【英文标准名称】:StandardPracticeforExtractionofMedicalPlastics
【原文标准名称】:医用塑料制品萃取的标准实施规程
【标准号】:ASTMF619-2003(2008)
【标准状态】:现行
【国别】:美国
【发布日期】:2003
【实施或试行日期】:
【发布单位】:美国材料与试验协会(US-ASTM)
【起草单位】:F04.16
【标准类型】:(Practice)
【标准水平】:()
【中文主题词】:
【英文主题词】:biocompatibility;extraction;liquids;plastics;specimensize;Biocompatibility;Extractionmethods;Materialextracts(inbiomedicalmaterials);Plasticsurgicaldevices/applications
【摘要】:Theseextractionproceduresaretheinitialpartofseveraltestproceduresusedinthebiocompatibilityscreeningofplasticsusedinmedicaldevices.Thelimitationsoftheresultsobtainedfromthispracticeshouldberecognized.Thechoiceofextractionvehicle,durationofimmersion,andtemperatureofthetestisnecessarilyarbitrary.Thespecificationoftheseconditionsprovidesabasisforstandardizationandservesasaguidetoinvestigatorswishingtocomparetherelativeresistanceofvariousplasticstoextractionvehicles.Correlationoftestresultswiththeactualperformanceorserviceabilityofmaterialsisnecessarilydependentuponthesimilaritybetweenthetestingandend-useconditions(see12.1.2andNote4).Cautionshouldbeexercisedintheunderstandingandintentofthispracticeasfollows:Noallowanceordistinctionismadeforvariablessuchasend-useapplicationanddurationofuse.DecisionsonselectionofteststobedoneshouldbemadebasedonPracticeF748.Thispracticewasoriginallydesignedforusewithnonporous,solidmaterials.Itsapplicationforothermaterials,suchasthosethatareporous,orabsorptive,orresorptive,shouldbeconsideredwithcaution.Considerationshouldbegiventoalteringthespecifiedmaterialtoliquidratiotoallowadditionalliquidtofullyhydratethematerialandadditionalliquidorothermethodstofullysubmergethetestarticle.Additionalproceduresthatfullyremovetheextractliquidfromthetestarticle,suchaspressureorphysicallysqueezingthematerial,shouldalsobeconsideredasappropriate.Althoughnodefinitionsaregiveninthispracticeforthefollowingterms,suchitemsasextractionvehiclesurfacetensionatthespecifiedextractionconditionandplasticspecimenphysicalstructureshouldbetakenintoaccount.TestMethodsD543,D570,andD1239maybeusefulinprovidingsupplementalinformation.1.1Thispracticecoversmethodsofextractionofmedicalplasticsandmaybeapplicabletoothermaterials.Thispracticeidentifiesamethodforobtainingx201C;extractliquidx201D;foruseindeterminingthebiologicalresponseinpreclinicaltesting.Furthertestingofthex201C;extractliquidx201D;isspecifiedinotherASTMstandards.Theextractmayundergochemicalanalysisaspartofthepreclinicalevaluationofthebiologicalresponse,andthematerialafterextractionmayalsobeexamined.1.2Thispracticemaybeusedfor,butisnotlimitedtothefollowingareas:partialevaluationofrawmaterials,auditingmaterialswithinthemanufacturingprocess,andtestingfinalproducts.Thispracticemayalsobeusedasarefereemethodforthemeasurementofextractablesinplasticsusedinmedicaldevices.1.3Thevaluesstatedininch-poundunitsaretoberegardedasstandard.ThevaluesgiveninparenthesesaremathematicalconversionstoSIunitsthatareprovidedforinformationonlyandarenotconsideredstandard.1.4Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:G33
【国际标准分类号】:83_080_01
【页数】:4P.;A4
【正文语种】:英语


【英文标准名称】:Industrialautomationsystemsandintegration-Productdatarepresentationandexchange-Part1061:Applicationmodule:Project
【原文标准名称】:工业自动化系统和集成.产品数据表示和交换.第1061部分:应用模块:项目
【标准号】:ISO/TS10303-1061-2006
【标准状态】:现行
【国别】:国际
【发布日期】:2006-12
【实施或试行日期】:
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:ISO/TC184
【标准类型】:()
【标准水平】:()
【中文主题词】:使用;自动化;自动化系统;计算机应用;数据交换;数据表示;工业产品;信息交流;信息交换;规划程序;产品数据;设计;项目;项目管理;表示法
【英文主题词】:Applications;Automation;Automationsystems;Computerapplications;Dataexchange;Datarepresentation;Industrialproducts;Informationexchange;Informationinterchange;Procedureofprojects;Productdata;Project;Projectmanagement;Representations
【摘要】:ISO/TS10303-1061:2006specifiestheapplicationmoduleforProject.ThefollowingarewithinthescopeofISO/TS10303-1061:2006:definitionofaproject,ofitsresponsibleorganizationandofitsplannedandactualexecutiondates;associationofaprojecttoactivityandproductdata;relationshipbetweentwoprojects.
【中国标准分类号】:N18
【国际标准分类号】:35_240_50
【页数】:12P.;A4
【正文语种】:英语