BS EN ISO 9713-2009 Neurosurgical implants - Self-closing intracranial aneurysm clips《神经外科植入物 颅内动脉瘤自闭夹》.pdf

1、BS EN ISO9713:2009ICS 11.040.40NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDNeurosurgicalimplants Self-closingintracranial aneurysmclips (ISO 9713:2002)This British Standardwas published under theauthority of the StandardsPolicy and StrategyCommittee on 31 Oc

2、tober2009 BSI 2009ISBN 978 0 580 68137 0Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 9713:2009National forewordThis British Standard is the UK implementation of EN ISO 9713:2009. Itis identical to ISO 9713:2002. It supersedes BS EN ISO 9713:2004 whichis withdrawn.The UK parti

3、cipation in its preparation was entrusted to TechnicalCommittee CH/150/3, Neurosurgical implants.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisionsof a contract. Users are responsi

4、ble for its correct application.Compliance with a British Standard cannot confer immunityfrom legal obligations.EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 9713May 2009ICS 11.040.40 Supersedes EN ISO 9713:2004 English VersionNeurosurgical implants - Self-closing intracranial aneurysm clips

5、(ISO 9713:2002)Implants neurochirurgicaux - Clips intracrniens pouranvrisme autofermeture (ISO 9713:2002)Neurochirurgische Implantate - Selbstschlieendeintrakranielle Aneurysmen-Clips (ISO 9713:2002)This European Standard was approved by CEN on 19 April 2009.CEN members are bound to comply with the

6、CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the CEN Management Centre or

7、to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial version

8、s.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,

9、Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Re

10、f. No. EN ISO 9713:2009: EBS EN ISO 9713:2009EN ISO 9713:2009 (E) 3 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 Commi

11、ttee 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 w

12、ithdrawn 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

13、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

14、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

15、, 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. BS EN ISO 9713:2009EN ISO 9713:2009 (E) 4

16、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 Ess

17、ential 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 stand

18、ard 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-cl

19、ause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 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 Sta

20、ndard. 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 r

21、isk of use error is not addressed in this European Standard. 11 5, 8.6, 8.7, 13.1 BS EN ISO 9713:2009EN ISO 9713:2009 (E) 5 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

22、.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 Euro

23、pean Standard. WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. BS EN ISO 9713:2009ISO 9713:2002(E) ISO 2002 All rights reserved iiiContents Page1 Scope . 12 Normative references . 13 Terms and definitions 14 Descriptio

24、n of aneurysm clips 35 Indication of dimensions . 36 Materials . 37 Determination of magnetic properties 68 Closing force . 69 Marking of clips . 610 Sterilization . 711 Packaging . 712 Labelling and accompanying documentation . 7BS EN ISO 9713:2009ISO 9713:2002(E)iv ISO 2002 All rights reservedFore

25、wordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISOmember bodies). The work of preparing International Standards is normally carried out through ISO technicalcommittees. Each member body interested in a subject for which a technica

26、l committee has been established hasthe right to be represented on that committee. International organizations, governmental and non-governmental, inliaison with ISO, also take part in the work. ISO collaborates closely with the International ElectrotechnicalCommission (IEC) on all matters of electr

27、otechnical 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 appro

28、val 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 ofpatent rights. ISO shall not be held responsible for identifying any or all such patent rights.International Standard ISO 9713

29、was prepared by Technical Committee ISO/TC 150, 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.BS EN ISO 9713:2009ISO 9713:2002(E) ISO 2002 All rights reserved vIntroduction

30、Magnetic fields of considerable strength e.g. to (tesla) or more are used in medicine with increasingfrequency as part of diagnostic techniques such as magnetic resonance imaging (MRI). Exposure to electromagneticradiation may pose a hazard to patients who have intracranial aneurysm clips. Clips wit

31、h magnetic properties (dia-,para-, antiferro-, ferro- and/or ferrimagnetic) become magnetized when subjected to a magnetic field and under thiscondition are liable to directing forces. These forces may result in the clip being removed from the aneurysm that itwas intended to occlude and even being m

32、oved through the tissues. Because of the very high field strengths, evenmaterials normally regarded as non-magnetic may exhibit some response to the magnetic field, such as minimaldeflection or rotation. It is therefore essential that aneurysm clips have weakly or non-magnetic properties.Compounds o

33、f certain non-magnetic elements may, when processed, have strong magnetic properties. The oppositealso occurs. The work done at manufacture may have an additional effect. However, material normally regarded asnon-magnetic may exhibit some response when subjected to MRI levels of field strength.A sec

34、ondary effect is that the presence of a metallic clip may interfere with the MRI process, resulting in deteriorationof the quality of the scanning image.One of the main intentions of this International Standard is to help to ensure that appropriate and comparableinformation is supplied for each clip

35、 in order to facilitate the choice of the correct clip by the surgeon. The closingforce of the clip is an important factor in the selection process, and this International Standard requires that themanufacturers determine the closing force in a uniform manner and state this value on the labelling. T

36、he actuation ofsome types of clip can unduly result in a reduction of the closing force.0,2 T 2,0 TBS EN ISO 9713:2009BS EN ISO 9713:2009INTERNATIONAL STANDARD ISO 9713:2002(E) ISO 2002 All rights reserved 1Neurosurgical implants Self-closing intracranial aneurysm clips1 ScopeThis International Stan

37、dard describes characteristics of self-closing aneurysm clips intended for permanentintracranial implantation and specifies requirements for their marking, packaging, sterilization and for labelling andaccompanying documentation. In addition it gives a method for the measurement of closing force.Thi

38、s International Standard is not applicable to malleable clips, or clips intended to be used during the course ofsurgery and removed before wound closure (temporary clips).2 Normative referencesThe following normative documents contain provisions which, through reference in this text, constitute prov

39、isions ofthis International Standard. For dated references, subsequent amendments to, or revisions of, any of thesepublications do not apply. However, parties to agreements based on this International Standard are encouraged toinvestigate the possibility of applying the most recent editions of the n

40、ormative documents indicated below. Forundated references, the latest edition of the normative document referred to applies. Members of ISO and IECmaintain registers of currently valid International Standards.ISO 5832-2, Implants for surgery Metallic materials Part 2: Unalloyed titaniumISO 5832-3, I

41、mplants for surgery Metallic materials Part 3: Wrought titanium 6-aluminium 4-vanadium alloyISO 5832-5, Implants for surgery Metallic materials Part 5: Wrought cobalt-chromium-tungsten-nickel alloyISO 5832-6, Implants for surgery Metallic materials Part 6: Wrought cobalt-nickel-chromium-molybdenum a

42、lloyISO 5832-7, Implants for surgery Metallic materials Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloyISO 5832-8, Implants for surgery Metallic materials Part 8: Wrought cobalt-nickel-chromium-molybdenum-tungsten-iron alloyISO 14630:1997, Non-active surgical implants

43、General requirementsISO 15223, Medical devices Symbols to be used with medical device labels, labelling and information to besuppliedISO 16061, Instrumentation for use in association with non-active surgical implants General requirements3 Terms and definitionsFor the purposes of this International S

44、tandard, the following terms and definitions apply.BS EN ISO 9713:2009ISO 9713:2002(E)2 ISO 2002 All rights reserved3.1 accuracyability of a measuring instrument to give responses close to a true valueNOTE “Accuracy” is a qualitative concept.3.2 aneurysm clipdevice primarily intended for the permane

45、nt occlusion of the neck or sac of an intracranial aneurysm3.3 closing forceforce produced between the blades of the clip3.3.1 nominal closing forceclosing force defined by the manufacturer for each type of clip3.3.2 actual closing forceclosing force measured on each clip by the manufacturer before

46、packaging3.4 image artifactinappropriate image signal in an MR imageNOTE Image artifact may be characterized as decreased signal intensity (voids) where signal should be produced, with orwithout geometric image distortion, but can also include abnormally increased signal intensity.3.5 magnetic prope

47、rtiesproperty of a material to become magnetized when subjected to a magnetic fieldNOTE 1 Materials which are ferro- or antiferrimagnetic are strongly magnetic. Dia- and paramagnetic materials are weaklymagnetic.NOTE 2 Materials which can exhibit strongly magnetic properties are not suitable for the

48、 manufacturer of aneurysm clips.3.6 magnetic inductionvector indicating both direction and magnitude of a magnetic field induced by an electric current flowing throughconducting wire or wiresNOTE 1 It is expressed in teslas (T) or volt seconds per square metre.NOTE 2 Values of magnetic inductance up

49、 to are used at the time of publication of this International Standard.3.7 MRI safeof a device demonstrated to present no additional risk to the patient when used in the MRI environment, but mayaffect the quality of the diagnostic informationNOTE MRI safe does not imply MRI compatibility in terms of magnetism.3.8 repeatabilityability of a measuring instrument to provide closely similar indications for repeated applications of the samemeasurand under the same conditionsB2TBS EN ISO 9713:2009ISO 9713:2002(E) ISO 20