ASTM F703-07
Standard Specification for Implantable Breast Prostheses

Standard No.

ASTM F703-07

Release Date

2007

Published By

American Society for Testing and Materials (ASTM)

Status

Be replaced

Replace By

ASTM F703-18

Latest

ASTM F703-18(2022)

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 Limitations8212;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 F 2051.

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 and health practices and determine the applicability of regulatory limitations prior to use.

ASTM F703-07 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*， 2024-04-19 Update
• ASTM F2042 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and Fabrication*， 2024-04-19 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

ASTM F703-07 history

• 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