BS EN ISO 14161-2009 医疗保健产品的灭菌.生物指示器.选择、使用和检验结果解释用指南

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【英文标准名称】:Sterilizationofhealthcareproducts-Biologicalindicators-Guidancefortheselection,useandinterpretationofresults
【原文标准名称】:医疗保健产品的灭菌.生物指示器.选择、使用和检验结果解释用指南
【标准号】:BSENISO14161-2009
【标准状态】:现行
【国别】:英国
【发布日期】:2010-01-31
【实施或试行日期】:2010-01-31
【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】:生物指示剂;定义;指导手册;保健;指示器;解释重点;解释;医疗器械;医疗设备;医疗产品;医学科学;医疗技术学;个人保健;产品;公共卫生;结果;选择;规范(验收);灭菌;示踪法;使用
【英文主题词】:Bio-indicators;Definitions;Guidebooks;Healthprotection;Indicators;Interpretationkey;Interpretations;Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Medicaltechnology;Personalhealth;Products;Publichealth;Results;Selection;Specification(approval);Sterilization(hygiene);Tracermethods;Use
【摘要】:ThisInternationalStandardprovidesguidancefortheselection,useandinterpretationofresultsfromapplicationofbiologicalindicatorswhenusedinthedevelopment,validationandroutinemonitoringofsterilizationprocesses.ThisInternationalStandardappliestobiologicalindicatorsforwhichInternationalStandardsexist.NOTE1See,forexample,theISO11138series.NOTE2ThegeneralinformationprovidedinthisInternationalStandardcanhaveusefulapplicationforprocessesandbiologicalindicatorsnotcurrentlyaddressedbyexistingInternationalStandards,e.g.,newanddevelopingsterilizationprocesses.ThisInternationalStandarddoesnotconsiderthoseprocessesthatrelysolelyonphysicalremovalofmicroorganisms,e.g.,filtration.ThisInternationalStandardisnotintendedtoapplytocombinationprocessesusing,forexample,washerdisinfectorsorflushingandsteamingofpipelines.ThisInternationalStandardisnotintendedtoapplytoliquidsterilizationprocesses.
【中国标准分类号】:C05
【国际标准分类号】:11_080_01
【页数】:72P.;A4
【正文语种】:英语