scope:

1.1 This specification covers the requirements for silicone gel-filled, saline inflatable silicone gel-filled, and saline inflatable, smooth-shell 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 The values stated in SI units are to be regarded as the standard. The inch-pound units given in parentheses are for information only.

1.4 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.