ASTM_F_881_-_94_2014.pdf

Designation:F88194(Reapproved 2014)Standard Specification forSilicone Elastomer Facial Implants1This standard is issued under the fixed designation F881;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 the requirements for siliconeelastomer implants used in facial surgery(that is,chin,nasal,malar,and ear implants).1.2 LimitationsThis specification does not cover implantscontaining silicone gels or other gels or liquids.It does notnecessarily cover any custom-fabricated prosthesis manufac-tured to any other specification.1.3 The following safety hazards caveat pertains only to themechanical testing and test methods portion,Section 7,of thisspecification:This standard does not purport to address all ofthe safety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2D412 Test Methods for Vulcanized Rubber and Thermoplas-tic ElastomersTensionD624 Test Method for Tear Strength of Conventional Vul-canized Rubber and Thermoplastic ElastomersD2240 Test Method for Rubber PropertyDurometer Hard-nessF604 Specification for Silicone Elastomers Used in MedicalApplications(Withdrawn 2001)3F748 Practice for Selecting Generic Biological Test Methodsfor Materials and DevicesF981 Practice for Assessment of Compatibility of Biomate-rials for Surgical Implants with Respect to Effect ofMaterials on Muscle and BoneF1251 Terminology Relating to Polymeric Biomaterials inMedical and Surgical Devices(Withdrawn 2012)32.2 Other Documents:United States Pharmacopeia,Volume XX4Federal Register,Title 21,Part 8205Dow Corning Corporate Test MethodCTM 0930AdhesionOneHundred Eighty Degree ShearThinElastometric Substrates63.Terminology3.1 Definitions:3.1.1 fixation sitean area on the surface of the implantwhich has material on it that allows tissue ingrowth.3.1.2 fused or adhered jointsall junctures of dissimilarmaterials;and all junctures of fully or partly formed orpreformed materials bonded or fused together to form a singleimplant unit.3.1.3 DiscussionImplants made from one material by asingle charge of unvulcanized elastomer by one-stepcompression,transfer,or reactive injection molding are notconsidered to have fused or adhered joints.3.1.4 orientation meansany locus on the surface of theimplant that is modified to assist the surgeon to position theimplant.4.Significance and Use4.1 The prostheses described in this specification are in-tended for implant use in the facial area.5.Materials5.1 The primary material of construction shall be fullyvulcanized silicone elastomer.5.1.1 Implants may have orientation means or sites ofattached fixation materials,or both.5.2 Biocompatibility:5.2.1 Biological testing to ensure the safety of facial implantdevices shall be selected and conducted in accordance withPractices F748 and F981.1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.32 on Plastic and Reconstructive Surgery.Current edition approved Oct.1,2014.Published November 2014.Originallyapproved in 1984.Last previous edition approved in 2006 as F881 94(2006).DOI:10.1520/F0881-94R14.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.3The last approved version of this historical standard is referenced onwww.astm.org.4Available from Mack Publishing Co.,1991 N Hampton St.Easton,PA.18042.5Available from Standardization Documents Order Desk,Bldg.4 Section D,700Robbins Ave.,Philadelphia,PA 19111-5094,Attn:NPODS.6Available from Dow Corning Corp.,P.O.Box 994,Midland,MI 48686-0994.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 5.2.2 In addition to biological testing as recommended byPractices F748 and F981,other biological testing may beappropriate.6.Dimensions6.1 The individual shape,range of sizes,and measurementsare determined by the manufacturer.6.1.1 Define sizing codes by typical dimensions andvolumes,where applicable.7.Mechanical Testing and Test Methods7.1 Typical Physical Properties of Elastomers:7.1.1 Elongation at FailureThe elongation at failure shallbe 200%,minimum,when tested in accordance with TestMethods D412.7.1.2 DurometerThe durometer shall have a maximum ofshore A80,depending on application,when tested in accor-dance with Test Method D2240.7.1.3 Tensile StrengthThe minimum tensile strength of allsilicone ela