ASTM_F_982_-_86_2008.pdf

Designation:F98286(Reapproved 2008)Standard Specification forDisclosure of Characteristics of Surgically ImplantedClamps for Carotid Occlusion1This standard is issued under the fixed designation F982;the number immediately following the designation indicates the year of originaladoption or,in the case of revision,the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscriptepsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This specification covers requirements for the disclosureof specific characteristics of screw-type adjustable clamps thatare designed for the gradual permanent occlusion of carotidarteries.These devices consist of an implantable portion and anexternally projecting removable screwdriver(see Fig.1).1.2 The following precautionary caveat pertains only to thetest method portion,Section 5,of this specification:Thisstandard does not purport to address all of the safety concerns,if any,associated with its use.It is the responsibility of the userof this standard to establish appropriate safety and healthpractices and determine the applicability of regulatory limita-tions prior to use.2.Referenced Documents2.1 The designations and titles of the applicable documentsfor this specification are listed in Annex A1 in the followinggroups:2.1.1 Materials,2.1.2 Finishing,2.1.3 Biocompatibility,2.1.4 Handling,and2.1.5 Analysis.3.Terminology3.1 Descriptions of Terms Specific to This Standard(see):3.1.1 access plateportion of the device that closes theframe.3.1.2 capcovering device to seal the lumen of the stemwhen the screwdriver is not in place.3.1.3 collarthreaded portion of the frame that acts as aguide and counter torque surface for the pressure plate screw.3.1.4 frameencircling portion of the device,usuallyU-shaped.3.1.5 guidecylinder within the stem to provide countertorque and guidance for the screwdriver.3.1.6 hingemeans of attaching the access plate to theframe.3.1.7 pressure platemovable compressing plate.3.1.8 pressure plate screwthreaded shaft that advances thepressure plate.3.1.9 screwdriverdevice used to provide torque to thepressure plate screw.The screwdriver should have permanentlymarked scale indicating advance ratio by millimetres.3.1.10 set screwscrew that secures the access plate to theframe.3.1.11 stemcylinder that is used to hold the frame and toprovide counter torque for the screwdriver.4.General Requirements4.1 This section contains requirements for disclosure ofinformation on screw-type adjustable clamps.4.2 Performance Disclosure:4.2.1 Materials:4.2.1.1 The manufacturer shall disclose the generic namesof the materials used in the manufacture of the clamp.Whenever available,ASTM material specification nomencla-ture shall be used(Annex A1).If multiple components areused,the names of each component shall be disclosed.4.2.1.2 The metals and alloys or other materials used inclamps that conform to this specification should be fabricatedof approved materials in accordance with the ASTM specifi-cations listed in A1.2.1.4.2.2 FinishingSurface cleanliness and characteristicsshould meet the requirements of theASTM specifications listedin A1.2.2.There should be no debris visible at 20 and noimperfections visible to the naked eye.4.2.3 BiocompatibilityClamps should be biocompatiblewith the tissue in which they are intended to be implanted.Metal components shall meet ASTM biologic compatibilityrequirements or equivalents listed in A1.2.3.Nonporous poly-meric materials should conform to the ASTM requirements orequivalents listed in the Annex.4.2.4 HandlingHandling procedures should be similar tothose suggested by several ASTM standards listed in A1.2.4.1This 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 Feb.1,2008.Published March 2008.Originallyapproved in 1986.Last previous edition approved in 2002 as F982 86(2002).DOI:10.1520/F0982-86R08.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 4.2.5 AnalysisAnalysis of clips removed for any reasonshould resemble that specified for removal of orthopedicimplants(see A1.2.5).4.2.6 Reporting of FailuresAll failures should be reportedboth to the manufacturer and to the Food and Drug Adminis-tration(FDA).4.2.7 Advance RatioThe manufacturer shall disclose thedistance(millimetres)advanced by the pressure plate for eachfull revolution of the screwdriver(see also 5.1).4.2.8 Pressure Plate Induced Laceration of VesselThemanufacturer shall disclose the torque at which the pressureplate will cause vessel laceration(see also 5.2).4.2.9 Slip Resistance of the ClampThe manufacturer shalldisclose whether the set screw will unwind and the pressureplate will retreat in the face of pulsatile pressure of 150/80 at80 cpm applied to the pressure plate when it is 2 mm fromclos