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ASTM-F2051:2000 Edition

ASTM-F2051:2000 Edition

$40.63

F2051-00 Standard Specification for Implantable Saline Filled Breast Prosthesis

Published By Publication Date Number of Pages
ASTM 2000 6
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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.

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