ASTM F703-2018 Standard Specification for Implantable Breast Prostheses《可植入乳房假体的标准规范》.pdf

1、Designation: F703 18Standard Specification forImplantable Breast Prostheses1This standard is issued under the fixed designation F703; the number immediately following the designation indicates the year of originaladoption or, in the case of revision, the year of last revision. A number in parenthese

2、s 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 siliconegel-filled and saline-inflatable silicone gel-filled implantablebreast prostheses intended for use i

3、n 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 F205

4、1.1.4 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 to e

5、stablish appro-priate safety, health, and environmental practices and deter-mine the applicability of regulatory limitations prior to use.1.6 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Princip

6、les for theDevelopment of International Standards, Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade (TBT) Committee.2. Referenced Documents2.1 ASTM Standards:2D412 Test Methods for Vulcanized Rubber and Thermoplas-tic ElastomersTensionD1349 Practice for R

7、ubberStandard Conditions for Test-ingF748 Practice for Selecting Generic Biological Test Methodsfor Materials and DevicesF1251 Terminology Relating to Polymeric Biomaterials inMedical and Surgical Devices (Withdrawn 2012)3F2038 Guide for Silicone Elastomers, Gels, and Foams Usedin Medical Applicatio

8、ns Part IFormulations and Un-cured MaterialsF2042 Guide for Silicone Elastomers, Gels, and Foams Usedin Medical Applications Part IICrosslinking and Fabri-cationF2051 Specification for Implantable Saline Filled BreastProsthesis2.2 Other Documents:Saline, Silicone Gel, and Alternative Breast Implants

9、Guidance for Industry and FDA Staff, November 17,20064ISO/AAMI/ANSI 10993-1 Biological Evaluation of MedicalDevicesPart 1: Evaluation and Testing53. Terminology3.1 Definitions:3.1.1 barrier coat, na silicone elastomer layer that is partof the shell of a silicone gel implantable breast prosthesis tha

10、tretards silicone bleed.3.1.2 fixation site, nan area of the shell of an implantablebreast prosthesis containing material that allows tissue in-growth.3.1.3 fused or adhered joints (seams), n sites in the shellor other parts of an implantable breast prosthesis wherematerials have been joined (fused

11、or bonded) together, with orwithout an adhesive, 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

12、with a pre-filled, fixedvolume of silicone gel.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 Feb. 1, 2018. Publishe

13、d March 2018. Originallyapproved in 1981. Last previous edition approved in 2007 as F703 07 which waswithdrawn January 2016 and reinstated February 2018. DOI: 10.1520/F0703-18.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. Fo

14、r 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 U.S. Department of Health and Human Services, Food andDrug Administration (FDA), 5600

15、 Fishers Ln., Rockville, MD 20857, http:/www.fda.gov/cdrh/ode/guidance/1239.5Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-295

16、9. United StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recommendations issued by the World Trade Organization Technical B

17、arriers to Trade (TBT) Committee.13.1.5.1 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 pros

18、thesis, nimplantable breastprosthesis 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

19、 to facilitate filling the voidbetween 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 adjustment by following the instructions provided inthe product literature.3.1

20、.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 notaccessible for volume adjustments of any kind. The innerlumen is contained w

21、ithin 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 tofacilitate post-operative saline volume adjustment by followingthe instructio

22、ns 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 implantablebreast prosthesis.3.1.7.1 DiscussionA lumen may contain either a fi

23、xed,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 volume of the prosthesis at thetime of use. More than one lumen may be formed w

24、ithin 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 chloride injection USP.3.1.10 shell, na silicone elastomer continuous layer ormembran

25、e container (sac) that encloses a lumen or multiplelumens of an implantable breast prosthesis.3.1.11 silicone elastomer, nan elastomer containing cross-linked silicone polymer and fumed amorphous (non-crystalline) silica as a reinforcing filler.3.1.12 silicone gel, na semisolid material consisting o

26、f acrosslinked silicone polymer network in which liquid siliconepolymer is held (see definition of gel in Terminology F1251).3.1.13 valve, nuser-sealable or self-sealing opening in aninflatable or gel saline prosthesis, extending from the exteriorsurface of the shell into a lumen, designed to facili

27、tate 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 applicable to variousconsiderations that have been identified as important to ensur

28、ereasonable 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 breast prostheses in intendedapplications. When new information becomes available o

29、rchanges 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 advances in state-of-the-artscience.5. Materials and Manufacture5.1 Silicone Elastom

30、erSelect and specify elastomers foruse in implantable breast prostheses in keeping with GuidesF2038 and F2042.5.1.1 FabricationFabrication techniques must necessarilybe varied depending on the type of elastomer, the portion of animplantable breast prosthesis fabricated, its shape and itslocation and

31、 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 specific prostheses. Final postcure is typically doneonly after the shell or shells a

32、nd 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 keeping with the chemical stoichiometry of the specific curesystems (for example, a

33、fter 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 F2038 and F2042.5.2.1 Fabrication, Vulcanization, and Postcure:5.2.1.1 Fabrication and CuringUnvulcanized liquid

34、 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 the specific implant type and shape.5.2.1.2 Vulcanization and PostcureThe time and t

35、empera-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, silicone gel does not undergo furthervulcanization with additional heating at the cu

36、re 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 prostheses are typically controlled byF703 182weight. 1 g = approximately 1 cm3. The weight

37、 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-Saline ProsthesesThe design or maximum rec-ommended volume of saline fill sha

38、ll be listed in the labeling.6.2 DimensionsThe ranges of shapes, volumes, base sizes,and anterior projections shall be determined by the manufac-turer. Pertinent information shall be contained in the labeling.7. Fixation Sites7.1 Fixation sites shall be optional features on a silicone gelimplantable

39、 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 prosthesis. When orientationmeans are claimed, the location and recommended tech

40、niquesfor use shall be clearly described in the labeling.9. Test Methods and Requirements9.1 Biocompatibility:9.1.1 Practice F748New or existing materials shall be incompliance with Practice F748 or other acceptable standardssuch as ISO/AAMI/ANSI 10993-1. Biocompatibility assays ofmaterials with no

41、or limited history of prior biocompatibilitytesting and successful clinical use for implant applications shallfollow guidelines of Practice F748. Assays recommended byPractice F748 include cell culture cytotoxicity assays, short-term intramuscular implantation assay, short-term subcutane-ous assay,

42、carcinogenicity, long-term implant test, systemicinjection (acute toxicity) assay, sensitization assay,mutagenicity, and pyrogenicity.9.1.2 Silicone Gel ProsthesesTest specimens for chronicimplantation assays (carcinogenicity and long term implanttests) shall be fabricated from the same combination

43、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 palpability of prostheses and to effectivelymimic the softness of breast tissue, silic

44、one 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 elastomer shell, silicone gel may notretain its physical shape and integrity. Clinical i

45、mplantation 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, surgery for removal of theruptured prosthesis (with or without prosthetic replacement) an

46、d 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 biocompat-ibility assays shall have silicone gel contained in an enclosing siliconeelastomer

47、 shell, similar to silicone gel prostheses. Specimens of freesilicone gel may be used in all other biocompatibility assays as specifiedin Practice F748 for implants used in tissue and tissue fluid contactapplications, including short-term intramuscular implantation assay.9.1.3 Prior Biocompatibility

48、 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 recentlydeveloped biocompatibility test method standards, such datamay satisfy all or part

49、of the specific biocompatibility require-ments of Practice F748 or equivalent methodology.9.2 Physical Properties:9.2.1 Test ProcedureSilicone prostheses shall demonstratean acceptable response in physical property tests. Prosthesesfor 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 temperature isrequired, one of t