ASTM F982-1986(2002) Standard Specification for Disclosure of Characteristics of Surgically Implanted Clamps for Carotid Occlusion《静动脉连接用外科植入夹的特性表示》.pdf

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1、Designation: F 982 86 (Reapproved 2002)Standard Specification forDisclosure of Characteristics of Surgically ImplantedClamps for Carotid Occlusion1This standard is issued under the fixed designation F 982; the number immediately following the designation indicates the year oforiginal adoption or, in

2、 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 disclosureof specific characteristi

3、cs 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, S

4、ection 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 pr

5、ior 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

6、to This Standard (seeFig. 1):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

7、.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

8、that advancesthe pressure 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 h

9、old 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 materia

10、ls used in the manufacture of the clamp.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 March 27, 1986. Published May 1986.FIG.

11、1 Screw-Type Adjustable Clamp Components1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.Whenever available, ASTM material specification nomencla-ture shall be used (Annex A1). If multiple components areused, the names of each compone

12、nt 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 require

13、ments of the ASTM specifications listedin A1.2.2. There should be no debris visible at 203 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 compatibili

14、tyrequirements 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 A1.2.4.4.2.5 AnalysisAnalysis of clips re

15、moved 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 (millimet

16、res) 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 manufa

17、cturer 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 fromclosure and when it is at the closed position (see also 5.3).5. Test Methods5.1 Advance RatioThis measureme

18、nt must be accurate to60.35 mm.5.2 Vessel DamageImplant the clamp aseptically around adog carotid artery and close using a torque wrench. Implantseveral animals, each having their clamp tightened to adifferent torque. Sacrifice the animals two weeks later andexamine microscopically as well as histol

19、ogically to determineif there is laceration. Clamps can be tightened to a torque justbelow that which will cause laceration.5.3 Slip Resistance Perform the study in vitro using dogcarotid arteries (average diameter 5 mm) or tubes of similardistensibility and a pulse duplicator system. Set the pulsed

20、uplicator to create a pulsatile cycle of pressure similar to thephysiologic systolic-diastolic pattern (150/80 at 80 cpm).During the experiment, keep the artery in a normal saline bathand connect it to the pulse duplicator system. Close the clampto a gap of 2 mm. Turn on the pulse duplicator and mea

21、sure theposition of the pressure plate relative to the basis of the frameevery 24 h for 72 h to determine if there has been any retreatof the pressure plate. Perform a second test keeping the pulseduplicator functioning at the same setting but with the clampclosed down to occlude the artery using th

22、e torque determinedsafe as detailed in 5.2. Again, measure the position of thepressure plate every 24 h for 72 h. A backoff of 0.2 mm (90turn) will be the maximum permitted. Measurement must beaccurate to 60.35 mm.6. Labeling Requirements6.1 All labeling must be consistent with applicable FederalReg

23、ulations. In addition, the labeling for carotid occlusiveclamps within the scope of this specification should complywith the following requirements:6.1.1 Package LabelThe following information shall beavailable with the unit package:6.1.1.1 Manufacturers name,6.1.1.2 Trade name,6.1.1.3 Catalog numbe

24、r,6.1.1.4 Manufacturers identification or lot number,6.1.1.5 Material(s),6.1.1.6 Magnetic properties,6.1.1.7 Advance ratio,6.1.1.8 Torque which causes vessel laceration, and6.1.1.9 Slip resistance.6.1.2 Product InsertThe product insert should include thefollowing information:6.1.2.1 Manufacturers na

25、me,6.1.2.2 Trade name,6.1.2.3 Catalog number,6.1.2.4 Manufacturers identification or lot number,6.1.2.5 Size,6.1.2.6 Length of compression plate,6.1.2.7 Width of compression plate,6.1.2.8 Compression surface,6.1.2.9 Advance ratio,6.1.2.10 Internal dimensions of clamp when fully opened,6.1.2.11 Mater

26、ial(s),6.1.2.12 Magnetic properties,6.1.2.13 Torque which causes vessel laceration, and6.1.2.14 Slip resistance.6.1.3 Catalog InformationRecommendation that only thescrewdriver specifically designed for the particular clamp beused (specify catalog number).7. Keywords7.1 cardiovascular surgical devic

27、es; carotid occlusion;clamps; disclosure; occlusions; resistance-slip; screw-typeclampsF 982 86 (2002)2ANNEX(Mandatory Information)A1. APPLICABLE DOCUMENTS AND RATIONALEA1.1 BackgroundA1.1.1 It is believed that the major sources for device-specific complications will result from suboptimal control o

28、fthe following:A1.1.1.1 Functional failure,A1.1.1.2 Vessel trauma, andA1.1.1.3 Biocompatibility.A1.1.2 The ASTM standards listed in A1.2 were designed toprevent such possibilities.A1.2 Referenced DocumentsA1.2.1 ASTM Standards for Materials:2F 55-82 Specification for Stainless Steel Bar and Wire for

29、Surgical ImplantsF 56-82 Specification for Stainless Steel Sheet and Strip forSurgical ImplantsF 67-83 Specification for Unalloyed Titanium for SurgicalImplant ApplicationsF 75-82 Specification for Cast Cobalt-Chromium-Molybdenum Alloy for Surgical Implant ApplicationsF 90-82 Specification for Wroug

30、ht Cobalt-ChromiumTungsten-Nickel Alloy for Surgical Implant Appli-cationsF 136-79 Specification for Wrought Titanium 6A1-4V ELIAlloy for Surgical Implant ApplicationsF 138-82 Specification for Stainless Steel Bars and Wire forSurgical Implants (Special Quality)F 139-82 Specification for Stainless S

31、teel Sheet and Strip forSurgical Implants (Special Quality)F 560-78 Specification for Unalloyed Tantalum for SurgicalImplant ApplicationsF 562-84 Specification for Wrought Cobalt-Nickel-Chromium-Molybdenum Alloy for Surgical Implant Applica-tionsF 563-83 Specification for Wrought Cobalt-Nickel-Chrom

32、ium-Molybdenum-Tungsten-Iron Alloy for Surgical Im-plant ApplicationsF 602-78 Criteria for Implantable Thermoset Epoxy PlasticsF 603-83 Specification for High-Purity Dense AluminumOxide for Surgical Implant ApplicationF 604-78 Classification for Silicone Elastomers Used inMedical ApplicationsF 620-7

33、9 Specification for Titanium 6A1-4V Alloy Forgingsfor Surgical ImplantsF 621-79 Specification for Stainless Steel Forgings forSurgical ImplantsF 624-81 Guide for Evaluation of Thermoplastic Polyure-thane Solids and Solutions for Biomedical ApplicationsF 639-79 Specification for Polyethylene Plastics

34、 for MedicalApplicationsF 648-83 Specification for Ultra-High-Molecular-WeightPolyethylene Powder and Fabricated Form for Surgical Im-plantsF 665-80 Classification for Vinyl Chloride Plastics Used inBiomedical ApplicationF 688-80 Specification for Wrought Cobalt-Nickel-Chromium-Molybdenum Alloy Plat

35、e, Sheet, and Foil forSurgical ImplantsF 702-81 Specification for Polysulfone Resin for MedicalApplicationsF 745-81 Specification for Stainless Steel for Cast andSolution Annealed Surgical Implant ApplicationsF 754-83 Specification for Implantable Polytetrafluoroethyl-ene (PTFE) Polymer Fabricated i

36、n Sheet, Tube, and RodShapesF 755-82 Specification for Selection of Porous Polyethylenefor Use in Surgical ImplantsF 799-82 Specification for Thermomechanically ProcessedCobalt-Chromium-Molybdenum Alloy for Surgical ImplantsA1.2.2 ASTM Standards for Finishing:2F 86-76 Practice for Surface Preparatio

37、n and Marking ofMetallic Surgical ImplantsF 601-78 Practice for Fluorescent Penetrant Inspection ofMetallic Surgical ImplantsF 746-81 Test Method for Pitting or Crevice Corrosion ofMetallic Surgical Implant MaterialsA1.2.3 ASTM Standards for Biocompatibility:2F 361-80 Practice for Assessment of Comp

38、atibility ofMetallic Materials for Surgical Implants with Respect to Effectof Materials on Tissue3F 469-78 Practice for Assessment of Compatibility ofNonporous Polymeric Materials for Surgical Implants withRegard to Effect of Materials on Tissue3F 619-79 Practice for Extraction of Medical PlasticsF

39、719-81 Practice for Testing Biomaterials in Rabbits forPrimary Skin IrritationF 720-81 Practice for Testing Guinea Pigs for ContactAllergens: Guinea Pig Maximization TestF 748-82 Practice for Selecting Generic Biological TestMethods for Materials and DevicesF 749-82 Practice for Evaluating Material

40、Extracts byIntracutaneous Injection in the RabbitF 750-82 Practice for Evaluating Material Extracts bySystemic Injection in the MouseF 763-82 Practice for Short-Term Screening of ImplantMaterialsF 813-83 Practice for Direct Contact Cell Culture Evaluationof Materials for Medical DevicesA1.2.4 ASTM S

41、tandards for Handling:2F 565-78 Practice for Care and Handling of Orthopedic2Annual Book of ASTM Standards, Vol 13.01.3Discontinued; See 1986 Annual Book of ASTM Standards, Vol 13.01.F 982 86 (2002)3Implants and InstrumentsF 700-81 Practice for Care and Handling of IntracranialAneurysm Clips and Ins

42、trumentsF 701-81 Practice for Care and Handling of NeurosurgicalImplants and InstrumentsA1.2.5 ASTM Standards for Analysis:2F 561-78 Practice for Retrieval and Analysis of MetallicOrthopedic ImplantsASTM International takes no position respecting the validity of any patent rights asserted in connect

43、ion with any item mentionedin this standard. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the riskof infringement of such rights, are entirely their own responsibility.This standard is subject to revision at any time by the responsibl

44、e technical committee and must be reviewed every five years andif not revised, either reapproved or withdrawn. Your comments are invited either for revision of this standard or for additional standardsand should be addressed to ASTM International Headquarters. Your comments will receive careful cons

45、ideration at a meeting of theresponsible technical committee, which you may attend. If you feel that your comments have not received a fair hearing you shouldmake your views known to the ASTM Committee on Standards, at the address shown below.This standard is copyrighted by ASTM International, 100 B

46、arr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org).F 982 86 (2002)4