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About This Item

 

Full Description

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 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.

 

Document History

  1. ASTM F703-18(2022)


    Standard Specification for Implantable Breast Prostheses

    • Most Recent
  2. ASTM F703-18


    Standard Specification for Implantable Breast Prostheses

    • Historical Version
  3. ASTM F703-07

    👀currently
    viewing


    Standard Specification for Implantable Breast Prostheses (Withdrawn 2016)

    • Historical Version
  4. ASTM F703-96(2002)e1


    Standard Specification for Implantable Breast Prostheses

    • Historical Version
  5. ASTM F703-96(2002)


    Standard Specification for Implantable Breast Prostheses

    • Historical Version
  6. ASTM F703-96


    Standard Specification for Implantable Breast Prostheses

    • Historical Version