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ASTM F 881 : 1994 : R2006

ASTM F 881 : 1994 : R2006

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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

Available format(s)

Hardcopy , PDF

Superseded date

11-11-2014

Superseded by

ASTM F 881 : 1994 : R2014

Language(s)

English

Published date

01-09-2006

Publisher

American Society for Testing and Materials

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Hardcopy - English
PDF - English
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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 2006
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy
Supersedes

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.

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 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.

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ASTM F 604 : 1994 Specification for Silicone Elastomers Used in Medical Applications (Withdrawn 2001)

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