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EN ISO 14602:2009

(Main)

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

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Withdrawn
Publication Date
12-May-2009
Withdrawal Date
14-Apr-2010
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
9960 - Withdrawal effective - Withdrawal
Start Date
15-Apr-2010
Completion Date
15-Apr-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
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
SIST EN ISO 14602:2009 - Non-active surgical implants - Implants for Osteosynthesis - Particular requirements (ISO 14602:1998)

Relations

Replaces
EN ISO 14602:1998 - Non-active surgical implants - Implants for Osteosynthesis - Particular requirements (ISO 14602:1998)
Effective Date
22-Dec-2008
Replaced By
EN ISO 14602:2010 - Non-active surgical implants - Implants for osteosynthesis - Particular requirements (ISO 14602:2010)
Effective Date
17-Apr-2010

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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.

---------------------- Page: 1 ----------------------

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.

---------------------- Page: 3 ----------------------

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 K
...

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