ASTM F 2051 : 2000 : R2014
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Standard Specification for Implantable Saline Filled Breast Prosthesis
Hardcopy , PDF
14-10-2022
English
27-11-2014
Important note : Users cannot be edited or removed once added to your Multi user PDF.CONTAINED IN VOL. 13.01, 2015 Defines 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.
| Committee |
F 04
|
| DocumentType |
Standard
|
| Pages |
6
|
| ProductNote |
Reconfirmed 2014
|
| PublisherName |
American Society for Testing and Materials
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
1.1This 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.
1.2Limitations:
1.2.1This specification does not cover custom fabricated implantable breast prostheses.
1.2.2This specification does not cover gel/saline type implants, which are within the scope of Specification F703.
1.3This 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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