ASTM F2051-25
Standard Specification for Implantable Saline-Filled Breast Prostheses
| Označení normy: | ASTM F2051-25 |
| Vydáno: | 01.12.2025 |
| Status: | Active |
| Počet stran: | 7 |
| Sekce: | 13.01 |
| Označení: | breast prosthesis; gel saline prosthesis; implant; saline inflatable prosthesis; silicone elastomer; soft tissue implant; |
| ASTM označení: | ASTM F2051 |
| Nahrazuje: | F2051-00R22 |
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.
1.1 This specification covers the requirements for saline inflatable silicone shell implantable breast prostheses intended for use in surgical reconstruction, augmentation, or replacement of the breast.
1.2 This specification does not cover saline inflatable silicone gel-filled implants and non-inflatable silicone gel-filled implants that are within the scope of Specification F703 or soft tissue expander devices that are within the scope of Specification F1441.
1.3 Units—The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in nonconformance with the standard.
1.4 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.