ASTM F 2051 : 2000 : R2006
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
11-11-2014
English
01-09-2006
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 2006
|
| PublisherName |
American Society for Testing and Materials
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
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 F 703.
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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| ASTM F 748 : 2016 : REDLINE | Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| AAMI ISO 11137 : 94 AMD 1 2002 | STERILIZATION OF HEALTH CARE PRODUCTS - REQUIREMENTS FOR THE VALIDATION AND ROUTINE CONTROL - RADIATION STERILIZATION |
| ASTM F 604 : 1994 | Specification for Silicone Elastomers Used in Medical Applications (Withdrawn 2001) |
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