ASTM F703-2007 Standard Specification for Implantable Breast Prostheses 《可植入假乳房标准规范》.pdf

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1、Designation: F 703 07Standard Specification forImplantable Breast Prostheses1This standard is issued under the fixed designation F 703; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A number in parenthe

2、ses 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 siliconegel-filled and saline-inflatable silicone gel-filled implantablebreast prostheses intended for us

3、e in surgical reconstruction,augmentation, or replacement of the breast.1.2 LimitationsThis specification does not cover customfabricated implantable breast prostheses.1.3 Single-use saline-inflatable, smooth, and textured sili-cone shell implantable breast prostheses are addressed inSpecification F

4、 2051.1.4 The values stated in SI units are to be regarded as thestandard. The inch-pound units given in parentheses are forinformation only.1.5 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

5、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:2D 412 Test Methods for Vulcanized Rubber and Thermo-plastic ElastomersTensionD 1349 Practice for RubberStandard Temperatures forTes

6、tingF 748 Practice for Selecting Generic Biological Test Meth-ods for Materials and DevicesF 1251 Terminology Relating to Polymeric Biomaterials inMedical and Surgical DevicesF 2038 Guide for Silicone Elastomers, Gels, and FoamsUsed in Medical Applications Part IFormulations andUncured MaterialsF 20

7、42 Guide for Silicone Elastomers, Gels, and FoamsUsed in Medical Applications Part IICrosslinking andFabricationF 2051 Specification for Implantable Saline Filled BreastProsthesis2.2 Other Documents:Saline, Silicone Gel, and Alternative Breast ImplantsGuidance for Industry and FDA Staff, November 17

8、,20063ISO/AAMI/ANSI 10993-1 Biological Evaluation of Medi-cal DevicesPart 1: Evaluation and Testing43. Terminology3.1 Definitions:3.1.1 barrier coat, na silicone elastomer layer that is partof the shell of a silicone gel implantable breast prosthesis thatretards silicone bleed.3.1.2 fixation site, n

9、an area of the shell of an implantablebreast prosthesis containing material that allows tissue in-growth.3.1.3 fused or adhered joints (seams), nsites in the shellor other parts of an implantable breast prosthesis wherematerials have been joined (fused or bonded) together, with orwithout an adhesive

10、, as part of the manufacturing process.3.1.4 gel bleed, ndiffusion of liquid silicone componentsof silicone gel through the shell of an implantable breastprosthesis.3.1.5 gel-filled breast prosthesis, nimplantable breastprosthesis designed and provided with a pre-filled, fixedvolume of silicone gel.

11、3.1.5.1 Type I breast prosthesis, nimplantable breast pros-thesis containing a single lumen containing a fixed amount ofsilicone gel.(1) DiscussionThe lumen of a Type I breast prostheses isnot accessible for volume adjustments of any kind.3.1.5.2 Type II breast prosthesis, nimplantable breastprosthe

12、sis comprised of two complete lumens, one inside theother.(1) DiscussionThe inner lumen of a Type II implantablebreast prosthesis contains a fixed amount of silicone gel and isnot accessible for volume adjustments of any kind. The outerlumen is provided with a valve to facilitate filling the void1Th

13、is 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 April 1, 2007. Published May 2007. Originallyapproved in 1981. Last prev

14、ious edition approved in 2002 as F 703 96 (2002)e1.2For 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.3Available

15、 from U.S. Department of Health and Human Services, Food andDrug Administration (FDA), 5600 Fishers Ln., Rockville, MD 20857, http:/www.fda.gov/cdrh/ode/guidance/1239.4Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.1Copyr

16、ight ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.between the inner and outer lumens with saline to adjust thetotal volume of the prosthesis, at the time of use. The valvesystem may also be designed to facilitate post-operative salinevolume

17、adjustment by following the instructions provided inthe product literature.3.1.5.3 Type III breast prosthesis, nimplantable breastprosthesis comprised of two complete lumens, one inside theother.(1) DiscussionThe area between the inner and outerlumens contains a fixed amount of silicone gel and is n

18、otaccessible for volume adjustments of any kind. The innerlumen is contained within the silicone gel contained in theouter lumen and has a valve system to facilitate filling the innerlumen with saline to increase the volume of the prosthesis atthe time of use. The valve system may also be designed t

19、ofacilitate post-operative saline volume adjustment by followingthe instructions provided in product literature.3.1.6 low bleed, nsilicone gel implantable breast prosthe-ses designed to have minimal silicone bleed when tested usingthe test method in 9.2.1.3.1.7 lumen, na cavity within a shell of an

20、implantablebreast prosthesis.3.1.7.1 DiscussionA lumen may contain either a fixed,non-adjustable volume of silicone gel, or it may be entirely orpartly empty and intended to be inflated (filled) with saline.Inflatable lumens are accessible by valve to facilitate theaddition of saline to adjust the v

21、olume of the prosthesis at thetime of use. More than one lumen may be formed within a shellby silicone elastomer membrane partitions.3.1.8 orientation means, nany mark or palpable portion ofan implantable breast prosthesis to assist the surgeon inpositioning the implant.3.1.9 saline, nsodium chlorid

22、e injection USP.3.1.10 shell, na silicone elastomer continuous layer ormembrane container (sac) that encloses a lumen or multiplelumens of an implantable breast prosthesis.3.1.11 silicone elastomer, nan elastomer containingcross-linked silicone polymer and fumed amorphous (non-crystalline) silica as

23、 a reinforcing filler.3.1.12 silicone gel, na semisolid material consisting of acrosslinked silicone polymer network in which liquid siliconepolymer is held (see definition of gel in Terminology F 1251).3.1.13 valve, nuser-sealable or self-sealing opening in aninflatable or gel saline prosthesis, ex

24、tending from the exteriorsurface of the shell into a lumen, designed to facilitate addingor removing saline to or from the prosthesis to increase ordecrease prosthesis volume.4. Significance and Use4.1 This specification contains requirements based on state-of-the-art science and technology as appli

25、cable to variousconsiderations that have been identified as important to ensurereasonable safety and efficacy in implantable breast prostheses.4.1.1 This specification is not intended to limit the scienceand technology which may be considered and applied to ensureperformance characteristics of breas

26、t prostheses in intendedapplications. When new information becomes available orchanges in state-of-the-art science and technology occur andrelevance to prostheses has been established by valid science,it is intended that this specification will be revised in keepingwith the new information or advanc

27、es in state-of-the-artscience.5. Materials and Manufacture5.1 Silicone ElastomerSelect and specify elastomers foruse in implantable breast prostheses in keeping with GuidesF 2038 and F 2042.5.1.1 FabricationFabrication techniques must necessarilybe varied depending on the type of elastomer, the port

28、ion of animplantable breast prosthesis fabricated, its shape and itslocation and function on the prosthesis.5.1.2 Vulcanization and PostcureTime and temperature ofvulcanization and postcure must be adjusted with considerationof the elastomer type and the multi-step fabrication require-ments of speci

29、fic prostheses. Final postcure is typically doneonly after the shell or shells and all other portions have beencompletely assembled. Time and temperature of final postcureshall be adequate to drive the chemistry of vulcanization of allelastomers to completion and remove by-products of the curein kee

30、ping with the chemical stoichiometry of the specific curesystems (for example, after postcure no additional vulcaniza-tion should occur when heated additionally at the recom-mended cure temperature).5.2 Silicone GelSelect and specify ingredients in keepingwith Guides F 2038 and F 2042.5.2.1 Fabricat

31、ion, Vulcanization, and Postcure:5.2.1.1 Fabrication and CuringUnvulcanized liquid gel istypically placed in the lumen of a shell and cured and postcuredin situ while the shell is maintained in its desired final shape.Fabrication techniques must necessarily be varied to satisfy therequirements of th

32、e specific implant type and shape.5.2.1.2 Vulcanization and PostcureThe time and tempera-ture of vulcanization and postcure shall be adequate to drivethe vulcanization chemistry of the gel to completion in keepingwith the chemical stoichiometry of specific silicone gels. Whenpostcure is adequate, si

33、licone gel does not undergo furthervulcanization with additional heating at the cure temperature.6. Volume and Dimensions6.1 Volumes of Prostheses:6.1.1 Silicone Gel and Gel-Saline ProsthesesBecause sili-con gel has a specific gravity of approximately one, volumes ofsilicone gel-containing prosthese

34、s are typically controlled byweight. 1 g = approximately 1 cm3. The weight tolerance of asilicone gel-containing prosthesis with volume$250 cm3shallbe 65 g. The weight tolerance of a silicone gel-containingprosthesis with volume 250 cm3shall be 62 % of labeledvolume in equivalent grams.6.1.2 Gel-Sal

35、ine ProsthesesThe design or maximum rec-ommended volume of saline fill shall be listed in the labeling.6.2 DimensionsThe ranges of shapes, volumes, basesizes, and anterior projections shall be determined by themanufacturer. Pertinent information shall be contained in thelabeling.F7030727. Fixation S

36、ites7.1 Fixation sites shall be optional features on a silicone gelimplantable breast prosthesis. When used, the size and loca-tions of fixation sites shall be clearly stated in the labeling.8. Orientation Means8.1 Orientation means shall be optional features on a sili-cone gel implantable breast pr

37、osthesis. When orientationmeans are claimed, the location and recommended techniquesfor use shall be clearly described in the labeling.9. Test Methods and Requirements9.1 Biocompatibility:9.1.1 Practice F 748New or existing materials shall be incompliance with Practice F 748 or other acceptable stan

38、dardssuch as ISO/AAMI/ANSI 10993-1. Biocompatibility assays ofmaterials with no or limited history of prior biocompatibilitytesting and successful clinical use for implant applications shallfollow guidelines of Practice F 748. Assays recommended byPractice F 748 include cell culture cytotoxicity ass

39、ays, short-term intramuscular implantation assay, short-term subcutane-ous assay, carcinogenicity, long-term implant test, systemicinjection (acute toxicity) assay, sensitization assay, mutagenic-ity, and pyrogenicity.9.1.2 Silicone Gel ProsthesesTest specimens for chronicimplantation assays (carcin

40、ogenicity and long term implanttests) shall be fabricated from the same combination of siliconeelastomer and gel and by the same or similar procedures andconditions used in fabricating prostheses. The thickness ofshell in specimens shall be typical of thickness used inprostheses.NOTE 1To minimize pa

41、lpability of prostheses and to effectivelymimic the softness of breast tissue, silicone gels used in implantable breastprostheses must be soft (have low modulus). State-of-the-art silicone gelswith required low modulus are also low strength. When implanted longterm without an enclosing silicone elas

42、tomer shell, silicone gel may notretain its physical shape and integrity. Clinical implantation of freesilicone gel sans shell is neither intended nor recommended. If shellrupture occurs in an implanted silicone gel breast prosthesis, resulting indirect contact between silicone gel and tissue, surge

43、ry for removal of theruptured prosthesis (with or without prosthetic replacement) and any freegel is recommended. To help assure relevancy of long term biocompat-ibility assays in animals to recommended clinical use of silicone gelimplantable breast prostheses, the specimens used in chronic biocompa

44、t-ibility assays shall have silicone gel contained in an enclosing siliconeelastomer shell, similar to silicone gel prostheses. Specimens of freesilicone gel may be used in all other biocompatibility assays as specifiedin Practice F 748 for implants used in tissue and tissue fluid contactapplication

45、s, including short-term intramuscular implantation assay.9.1.3 Prior Biocompatibility AssaysWhen prior biocom-patibility data are available for silicone elastomers and gels thatmay also have histories of clinical use in breast implants, evenif not done by the exact protocols described in more recent

46、lydeveloped biocompatibility test method standards, such datamay satisfy all or part of the specific biocompatibility require-ments of Practice F 748 or equivalent methodology.9.2 Physical Properties:9.2.1 Test ProcedureSilicone prostheses shall demon-strate an acceptable response in physical proper

47、ty tests. Pros-theses for testing should be selected from standard productionbatches, or equivalent, which have gone through all manufac-turing processes, including sterilization. Unless otherwisespecified, the standard temperature for testing shall be 23 62C (73.4 6 3.6F). When testing at any other

48、 temperature isrequired, one of the temperatures specified in Practice D 1349shall be used. Requirements are as follows:9.2.1.1 Shell Test MethodCut the test specimens fromunits made from standard production batches, or equivalent,which have gone through all manufacturing processes, includ-ing steri

49、lization. With silicone gel prostheses, remove gel andclean shell with appropriate polar (for example, 2-propanol) ornon-polar (aliphatic, aromatic, or chlorinated hydrocarbon)solvent, or both. If solvent cleaned, condition shell afterwardsfor3hat150F (65.6C) in an air circulation oven to removesolvent. Test shells shall be wiped clean (not soaked orsubmerged), using lint-free tissue and isopropyl alcohol, thenleft to dry at room temperature for at least two hours. Cutrequired tensile test dumbbell specimens from shells with TestMethods