This specification covers the requirements for single use saline inflatable, smooth and textured silicone shell implantable breast prostheses, intended for use in surgical reconstruction, augmentation, or replacement of the breast. This specification does not cover custom fabricated implantable breast prostheses and other gel-saline type implants. The silicone elastomer compositions for use as primary material of construction of the shell including the exterior (tissue contact) surface shall include: (1) polymer types MQ or VMQ, (2) fillers A, B, or C, (3) additive J (for radiopacity), and (4) catalysts B, G, J, or K. The requirements for the following are specified: (1) fabrication including vulcanization and postcure, (2) volume and dimension of saline filled prostheses, (3) fixation sites, and (4) orientation means. The following tests shall be performed: (1) physical property tests such as shell leakage and tension tests (2) biocompatibility test, (3) shell rupture or failure test, (4) valve competence, and (5) abrasion test. The physical property requirements are specified for (1) shell percent elongation, breaking strength, and tensile set, and (2) critical and non-critical fused or adhered joints. Illustrations for testing fused or adhered joints are provided. Requirements for sterilization, packaging, labeling, and package inserts are detailed as well.
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1.1 This specification covers the requirements for single use saline inflatable, smooth and textured silicone shell implantable breast prostheses, intended for use in surgical reconstruction, augmentation, or replacement of the breast.
1.2.1 This specification does not cover custom fabricated implantable breast prostheses.
1.2.2 This specification does not cover gel/saline type implants, which are within the scope of Specification F 703.
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 appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
D412 Test Methods for Vulcanized Rubber and Thermoplastic Elastomers--Tension
D1349 Practice for Rubber--Standard Temperatures for Testing
D3389 Test Method for Coated Fabrics Abrasion Resistance (Rotary Platform Abrader)
F604 Specification for Silicone Elastomers Used in Medical Applications
F703 Specification for Implantable Breast Prostheses
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
F1251 Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices
FDA Draft Guidance for Preparation of PMA Applications for Silicone Inflatable (Saline) Breast Prostheses Available from Food and Drug Administration (FDA), 5600 Fishers Ln., Rockville, MD 20857, http://www.fda.gov.
breast prosthesis; gel saline prosthesis; implant; saline inflatable prosthesis; silicone elastomer; soft tissue implant;
ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
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