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EN ISO 9713:2004

(Main)

Neurosurgical implants - Self-closing intracranial aneurysm clips (ISO 9713:2002)

Neurosurgical implants - Self-closing intracranial aneurysm clips (ISO 9713:2002)

UAP on ISO 9713 (TC Res 241/2000) (CC/010710)

Neurochirurgische Implantate - Selbstschließende intrakranielle Aneurysmen-Clips (ISO 9713:2002)

Diese Internationale Norm beschreibt Kenngrößen von selbstschließenden Aneurysmen-Clips, die für permanente intrakranielle Implantationen bestimmt sind, und legt die Anforderungen für ihre Markierung, Verpackung, Sterilisation sowie für Beschilderung und begleitende Dokumentation fest. Zusätzlich enthält diese Norm eine Methode für die Messung der Schließkraft.
Diese Internationale Norm gilt nicht für formbare Clips oder für Clips, die für die Dauer eines chirurgischen Eingriffs bestimmt sind und vor Wundverschluss entfernt werden (temporäre Clips).

Implants neurochirurgicaux - Clips intracrâniens pour anévrisme à autofermeture (ISO 9713:2002)

Neurosurgical implants - Self-closing intracranial aneurysm clips (ISO 9713:2002)

General Information

Status
Withdrawn
Publication Date
17-Feb-2004
Withdrawal Date
12-May-2009
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
CEN/TC 285 - Non-active surgical implants
Drafting Committee
CEN/TC 285 - Non-active surgical implants
Current Stage
9960 - Withdrawal effective - Withdrawal
Start Date
13-May-2009
Completion Date
13-May-2009
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
SIST EN ISO 9713:2004 - Neurosurgical implants - Self-closing intracranial aneurysm clips (ISO 9713:2002)

Relations

Replaced By
EN ISO 9713:2009 - Neurosurgical implants - Self-closing intracranial aneurysm clips (ISO 9713:2002)
Effective Date
20-May-2009

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SLOVENSKI STANDARD
SIST EN ISO 9713:2004
01-oktober-2004
Neurosurgical implants - Self-closing intracranial aneurysm clips (ISO 9713:2002)
Neurosurgical implants - Self-closing intracranial aneurysm clips (ISO 9713:2002)
Neurochirurgische Implantate - Selbstschließende intrakranielle Aneurysmen-Clips (ISO
9713:2002)
Implants neurochirurgicaux - Clips intracrâniens pour anévrisme a autofermeture (ISO
9713:2002)
Ta slovenski standard je istoveten z: EN ISO 9713:2004
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
SIST EN ISO 9713:2004 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 9713:2004

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SIST EN ISO 9713:2004
EUROPEAN STANDARD
EN ISO 9713
NORME EUROPÉENNE
EUROPÄISCHE NORM
February 2004
ICS 11.040.40
English version
Neurosurgical implants - Self-closing intracranial aneurysm clips
(ISO 9713:2002)
Implants neurochirurgicaux - Clips intracrâniens pour Neurochirurgische Implantate - Selbstschließende
anévrisme à autofermeture (ISO 9713:2002) intrakranielle Aneurysmen-Clips (ISO 9713:2002)
This European Standard was approved by CEN on 2 January 2004.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2004 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 9713:2004: E
worldwide for CEN national Members.

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SIST EN ISO 9713:2004
EN ISO 9713:2004 (E)
Foreword
The text of ISO 9713:2002 has been prepared by Technical Committee ISO/TC 150/SC 3
"Neurosurgical implants” of the International Organization for Standardization (ISO) and has
been taken over as EN ISO 9713:2004 by Technical Committee CEN/TC 285 "Non-active
surgical implants", the secretariat of which is held by NEN.
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 August 2004, and conflicting national
standards shall be withdrawn at the latest by August 2004.
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(s).
For relationship with EU Directive(s), see informative Annex ZB, 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,
Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary,
Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Endorsement notice
The text of ISO 9713:2002 has been approved by CEN as EN ISO 9713:2004 without any
modifications.
NOTE Normative references to International Standards are listed in annex ZA (normative).
2

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SIST EN ISO 9713:2004
EN ISO 9713:2004 (E)
Annex ZA
(normative)
Normative references to international publications
with their relevant European publications
This European Standard incorporates by dated or undated reference, provisions from other
publications. These normative references are cited at the appropriate places in the text and the
publications are listed hereafter. For dated references, subsequent amendments to or revisions of
any of these publications apply to this European Standard only when incorporated in it by
amendment or revision. For undated references the latest edition of the publication referred to
applies (including amendments).
NOTE Where an International Publication has been modified by c
...

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