ASTM_F_1542_-_94_2000.pdf

Designation:F 1542 94(Reapproved 2000)Standard Specification forthe Requirements and Disclosure of Self-Closing AneurysmClips1This standard is issued under the fixed designation F 1542;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon(e)indicates an editorial change since the last revision or reapproval.1.Scope1.1 This specification covers requirements for the specificcharacteristics of self-closing aneurysm clips that are intendedfor permanent implantation.Appropriate test requirements arealso included.1.2 Since all of the properties that contribute to aneurysmclip performance may not be known,this specification isintended to reflect the state of our knowledge to date.1.3 Miniatures of“microclips”that are not intended for theobliteration of aneurysms are excluded from this specification.2.Referenced Documents2.1 ASTM Standards:F 55 Specification for Stainless Steel Bar and Wire forSurgical Implants2F 56 Specification for Stainless Steel Sheet and Strip forSurgical Implants2F 67 Specification for Unalloyed Titanium for SurgicalImplant Applications3F 75 Specification for Cast Cobalt-Chromium-MolybdenumAlloy for Surgical Implant Applications3F 90 SpecificationforWroughtCobalt-Chromium-Tungsten-Nickel Alloy for Surgical Implant Applications3F 136 Specification for Wrought Titanium 6A1-4V ELIAlloy for Surgical Implant Applications3F 138 Specification for Stainless Steel Bar and Wire forSurgical Implants(Special Quality)3F 139 Specification for Stainless Steel Sheet and Strip forSurgical Implants(Special Quality)3F 361 Practice for Assessment of Compatibility of MetallicMaterials for Surgical Implants with Respect to Effect ofMaterials on Tissues4F 469 Practice for Assessment of Compatibility of Nonpo-rous Polymeric Materials for Surgical Implants with Re-gard to Effect of Materials on Tissues4F 560 Specification for Unalloyed Tantalum for SurgicalImplant Applications3F 562 Specification for Wrought Cobalt-Nickel-Chromium-Molybdenum Alloy for Surgical Implant Applications3F 563 Specification for Wrought Cobalt-Nickel-Chromium-Molybdenum-Tungsten-Iron Alloy for Surgical ImplantApplications3F 688 Specification for Wrought Cobalt-Nickel-Chromium-Molybdenum Alloy Plate,Sheet,and Foil for SurgicalImplants3F 700 Practice for Care and Handling of Intracranial Aneu-rysm Clips and Instruments3F 748 Practice for Selecting Generic Biological Test Meth-ods for Materials and Devices3F 981 Practice for Assessment of Compatibility of Bioma-terials(Non-Porous)for Surgical Implants with Respect toEffect of Materials in Muscle and Bone32.2ISO Standard:5ISO TC 1503.Requirements3.1 GeneralThis section contains requirements for thedisclosure of information on aneurysm clip force measure-ments and requirements for labeling the materials and biocom-patibility of the device.3.2 Performance Disclosure:3.2.1 Force(See X1.2)The manufacturer shall disclosethe closing force(measured in g)exerted by the blades whentested in accordance with 4.2.3.2.2 Force RangeThe manufacturer shall measure eachclip as defined in 3.2.1 and report either the closing force of theindividual clip,a minimum closing force for that specific clip,or a range within which the specific clip lies.If a range isreported,defined ranges shall be no greater than 610%of themedian force.3.2.3 Materials:3.2.3.1 The manufacturer shall disclose the generic namesof the materials used in the manufacture of the clip.ASTMmaterial specification nomenclature shall be used wheneveravailable.If the clips are made of multiple components,thename of the material for each component shall be disclosed.3.2.3.2 Clips will be manufactured so as to be nonferromag-netic.The aneurysm clip must possess the following material1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.31 on Neurosurgical Standards.Current edition approved Aug.15,1994.Published October 1994.2Discontinued 1991See Annual Book of ASTM Standards,Vol 13.01.3Annual Book of ASTM Standards,Vol 13.01.4DiscontinuedSee Annual Book of ASTM Standards,Vol 13.01.5Available from American National Standards Institute,25 W.43rd St.,4thFloor,New York,NY 10036.1Copyright ASTM,100 Barr Harbor Drive,West Conshohocken,PA 19428-2959,United States.property in order to be judged as nonferromagnetic.The forceexerted on a finished aneurysm clip by a 1.5 tesla whole bodyMRI magnet must not exceed the gravitational force on the clip(that is,its own weight).3.2.3.3(See X1.4)The materials and alloys used in aneu-rysm clips conforming to this specification should be fabricatedin accordance with one of the following ASTM specifications:F 55,F 56,F 67,F 75,F 90,F 136,F 138,F 139,F 560,F 562,F 563,F 688,ISO TC 150,or subsequently approved ASTMCommittee F04 standards.Clips manufact