ASTM F881-94(2000)

Standard Specification for Silicone Elastomer Facial Implants

STANDARD published on 1.1.2000

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The information about the standard:

Designation standards: ASTM F881-94(2000)
Note: WITHDRAWN
Publication date standards: 1.1.2000
SKU: NS-56802
The number of pages: 3
Approximate weight : 9 g (0.02 lbs)
Country: American technical standard
Category: Technical standards ASTM

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Annotation of standard text ASTM F881-94(2000) :

Keywords:

facial implants, oral/maxillofacial surgery, silicone surgical implant materials, silicone gel/silicone solid (non-porous) facial implants, ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

Additional information

1. Scope

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.

2. Referenced Documents

D624-00(2020)	Standard Test Method for Tear Strength of Conventional Vulcanized Rubber and Thermoplastic Elastomers
D412-16(2021)	Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension
Federal Register,	Title 21, Part 820 Available from Standardization Documents Order Desk, Bldg. 4 Section D, 700 Robbins Ave., Philadelphia, PA 19111-5094, Attn: NPODS.
United States Pharmacopeia,	Volume XX Available from Mack Publishing Co., 1991 N Hampton St. Easton, PA. 18042.
F1251-89(1995)	Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices
F981-23	Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices
F604-94	Specification for Silicone Elastomers Used in Medical Applications (Withdrawn 2001)
D2240-15(2021)	Standard Test Method for Rubber Property—Durometer Hardness
Dow Corning Corporate	Test Method--CTM 0930--Adhesion--OneHundred Eighty Degree Shear--Thin Elastometric Substrates Available from Dow Corning Corp., P.O. Box 994, Midland, MI 48686-0994.
F748-16	Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices

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