ASTM F703 - 26
Standard Specification for Implantable Breast Prostheses
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| Fecha edición: |
2026-03-01
En Vigor
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| Idiomas disponibles: | Inglés |
| Resumen: | 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. Breast prosthesis are classified into three types: type I breast prosthesis, n - implantable breast prosthesis containing a single lumen containing a fixed amount of silicone gel, Type II breast prosthesis, n - implantable breast prosthesis comprised of two complete lumens, one inside the other, and type III breast prosthesis, n - implantable breast prosthesis comprised of two complete lumens, one inside the other. Elongation, breaking strength, tensile set, critical fused or adhered joints, shell rupture, and shell leakage shall be tested to meet the requirements prescribed. Gel cohesion, gel bleeding, and gel penetration shall be tested to meet the requirements prescribed. |
| Keywords: | breast prosthesis; gel-saline prosthesis; implant; saline inflatable prosthesis; silicone elastomer; silicone gel prosthesis; soft tissue implant; |
| 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 Saline-inflatable, silicone shell implantable breast prostheses are addressed in Specification F2051. Specification F1441 provides requirements for soft-tissue expander devices. 1.3 Units—The values stated in SI units are to be regarded as the standard. The inch-pound units given in parentheses are for information only. 1.4 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. |
| ICS: | 11.040.40 - Implantes quirúrgicos, prótesis y ortesis |
| CTN: | F04.32 - F04.32 |
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Anulaciones Normas |
Anula a F703 - 25 |
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Otras Relaciones |
Es referenciada por F2051 - 25 Es referenciada por F1441 - 03(2022) |
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