ASTM F881-1994(2006) Standard Specification for Silicone Elastomer Facial Implants《硅树脂胶和硅树脂固体(非多孔)面部植入物》.pdf

1、Designation: F 881 94 (Reapproved 2006)Standard Specification forSilicone Elastomer Facial Implants1This standard is issued under the fixed designation F 881; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revisio

2、n. 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 the requirements for siliconeelastomer implants used in facial surgery (that is, chin, nasal,malar, and

3、 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 tes

4、ting 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-b

5、ility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2D 412 Test Methods for Vulcanized Rubber and Thermo-plastic ElastomersTensionD 624 Test Method for Tear Strength of ConventionalVulcanized Rubber and Thermoplastic ElastomersD 2240 Test Method for Rubber Property

6、DurometerHardnessF 604 Specification for Silicone Elastomers Used in Medi-cal Applications3F 748 Practice for Selecting Generic Biological Test Meth-ods for Materials and DevicesF 981 Practice for Assessment of Compatibility of Bioma-terials for Surgical Implants with Respect to Effect ofMaterials o

7、n Muscle and BoneF 1251 Terminology Relating to Polymeric Biomaterials inMedical and Surgical Devices2.2 Other Documents:United States Pharmacopeia, Volume XX4Federal Register, Title 21, Part 8205Dow Corning Corporate Test MethodCTM 0930AdhesionOneHundred Eighty Degree ShearThinElastometric Substrat

8、es63. 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

9、to form a singleimplant unit.3.1.3 DiscussionImplants made from one material by asingle charge of unvulcanized elastomer by one-step compres-sion, transfer, or reactive injection molding are not consideredto have fused or adhered joints.3.1.4 orientation meansany locus on the surface of theimplant t

10、hat 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

11、have orientation means or sites ofattached fixation materials, or both.5.2 Biocompatibility: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.Cu

12、rrent edition approved Sept. 1, 2006. Published September 2006. Originallyapproved in 1984. Last previous edition approved in 2000 as F 881 94 (2000).2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStand

13、ards volume information, refer to the standards Document Summary page onthe ASTM website.3Withdrawn.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: N

14、PODS.6Available from Dow Corning Corp., P.O. Box 994, Midland, MI 48686-0994.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.5.2.1 Biological testing to ensure the safety of facial implantdevices shall be selected and conducted in ac

15、cordance withPractices F 748 and F 981.5.2.2 In addition to biological testing as recommended byPractices F 748 and F 981, 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

16、 typical dimensions and vol-umes, 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 D 412.7.1.2 DurometerThe durometer shall have

17、 a maximum ofshore A80, depending on application, when tested in accor-dance with Test Method D 2240.7.1.3 Tensile StrengthThe minimum tensile strength of allsilicone elastomers and adhesives used to fabricate facialimplants shall be 200 psi when tested in accordance with TestMethods D 412.7.1.4 Mod

18、ulusTest in accordance with Test MethodsD 412.7.1.5 TearTest in accordance with Test Method D 624.7.1.6 DurometerTest in accordance with Test MethodD 2240.7.2 Fused or Adhered Joints:7.2.1 Techniques and materials used for adhered or fusedjoints or seams that are critical to the integrity of the imp

19、lantshall demonstrate a strength greater than 20 ppi when testspecimens made of the same materials and fabricated bysimilar techniques are tested in accordance with Dow CorningCorporate Test Method-CTM 0930.8. Sterilization8.1 The units may be supplied presterilized in accordancewith the United Stat

20、es Pharmacopeia and good manufacturingpractices released by the Food and Drug Administration(FDA).8.2 Instructions for cleaning and sterilization shall be sup-plied with the package insert.9. Packaging, Labeling, and Package Inserts9.1 Packaging (Primary):9.1.1 Packages shall be sealed to prevent co

21、ntamination andto maintain sterility.9.1.2 Units shall be packaged with suitable containers thatwill prevent damage in transit.9.2 Labeling:9.2.1 Each implant shall be labeled in a manner that ensuresthe labeling arrives at the point of use with the device. Labelingshall include the following inform

22、ation:9.2.1.1 Product name and manufacturer.9.2.1.2 Configuration or type.9.2.1.3 Size, dimensions, and durometer.9.2.1.4 Special storage requirements, if any.9.2.2 With each unit, a self-adhering tab shall be providedthat is suitable for attaching to the patients chart. The tab shallinclude the fol

23、lowing information:9.2.2.1 Product name and manufacturer.9.2.2.2 Product lot number.9.2.2.3 Product size and dimensions.9.3 Package InsertThe package insert shall provide spe-cific instructions for use, cleaning, sterilization, and storage.APPENDIX(Nonmandatory Information)X1. STATEMENT OF RATIONALE

24、 FOR SPECIFICATION F 881X1.1 Silicone elastomer facial implants described in thisspecification have generally been available to hospitals andphysicians for surgical procedures requiring tissue augmenta-tion in both aesthetic and reconstructive surgery. The uses ofsilicone elastomer implants for chin

25、, nasal, malar, and earaugmentation have been reviewed by the plastic and recon-structive surgery sections of the Medical Device ClassificationPanels in keeping with the provisions of the Medical DeviceAmendments of 1976 to the Federal Food, Drugs, and Cos-metic Act. This panel recommended a Class I

26、I (standards)classification. This specification is thus needed both to satisfyregulatory considerations, and to provide enduser physiciansand other health-care professionals with an adequate descrip-tion of the properties and characteristics of silicone materialsused for implant construction.X1.2 Th

27、e potential risk and hazards to health identified atthe time of review by FDA classification panels included thepossible presence of adulterants, adverse tissue reaction, ex-trusion, rejection, and infection. The test methods and require-ments suggested in this specification have been selectedspecif

28、ically to provide reasonable assurance that none of theidentified risks and hazards to health occur as a result ofdefective or adulterated materials. Label copy requirementsinclude directions for handling and use, sterilization, andstorage to minimize the occurrence of risks and hazards tohealth due

29、 to technique-of-use considerations.F 881 94 (2006)2X1.3 This specification includes suggested test methodsand requirements for physical, chemical, and biological prop-erties for silicone elastomer used in facial implant surgery.Criteria for dimensions, volume, physical characteristics, ster-ilizati

30、on, packaging, and labeling are discussed thoroughly.Pertinent ASTM methods for biological testing of implantmaterials are cited. This specification assumes the following:(1) all formulations of various ingredients have been qualifiedby biological testing; (2) formulation ingredients and process-ing

31、 procedures are not changed from those used with biologicaltest specimens; (3) all manufacturing starts with characteriz-able, well-characterized materials and is performed in plantsthat fully comply with regulatory GMPS; and (4) when theconditions stated in X1.1, X1.2 and X1.3 are satisfied and all

32、the requirements as described in this specification for ingredi-ents, and for physical and chemical properties, have beensatisfied, silicone elastomers are duplicated adequately on abatch-to-batch basis to provide reasonable assurance of suit-ability for implant use.ASTM International takes no posit

33、ion 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 responsibilit

34、y.This 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

35、 International 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 s

36、hown 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).F 881 94 (2006)3