ASTM F703-18(2022) PDF

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 silicone 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 appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.6 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.

ASTM F703-18(2022) Referenced Document

ASTM D1349 Standard Practice for Rubber-Standard Temperatures for Testing
ASTM D412 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers8212;Tension
ASTM F1251 Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices
ASTM F2038 Standard Guide for Silicone Elastomers, Gels and Foams Used in Medical Applications Part I - Formulations and Uncured Materials*， 2024-04-21 Update
ASTM F2042 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and Fabrication*， 2024-04-21 Update
ASTM F2051 Standard Specification for Implantable Saline-Filled Breast Prostheses
ASTM F748 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices

2022 ASTM F703-18(2022) Standard Specification for Implantable Breast Prostheses
2018 ASTM F703-18 Standard Specification for Implantable Breast Prostheses
2007 ASTM F703-07 Standard Specification for Implantable Breast Prostheses
1996 ASTM F703-96(2002)e1 Standard Specification for Implantable Breast Prostheses
1996 ASTM F703-96(2002) Standard Specification for Implantable Breast Prostheses
1996 ASTM F703-96 Standard Specification for Implantable Breast Prostheses