ASTM F2038-00e1

Standard Guide for Silicone Elastomers, Gels and Foams Used in Medical Applications Part I - Formulations and Uncured Materials

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

• Status: Historical
• Publication Date: 09-Jun-2000
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.11 - Polymeric Materials

Relations

• Replaces: ASTM F2038-00 - Standard Guide for Silicone Elastomers, Gels and Foams Used in Medical Applications Part I - Formulations and Uncured Materials
• Effective Date: 10-Jun-2000
• Replaced By: ASTM F2038-00(2005) - Standard Guide for Silicone Elastomers, Gels and Foams Used in Medical Applications Part I - Formulations and Uncured Materials
• Effective Date: 01-Mar-2005
• Referred By: ASTM F703-18(2022) - Standard Specification for Implantable Breast Prostheses
• Effective Date: 10-Jun-2000
• Referred By: ASTM F2042-18 - Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II—Crosslinking and Fabrication
• Effective Date: 10-Jun-2000
• Referred By: ASTM F1781-21 - Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants
• Effective Date: 10-Jun-2000
• Referred By: ASTM F1441-03(2022) - Standard Specification for Soft-Tissue Expander Devices
• Effective Date: 10-Jun-2000

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
e1
Designation:F2038–00
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 F 2038; 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 (e) indicates an editorial change since the last revision or reapproval.
1
e NOTE—Fig. 2 was editorially revised in June 2001.
1. Scope F 813 Standard Practice for Direct Contact Cell Culture
3
Evaluation of Materials for Medical Devices
1.1 This guide is intended to educate potential users of
4
2.2 Sterility Standards:
silicone elastomers, gels and foams relative to their formula-
ANSI/AAMI ST41 Good Hospital Practice: Ethylene Oxide
tionanduse.Itdoesnotprovideinformationrelativetosilicone
Sterilization and Sterility Assurance
powders, fluids, and other silicones. The information provided
ANSI/AAMI ST50 Dry Heat (Heated Air) Sterilizers
is offered to guide users in the selection of appropriate
ANSI/AAMI ST29 Recommended Practice for Determin-
materials, after consideration of the chemical, physical and
ing Ethylene Oxide in Medical Devices
toxicological properties of individual ingredients or by-
ANSI/AAM1 ST30 Determining Residual Ethylene Chlo-
products. This standard offers general information about sili-
rohydrin and Ethylene Glycol in Medical Devices
cone materials typically used for medical applications. Detail
AAMI 13409-251 Sterilization of Health Care Products—
on the crosslinking and fabrication of silicone materials is
Radiation Sterilization—Substantiation of 25kGy as a
found in Part II of this standard.
Sterilization Dose for Small or Infrequent Production
1.2 Fabrication and properties of elastomers is covered in
Batches
the companion document, F 604, Part II. This monograph
AAMI TIRS-251 Microbiological Methods for Gamma Ir-
addresses only components of uncured elastomers, gels and
radiation Sterilization of Medical Devices
foams.
5
2.3 Quality Standards :
1.3 Silicone biocompatibility issues can be addressed at
ANSI/ASQC Q9001 Quality Systems—Model for Quality
several levels, but ultimately the device manufacturer must
Assurance in Design, Development Production, Installa-
assess biological suitability relative to intended use.
tion, and Servicing
1.4 This standard does not purport to address all of the
21 CFR 820 Quality System Regulation (current revision)
safety concerns, if any, associated with its use. It is the
21 CFR 210 Current Good Manufacturing Practice in
responsibility of the user of this standard to establish appro-
Manufacturing, Processing, Packing or Holding of Drugs;
priate safety and health practices and determine the applica-
General (current revision)
bility of regulatory limitations prior to use. Users are also
21 CFR 211 Current Good Manufacturing Practice for
advised to refer to Material Safety Data Sheets provided with
Finished Pharmaceuticals (current revision)
uncured silicone components.
1.5 Biological and physical properties tend to be more
3. Terminology
reproducible when materials are manufactured in accordance
3.1 Additionalpertinentdefinitionscanbefoundinstandard
with accepted quality standards such as ANSI ISO 9001 and
D 1566.
current FDAQuality System Regulations/Good Manufacturing
3.2 Definitions:
Practice Regulations.
3.2.1 silicone polymer—polymer chains having a backbone
2. Referenced Documents consisting of repeating silicon-oxygen atoms where each
silicon atom bears two organic groups. The organic groups are
2.1 ASTM Standards:
2
typically methyl, but can be vinyl, phenyl, fluorine, or other
D 1566 Standard Terminology Relating to Rubber
organic groups.
1 3
This specification is under the jurisdiction of ASTM Committee F04 on Annual Book of ASTM Standards, Vol. 13.01
4
Medical and Surgical Materials and Devicesand is the direct responsibility of Available from the American National Standards Institute, 11 West 42nd St.,
Subcommittee F04.11on Polymeric Materials. 13th Floor, New York NY 10036.
5
Current edition approved June 10, 2000. Published September 2000. Available from the Superintendent of Documents, U.S. government Printing
2
Annual Book of ASTM Standards, Vol. 09.01 Office, Washington, DC 20402.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
F2038
3.2.2 cyclics and linears—low molecular weight volatile 3.2.10.3 RTVs (room temperature vulcanization)— are one-
cyclic siloxane species are referred to using the “D” nomen- part elastomers which cure in the presence of atmospheric
clature which designates the number of Si-O linkages
...