ASTM F881-1994(2014) Standard Specification for Silicone Elastomer Facial Implants《硅橡胶面部植入物的标准规格》.pdf

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1、Designation: F881 94 (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.

2、 A number in parentheses indicates the year of last reapproval. A superscriptepsilon () 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 ea

3、r 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 testin

4、g 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-bilit

5、y 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 PropertyDurom

6、eter Hard-nessF604 Specification for Silicone Elastomers Used in MedicalApplications (Withdrawn 2001)3F748 Practice for Selecting Generic Biological Test Methodsfor Materials and DevicesF981 Practice for Assessment of Compatibility of Biomate-rials for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 ofMate

7、rials on Muscle and BoneF1251 Terminology Relating to Polymeric Biomaterials inMedical and Surgical Devices (Withdrawn 2012)32.2 Other Documents:United States Pharmacopeia, Volume XX4Federal Register, Title 21, Part 8205Dow Corning Corporate Test MethodCTM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 ShearT

8、hinElastometric 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 b

9、onded 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 s

10、urface 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 elastom

11、er.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 jurisdic

12、tion 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 F

13、881 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 ver

14、sion 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.

15、, P.O. Box 994, Midland, MI 48686-0994.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States15.2.2 In addition to biological testing as recommended byPractices F748 and F981, other biological testing may beappropriate.6. Dimensions6.1 The i

16、ndividual 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 sh

17、allbe 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 elastomers and adhesives

18、used to fabricate facialimplants shall be 200 psi when tested in accordance with TestMethods D412.7.1.4 ModulusTest in accordance with Test MethodsD412.7.1.5 TearTest in accordance with Test Method D624.7.1.6 DurometerTest in accordance with Test MethodD2240.7.2 Fused or Adhered Joints:7.2.1 Techniq

19、ues and materials used for adhered or fusedjoints or seams that are critical to the integrity of the implantshall 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 Metho

20、d-CTM 0930.8. Sterilization8.1 The units may be supplied presterilized in accordancewith the United States 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. Pack

21、aging, Labeling, and Package Inserts9.1 Packaging (Primary):9.1.1 Packages shall be sealed to prevent contamination 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 ens

22、uresthe labeling arrives at the point of use with the device. Labelingshall include the following information: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

23、 tab shall be providedthat is suitable for attaching to the patients chart. The tab shallinclude the following 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 fo

24、r use, cleaning, sterilization, and storage.APPENDIX(Nonmandatory Information)X1. STATEMENT OF RATIONALE FOR SPECIFICATION F881X1.1 Silicone elastomer facial implants described in thisspecification have generally been available to hospitals andphysicians for surgical procedures requiring tissue augm

25、enta-tion in both aesthetic and reconstructive surgery. The uses ofsilicone elastomer implants for chin, 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 D

26、eviceAmendments of 1976 to the Federal Food, Drugs, and Cos-metic Act. This panel recommended a Class II (standards)classification. This specification is thus needed both to satisfyregulatory considerations, and to provide enduser physiciansand other health-care professionals with an adequate descri

27、p-tion of the properties and characteristics of silicone materialsused for implant construction.X1.2 The potential risk and hazards to health identified atthe time of review by FDA classification panels included thepossible presence of adulterants, adverse tissue reaction,extrusion, rejection, and i

28、nfection. The test methods andrequirements suggested in this specification have been selectedspecifically 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 handl

29、ing and use, sterilization, andstorage to minimize the occurrence of risks and hazards tohealth due to technique-of-use considerations.X1.3 This specification includes suggested test methods andrequirements for physical, chemical, and biological propertiesfor silicone elastomer used in facial implan

30、t surgery. CriteriaF881 94 (2014)2for dimensions, volume, physical characteristics, sterilization,packaging, and labeling are discussed thoroughly. PertinentASTM methods for biological testing of implant materials arecited. This specification assumes the following: (1) all formu-lations of various i

31、ngredients have been qualified by biologicaltesting; (2) formulation ingredients and processing proceduresare not changed from those used with biological test speci-mens; (3) all manufacturing starts with characterizable, well-characterized materials and is performed in plants that fullycomply with

32、regulatory GMPS; and (4) when the conditionsstated in X1.1, X1.2 and X1.3 are satisfied and all therequirements as described in this specification for ingredients,and for physical and chemical properties, have been satisfied,silicone elastomers are duplicated adequately on a batch-to-batch basis to

33、provide reasonable assurance of suitability forimplant use.ASTM International takes no position 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 pat

34、ent rights, and the riskof infringement of such rights, are entirely their own responsibility.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 eit

35、her for revision of this standard or for additional standardsand should be addressed to ASTM 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

36、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 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United States. Individual reprints (single or multiple copies) of this stand

37、ard 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:/ 94 (2014)3