【英文标准名称】:Biologicalevaluationofmedicaldevices-Ethyleneoxidesterilizationresiduals
【原文标准名称】:医疗器械的生物学评定.环氧乙烷消毒残余物
【标准号】:BSENISO10993-7-1996
【标准状态】:作废
【国别】:英国
【发布日期】:1996-04-15
【实施或试行日期】:1996-04-15
【发布单位】:英国标准学会(GB-BSI)
【起草单位】:BSI
【标准类型】:()
【标准水平】:()
【中文主题词】:气相色谱法;安全措施;温度;生物分析和试验;抽样方法;医疗设备;氧化乙烯;水解萃取法;安全系数;生物危害;溶剂萃取方法;试验条件;精密度;重量;药物量;文献索引;含量测定;公式;灭菌;校正;环氧乙烷;化学危害;无菌设备;标准溶液;萃取分析法;化学分析和试验;合格
【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】:ThispartofISO10993specifiesallowablelimitsforresidualethyleneoxide(EO)andethylenechlorohydrin(ECH)inindividualEO-sterilizedmedicaldevices,proceduresforthemeasurementofEOandECH,andmethodsfordeterminingcompliancesothatdevicesmaybereleased.Additionalbackgroundandguidancealsoisincludedininformativeannexes.EO-sterilizeddevicesthathavenopatientcontact(e.g.invitrodiagnosticdevices)arenotcoveredbythisInternationalStandard.
【中国标准分类号】:C30
【国际标准分类号】:11_100_20
【页数】:50P;A4
【正文语种】:英语


Product Code:SAE AMS7471
Title:Bolts And Screws, Corrosion And Heat Resistant Nickel Alloy Upsetheaded, Heat Treated, Roll Threaded (Cancelled Jul 2002)
Issuing Committee:Ams F Corrosion Heat Resistant Alloys Committee
Scope: