1、Designation: F2051 00 (Reapproved 2014)Standard Specification forImplantable Saline Filled Breast Prosthesis1This standard is issued under the fixed designation F2051; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of las
2、t revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This specification covers the requirements for single usesaline inflatable, smooth and textured silicone shell implant-ab
3、le breast prostheses, intended for use in surgicalreconstruction, augmentation, or replacement of the breast.1.2 Limitations:1.2.1 This specification does not cover custom fabricatedimplantable breast prostheses.1.2.2 This specification does not cover gel/saline typeimplants, which are within the sc
4、ope of Specification F703.1.3 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 establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations pr
5、ior to use.2. Referenced Documents2.1 ASTM Standards:2D412 Test Methods for Vulcanized Rubber and Thermoplas-tic ElastomersTensionD1349 Practice for RubberStandard Conditions for Test-ingD3389 Test Method for Coated Fabrics Abrasion Resistance(Rotary Platform Abrader)F604 Specification for Silicone
6、Elastomers Used in MedicalApplications (Withdrawn 2001)3F703 Specification for Implantable Breast ProsthesesF748 Practice for Selecting Generic Biological Test Methodsfor Materials and DevicesF1251 Terminology Relating to Polymeric Biomaterials inMedical and Surgical Devices (Withdrawn 2012)32.2 Oth
7、er Documents:USP (United States Pharmacopeia)4Federal Register, Title 21, Part 8205Association for the Advancement of Medical Instrumenta-tion6ANSI/AAMI/ISO 10993-1 Biological Testing of Medicaland Dental Materials and DevicesPart 1: Guidance onSelection of Tests7ANSI/AAMI/ST50-1995 Dry Heat (Heated
8、 Air) Sterilizers7ANSI/AAMI/ISO 111355-1994 Medical DevicesValidation and Routine Control of Ethylene Oxide Steril-ization7ANSI/AAMI/ISO 11137-1994 Sterilization of Health CareProductsRequirements for Validation and Routine andRoutine ControlRadiation Sterilization7ANSI/AAMI/ISO 11134-1993 Steriliza
9、tion of Health CareProductsRequirements for Validation and RoutineControlIndustrial Moist Heat Sterilization7Parenteral Drug Association, 1981 Technical Report No. 3,Validation of Dry Heat Processes Used for Sterilizationand Depyrogenation8FDA Draft Guidance for Preparation of PMA Applicationsfor Si
10、licone Inflatable (Saline) Breast Prostheses93. Terminology3.1 Definitions:3.1.1 fused or adhered joints (seams)sites in the shell orother parts of implantable breast prosthesis where materialshave been joined (fused or bonded) together, with or withoutadhesive, as part of the manufacturing process.
11、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 2000. La
12、st previous edition approved in 2006 as F2051 00(2006).DOI: 10.1520/F2051-00R14.2For 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
13、onthe ASTM website.3The last approved version of this historical standard is referenced onwww.astm.org.4United States Pharmacopeia, Vol XXI, Mack Publishing Company, Easton, PA1989. Available from Pharmacopeia Convention, Inc., 12601 Twinbrook Parkway,Rockville, NC 00852.5Federal Register, Vol. 43,
14、No. 141, Friday, July 21, 1978 Part II.Available fromU.S. Government Printing Office Superintendent of Documents, 732 N. Capitol St.,NW, Mail Stop: SDE, Washington, DC 20401, http:/www.access.gpo.gov.6Available from Association for the Advancement of Medical Instrumentation(AAMI), 1110 N. Glebe Rd.,
15、 Suite 220, Arlington, VA 222014795. http:/www.aami.org.7Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.8Available from Parenteral Drug Association (PDA), Bethesda Towers, 4350East West Hwy., Suite 200, Bethesda, MD 20814
16、. http:/www.pda.org.9Available from Food and Drug Administration (FDA), 5600 Fishers Ln.,Rockville, MD 20857, http:/www.fda.gov.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States13.1.2 inflatable breast prosthesisimplantable breast pros-
17、theses not containing silicone gel implantable breast pros-theses designed and provided prefilled with saline or empty andto be filled with saline at the time of use to adjust the volumeof the prosthesis.3.1.2.1 type 1fixed volume inflatable breastprosthesisan implantable breast prosthesis composed
18、of asingle lumen, empty when supplied and having a valve tofacilitate filling the lumen with saline at the time of use.3.1.2.2 type 2variable volume inflatable breastprosthesisan implantable breast prosthesis composed of asingle lumen, empty when supplied and having a valve tofacilitate filling the
19、lumen with a portion of the volume ofsaline at the time of use. The valve system is designed tofacilitate further post-operative adjustment with saline asinstructed in product literature.3.1.2.3 type 3fixed volume inflatable breastprosthesisan implantable breast prosthesis composed of asingle lumen,
20、 prefilled with saline by the manufacturer prior totime of use.3.1.3 lumena cavity within a shell of an implantablebreast prosthesis. Inflatable lumens are accessible by valve tofacilitate the addition of saline to adjust the volume of theprosthesis at the time of use.3.1.4 orientation meansany mark
21、 or palpable portion ofan implantable breast prosthesis to assist the surgeon inpositioning the implant.3.1.5 salineonly sodium chloride for injection (USP) isrecommended for filling lumens of inflatable breast prosthesis.3.1.6 shella silicone elastomer continuous layer or mem-brane container (sac)
22、which encloses a lumen of an implantablebreast prosthesis.3.1.7 silicone elastomeran elastomer containing cross-linked silicone polymer and fumed amorphous (non-crystalline) silica as a reinforcing filler.3.1.8 valvesealable or self sealing opening in an inflatableprosthesis, extending from the exte
23、rior surface of the shell intoa lumen, designed to facilitate addition of saline at the time ofuse or postoperatively to adjust prosthesis volume.3.1.9 patcha piece of silicone elastomer which covers andseals the hole which results from the manufacturing process ofshell fabrication.4. Significance a
24、nd Use4.1 This specification contains requirements based on state-of-art science and technology as applicable to various consid-erations that have been identified as important to ensurereasonable safety and efficacy as it relates to the biocompat-ibility and the mechanical integrity of the device co
25、mponentsin implantable breast prostheses.4.1.1 This specification is not intended to limit the scienceand technology that may be considered and applied to assureperformance characteristics of subject breast prostheses inintended applications. When new information becomes avail-able or changes in sta
26、te-of-art science and technology occurand relevance to subject prostheses has been established byvalid science, it is intended that this specification will berevised in accordance with ASTM guidelines.5. Materials5.1 Silicone ElastomerSelect and specify elastomers foruse in implantable breast prosth
27、eses in keeping with Specifi-cation F604.5.1.1 ShellThe following describes suitable silicone elas-tomer compositions for use as the primary material of con-struction of the shell including the exterior (tissue contact)surface:polymer types MQ or VMQfillers A, B or Cadditive J (for radiopacity)catal
28、ysts B, G, J or KNOTE 1The composition listed in this section are not intended to limitthe compositions that may be used providing all other requirements of thisspecification are satisfied.5.1.2 FabricationFabrication techniques must necessarilybe dependent on the type of elastomer, the portion of a
29、nimplantable breast prosthesis fabricated, its shape, location andfunction on the prosthesis.5.1.3 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.
30、 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 allelastomer to completion and remove by-products of the cure inkeeping with the ch
31、emical stoichiometry of the specific curesystem (e.g., after postcure no additional vulcanization shouldoccur when heated additionally at recommended cure tempera-ture).5.1.4 Physical Property Testing and RequirementsSilicone elastomer shells shall demonstrate an acceptableresponse in physical prope
32、rty tests. Prostheses for testingshould be selected from standard production batches whichhave gone through all manufacturing processes, includingsterilization.5.1.4.1 Specimen PreparationCut required tests speci-mens from shells with Test Method D412 Dies. Devices orspecimens shall be conditioned b
33、efore testing for at least1hat23 6 2C (73.4 6 3.6F).5.1.4.2 DimensionThe individual shape, range of volume(displacement), base size, and anterior projection are deter-mined by the manufacturer.6. Volume and Dimensions6.1 Volumes of Prostheses:6.1.1 Saline Inflatable ProsthesesThe designed or mini-mu
34、m and maximum recommended volume of saline fill shallbe listed in instructions for use.6.2 DimensionsThe ranges of shapes, volumes, base sizes,and anterior projections are determined by the manufacturer.Pertinent information shall be contained in the package insert.F2051 00 (2014)27. Fixation Sites7
35、.1 The presence of fixation sites on any type of implantablebreast prosthesis is optional. When used, the size and locationsof fixation sites shall be clearly stated in instructions for use.8. Orientation Means8.1 Orientation means are optional features of subject pros-theses. When orientation means
36、 are claimed, the location andrecommended techniques for use shall be clearly described ininstructions for use.9. Test Methods and Requirements9.1 Biocompatibility:9.1.1 Practice F748New or existing materials shall be incompliance with Practice F748 or other accepted standardssuch as ISO/AAMI/ANSI 1
37、0993-1. Assays recommended byPractice F748 include Cell Culture CytotoxicityAssays, Short-Term Intramuscular Implantation Assay, Short-Term Subcuta-neous Assay, Carcinogenicity, Long-Term Implant Test, Sys-temic Injection (Acute Toxicity) Assay, Sensitization Assay,Mutagenicity, and Pyrogenicity.9.1
38、.2 Silicone Saline Filled ProsthesesTest specimens forchronic implantation assays (carcnogenciity and long termimplant tests) shall be fabricated from the same combination ofsilicone elastomer and by the same or similar procedures andconditions used in fabricating prostheses. The thickness ofshell i
39、n specimens shall be typical of thickness used inprostheses.9.1.3 Prior Biocompatibility AssaysWhen prior biocom-patibility data are available for silicone elastomer in clinicaluse in breast implants, even if not done by the exact protocolsdescribed in more standards, such data may satisfy all or pa
40、rtof the specific biocompatibility requirements of Practice F748or equivalent methodology.9.2 Physical Properties:9.2.1 Unless otherwise specified, the standard temperaturefor testing shall be 23 6 2C (73.4 6 3.6F). When testing atany other temperature is required, use one of temperaturesspecified i
41、n Practice D1349. Tests are as follows:9.2.2 Shell Leakage TestingFilla5to8qtstainless steelbowl with 70 % isopropyl alcohol. Submerge patched shell inbowl and gently apply pressure to the shell assembly. Visuallyinspect for any bubbles. Reposition shell in hand until entiresurface of shell has been
42、 tested while exposed. Reject shellswhenever any bubbles are seen.9.2.3 ShellCut the test specimens from units made bystandard production processes including sterilization. Cleanwith appropriate (polar, for example, 2-propanol, or non polar,for example, 1,1,1-trichloroethane) solvent if necessary.9.
43、2.3.1 Percent ElongationThree thickness measurementsshall be taken prior to test, percentage elongation shall be 350% minimum when tested in accordance with Test MethodD412, Die C.9.2.3.2 Breaking StrengthUltimate Breaking Force inTen-sion shall be no less when 2.5 lb (11.12 N) when tested inaccorda
44、nce with Test Method D412, Die C.9.2.3.3 Tensile SetThe tensile set shall be 10%, deter-mine in accordance with Test Method D412. Determine tensileat 300 % elongation, stress the specimen for 3 min, then allow3 min for relaxation.9.2.3.4 Fused or Adhered JoinedRequirements for ad-hered or fused sili
45、cone rubber materials shall be critical to theirintegrity.FIG. 1 Testing Fused or Adhered JointsF2051 00 (2014)3(1) Critical Fused or Adhered JointsJoints or seams thatare critical to the integrity of the prostheses envelope shall notfail when the shell adjacent to the joint stressed to 200 %elongat
46、ion for 10 s (see Fig. 1).(2) Non-Critical Fused or Adhered JointsFused joints orseams that are bonded to the prosthesis envelope but are notcritical to the envelope integrity (fixation sites, orientationmeans, valve covers, and so forth) shall not fail when the shelladjacent to the joint is stresse
47、d to 100 % elongation for 10 s(see Fig. 1).9.3 Shell Rupture/Failure TestingNo standard test forassessing shell rupture has yet been developed. When such testmethod has been developed it will be added to this specifica-tion.9.4 Valve Competence:9.4.1 Test MethodPrior to testing, manipulate valve tod
48、uplicate its use for filling and inflate prosthesis with saline asdescribed in instructions for use. Test such manipulated valveat both high and low retrograde pressures. Use air or othersuitable gas, distilled water or isotonic saline as test media.Pressures, in order to be tested, are 30 cm and 3
49、cm H2Opressure respectively. Maintain each test pressure for 5 min.When air or other suitable gases are tested, immediatelyimmerse valve opening in water to check for leakage (bubbles).With water or isotonic saline check for droplets at the valveopening.9.4.2 Test RequirementsNo observable or detectable leak-age.9.5 Abrasion TestingThe criteria for shell abrasion in thistesting have not been established.9.5.1 Abrasion TestingWet methodSee A1.1.9.5.2 Abrasion TestingDry methodSee A1.2.9.5.3 Particle sizes generated by t
