ASTM-F2051:2014 Edition
$40.63
F2051-00(2014) Standard Specification for Implantable Saline Filled Breast Prosthesis
| Published By | Publication Date | Number of Pages |
| ASTM | 2014 | 6 |
ASTM F2051-00-Reapproved2014
Historical Standard: Standard Specification for Implantable Saline Filled Breast Prosthesis
ASTM F2051
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.
Keywords
breast prosthesis; gel saline prosthesis; implant; saline inflatable prosthesis; silicone elastomer; soft tissue implant;
ICS Code
ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
DOI: 10.1520/F2051-00R14
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