DIN EN ISO 9713-2009 Neurosurgical implants - Self-closing intracranial aneurysm clips (ISO 9713 2002) English version of DIN EN ISO 9713 2009-08《神经外科植入物 自锁颅内动脉瘤夹钳(ISO 9713-2002) 德.pdf

1、August 2009DEUTSCHE NORM English price group 11No part of this standard may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.040.40!$Y=k“1542672w

2、ww.din.deDDIN EN ISO 9713Neurosurgical implants Self-closing intracranial aneurysm clips (ISO 9713:2002)English version of DIN EN ISO 9713:2009-08Neurochirurgische Implantate Selbstschlieende intrakranielle Aneurysmen-Clips (ISO 9713:2002)Englische Fassung DIN EN ISO 9713:2009-08SupersedesDIN EN ISO

3、 9713:2004-05See start of validitywww.beuth.deDocument comprises 17 pagesDIN EN ISO 9713:2009-08 2 Start of validity This standard takes effect on 1 August 2009. DIN EN ISO 9713:2004-05 may be used in parallel until 21 March 2010. National foreword This standard has been prepared by Technical Commit

4、tee ISO/TC 150 “Implants for surgery” in collaboration with Technical Committee CEN/TC 285 “Non-active surgical implants” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the Normenausschuss Feinmechanik und Optik (Optics and Precision Mechanics Standards Comm

5、ittee), Technical Committee NA 027-02-16 AA Neuro-chirurgische Implantate . This standard contains specifications meeting the essential requirements set out in EU Directive 93/42/EEC on medical devices. The DIN Standards corresponding to the International and European Standards referred to in clause

6、 2 of this document are as follows: ISO 5832-2 DIN ISO 5832-2 ISO 5832-3 DIN ISO 5832-3 ISO 5832-5 DIN ISO 5832-5 ISO 5832-6 DIN ISO 5832-6 ISO 5832-7 DIN ISO 5832-7 ISO 5832-8 DIN ISO 5832-8 ISO 14630 DIN EN ISO 14630 Amendments This standard differs from DIN EN ISO 9713:2004-05 as follows: require

7、ments of EU Directive 93/42/EEC on medical devices has been updated on the basis of EU Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directives 90/385/EEC on the approximation of the laws of the Member States relating to active implantable me

8、dical devices and 93/42/EEC on medical devices and EU Directive 98/8/EC on the placing on the market of biocidal products. Previous editions DIN EN ISO 9713: 2004-05 a) Annex ZA (informative) concerning the relationship between this European Standard and the essential DIN EN ISO 9713:2009-08 3 Natio

9、nal Annex NA (informative) Bibliography DIN ISO 5832-2, Implants for surgery Metallic materials Part 2: Unalloyed titanium DIN ISO 5832-3, Implants for surgery Metallic materials Part 3: Wrought titanium 6-aluminium 4-vanadium alloy DIN ISO 5832-5, Implants for surgery Metallic materials Part 5: Wro

10、ught cobalt-chromium-tungsten-nickel alloy DIN ISO 5832-6, Implants for surgery Metallic materials Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy DIN ISO 5832-7, Implants for surgery Metallic materials Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy DIN ISO 58

11、32-8, Implants for surgery Metallic materials Part 8: Wrought cobalt-nickel-chromium-molybdenum-tungsten-iron alloy DIN EN ISO 14630, Non-active surgical implants General requirements DIN EN ISO 9713:2009-08 4 This page is intentionally blank EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 971

12、3May 2009ICS 11.040.40 Supersedes EN ISO 9713:2004 English VersionNeurosurgical implants - Self-closing intracranial aneurysm clips(ISO 9713:2002)Implants neurochirurgicaux - Clips intracrniens pouranvrisme autofermeture (ISO 9713:2002)Neurochirurgische Implantate - Selbstschlieendeintrakranielle An

13、eurysmen-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 EuropeanStandard the status of a national standard without any alteration. Up-to-date lis

14、ts and bibliographical references concerning such nationalstandards 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 translationunder the respon

15、sibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Greece, Hungary, Icelan

16、d, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: Avenue Marnix

17、 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 9713:2009: EContents Page Foreword3 1 Scope .5 2 Normative references .5 3 Terms and definitions 5 4 Description of aneurysm clips 7 5 Indication of dimens

18、ions .7 6 Materials 7 7 Determination of magnetic properties . 10 8 Closing force 10 9 Marking of clips 10 10 Sterilization . 11 11 Packaging . 11 12 Labelling and accompanying documentation . 11 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU

19、Directive 93/42/EEC. 12 2 DIN EN ISO 9713:2009-08 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 Co

20、mmittee 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 b

21、e 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. Th

22、is 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 t

23、he 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, Lithua

24、nia, 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 EN ISO 9713:2009 (E) DIN EN ISO 9713:

25、2009-08 IntroductionMagnetic 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 aneur

26、ysm clips. Clips with 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 occl

27、ude and even being moved 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 pr

28、operties.Compounds of 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

29、field strength.A secondary 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 su

30、pplied for each clip 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

31、 on the labelling. The actuation ofsome types of clip can unduly result in a reduction of the closing force.0,2 T 2,0 T4 DIN EN ISO 9713:2009-08 EN ISO 9713:2009 (E) 1 ScopeThis International Standard describes characteristics of self-closing aneurysm clips intended for permanentintracranial implant

32、ation 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.This International Standard is not applicable to malleable clips, or clips intended to be used during the c

33、ourse ofsurgery and removed before wound closure (temporary clips).2 Normative referencesThe following normative documents contain provisions which, through reference in this text, constitute provisions ofthis International Standard. For dated references, subsequent amendments to, or revisions of, a

34、ny 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 normative documents indicated below. Forundated references, the latest edition of the normative document

35、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, Implants for surgery Metallic materials Part 3: Wrought titanium 6-aluminium 4-vanadium alloyISO 5832-5,

36、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 alloyISO 5832-7, Implants for surgery Metallic materials Part 7: Forgeable and cold-formed cobalt-chromiu

37、m-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 General requirementsISO 15223, Medical devices Symbols to be used with medical device labels, labelling

38、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 Standard, the following terms and definitions apply.5 EN ISO 9713:2009 (E) DIN EN ISO 9713:2009-08 3.1 ac

39、curacyability 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 permanent occlusion of the neck or sac of an intracranial aneurysm3.3 closing forceforce produced between the blades of the clip3

40、.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 packaging3.4 image artifactinappropriate image signal in an MR imageNOTE Image artifact may be characterized as decreased

41、signal intensity (voids) where signal should be produced, with orwithout geometric image distortion, but can also include abnormally increased signal intensity.3.5 magnetic propertiesproperty of a material to become magnetized when subjected to a magnetic fieldNOTE 1 Materials which are ferro- or an

42、tiferrimagnetic are strongly magnetic. Dia- and paramagnetic materials are weaklymagnetic.NOTE 2 Materials which can exhibit strongly magnetic properties are not suitable for the manufacturer of aneurysm clips.3.6 magnetic inductionvector indicating both direction and magnitude of a magnetic field i

43、nduced 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 to are used at the time of publication of this International Standard.3.7 MRI safeof a device demonstrated to present no

44、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 applicat

45、ions of the samemeasurand under the same conditionsB2T6 DIN EN ISO 9713:2009-08 EN ISO 9713:2009 (E) NOTE These conditions include reduction to a minimum of the variations due to the observer, the same measurement procedure, the same observer, the same measurement equipment, used under the same cond

46、itions, the same location, repetition over a short period of time.4 Description of aneurysm clips4.1 Mechanism of actionThe description of certain clip mechanisms and their gripping action is shown in Figure 1.4.2 GeometryDiagrammatic representation (not to scale) of a some examples of clip forms is

47、 indicated in Figure 2. 5 Indication of dimensionsThe following dimensions of clips and components shall be indicated:a) the overall length;b) the length of the blades;c) the width of the blades giving, as appropriate, the width (disregarding any radius or taper at the tip) of blades ofuniform width

48、, the minimum and maximum widths of non-uniform blades, and the overall width of fenestratedblades;d) the internal diameter of any encircling or encompassing portions of the clip.The variety of designs of clip does not make it feasible to specify the points between which the blade length shouldbe me

49、asured. Manufacturers should indicate these points clearly on all diagrams. Examples of indication ofdimensions are given in Figure 3. The diagrams are for illustration only and do not indicate a definitive requirement.NOTE It is suggested that the blade length be indicated as that portion of the jaw which comes into contact with the other jawwhen the clip is closed without a vessel in place or, for encircling clips, the longitudinal internal dimension of the clip when closed.6 MaterialsThe materials s