ASTM F2051-00(2022) PDF

Scope: 1.1 This specification covers the requirements for singleuse, saline inflatable, smooth and textured silicone shell implantable breast prostheses intended for use in surgical reconstruction, augmentation, or replacement of the breast. 1.2 Limitations: 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 F703. 1.3 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. 1.4 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 F2051-00(2022) Referenced Document

ANSI/AAMI/ISO 10993-1 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process
ASTM D1349 Standard Practice for Rubber-Standard Temperatures for Testing
ASTM D3389 Standard Test Method for Coated Fabrics Abrasion Resistance (Rotary Platform, Double-Head Abrader)
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ASTM F604 Specification for Silicone Elastomers Used in Medical Applications (Withdrawn 2001)
ASTM F703 Standard Specification for Implantable Breast Prostheses
ASTM F748 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices

2022 ASTM F2051-00(2022) Standard Specification for Implantable Saline-Filled Breast Prostheses
2000 ASTM F2051-00(2014) Standard Specification for Implantable Saline Filled Breast Prosthesis
2000 ASTM F2051-00(2006) Standard Specification for Implantable Saline Filled Breast Prosthesis
2000 ASTM F2051-00 Standard Specification for Implantable Saline Filled Breast Prosthesis