1、Designation:F75408(Reapproved 2015)Standard Specification forImplantable Polytetrafluoroethylene(PTFE)Sheet,Tube,andRod Shapes Fabricated from Granular Molding Powders1This standard is issued under the fixed designation F754;the number immediately following the designation indicates the year of orig
2、inaladoption 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 describes the physical,chemical,andmechanical performa
3、nce requirements for polytetrafluoroeth-ylene(PTFE)pre-fabricated by compression molding or extru-sion into sheet,tube,and rod shapes which may be used forimplant products.1.2 PTFE is a high molecular weight straight chain memberof the generic class of perfluorocarbon(containing only theelements flu
4、orine and carbon)polymers.1.3Perfluorocarbon high polymers exhibit extraordinarythermal and chemical stability and do not require stabilizingadditives of any kind.1.4 This specification applies to primarily void-free moldedor extruded PTFE shapes formed from granular moldingpowders.This specificatio
5、n does not apply to shapes formedfrom“fine powder”resins by lubricated paste extrusion,whichincludes expanded PTFE.1.5 This specification does not apply to specific surgicalimplant products,including their packaging,sterilization,ormaterial boicompatibility and/or suitability for a particularend-use
6、 application.1.6 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.7 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to estab
7、lish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2D1710 Specification for Extruded Polytetrafluoroethylene(PTFE)Rod,Heavy Walled Tubing and Basic ShapesD3294 Specification for Polytetrafluor
8、oethylene(PTFE)Resin Molded Sheet and Molded Basic ShapesD4894 Specification for Polytetrafluoroethylene(PTFE)Granular Molding and Ram Extrusion MaterialsE1994 Practice for Use of Process Oriented AOQL andLTPD Sampling Plans2.2 AAMI Standards:3AAMI STBK91 SterilizationPart 1:Sterilization inHealth C
9、are FacilitiesAAMI STBK92 SterilizationPart 2:Sterilization Equip-mentAAMI STBK93 SterilizationPart 3:Industrial ProcessControl2.3 ANSI Standards:4ANSI/ISO/ASQ Q9000 Quality Management SystemsFundamentals and VocabularyANSI/ISO/ASQ Q9001 Quality Management SystemsRequirements2.4 ISO Standards:4ISO 1
10、0993 Biological Evaluation of Medical Devices2.5 U.S.Code of Federal Regulations:521 CFR 820 Quality System Regulation1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.11 on Polymeric M
11、aterials.Current edition approved March 1,2015.Published May 2015.Originallyapproved in 1983.Last previous edition approved in 2008 as F754 08.DOI:10.1520/F0754-08R15.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book
12、 of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.3Available from Association for the Advancement of Medical Instrumentation(AAMI),1110 N.Glebe Rd.,Suite 220,Arlington,VA 222014795.4Available from American National Standards Institute(ANSI),25 W.43r
13、d St.,4th Floor,New York,NY 10036,http:/www.ansi.org.5Available from U.S.Government Printing Office Superintendent of Documents,732 N.Capitol St.,NW,Mail Stop:SDE,Washington,DC 20401,http:/www.access.gpo.gov.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-29
14、59.United States1 2.6 U.S.Pharmacopeia(USP)Standards:6USP30/NF25 Sterilization and Sterility Assuranceof Compendial Articles3.Significance and Use3.1 Fabricated PTFE meeting the requirements of this speci-fication can be expected to exhibit consistent and reproduciblechemical,physical,and biological
15、 properties.3.1.1 This specification provides an analytic method toextract organic contaminants from fabricated configurations,which includes a limit to the presence of residual adulterants,additives,or processing aids.3.1.2 This specification addresses the characteristics ofvirgin raw granular mold
16、ing powders obtained from resinmanufacturers and used for producing implant configurations.4.Physical Property Requirements4.1 Molding and Extrusion Powders:4.1.1 PTFE PolymerGranular molding and extrusionpowders used for fabrication of implant configurations shall bevirgin product and shall conform to Specification D4894.4.2 PTFE Standard Shapes:4.2.1 Standard shapes,such as molded sheet,rod,and/ortube utilized in implants,shall have been prepared from virginmolding or extrusion materials which
