ASTM F 881 : 1994 : 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 Silicone Elastomer Facial Implants
Hardcopy , PDF
14-10-2022
English
27-11-2014
Important note : All end users must be registered with an Account prior to user licenses being assigned.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 2014
|
| PublisherName |
American Society for Testing and Materials
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
1.1This specification covers the requirements for silicone elastomer implants used in facial surgery (that is, chin, nasal, malar, and ear implants).
1.2Limitations—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.
1.3The 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 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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| CFR 21(PTS800-1299) : 0 | FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299 |
| ASTM D 412 : 2016 : EDT 1 | Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension |
| ASTM D 2240 : 2004 : EDT 1 | Standard Test Method for Rubber Property—Durometer Hardness |
| ASTM D 412 : 2016 | Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension |
| ASTM D 2240 : 2015 : R2021 | Standard Test Method for Rubber Property—Durometer Hardness |
| ASTM D 2240 : 2002 | Standard Test Method for Rubber Property—Durometer Hardness |
| ASTM F 748 : 2016 : REDLINE | Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices |
| ASTM D 2240 : 2015 | Standard Test Method for Rubber Property—Durometer Hardness |
| ASTM D 2240 : 2003 | Standard Test Method for Rubber Property—Durometer Hardness |
| ASTM D 2240 : 2002 : REV B | Standard Test Method for Rubber Property—Durometer Hardness |
| ASTM D 2240 : 2015 : EDT 1 | Standard Test Method for Rubber Property—Durometer Hardness |
| ASTM D 412 : 2016 : R2021 | Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension |
| ASTM D 2240 : 2005 | Standard Test Method for Rubber Property—Durometer Hardness |
| ASTM D 2240 : 2005 : R2010 | Standard Test Method for Rubber Property—Durometer Hardness |
| ASTM F 604 : 1994 | Specification for Silicone Elastomers Used in Medical Applications (Withdrawn 2001) |
| ASTM D 2240 : 2002 : REV A | Standard Test Method for Rubber Property—Durometer Hardness |
| ASTM F 1251 : 1989 : R2003 | Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices (Withdrawn 2012) |
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