ASTM F2038-00(2005)
(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.
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, and 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 standard 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 standard.
1.2 Fabrication and properties of elastomers is covered in the companion document, F604, 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 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 and health 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.
1.5 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.
General Information
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Standards Content (Sample)
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Designation:F2038–00 (Reapproved 2005)
Standard Guide for
Silicone Elastomers, Gels, and Foams Used in Medical
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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 2. Referenced Documents
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1.1 This guide is intended to educate potential users of 2.1 ASTM Standards:
silicone elastomers, gels, and foams relative to their formula- D1566 Terminology Relating to Rubber
tionanduse.Itdoesnotprovideinformationrelativetosilicone F813 Practice for Direct Contact Cell Culture Evaluation of
powders, fluids, and other silicones. The information provided Materials for Medical Devices
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is offered to guide users in the selection of appropriate 2.2 Sterility Standards:
materials, after consideration of the chemical, physical, and ANSI/AAMIST41 GoodHospitalPractice:EthyleneOxide
toxicological properties of individual ingredients or by- Sterilization and Sterility Assurance
products. This guide offers general information about silicone ANSI/AAMI ST50 Dry Heat (Heated Air) Sterilizers
materials typically used for medical applications. Detail on the ANSI/AAMI ST29 Recommended Practice for Determin-
crosslinking and fabrication of silicone materials is found in ing Ethylene Oxide in Medical Devices
Part II of this guide. ANSI/AAM1 ST30 Determining Residual Ethylene Chlo-
1.2 Fabrication and properties of elastomers is covered in rohydrin and Ethylene Glycol in Medical Devices
the companion document, F604, Part II. This monograph AAMI 13409-251 Sterilization of Health Care Products—
addresses only components of uncured elastomers, gels, and Radiation Sterilization—Substantiation of 25kGy as a
foams. Sterilization Dose for Small or Infrequent Production
1.3 Silicone biocompatibility issues can be addressed at Batches
several levels, but ultimately the device manufacturer must AAMI TIRS-251 Microbiological Methods for Gamma Ir-
assess biological suitability relative to intended use. radiation Sterilization of Medical Devices
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1.4 Biological and physical properties tend to be more 2.3 Quality Standards :
reproducible when materials are manufactured in accordance ANSI/ASQC Q9001 Quality Systems—Model for Quality
with accepted quality standards such as ANSI ISO 9001 and Assurance in Design, Development Production, Installa-
current FDAQuality System Regulations/Good Manufacturing tion, and Servicing
Practice Regulations. 21 CFR 820 Quality System Regulation (current revision)
1.5 This standard does not purport to address all of the 21 CFR 210 Current Good Manufacturing Practice in
safety concerns, if any, associated with its use. It is the Manufacturing, Processing, Packing or Holding of Drugs;
responsibility of the user of this standard to establish appro- General (current revision)
priate safety and health practices and determine the applica- 21 CFR 211 Current Good Manufacturing Practice for
bility of regulatory limitations prior to use. Users are also Finished Pharmaceuticals (current revision)
advised to refer to Material Safety Data Sheets provided with
3. Terminology
uncured silicone components.
3.1 Additional pertinent definitions can be found in Termi-
nology D1566.
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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
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This specification is under the jurisdiction of ASTM Committee F04 on Standards volume information, refer to the standard’s Document Summary page on
Medical and Surgical Materials and Devices and is the direct responsibility of the ASTM website.
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Subcommittee F04.11 on Polymeric Materials. Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
Current edition approved Mar. 1, 2005. Published March 2005. Originally 4th Floor, New York, NY 10036.
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published in 2000. Last previous edition approved in 2000 as F2038 – 00 . DOI: AvailablefromU.S.GovernmentPrintingOfficeSuperintendentofDocuments,
10.1520/F2038-00R05. 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
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F2038–00 (2005)
3.2 Definitions: such as a two-roll mill and parts are typically fabricated using
compression or transfer molding techniques.
3.2.1 silicone polymer—polymer chains having a backbone
3.2.10.2 low consistency rubbers or liquid silicone rubbers
consisting of repeating silicon-oxygen atoms where each
silicon atom
...
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