ASTM F2051-00(2006) - 1.9.2006
 
1. Scope

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 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 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

D412-16(2021)

Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension

F1251-89(1995)

Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices

F748-16

Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices

F703-18(2022)

Standard Specification for Implantable Breast Prostheses

F604-94

Specification for Silicone Elastomers Used in Medical Applications (Withdrawn 2001)

D1349-14(2019)

Standard Practice for Rubber´Standard Conditions for Testing

D3389-21

Standard Test Method for Coated Fabrics Abrasion Resistance (Rotary Platform Abrader)