BS EN ISO 14161-2001 医疗保健产品灭菌.生物指示物.选择、使用和检验结果解释指南

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【英文标准名称】:Sterilizationofhealthcareproducts-Biologicalindicators-Guidancefortheselection,useandinterpretationofresults
【原文标准名称】:医疗保健产品灭菌.生物指示物.选择、使用和检验结果解释指南
【标准号】:BSENISO14161-2001
【标准状态】:作废
【国别】:英国
【发布日期】:2001-02-15
【实施或试行日期】:2001-02-15
【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】:生物测定;使用说明;无菌设备;医疗器械;生物分析和试验;灭菌器;分析;医疗设备;选择;灭菌
【英文主题词】:Bio-indicators;Definitions;Guidebooks;Healthprotection;Indicators;Interpretationkey;Interpretations;Medicaldevices;Medicalequipment;Medicalproducts;Medicaltechnology;Personalhealth;Products;Results;Selection;Specification(approval);Sterilization(hygiene);Tracermethods;Use
【摘要】:ThisInternationalStandardprovidesguidancefortheselection,useandinterpretationofresultsfromapplicationofbiologicalindicatorswhenusedinthedevelopment,validationandroutinemonitoringofsterilizationprocesses.ThisInternationalStandardappliestobiologicalindicatorsforwhichInternationalStandardsexist.NOTE1SeeforexampletheISO11138series.NOTE2ThegeneralinformationprovidedinthisInternationalStandardmayhaveusefulapplicationforprocessesandbiologicalindicatorsnotcurrentlyaddressedbyexistingInternationalStandards,e.g.newanddevelopingsterilizationprocesses.ThisInternationalStandarddoesnotconsiderthoseprocessesthatrelysolelyonphysicalremovalofmicroorganisms,e.g.filtration.ThisInternationalStandardisnotintendedtoapplytocombinationprocesses,usingforexamplewasherdisinfectorsorflushingandsteamingofpipelines.ThisInternationalStandardisnotintendedtoapplytoliquidsterilizationprocesses.
【中国标准分类号】:C04
【国际标准分类号】:11_080_20
【页数】:52P;A4
【正文语种】:英语