO 14630, ISO 14602:2010 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 14602:2010)

Diese Internationale Norm legt besondere Anforderungen für nichtaktive chirurgische Implantate zur Osteo-synthese fest, die nachstehend als Implantate bezeichnet werden.
Zusätzlich zur ISO 14630 enthält diese Internationale 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 14602:2010)

L'ISO 14602:2010 spécifie des exigences particulières relatives aux implants chirurgicaux non actifs pour ostéosynthèse, ci-après désignés implants.
En complément de l'ISO 14630, l'ISO 14602:2010 donne des exigences particulières en matière de performances prévues, de caractéristiques de conception, de matériaux, d'évaluation de la conception, de fabrication, de stérilisation, d'emballage et d'informations fournies par le fabricant.

Neaktivni kirurški vsadki (implantati) - Vsadki za osteosintezo - Posebne zahteve (ISO 14602:2010)

ISO 14602:2010 določa posebne zahteve za neaktivne kirurške vsadke (implantate) za osteosintezo, imenovane implantati. Poleg ISO 14630, ISO 14602:2010 podaja posebne zahteve za predvideno delovanje, lastnosti modela, materiale, ovrednotenje zasnove, izdelavo, sterilizacijo, pakiranje in informacije, ki jih priskrbi proizvajalec.

General Information

Status
Published
Publication Date
18-Oct-2011
Withdrawal Date
29-Apr-2012
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
CEN/TC 285 - Non-active surgical implants
Drafting Committee
CEN/TC 285/WG 5 - Osteosynthesis
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
19-Oct-2011
Completion Date
19-Oct-2011
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
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
M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
Ref Project
SIST EN ISO 14602:2012 - Non-active surgical implants - Implants for osteosynthesis - Particular requirements (ISO 14602:2010)

Relations

Replaces
EN ISO 14602:2010 - Non-active surgical implants - Implants for osteosynthesis - Particular requirements (ISO 14602:2010)
Effective Date
24-Oct-2011

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Standards Content (Sample)

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, Slo
...

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