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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
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).
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 common modifications, indicated
by (mod.), the relevant EN/HD applies.
Publication Year Title EN Title Year
ISO 14630 1997 Non-active surgical EN ISO 14630 Non-active surgical 1997
implants - General implants - General
requirements requirements (ISO
14630:1997)
ISO 15223 2000 Medical devices - EN 980 Graphical symbols 1996
Symbols to be used for use in the
with medical device labelling of medical
labels, labelling and devices
information to be
supplied EN 1041 Information supplied 1998
by the manufacturer
with medical
devices
ISO 16061 2000 Instrumentation for EN 12011 Instrumentation to 1998
use in association be used in
with non-active association with
surgical implants - non-active surgical
General requirements implants - General
requirements
Annex ZB
(informative)
Clauses of this European Standard addressing essential requirements or
other provisions of EU Directives
This European Standard 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 93/42/EEC of 14 June 1993 concerning medical devices.
WARNING Other requirements and other EU Directives may be applicable to the
product(s) falling within the scope of this standard.
The following clauses of this standard are likely to support requirements of Directive 93/42/EEC.
Compliance with these clauses of this standard provides one means of conforming with the
specific essential requirements of the Directive concerned and associated EFTA regulations.
Table ZB.1— Correspondence between this European Standard and EU Directives
Clauses/subclauses of this Essential requirements (ERs) of
European Standard Directive 93/42/EEC
5 1, 2, 3, 9.2
6 1, 2, 7.1, 7.3, 9.2
76, 9.2
83, 4,
9 13.1, 13.3
10 1, 5, 7.2, 8.1, 8.3, 8.4, 8.5
11 5, 8.6, 8.7, 13.1
12 8.7, 13.1, 13.2, 13.3, 13.4,13.6
INTERNATIONAL ISO
STANDARD 9713
Second edition
2002-09-01
Neurosurgical implants — Self-closing
intracranial aneurysm clips
Implants neurochirurgicaux — Clips intracrâniens pour anévrisme à
autofermeture
Reference number
ISO 9713:2002(E)
ISO 9713:2002(E)
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©
ii ISO 2002 – All rights reserved
ISO 9713:2002(E)
Contents Page
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Description of aneurysm clips . 3
5 Indication of dimensions . 3
6 Materials . 3
7 Determination of magnetic properties . 6
8 Closing force . 6
9 Marking of clips . 6
10 Sterilization . 7
11 Packaging . 7
12 Labelling and accompanying documentation . 7
©
ISO 2002 – All rights reserved iii
ISO 9713:2002(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 3.
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 International Standard may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
International Standard ISO9713 was prepared by Technical Committee ISO/TC150, Implants for surgery,
Subcommittee SC 3, Neurosurgical implants.
This second edition cancels and replaces the first edition (ISO 9713:1990), which has been technically revised.
©
iv ISO 2002 – All rights reserved
ISO 9713:2002(E)
Introduction
Magnetic fields of considerable strength [e.g. 0,2 T to 2,0 T (tesla) or more] are used in medicine with increasing
frequency as part of diagnostic techniques such as magnetic resonance imaging (MRI). Exposure to electromagnetic
radiation may pose a hazard to patients who have intracranial aneurysm clips. Clips with magnetic properties (dia-,
para-, antiferro-, ferro- and/or ferrimagnetic) become magnetized when subjected to a magnetic field and under this
condition are liable to directing forces. These forces may result in the clip being removed from the aneurysm that it
was intended to occlude and even being moved through the tissues. Because of the very high field strengths, even
materials normally regarded as non-magnetic may exhibit some response to the magnetic field, such as minimal
deflection or rotation. It is therefore essential that aneurysm clips have weakly or non-magnetic properties.
Compounds of certain non-magnetic elements may, when processed, have strong magnetic properties. The opposite
also occurs. The work done at manufacture may have an additional effect. However, material normally regarded as
non-magnetic may exhibit some response when subjected to MRI levels of field strength.
A secondary effect is that the presence of a metallic clip may interfere with the MRI process, resulting in deterioration
of the quality of the scanning image.
One of the main intentions of this International Standard is to help to ensure that appropriate and comparable
information is supplied for each clip in order to facilitate the choice of the correct clip by the surgeon. The closing
force of the clip is an important factor in the selection process, and this International Standard requires that the
manufacturers determine the closing force in a uniform manner and state this value on the labelling. The actuation of
some types of clip can unduly result in a reduction of the closing force.
©
ISO 2002 – All rights reserved v
INTERNATIONAL STANDARD ISO 9713:2002(E)
Neurosurgical implants — Self-closing intracranial aneurysm clips
1 Scope
This International Standard describes characteristics of self-closing aneurysm clips intended for permanent
intracranial impla
...
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