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ASTM F2051-00

Current Revision

Standard Specification for Implantable Saline-Filled Breast Prostheses

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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.


SDO ASTM: ASTM International
Document Number F2051
Publication Date July 10, 2000
Language en - English
Page Count 6
Revision Level 00
Supercedes
Committee F04.32
Publish Date Document Id Type View
July 10, 2000 F2051-00 Revision
Oct. 1, 2022 F2051-00R22 Reaffirmation
Oct. 1, 2014 F2051-00R14 Reaffirmation
Sept. 1, 2006 F2051-00R06 Reaffirmation