【英文标准名称】:BiologicalEvaluationofMedicalDevices-Part7:EthyleneOxideSterilizationResiduals
【原文标准名称】:医疗器械的生物评价.第7部分:环氧乙烷残留物
【标准号】:ANSI/AAMI/ISO10993-7-1995
【标准状态】:作废
【国别】:美国
【发布日期】:1995
【实施或试行日期】:
【发布单位】:美国国家标准学会(US-ANSI)
【起草单位】:ANSI
【标准类型】:()
【标准水平】:()
【中文主题词】:医疗技术学;灭菌;卫生学
【英文主题词】:Biologicalanalysisandtesting;Biologicaltests;Chemicalresidues;Definition;Definitions;Dentalequipment;Ethyleneoxide;Evaluations;Gaschromatography;Gaseous;Healthprotection;Limits(mathematics);Measurement;Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Methodsofanalysis;Qualityassurance;Qualityassurancesystems;Residualcontent;Residue;Residues;Specification(approval);Steriletechnology;Sterilization(hygiene);Sterilizinggases;Surgicalequipment;Surgicalimplants;Surgicalinstruments;Testing;Validation
【摘要】:Specifiesallowablelimitsforresidualethyleneoxide(EO)andethylenechlorohydrin(ECH)inindividualEO-sterilizedmedicaldevices,proceduresforthemeasurementofEOandECH,andmethodsfordeterminingcompliancesothatdevicesmayberealeased.
【中国标准分类号】:C30
【国际标准分类号】:11_100_20
【页数】:40P.;A4
【正文语种】:英语