ASTM F2038-18
(Guide)Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I—Formulations and Uncured Materials
Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I—Formulations and Uncured Materials
SIGNIFICANCE AND USE
4.1 This guide is intended to provide guidance for the specification and selection of silicone materials for medical device applications.
4.2 Silicone manufacturers supplying materials to the medical device industry should readily provide information regarding non-proprietary product formulation to their customers either directly, or through the US FDA master file program.
SCOPE
1.1 This guide is intended to educate potential users of silicone elastomers, gels, and foams relative to their formulation and use. It does not provide information relative to silicone powders, fluids, or other silicones. The information provided is offered to guide users in the selection of appropriate materials, after consideration of the chemical, physical, and toxicological properties of individual ingredients or by-products. This guide offers general information about silicone materials typically used for medical applications. Detail on the crosslinking and fabrication of silicone materials is found in Part II of this guide.
1.2 Fabrication and properties of elastomers is covered in the companion document, F2042. This monograph addresses only components of uncured elastomers, gels, and foams.
1.3 Silicone biocompatibility issues can be addressed at several levels, but ultimately the device manufacturer must assess biological suitability relative to intended use.
1.4 Biological and physical properties tend to be more reproducible when materials are manufactured in accordance with accepted quality standards such as ISO 9001 and current FDA Quality System Regulations/Good Manufacturing Practice Regulations (21CFR, Parts 210, 211, and 820).
1.5 The 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.
1.6 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, 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.
1.7 This 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.
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Standards Content (Sample)
This 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.
Designation: F2038 − 18
Standard Guide for
Silicone Elastomers, Gels, and Foams Used in Medical
1
Applications Part I—Formulations and Uncured Materials
This standard is issued under the fixed designation F2038; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope ization established in the Decision on Principles for the
Development of International Standards, Guides and Recom-
1.1 This guide is intended to educate potential users of
mendations issued by the World Trade Organization Technical
silicone elastomers, gels, and foams relative to their formula-
Barriers to Trade (TBT) Committee.
tionanduse.Itdoesnotprovideinformationrelativetosilicone
powders, fluids, or other silicones.The information provided is
2. Referenced Documents
offered to guide users in the selection of appropriate materials,
2
2.1 ASTM Standards:
after consideration of the chemical, physical, and toxicological
D1566 Terminology Relating to Rubber
properties of individual ingredients or by-products. This guide
F2042 GuideforSiliconeElastomers,Gels,andFoamsUsed
offers general information about silicone materials typically
in Medical Applications Part II—Crosslinking and Fabri-
used for medical applications. Detail on the crosslinking and
cation
fabricationofsiliconematerialsisfoundinPartIIofthisguide.
3
2.2 Sterility Standards:
1.2 Fabrication and properties of elastomers is covered in
ANSI/AAMI ST41 Ethylene oxide sterilization in health
the companion document, F2042. This monograph addresses
care facilities: Safety and effectiveness
only components of uncured elastomers, gels, and foams.
ANSI/AAMI ST50 Dry Heat (Heated Air) Sterilizers
1.3 Silicone biocompatibility issues can be addressed at
ANSI/AAMI ST79 Comprehensive guide to steam steriliza-
several levels, but ultimately the device manufacturer must
tion and sterility assurance in health care facilities
assess biological suitability relative to intended use.
ANSI/AAM1 ST30 Determining Residual Ethylene Chlo-
1.4 Biological and physical properties tend to be more rohydrin and Ethylene Glycol in Medical Devices
reproducible when materials are manufactured in accordance ISO 10993-7 Biological evaluation of medical devices—
with accepted quality standards such as ISO 9001 and current Part 7: Ethylene oxide sterilization residuals
FDA Quality System Regulations/Good Manufacturing Prac-
2.3 Quality Standards:
3
tice Regulations (21CFR, Parts 210, 211, and 820).
ISO 9001 Quality Management Systems—Requirements
4
21 CFR 820 Quality System Regulation
1.5 The values stated in SI units are to be regarded as
21 CFR 210 Current Good Manufacturing Practice in
standard. The values given in parentheses are mathematical
Manufacturing, Processing, Packing or Holding of Drugs;
conversions to inch-pound units that are provided for informa-
4
General
tion only and are not considered standard.
21 CFR 211 Current Good Manufacturing Practice for Fin-
1.6 This standard does not purport to address all of the
4
ished Pharmaceuticals
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
3. Terminology
priate safety, health, and environmental practices and deter-
3.1 Additional pertinent definitions can be found in Termi-
mine the applicability of regulatory limitations prior to use.
nology D1566.
Users are also advised to refer to Material Safety Data Sheets
provided with uncured silicone components.
1.7 This international standard was developed in accor-
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
dance with internationally recognized principles on standard-
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
1
This specification is under the jurisdiction of ASTM Committee F04 on the ASTM website.
3
Medical and Surgical Materials and Devices and is the direct responsibility of Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
Subcommittee F04.11 on Polymeric Materials. 4th Floor, New York, NY 10036, http://www.ansi.org.
4
Current edition approved Dec. 1, 2018. Published February 2019. Originally AvailablefromU.S.GovernmentPrintingOfficeSuperintendentofDocuments,
published in 2000. Last previous edition approved in 2011 as F2038 – 00 (2011). 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http://
DOI: 10.15
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F2038 − 00 (Reapproved 2011) F2038 − 18
Standard Guide for
Silicone Elastomers, Gels, and Foams Used in Medical
1
Applications Part I—Formulations and Uncured Materials
This standard is issued under the fixed designation F2038; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope
1.1 This guide is intended to educate potential users of silicone elastomers, gels, and foams relative to their formulation and use.
It does not provide information relative to silicone powders, fluids, andor other silicones. The information provided is offered to
guide users in the selection of appropriate materials, after consideration of the chemical, physical, and toxicological properties of
individual ingredients or by-products. This guide offers general information about silicone materials typically used for medical
applications. Detail on the crosslinking and fabrication of silicone materials is found in Part II of this guide.
1.2 Fabrication and properties of elastomers is covered in the companion document, F604F2042, Part II. . This monograph
addresses only components of uncured elastomers, gels, and foams.
1.3 Silicone biocompatibility issues can be addressed at several levels, but ultimately the device manufacturer must assess
biological suitability relative to intended use.
1.4 Biological and physical properties tend to be more reproducible when materials are manufactured in accordance with
accepted quality standards such as ANSI ISO 9001 and current FDA Quality System Regulations/Good Manufacturing Practice
Regulations.Regulations (21CFR, Parts 210, 211, and 820).
1.5 The values stated in inch-poundSI units are to be regarded as standard. The values given in parentheses are mathematical
conversions to SIinch-pound units that are provided for information only and are not considered standard.
1.6 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 safety, health, and healthenvironmental 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.
1.7 This 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.
2. Referenced Documents
2
2.1 ASTM Standards:
D1566 Terminology Relating to Rubber
F813F2042 Practice for Direct Contact Cell Culture Evaluation of Materials for Medical DevicesGuide for Silicone Elastomers,
Gels, and Foams Used in Medical Applications Part II—Crosslinking and Fabrication
3
2.2 Sterility Standards:
ANSI/AAMI ST41 Good Hospital Practice: Ethylene Oxide Sterilization and Sterility AssuranceEthylene oxide sterilization in
health care facilities: Safety and effectiveness
ANSI/AAMI ST50 Dry Heat (Heated Air) Sterilizers
ANSI/AAMI ST29ST79 Recommended Practice for Determining Ethylene Oxide in Medical DevicesComprehensive guide to
steam sterilization and sterility assurance in health care facilities
1
This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.11 on Polymeric Materials.
Current edition approved Dec. 1, 2011Dec. 1, 2018. Published January 2012February 2019. Originally published in 2000. Last previous edition approved in 20052011 as
F2038 – 00 (2005).(2011). DOI: 10.1520/F2038-00R11.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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F2038 − 18
ANSI/AAM1 ST30 Determining Residual Ethy
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