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ASTM F703

Standard Specification for Implantable Breast Prostheses

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Organization: ASTM
Publication Date: 1 February 2018
Status: active
Page Count: 10
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40
scope:

This specification covers the requirements for silicone gel-filled and saline-inflatable silicone gel-filled implantable breast prostheses intended for use in surgical reconstruction, augmentation, or replacement of the breast.

Limitations-This specification does not cover custom fabricated implantable breast prostheses.

Single-use saline-inflatable, smooth, and textured silicone shell implantable breast prostheses are addressed in Specification F2051.

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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Document History

ASTM F703
February 1, 2018
Standard Specification for Implantable Breast Prostheses
This specification covers the requirements for silicone gel-filled and saline-inflatable silicone gel-filled implantable breast prostheses intended for use in surgical reconstruction, augmentation,...
April 1, 2007
Standard Specification for Implantable Breast Prostheses
This specification covers the requirements for silicone gel-filled and saline-inflatable silicone gel-filled implantable breast prostheses intended for use in surgical reconstruction, augmentation,...
June 10, 1996
Standard Specification for Implantable Breast Prostheses
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...
June 10, 1996
Standard Specification for Implantable Breast Prostheses
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...
June 10, 1996
Standard Specification for Implantable Breast Prostheses
1. 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...
April 6, 1981
Standard Specificatin for Implantable Breast Prostheses
This specification covers the requirements for fixed and variable volume mammary prostheses used for breast augmentation or replacement. Limitations - This specification does not necessarily cover...
January 1, 1981
Implantable Breast Prostheses, Spec. for
A description is not available for this item.

References

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