1、Designation: F 2051 00 (Reapproved 2006)Standard Specification forImplantable Saline Filled Breast Prosthesis1This standard is issued under the fixed designation F 2051; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of l
2、ast revision. 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 single usesaline inflatable, smooth and textured silicone shell implant
3、-able breast prostheses, intended for use in surgical reconstruc-tion, 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 type im-plants, which are within
4、 the scope of Specification F 703.1.3 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 limita
5、tions 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 forTestingD 3389 Test Method for Coated Fabrics Abrasion Resis-tance (Rotary Platform Abrader)F 604 Specification
6、 for Silicone Elastomers Used in Medi-cal Applications3F 703 Specification for Implantable Breast ProsthesesF 748 Practice for Selecting Generic Biological Test Meth-ods for Materials and DevicesF 1251 Terminology Relating to Polymeric Biomaterials inMedical and Surgical Devices2.2 Other Documents:U
7、SP (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 Air) Steriliz
8、ers7ANSI/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 Sterilization of Health
9、 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 Silicone Inflata
10、ble (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.1This specific
11、ation 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 Sept. 1, 2006. Published September 2006. Originallyapproved in 2000. Last previous
12、edition approved in 2000 as F 2051 00.2For 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.3Withdrawn.4United Stat
13、es Pharmacopeia, Vol XXI, Mack Publishing Company, Easton, PA1989. Available from Pharmacopeia Convention, Inc., 12601 Twinbrook Parkway,Rockville, NC 00852.5Federal Register, Vol. 43, No. 141, Friday, July 21, 1978 Part II.Available fromU.S. Government Printing Office Superintendent of Documents, 7
14、32 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., Suite 220, Arlington, VA 222014795. http:/www.aami.org.7Available from American National Standards Institute (ANSI
15、), 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. http:/www.pda.org.9Available from Food and Drug Administration (FDA), 5600 Fishers Ln.,Rockville, MD 20857, http:
16、/www.fda.gov.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.3.1.2 inflatable breast prosthesisimplantable breast pros-theses not containing silicone gel implantable breast pros-theses designed and provided prefilled with saline or e
17、mpty 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 of asingle lumen, empty when supplied and having a valve tofacilitate filling the lumen with saline at the time of
18、 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 lumen with a portion of the volume ofsaline at the time of use. The valve system is designed tofacilitate further
19、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, prefilled with saline by the manufacturer prior totime of use.3.1.3 lumena cavity within a shell of an implantabl
20、ebreast 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 or palpable portion ofan implantable breast prosthesis to assist the surgeon inpositioning the implant.3.1.5 sali
21、neonly 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) which encloses a lumen of an implantablebreast prosthesis.3.1.7 silicone elastomeran elastomer containing cross-li
22、nked 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 exterior surface of the shell intoa lumen, designed to facilitate addition of saline at the time ofuse or postoperativ
23、ely 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 and Use4.1 This specification contains requirements based on state-of-art science and technology as applicable to v
24、arious 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 componentsin implantable breast prostheses.4.1.1 This specification is not intended to limit the scienceand technolo
25、gy that may be considered and applied to assureperformance characteristics of subject breast prostheses inintended applications. When new information becomes avail-able or changes in state-of-art science and technology occurand relevance to subject prostheses has been established byvalid science, it
26、 is intended that this specification will berevised in accordance with ASTM guidelines.5. Materials5.1 Silicone ElastomerSelect and specify elastomers foruse in implantable breast prostheses in keeping with Specifi-cation F 604.5.1.1 ShellThe following describes suitable silicone elas-tomer composit
27、ions 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)catalysts B, G, J or KNOTE 1The composition listed in this section are not intended to limitthe compositions that may
28、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 animplantable breast prosthesis fabricated, its shape, location andfunction on the prosthesis.5.1.3 Vulcanization
29、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 and all other portions have beencompletely assemb
30、led. 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 chemical stoichiometry of the specific curesystem (e.g., after postcure no additional vulcanization shouldoccur whe
31、n heated additionally at recommended cure tempera-ture).5.1.4 Physical Property Testing and RequirementsSilicone elastomer shells shall demonstrate an acceptableresponse in physical property tests. Prostheses for testingshould be selected from standard production batches whichhave gone through all m
32、anufacturing processes, includingsterilization.5.1.4.1 Specimen PreparationCut required tests speci-mens from shells with Test Method D 412 Dies. Devices orspecimens shall be conditioned before testing for at least1hat23 6 2C (73.4 6 3.6F).5.1.4.2 DimensionThe individual shape, range of volume(displ
33、acement), 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-mum and maximum recommended volume of saline fill shallbe listed in instructions for use.6.2 DimensionsThe ranges
34、of shapes, volumes, basesizes, and anterior projections are determined by the manufac-turer. Pertinent information shall be contained in the packageinsert.7. Fixation Sites7.1 The presence of fixation sites on any type of implantablebreast prosthesis is optional. When used, the size and locationsof
35、fixation sites shall be clearly stated in instructions for use.F 2051 00 (2006)28. Orientation Means8.1 Orientation means are optional features of subject pros-theses. When orientation means are claimed, the location andrecommended techniques for use shall be clearly described ininstructions for use
36、.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 accepted standardssuch as ISO/AAMI/ANSI 10993-1. Assays recommended byPractice F 748 include Cell Culture CytotoxicityAssays, Short-Term Intramuscula
37、r Implantation Assay, Short-Term Subcuta-neous Assay, Carcinogenicity, Long-Term Implant Test, Sys-temic Injection (Acute Toxicity) Assay, Sensitization Assay,Mutagenicity, and Pyrogenicity.9.1.2 Silicone Saline Filled ProsthesesTest specimens forchronic implantation assays (carcnogenciity and long
38、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 in specimens shall be typical of thickness used inprostheses.9.1.3 Prior Biocompatibility AssaysWhen prior b
39、iocom-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 partof the specific biocompatibility requirements of Practice F 748or equivalent methodology.9.2 Physical Pro
40、perties: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 in Practice D 1349. Tests are as follows:9.2.2 Shell Leakage TestingFilla5to8qtstainless steelbowl with 70
41、% 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 tested while exposed. Reject shellswhenever any bubbles are seen.9.2.3 ShellCut the test specimens from
42、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.9.2.3.1 Percent ElongationThree thickness measurementsshall be taken prior to test, percentage elongation s
43、hall be 350% minimum when tested in accordance with Test MethodD 412, Die C.9.2.3.2 Breaking StrengthUltimate Breaking Force inTension shall be no less when 2.5 lb (11.12 N) when tested inaccordance with Test Method D 412, Die C.9.2.3.3 Tensile SetThe tensile set shall be 10%, deter-mine in accordan
44、ce with Test Method D 412. 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 silicone rubber materials shall be critical to theirintegrity.(1) Critical Fused or Adhered JointsJoints or
45、 seams thatare critical to the integrity of the prostheses envelope shall notfail when the shell adjacent to the joint stressed to 200 %elongation 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
46、envelope integrity (fixation sites, orientationmeans, valve covers, and so forth) shall not fail when the shelladjacent to the joint is stressed to 100 % elongation for 10 s(see Fig. 1).FIG. 1 Testing Fused or Adhered JointsF 2051 00 (2006)39.3 Shell Rupture/Failure TestingNo standard test forassess
47、ing 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 toduplicate its use for filling and inflate prosthesis with saline asdescribed in instructions for use. T
48、est 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 cm H2Opressure respectively. Maintain each test pressure for 5 min.When air or other suitable gases ar
49、e 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 these test methods may notbe able to be correlated with particulates resulting from clinicaluse, and the
