ASTM F982 - 86(2008) Standard Specification for Disclosure of Characteristics of Surgically Implanted Clamps for Carotid Occlusion (Withdrawn 2017).pdf

1、Designation: F982 86 (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 t

2、he 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 s

3、crew-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

4、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

5、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

6、 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 frameen

7、circling 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 advance

8、s 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 fram

9、e 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 t

10、he 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

11、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 nak

12、ed 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 orequivale

13、nts 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 F0

14、4.31 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 19428-295

15、9. United StatesNOTICE: This standard has either been superseded and replaced by a new version or withdrawn.Contact ASTM International (www.astm.org) for the latest information14.2.5 AnalysisAnalysis of clips removed for any reasonshould resemble that specified for removal of orthopedicimplants (see

16、 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

17、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

18、 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 measurement must be accurate to60.35 mm.5.2 Vessel DamageImplant the clamp aseptically around adog

19、 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 histologically to determineif there is laceration. Clamps can be tightened to a torque justbelo

20、w 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 pulseduplicator to create a pulsatile cycle of pressure similar to thephysiologic systolic-dias

21、tolic 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 measure theposition of the pressure plate relative to the basis of the frameevery 24 h for 7

22、2 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 the torque determinedsafe as detailed in 5.2. Again, measure the position of thepressure pl

23、ate 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 FederalRegulations. In addition, the labeling for carotid occlusiveclamps within the scope of this

24、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 number,6.1.1.4 Manufacturers identification or lot number,6.1.1.5 Material(s),6.1.1.6 Magnetic

25、 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 name,6.1.2.2 Trade name,6.1.2.3 Catalog number,6.1.2.4 Manufacturers identification or lot

26、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 Material(s),6.1.2.12 Magnetic properties,6.1.2.13 Torque which causes vessel laceration, and6.

27、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 devices; carotid occlusion;clamps; disclosure; occlusions; resistance-slip; screw-typeclampsFI

28、G. 1 Screw-Type Adjustable Clamp ComponentsF982 86 (2008)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 ofthe following:A1.1.1.1 Functional failure,A1

29、.1.1.2 Vessel trauma, andA1.1.1.3 Biocompatibility.A1.1.2 TheASTM standards listed in A1.2 were designed toprevent such possibilities.A1.2 Referenced DocumentsA1.2.1 ASTM Standards for Materials:2F55-82 Specification for Stainless Steel Bar and Wire forSurgical ImplantsF56-82 Specification for Stain

30、less Steel Sheet and Strip forSurgical ImplantsF67-83 Specification for Unalloyed Titanium for SurgicalImplant ApplicationsF75-82 Specification for Cast Cobalt-Chromium-Molybdenum Alloy for Surgical Implant ApplicationsF90-82 Specification for Wrought Cobalt-ChromiumTungsten-Nickel Alloy for Surgica

31、l Implant Appli-cationsF136-79 Specification for Wrought Titanium 6A1-4V ELIAlloy for Surgical Implant ApplicationsF138-82 Specification for Stainless Steel Bars and Wire forSurgical Implants (Special Quality)F139-82 Specification for Stainless Steel Sheet and Strip forSurgical Implants (Special Qua

32、lity)F560-78 Specification for Unalloyed Tantalum for SurgicalImplant ApplicationsF562-84 Specification for Wrought Cobalt-Nickel-Chromium-Molybdenum Alloy for Surgical Implant Applica-tionsF563-83 Specification for Wrought Cobalt-Nickel-Chromium-Molybdenum-Tungsten-IronAlloy for Surgical Im-plant A

33、pplicationsF602-78 Criteria for Implantable Thermoset Epoxy PlasticsF603-83 Specification for High-Purity Dense AluminumOxide for Surgical Implant ApplicationF604-78 Classification for Silicone Elastomers Used inMedical ApplicationsF620-79 Specification for Titanium 6A1-4V Alloy Forgingsfor Surgical

34、 ImplantsF621-79 Specification for Stainless Steel Forgings for Sur-gical ImplantsF624-81 Guide for Evaluation of Thermoplastic Polyure-thane Solids and Solutions for Biomedical ApplicationsF639-79 Specification for Polyethylene Plastics for MedicalApplicationsF648-83 Specification for Ultra-High-Mo

35、lecular-WeightPolyethylene Powder and Fabricated Form for Surgical Im-plantsF665-80 Classification for Vinyl Chloride Plastics Used inBiomedical ApplicationF688-80 Specification for Wrought Cobalt-Nickel-Chromium-Molybdenum Alloy Plate, Sheet, and Foil forSurgical ImplantsF702-81 Specification for P

36、olysulfone Resin for MedicalApplicationsF745-81 Specification for Stainless Steel for Cast andSolution Annealed Surgical Implant ApplicationsF754-83 Specification for Implantable Polytetrafluoroethyl-ene (PTFE) Polymer Fabricated in Sheet, Tube, and RodShapesF755-82 Specification for Selection of Po

37、rous Polyethylenefor Use in Surgical ImplantsF799-82 Specification for Thermomechanically ProcessedCobalt-Chromium-Molybdenum Alloy for Surgical ImplantsA1.2.2 ASTM Standards for Finishing:2F86-76 Practice for Surface Preparation and Marking ofMetallic Surgical ImplantsF601-78 Practice for Fluoresce

38、nt Penetrant Inspection ofMetallic Surgical ImplantsF746-81 Test Method for Pitting or Crevice Corrosion ofMetallic Surgical Implant MaterialsA1.2.3 ASTM Standards for Biocompatibility:2F361-80 Practice for Assessment of Compatibility of Metal-lic Materials for Surgical Implants with Respect to Effe

39、ct ofMaterials on Tissue3F469-78 Practice for Assessment of Compatibility of Non-porous Polymeric Materials for Surgical Implants with Regardto Effect of Materials on Tissue3F619-79 Practice for Extraction of Medical PlasticsF719-81 Practice for Testing Biomaterials in Rabbits forPrimary Skin Irrita

40、tionF720-81 Practice for Testing Guinea Pigs for Contact Aller-gens: Guinea Pig Maximization TestF748-82 Practice for Selecting Generic Biological TestMethods for Materials and Devices2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm

41、.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3Withdrawn.F982 86 (2008)3F749-82 Practice for Evaluating Material Extracts by Intra-cutaneous Injection in the RabbitF750-82 Practice for Evaluating Material Extracts by Sys-te

42、mic Injection in the MouseF763-82 Practice for Short-Term Screening of ImplantMaterialsF813-83 Practice for Direct Contact Cell Culture Evaluationof Materials for Medical DevicesA1.2.4 ASTM Standards for Handling:2F565-78 Practice for Care and Handling of OrthopedicImplants and InstrumentsF700-81 Pr

43、actice for Care and Handling of IntracranialAneurysm Clips and InstrumentsF701-81 Practice for Care and Handling of NeurosurgicalImplants and InstrumentsA1.2.5 ASTM Standards for Analysis:2F561-78 Practice for Retrieval and Analysis of MetallicOrthopedic ImplantsASTM International takes no position

44、respecting the validity of any patent rights asserted in connection 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.Th

45、is standard is subject to revision at any time by the responsible 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 Int

46、ernational Headquarters. Your comments will receive careful consideration 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

47、 below.This standard is copyrighted by ASTM International, 100 Barr 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). Permission rights to photocopy the standard may also be secured from the Copyright Clearance Center, 222Rosewood Drive, Danvers, MA 01923, Tel: (978) 646-2600; http:/ 86 (2008)4