ASTM F703-2018 pdf free download

ASTM F703-2018 pdf free download.Standard Specification for Implantable Breast Prostheses
1. Scope
1.1 This specification covers the requirements for silicone gel-filled and saline-inflatable silicone gel-filled implantable breast prostheses intended for use in surgical reconstruction, augmentation, or replacement of the breast. 1.2 Limitations—This specification does not cover custom fabricated implantable breast prostheses. 1.3 Single-use saline-inflatable, smooth, and textured sili- cone shell implantable breast prostheses are addressed in Specification F2051. 1.4 The values stated in SI units are to be regarded as the standard. The inch-pound units given in parentheses are for information only. 1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appro- priate safety, health, and environmental practices and deter- mine the applicability ofregulatory 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 Principles for the Development of International Standards, Guides and Recom- mendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
4. Significance and Use
4.1 This specification contains requirements based on state- of-the-art science and technology as applicable to various considerations that have been identified as important to ensure reasonable safety and efficacy in implantable breast prostheses. 4.1.1 This specification is not intended to limit the science and technology which may be considered and applied to ensure performance characteristics of breast prostheses in intended applications. When new information becomes available or changes in state-of-the-art science and technology occur and relevance to prostheses has been established by valid science, it is intended that this specification will be revised in keeping with the new information or advances in state-of-the-art science.
5. Materials and Manufacture
5.1 Silicone Elastomer—Select and specify elastomers for use in implantable breast prostheses in keeping with Guides F2038 and F2042. 5.1.1 Fabrication—Fabrication techniques must necessarily be varied depending on the type of elastomer, the portion of an implantable breast prosthesis fabricated, its shape and its location and function on the prosthesis. 5.1.2 Vulcanization and Postcure—Time and temperature of vulcanization and postcure must be adjusted with consideration of the elastomer type and the multi-step fabrication require- ments of specific prostheses. Final postcure is typically done only after the shell or shells and all other portions have been completely assembled. Time and temperature of final postcure shall be adequate to drive the chemistry of vulcanization of all elastomers to completion and remove by-products of the cure in keeping with the chemical stoichiometry of the specific cure systems (for example, after postcure no additional vulcaniza- tion should occur when heated additionally at the recom- mended cure temperature). 5.2 Silicone Gel—Select and specify ingredients in keeping with Guides F2038 and F2042.5.2.1 Fabrication, Vulcanization, and Postcure: 5.2.1.1 Fabrication and Curing—Unvulcanized liquid gel is typically placed in the lumen ofa shell and cured and postcured in situ while the shell is maintained in its desired final shape. Fabrication techniques must necessarily be varied to satisfy the requirements of the specific implant type and shape. 5.2.1.2 Vulcanization and Postcure—The time and tempera- ture of vulcanization and postcure shall be adequate to drive the vulcanization chemistry ofthe gel to completion in keeping with the chemical stoichiometry ofspecific silicone gels. When postcure is adequate, silicone gel does not undergo further vulcanization with additional heating at the cure temperature.
9. Test Methods and Requirements
9.1 Biocompatibility: 9.1.1 Practice F748—New or existing materials shall be in compliance with Practice F748 or other acceptable standards such as ISO/AAMI/ANSI 10993-1. Biocompatibility assays of materials with no or limited history of prior biocompatibility testing and successful clinical use for implant applications shall follow guidelines of Practice F748. Assays recommended by Practice F748 include cell culture cytotoxicity assays, short- term intramuscular implantation assay, short-term subcutane- ous assay, carcinogenicity, long-term implant test, systemic injection (acute toxicity) assay, sensitization assay, mutagenicity, and pyrogenicity. 9.1.2 Silicone Gel Prostheses—Test specimens for chronic implantation assays (carcinogenicity and long term implant tests) shall be fabricated from the same combination ofsilicone elastomer and gel and by the same or similar procedures and conditions used in fabricating prostheses. The thickness of shell in specimens shall be typical of thickness used in prostheses.