【英文标准名称】:Bindersforpaintsandvarnishes-Alkydresins-Part3:Determinationofunsaponifiablemattercontent(ISO6744-3:1999);GermanversionENISO6744-3:2004
【原文标准名称】:色漆和清漆用粘合剂.醇酸树脂.第3部分:非皂化物含量的测定
【标准号】:DINENISO6744-3-2004
【标准状态】:现行
【国别】:德国
【发布日期】:2004-09
【实施或试行日期】:
【发布单位】:德国标准化学会(DIN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:测定;试验;涂料;定义;不可皂化物质;清漆;粘合剂;含量测定;覆层材料;醇酸树脂
【英文主题词】:Alkydresins;Bindingagents;Coatingmaterials;Definition;Definitions;Determination;Determinationofcontent;Paints;Testing;Tests;Unsaponifiablematter;Varnishes
【摘要】:Thestandardspecifiesamethodfordeterminingtheunsaponifiablemattercontentofalkydresins.
【中国标准分类号】:G50
【国际标准分类号】:87_060_20
【页数】:10P;A4
【正文语种】:德语


【英文标准名称】:StandardPracticeforDirectContactCellCultureEvaluationofMaterialsforMedicalDevices
【原文标准名称】:直接接触细胞培养评估医疗器械材料的标准实施规程
【标准号】:ASTMF813-2007
【标准状态】:现行
【国别】:
【发布日期】:2007
【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】:细胞;评定;材料;医疗设备;医学科学;微生物学
【英文主题词】:biocompatibility;cellculture;cytotoxicitytesting;directcontactcytotoxicity
【摘要】:Thispracticeisusefulforassessingcytotoxicpotentialbothwhenevaluatingnewmaterialsorformulationsforpossibleuseinmedicalapplications,andaspartofaqualitycontrolprogramforestablishedmedicalmaterialsandmedicaldevices.Thispracticeassumesthatassessmentofcytotoxicitypotentialprovidesonemethodforpredictingthepotentialforcytotoxicornecroticreactionstomedicalmaterialsanddevicesduringclinicalapplicationstohumans.Ingeneral,cellculturetestingmethodshaveshowngoodcorrelationwithanimalassaysandarefrequentlymoresensitivetotoxicmoieties.Thiscellculturetestmethodissuitableforadoptioninspecificationsandstandardsformaterialsforuseintheconstructionofmedicaldevicesthatareintendedtobeimplantedinthehumanbodyorplacedincontactwithtissue,tissuefluids,orbloodonalong-termbasis.However,careshouldbetakenwhentestingmaterialsthatareresorbabletobesurethemethodisapplicable.Sincecellsinthisdirectcontacttestmethodarenotprotectedbyanoverlyingagaroselayer,theyaremoresusceptibletopotentialmechanicaldamageimpartedbytheoverlyingtestsample.Investigatorswishingtoevaluatethecytotoxicresponseofcellsunderlyingthetestsampleshouldconsideragarose-basedmethodssimilartoTestMethodF895.Alternatively,dependentonsamplecharacteristics,extractionmethodssuchasPracticeF619mayalsobeconsidered.1.1Thispracticecoversareferencemethodofdirectcontactcellculturetestingwhichmaybeusedinevaluatingthecytotoxicpotentialofmaterialsforuseintheconstructionofmedicalmaterialsanddevices.1.2Thispracticemaybeusedeitherdirectlytoevaluatematerialsorasareferenceagainstwhichothercytotoxicitytestmethodsmaybecompared.1.3Thisisoneofaseriesofreferencetestmethodsfortheassessmentofcytotoxicpotential,employingdifferenttechniques.1.4Assessmentofcytotoxicityisoneofseveraltestsemployedindeterminingthebiologicalresponsetoamaterial,asrecommendedinPracticeF748.1.5TheL-929celllinewaschosenbecauseithasasignificanthistoryofuseinassaysofthistype.Thisisnotintendedtoimplythatitsuseispreferred;onlythattheL-929isawell-characterized,readilyavailable,establishedcelllinethathasdemonstratedreproducibleresultsinseverallaboratories.1.6Sincethetestsampleisnotremovedatthetimeofmicroscopicevaluationandunderlyingcellsmaybeaffectedbythespecificgravityofthetestsample,thispracticeislimitedtoevaluationofcellsoutsidetheperimeteroftheoverlyingtestsample.Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C30
【国际标准分类号】:07_100_10
【页数】:4P.;A4
【正文语种】: