1、Designation:F203800(Reapproved 2011)Standard Guide forSilicone Elastomers,Gels,and Foams Used in MedicalApplications Part IFormulations and Uncured Materials1This standard is issued under the fixed designation F2038;the number immediately following the designation indicates the year oforiginal adopt
2、ion or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This guide is intended to educate potential users ofsilicone elastomers,gels,and
3、 foams relative to their formula-tion and use.It does not provide information relative to siliconepowders,fluids,and other silicones.The information providedis offered to guide users in the selection of appropriatematerials,after consideration of the chemical,physical,andtoxicological properties of
4、individual ingredients or by-products.This guide offers general information about siliconematerials typically used for medical applications.Detail on thecrosslinking and fabrication of silicone materials is found inPart II of this guide.1.2 Fabrication and properties of elastomers is covered inthe c
5、ompanion document,F604,Part II.This monographaddresses only components of uncured elastomers,gels,andfoams.1.3 Silicone biocompatibility issues can be addressed atseveral levels,but ultimately the device manufacturer mustassess biological suitability relative to intended use.1.4 Biological and physi
6、cal properties tend to be morereproducible when materials are manufactured in accordancewith accepted quality standards such as ANSI ISO 9001 andcurrent FDAQuality System Regulations/Good ManufacturingPractice Regulations.1.5 The values stated in inch-pound units are to be regardedas standard.The va
7、lues given in parentheses are mathematicalconversions to SI units that are provided for information onlyand are not considered standard.1.6 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to estab
8、lish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.Users are alsoadvised to refer to Material Safety Data Sheets provided withuncured silicone components.2.Referenced Documents2.1 ASTM Standards:2D1566 Terminology Relating to RubberF
9、813 Practice for Direct Contact Cell Culture Evaluation ofMaterials for Medical Devices2.2 Sterility Standards:3ANSI/AAMI ST41 Good Hospital Practice:Ethylene OxideSterilization and Sterility AssuranceANSI/AAMI ST50 Dry Heat(Heated Air)SterilizersANSI/AAMI ST29 Recommended Practice for DeterminingEt
10、hylene Oxide in Medical DevicesANSI/AAM1 ST30 Determining Residual Ethylene Chlo-rohydrin and Ethylene Glycol in Medical DevicesAAMI 13409-251 Sterilization of Health Care ProductsRadiation SterilizationSubstantiation of 25kGy as aSterilization Dose for Small or Infrequent ProductionBatchesAAMI TIRS
11、-251 Microbiological Methods for Gamma Irra-diation Sterilization of Medical Devices2.3 Quality Standards4:ANSI/ASQC Q9001 Quality SystemsModel for QualityAssuranceinDesign,DevelopmentProduction,Installation,and Servicing21 CFR 820 Quality System Regulation(current revision)21 CFR 210 Current Good M
12、anufacturing Practice inManufacturing,Processing,Packing or Holding of Drugs;General(current revision)21 CFR 211 Current Good Manufacturing Practice for Fin-ished Pharmaceuticals(current revision)3.Terminology3.1 Additional pertinent definitions can be found in Termi-nology D1566.1This specification
13、 is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.11 on Polymeric Materials.Current edition approved Dec.1,2011.Published January 2012.Originallypublished in 2000.Last previous edition approved in 2005 as
14、 F2038 00(2005).DOI:10.1520/F2038-00R11.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.3Available from American N
15、ational Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036,http:/www.ansi.org.4Available from U.S.Government Printing Office Superintendent of Documents,732 N.Capitol St.,NW,Mail Stop:SDE,Washington,DC 20401,http:/www.access.gpo.gov.Copyright ASTM International,100 Barr Harbor Drive
16、,PO Box C700,West Conshohocken,PA 19428-2959.United States1 3.2 Definitions:3.2.1 silicone polymerpolymer chains having a backboneconsisting of repeating silicon-oxygen atoms where eachsilicon atom bears two organic groups.The organic groups aretypically methyl,but can be vinyl,phenyl,fluorine,or otherorganic groups.3.2.2 cyclics and linearslow molecular weight volatilecyclic siloxane species are referred to using the“D”nomen-clature which designates the number of Si-O linkages in thematerial(us