Standard Historical Last Updated: Aug 16, 2017 Track Document
ASTM F2051-00

Standard Specification for Implantable Saline Filled Breast Prosthesis

Standard Specification for Implantable Saline Filled Breast Prosthesis F2051-00 ASTM|F2051-00|en-US Standard Specification for Implantable Saline Filled Breast Prosthesis Standard new BOS Vol. 13.01 Committee F04
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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 F703 (Standard Specification for Implantable Breast Prostheses).

1.3 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: 6
DOI: 10.1520/F2051-00
ICS Code: 11.040.40