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ASTM F 2042 : 2018

Current

Current

The latest, up-to-date edition.

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

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-12-2018

€56.53
Excluding VAT

This guide is intended to educate potential users of silicone elastomers, gels and foams relative to their fabrication and processing.

Committee
F 04
DocumentType
Guide
Pages
7
ProductNote
THIS STANDARD ALSO REFERS TO ANSI/AAMI ST79,21 CFR 820,21 CFR 210,21 CFR 211,CTM 0155,CTM 0813
PublisherName
American Society for Testing and Materials
Status
Current
Supersedes

1.1This 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.

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

1.3Formulation and selection of appropriate starting materials is covered in the companion document, F2038. This monograph addresses only the curing, post-curing, and processing of elastomers, gels and foams as well as how the resulting product is evaluated.

1.4Silicone 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 (21 CFR, Parts 210, 211, and 820). 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 ISO 10993–12 and the HIMA Memorandum 7/14/93 for examples of extraction methods).

1.5The values stated in SI units are to be regarded as standard. The values given in parentheses are mathematical conversions to inch-pound units that are provided for information only and are not considered standard.

1.6This 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. Users are also advised to refer to Material Safety Data Sheets provided with uncured silicone components.

1.7This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

ASTM F 2038 : 2018 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I—Formulations and Uncured Materials
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ASTM D 1566 : 2019 Standard Terminology Relating to Rubber
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ASTM D 1566 : 2008 Standard Terminology Relating to Rubber
ASTM D 1566 : 2005 : REV A Standard Terminology Relating to Rubber
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ASTM D 2240 : 2004 : EDT 1 Standard Test Method for Rubber Property—Durometer Hardness
ASTM D 1566 : 2006 : REV A Standard Terminology Relating to Rubber
ASTM D 1566 : 2003 : REV A Standard Terminology Relating to Rubber
ASTM D 1566 : 2006 : REV B Standard Terminology Relating to Rubber
ASTM D 412 : 2016 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension
ASTM D 1566 : 2005 : REV B Standard Terminology Relating to Rubber
ASTM D 1349 : 1999 Standard Practice for Rubber-Standard Temperatures For Testing
ASTM D 1566 : 2011 Standard Terminology Relating to Rubber
ASTM D 2240 : 2015 : R2021 Standard Test Method for Rubber Property—Durometer Hardness
ASTM D 1566 : 2021 Standard Terminology Relating to Rubber
ASTM D 1566 : 2000 : REV B Standard Terminology Relating to Rubber
ASTM D 2240 : 2002 Standard Test Method for Rubber Property—Durometer Hardness
ASTM D 1349 : 2009 Standard Practice for Rubber-Standard Temperatures for Testing
ASTM D 1349 : 2014 Standard Practice for Rubber—Standard Conditions for Testing
ASTM D 1566 : 2014 Standard Terminology Relating to Rubber
ASTM D 926 : 2017 Standard Test Method for Rubber Property—Plasticity and Recovery (Parallel Plate Method)
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 926 : 1998 Standard Test Method for Rubber Property-Plasticity and Recovery (Parallel Plate Method)
ASTM D 1566 : 2010 Standard Terminology Relating to Rubber
ASTM D 2240 : 2002 : REV B Standard Test Method for Rubber Property—Durometer Hardness
ASTM D 955 : 2021 Standard Test Method of Measuring Shrinkage from Mold Dimensions of Thermoplastics
ASTM F 2038 : 2000 : R2005 Standard Guide for Silicone Elastomers, Gels and Foams Used in Medical Applications Part I - Formulations and Uncured Materials
ASTM D 2240 : 2015 : EDT 1 Standard Test Method for Rubber Property—Durometer Hardness
ASTM D 1566 : 2003 Standard Terminology Relating to Rubber
ASTM D 926 : 2017 : R2022 Standard Test Method for Rubber Property—Plasticity and Recovery (Parallel Plate Method)
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ASTM D 1349 : 2007 Standard Practice for Rubber-Standard Temperatures for Testing
ASTM D 1566 : 2000 Standard Terminology Relating to Rubber
ASTM F 2038 : 2018 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I—Formulations and Uncured Materials
ASTM D 2240 : 2005 Standard Test Method for Rubber Property—Durometer Hardness
ASTM F 2038 : 2000 Standard Guide for Silicone Elastomers, Gels and Foams Used in Medical Applications Part I - Formulations and Uncured Materials
ASTM D 2240 : 2005 : R2010 Standard Test Method for Rubber Property—Durometer Hardness
ASTM D 1566 : 2020 Standard Terminology Relating to Rubber
ASTM D 1566 : 2007 : REV A Standard Terminology Relating to Rubber
ASTM D 1566 : 2005 : REV C Standard Terminology Relating to Rubber
ASTM D 2240 : 2002 : REV A Standard Test Method for Rubber Property—Durometer Hardness
ASTM F 2038 : 2000 : R2011 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I—Formulations and Uncured Materials
ASTM D 1566 : 2010 : EDT 1 Standard Terminology Relating to Rubber
ASTM F 2038 : 2000 : EDT 1 Standard Guide for Silicone Elastomers, Gels and Foams Used in Medical Applications Part I - Formulations and Uncured Materials
ASTM D 1566 : 2008 : REV B Standard Terminology Relating to Rubber

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