【英文标准名称】:Biologicalevaluationofmedicaldevices-Part7:Ethyleneoxidesterilizationresiduals(ISO10993-7:2008);EnglishversionofDINENISO10993-7:2009-02
【原文标准名称】:医疗装置的生物学评定第7部分:环氧乙烷灭菌残留物
【标准号】:DINENISO10993-7-2009
【标准状态】:现行
【国别】:德国
【发布日期】:2009-02
【实施或试行日期】:
【发布单位】:德国标准化学会(DE-DIN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:生物分析和试验;生物试验;化学残余物;定义;牙科设备;环氧乙烷;评定;气相色谱法;气体的;保健;极限(数学);数学计算;测量;测量技术;医疗器械;医疗设备;医疗产品;医学科学;分析方法;质量保证;质量保证体系;残留物含量;残留物;规范(验收);灭菌技术;灭菌;灭菌气体;外科设备;外科植入物;外科器械;测试;证实
【英文主题词】:Biologicalanalysisandtesting;Biologicaltests;Chemicalresidues;Definition;Definitions;Dentalequipment;Ethyleneoxide;Evaluations;Gaschromatography;Gaseous;Healthprotection;Limits(mathematics);Mathematicalcalculations;Measurement;Measuringtechniques;Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Methodsofanalysis;Qualityassurance;Qualityassurancesystems;Residualcontent;Residue;Residues;Specification(approval);Steriletechnology;Sterilization(hygiene);Sterilizinggases;Surgicalequipment;Surgicalimplants;Surgicalinstruments;Testing;Validation
【摘要】:ThispartofISO10993specifiesallowablelimitsforresidualethyleneoxide(EO)andethylenechlorohydrin(ECH)inindividualEO-sterilizedmedicaldevices,proceduresforthemeasurementofEOandECH,andmethodsfordeterminingcompliancesothatdevicesmaybereleased.Additionalbackground,includingguidanceandaflowchartshowinghowthisdocumentisapplied,arealsoincludedintheinformativeannexes.EO-sterilizeddevicesthathavenopatientcontact(e.g.,invitrodiagnosticdevices)arenotcoveredbythispartofISO10993.NOTEThispartofISO10993doesnotspecifylimitsforethyleneglycol(EG).
【中国标准分类号】:C30
【国际标准分类号】:11_100_20
【页数】:96P.;A4
【正文语种】:英语