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ASTM International - ASTM F2051-00(2014)

Standard Specification for Implantable Saline Filled Breast Prosthesis

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Organization: ASTM International
Publication Date: 1 October 2014
Status: active
Page Count: 6
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40
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 Specification F703.

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.

abstract:

This specification covers the requirements for single use saline inflatable, smooth and textured silicone shell implantable breast prostheses, intended for use in surgical reconstruction,... View More

Document History

ASTM F2051-00(2014)
October 1, 2014
Standard Specification for Implantable Saline Filled Breast Prosthesis
This specification covers the requirements for single use saline inflatable, smooth and textured silicone shell implantable breast prostheses, intended for use in surgical reconstruction,...
September 1, 2006
Standard Specification for Implantable Saline Filled Breast Prosthesis
This specification covers the requirements for single use saline inflatable, smooth and textured silicone shell implantable breast prostheses, intended for use in surgical reconstruction,...
July 10, 2000
Standard Specification for Implantable Saline Filled Breast Prosthesis
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,...
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