ASTM F 881 : 1994 : R2000
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Standard Specification for Silicone Elastomer Facial Implants
Hardcopy , PDF
11-11-2014
English
01-01-2000
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 silicone elastomer implants used in facial surgery (that is, chin, nasal, malar, and ear implants).
| Committee |
F 04
|
| DocumentType |
Standard
|
| Pages |
3
|
| ProductNote |
Reconfirmed 2000
|
| PublisherName |
American Society for Testing and Materials
|
| Status |
Superseded
|
| SupersededBy |
1.1 This specification covers the requirements for silicone elastomer implants used in facial surgery (that is, chin, nasal, malar, and ear implants).
1.2 Limitations--This specification does not cover implants containing silicone gels or other gels or liquids. It does not necessarily cover any custom-fabricated prosthesis manufactured to any other specification.
1.3 The following safety hazards caveat pertains only to the mechanical testing and test methods portion, Section 7, of this specification: This standard does not purport to address all of the safety problems, 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.
| CFR 21(PTS800-1299) : 0 | FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299 |
| ASTM F 748 : 2016 : REDLINE | Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices |
| ASTM F 604 : 1994 | Specification for Silicone Elastomers Used in Medical Applications (Withdrawn 2001) |
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