【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】:ISO14161-2000
【标准状态】:作废
【国别】:国际
【发布日期】:2000-10
【实施或试行日期】:
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:ISO/TC198
【标准类型】:()
【标准水平】:()
【中文主题词】:医疗技术学;解释要素;保健;生物指示剂;医疗设备;结果;示踪法;个人保健;灭菌;选择;定义;规范(验收);产品;解释;指导手册;医疗产品;指示器;应用
【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】:C05
【国际标准分类号】:11_080_20
【页数】:40P.;A4
【正文语种】:英语