SIST EN ISO 9713:2009
(Main)Neurosurgical implants - Self-closing intracranial aneurysm clips (ISO 9713:2002)
Neurosurgical implants - Self-closing intracranial aneurysm clips (ISO 9713:2002)
This International Standard describes characteristics of self-closing aneurysm clips intended for permanent intracranial implantation and specifies requirements for their marking, packaging, sterilization and for labelling and accompanying documentation. In addition it gives a method for the measurement of closing force. This International Standard is not applicable to malleable clips, or clips intended to be used during the course of surgery and removed before wound closure (temporary clips).
Neurochirurgische Implantate - Selbstschließende intrakranielle Aneurysmen-Clips (ISO 9713:2002)
Implants neurochirurgicaux - Clips intracrâniens pour anévrisme à autofermeture (ISO 9713:2002)
L'ISO 9713:2002 décrit les caractéristiques des clips pour anévrisme à auto-fermeture destinés à une implantation intracranienne permanente et spécifie les exigences pour leur marquage, l'emballage, la stérilisation et l'étiquetage, ainsi que pour la documentation d'accompagnement. En outre, elle donne une méthode pour mesurer la force de fermeture.
L'ISO 9713:2002 ne couvre ni les clips malléables, ni les clips prévus pour être utilisés en cours d'opération et retirés avant la fermeture de la plaie (clips temporaires).
Nevrokirurški vsadki (implantati) - Samozapiralne sponke za uporabo pri intrakranialnih anevrizmah (ISO 9713:2002)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 9713:2009
01-julij-2009
1DGRPHãþD
SIST EN ISO 9713:2004
Nevrokirurški vsadki (implantati) - Samozapiralne sponke za uporabo pri
intrakranialnih anevrizmah (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 à autofermeture (ISO
9713:2002)
Ta slovenski standard je istoveten z: EN ISO 9713:2009
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
SIST EN ISO 9713:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 9713:2009
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SIST EN ISO 9713:2009
EUROPEAN STANDARD
EN ISO 9713
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2009
ICS 11.040.40 Supersedes EN ISO 9713:2004
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 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 9713:2009: E
worldwide for CEN national Members.
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SIST EN ISO 9713:2009
EN ISO 9713:2009 (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 9713:2009
EN ISO 9713:2009 (E)
Foreword
The text of ISO 9713:2002 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 9713:2009 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 9713:2004.
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 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 Kingdom.
Endorsement notice
The text of ISO 9713:2002 has been approved by CEN as a EN ISO 9713:2009 without any modification.
3
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SIST EN ISO 9713:2009
EN ISO 9713:2009 (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.
Once this standard is cited in the Official Journal of the European Communities 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 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 — Correspondence between this European Standard and Directive 93/42/EEC
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) of Qualifying remarks/Notes
EN Directive 93/42/EEC
5 1, 2, 3, 9.2 Part of ER 1 relating to risk of
use error is not addressed in this
European Standard.
6 1, 2, 7.1, 7.3, 9.2 Part of ER 1 relating to risk of
use error is not addressed in this
European Standard.
Part of ER 7.1 relating to the
result of biophysical or modelling
research is not addressed in this
European Standard.
7 6, 9.2
8 3, 4,
9 13.1, 13.3 Part of ER 13.3.f relating to
single use is not addressed in
this European Standard.
10 1, 5, 7.2, 8.1, 8.3, 8.4, 8.5 Part of ER 1 relating to risk of
use error is not addressed in this
European Standard.
11 5, 8.6, 8.7, 13.1
4
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SIST EN ISO 9713:2009
EN ISO 9713:2009 (E)
12 8.7, 13.1, 13.2, 13.3, 13.4,13.6 The part of ER 13.3.a)
concerning the information on
the authorized representative is
not addressed in this European
Standard.
Part of ER 13.3.f relating to
safety issues of single use is not
addressed in this European
Standard.
Part of ER 13.6.h relating to
single use is not addressed in
this European Standard.
Part of ER 13.6.q) relating to
date of issue is not addressed in
this European Standard.
ER 6.a) is not addressed in this
European Standard.
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 9713:2009
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SIST EN ISO 9713:2009
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 2002
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SIST EN ISO 9713:2009
ISO 9713:2002(E)
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©
ii ISO 2002 – All rights reserved
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SIST EN ISO 9713:2009
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
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SIST EN ISO 9713:2009
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
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SIST EN ISO 9713:2009
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 f
...
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