ASTM F2042-18
(Guide)Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II—Crosslinking and Fabrication
Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II—Crosslinking and Fabrication
SIGNIFICANCE AND USE
4.1 This guide is intended to provide guidance for the specification and selection of fabrication methods for silicones used in medical devices. It also provides guidance relative to testing that might be done to qualify lots of acceptable material, based on desired performance properties.
4.2 Silicone manufacturers supplying material 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 fabrication and processing. It does not provide information relative to silicone powders, fluids, pressure sensitive adhesives, or other types of silicone products.
1.2 The information provided is offered to guide users in the selection of appropriate processing conditions for specific medical device applications.
1.3 Formulation 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.
1.4 Silicone 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).
1.5 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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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: F2042 − 18
Standard Guide for
Silicone Elastomers, Gels, and Foams Used in Medical
1
Applications Part II—Crosslinking and Fabrication
This standard is issued under the fixed designation F2042; 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 responsibility of the user of this standard to establish appro-
priate safety, health, and environmental practices and deter-
1.1 This guide is intended to educate potential users of
mine the applicability of regulatory limitations prior to use.
silicone elastomers, gels and foams relative to their fabrication
Users are also advised to refer to Material Safety Data Sheets
and processing. It does not provide information relative to
provided with uncured silicone components.
silicone powders, fluids, pressure sensitive adhesives, or other
1.7 This international standard was developed in accor-
types of silicone products.
dance with internationally recognized principles on standard-
1.2 Theinformationprovidedisofferedtoguideusersinthe
ization established in the Decision on Principles for the
selection of appropriate processing conditions for specific
Development of International Standards, Guides and Recom-
medical device applications.
mendations issued by the World Trade Organization Technical
1.3 Formulation and selection of appropriate starting mate- Barriers to Trade (TBT) Committee.
rials is covered in the companion document, F2038. This
monograph addresses only the curing, post-curing, and pro- 2. Referenced Documents
2
cessing of elastomers, gels and foams as well as how the
2.1 ASTM Standards:
resulting product is evaluated.
D395 Test Methods for Rubber Property—Compression Set
D412 Test Methods forVulcanized Rubber andThermoplas-
1.4 Silicone biocompatibility issues can be addressed at
tic Elastomers—Tension
several levels, but ultimately the device manufacturer must
D430 Test Methods for Rubber Deterioration—Dynamic
assess biological suitability relative to intended use. Biocom-
Fatigue
patibilitytestingmaybedoneoncuredelastomerspriortofinal
D624 Test Method for Tear Strength of Conventional Vul-
fabrication,butthemostrelevantdataarethoseobtainedonthe
canized Rubber and Thermoplastic Elastomers
finished device. Data on selected lots of material are only
representative when compounding and fabrication are per- D792 Test Methods for Density and Specific Gravity (Rela-
tive Density) of Plastics by Displacement
formed under accepted quality systems such as ISO 9001 and
current Good Manufacturing Practice Regulations (21 CFR, D813 TestMethodforRubberDeterioration—CrackGrowth
D814 Test Method for Rubber Property—Vapor Transmis-
Parts 210, 211, and 820). Extractables analyses may also be of
interest for investigation of biocompatibility, and the proce- sion of Volatile Liquids
D926 Test Method for Rubber Property—Plasticity and
dures for obtaining such data depend on the goal of the study
(see ISO 10993–12 and the HIMA Memorandum 7/14/93 for Recovery (Parallel Plate Method)
D955 Test Method of Measuring Shrinkage from Mold
examples of extraction methods).
Dimensions of Thermoplastics
1.5 The values stated in SI units are to be regarded as
D1349 Practice for Rubber—Standard Conditions for Test-
standard. The values given in parentheses are mathematical
ing
conversions to inch-pound units that are provided for informa-
D1566 Terminology Relating to Rubber
tion only and are not considered standard.
D2240 Test Method for Rubber Property—Durometer Hard-
1.6 This standard does not purport to address all of the
ness
safety concerns, if any, associated with its use. It is the
F748 PracticeforSelectingGenericBiologicalTestMethods
for Materials and Devices
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and
Surgical Materials and Devices and is the direct responsibility of Subcommittee
2
F04.11 on Polymeric Materials. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved Dec. 1, 2018. Published February 2019. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approved in 2000. Last previous edition approved in 2011 as F2042 – 00 (2011). Standards volume information, refer to the standard’s Document Summary page on
DOI: 10.1520/F2042-18. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
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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: F2042 − 00 (Reapproved 2011) F2042 − 18
Standard Guide for
Silicone Elastomers, Gels, and Foams Used in Medical
1
Applications Part II—Crosslinking and Fabrication
This standard is issued under the fixed designation F2042; 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 fabrication and
processing. It does not provide information relative to silicone powders, fluids, pressure sensitive adhesives, or other types of
silicone products.
1.2 The information provided is offered to guide users in the selection of appropriate processing conditions for specific medical
device applications.
1.3 Formulation and selection of appropriate starting materials is covered in the companion document, F2038 Part I. . This
monograph addresses only the curing, post-curing, and processing of elastomers, gels and foams as well as how the resulting
product is evaluated.
1.4 Silicone 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,compounding and fabrication are performed under accepted quality systems such as ISO 9001 and current Good
Manufacturing Practice Regulations. 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 F619,
ISO 10993–12 and the HIMA Memorandum 7/14/93, and USP 23, 7/14/93 for examples of extraction methods).
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.
2. Referenced Documents
2
2.1 ASTM Standards:
D395 Test Methods for Rubber Property—Compression Set
D412 Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension
D430 Test Methods for Rubber Deterioration—Dynamic Fatigue
D624 Test Method for Tear Strength of Conventional Vulcanized Rubber and Thermoplastic Elastomers
D792 Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
D813 Test Method for Rubber Deterioration—Crack Growth
D814 Test Method for Rubber Property—Vapor Transmission of Volatile Liquids
1
This guide 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 approved in 2000. Last previous edition approved in 20052011 as
F2042 – 00 (2005).(2011). DOI: 10.1520/F2042-00R11.10.1520/F2042-18.
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.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F2042 − 18
D926 Test Method for Rubber Property—Plasticity and Recovery (Parallel Plate Method)
D95
...
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