ASTM International - ASTM F2042-00e1

Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and Fabrication

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Organization: ASTM International
Publication Date: 10 July 2000
Status: historical
Page Count: 7
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40
scope:

1.1 This guide is intended to educate potential users of silicone elastomers, gels and foams relative to their fabrication and processing. It does not provide information relative to silicone powders, fluids, pressure sensitive adhesives, or other types of silicone products.

1.2 The information provided is offered to guide users in the selection of appropriate processing conditions for specific medical device applications.

1.3 Formulation and selection of appropriate starting materials is covered in the companion document, F 2038 Part I. This monograph addresses only the curing, post-curing, and processing of elastomers, gels and foams as well as how the resulting product is evaluated.

1.4 Silicone biocompatibility issues can be addressed at several levels, but ultimately the device manufacturer must assess biological suitability relative to intended use. Biocompatibility testing may be done on cured elastomers prior to final fabrication, but the most relevant data are those obtained on the finished device. Data on selected lots of material are only representative when compounding, and fabrication are performed under accepted quality systems such as ISO 9001 and current Good Manufacturing Practice Regulations. Extractables analyses may also be of interest for investigation of biocompatibility, and the procedures for obtaining such data depend on the goal of the study (see F619, the HIMA Memorandum 7/14/93, and USP 23, for examples of extraction methods).

Document History

December 1, 2018
Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II—Crosslinking and Fabrication
1.1 This guide is intended to educate potential users of silicone elastomers, gels and foams relative to their fabrication and processing. It does not provide information relative to silicone...
December 1, 2011
Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II—Crosslinking and Fabrication
1.1 This guide is intended to educate potential users of silicone elastomers, gels and foams relative to their fabrication and processing. It does not provide information relative to silicone...
March 1, 2005
Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and Fabrication
1.1 This guide is intended to educate potential users of silicone elastomers, gels and foams relative to their fabrication and processing. It does not provide information relative to silicone...
July 10, 2000
Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and Fabrication
1.1 This guide is intended to educate potential users of silicone elastomers, gels and foams relative to their fabrication and processing. It does not provide information relative to silicone...
ASTM F2042-00e1
July 10, 2000
Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and Fabrication
1.1 This guide is intended to educate potential users of silicone elastomers, gels and foams relative to their fabrication and processing. It does not provide information relative to silicone...
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