【英文标准名称】:StandardTestMethodforExtractingResiduefromMetallicMedicalComponentsandQuantifyingviaGravimetricAnalysis
【原文标准名称】:从金属医疗部件提取残余物并经由化学分离测重法确定数量的标准试验方法
【标准号】:ASTMF2459-2005
【标准状态】:现行
【国别】:
【发布日期】:2005
【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】:F04.15
【标准类型】:(TestMethod)
【标准水平】:()
【中文主题词】:
【英文主题词】:extractableresidue;gravimetricanalysis;metallicmedicalcomponents;non-solubleextractables;non-solubledebris;watersolubleextractables
【摘要】:Thistestmethodissuitablefordeterminationoftheextractableresidueinmetallicmedicalcomponents.Extractableresidueincludesaqueousandnon-aqueousresidue,aswellasnon-solubleresidue.Thistestmethodrecommendstheuseofasonicationtechniquetoextractresiduefromthemedicalcomponent.Othertechniques,suchassolventrefluxextraction,couldbeusedbuthavebeenshowntobelessefficientinsometests,asdiscussedinX1.2.Thistestmethodisnotapplicableforevaluatingtheextractableresidueforthereuseofasingle-usecomponent(SUD).1.1Thistestmethodcoversthequantitativeassessmentoftheamountofresidueobtainedfrommetallicmedicalcomponentswhenextractedwithaqueousororganicsolvents.1.2Thistestmethoddoesnotadvocateanacceptablelevelofcleanliness.Itidentifiesonetechniquetoquantifyextractableresidueonmetallicmedicalcomponents.Inaddition,itisrecognizedthatthistestmethodmaynotbetheonlymethodtodetermineandquantifyextractables.1.3Althoughthesemethodsmaygivetheinvestigatorameanstocomparetherelativelevelsofcomponentcleanliness,itisrecognizedthatsomeformsofcomponentresiduemaynotbeaccountedforbythesemethods.1.4Theapplicabilityofthesegeneralgravimetricmethodshavebeendemonstratedbymanyliteraturereports;however,thespecificsuitabilityforapplicationstoall-metalmedicalcomponentswillbevalidatedbyanInterlaboratoryStudy(ILS)conductedaccordingtoPracticeE691.1.5Thistestmethodisnotintendedtoevaluatetheresiduelevelinmedicalcomponentsthathavebeencleanedforreuse.Thistestmethodisalsonotintendedtoextractresidueforuseinbiocompatibilitytesting.1.6ThevaluesstatedinSIunitsaretoberegardedasthestandard.Thevaluesgiveninparenthesesareforinformationonly.1.7Thisstandardmayinvolvehazardousorenvironmentally-restrictedmaterials,operations,andequipment.Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C30
【国际标准分类号】:11_100_99
【页数】:6P.;A4
【正文语种】: