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ASTM F 2042 : 2018
Current
The latest, up-to-date edition.
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Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II—Crosslinking and Fabrication
Hardcopy , PDF
English
01-12-2018
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 1349 : 2014 : R2019 | Standard Practice for Rubber—Standard Conditions for Testing |
ASTM D 1566 : 2005 | Standard Terminology Relating to Rubber |
ASTM D 1566 : 2002 : REV A | Standard Terminology Relating to Rubber |
ASTM D 1566 : 2007 | Standard Terminology Relating to Rubber |
ASTM D 1566 : 2019 | Standard Terminology Relating to Rubber |
ASTM D 2240 : 2004 | Standard Test Method for Rubber Property—Durometer Hardness |
ASTM D 1566 : 2015 | Standard Terminology Relating to Rubber |
ASTM D 1566 : 2008 | Standard Terminology Relating to Rubber |
ASTM D 1566 : 2005 : REV A | Standard Terminology Relating to Rubber |
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 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) |
ASTM D 412 : 2016 : R2021 | Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension |
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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