Standard Historical Last Updated: Aug 16, 2017 Track Document
ASTM F703-96(2002)e1

Standard Specification for Implantable Breast Prostheses

Standard Specification for Implantable Breast Prostheses F0703-96R02E01 ASTM|F0703-96R02E01|en-US Standard Specification for Implantable Breast Prostheses Standard new BOS Vol. 13.01 Committee F04
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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.

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.

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Details
Book of Standards Volume: 13.01
Developed by Subcommittee: F04.32
Pages: 9
DOI: 10.1520/F0703-96R02E01
ICS Code: 11.040.40