ISO 15882-2008 保健产品的消毒.化学指示剂.选择、使用和结果说明用指南

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【英文标准名称】:Sterilizationofhealthcareproducts-Chemicalindicators-Guidanceforselection,useandinterpretationofresults
【原文标准名称】:保健产品的消毒.化学指示剂.选择、使用和结果说明用指南
【标准号】:ISO15882-2008
【标准状态】:现行
【国别】:国际
【发布日期】:2008-09
【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】:化学指示剂;分类;定义;开发;指导手册;指示器;解释;医疗设备;医疗产品;医学科学;质量保证;结果;选择;规范(验收);绝育;灭菌;杀菌器具;监督(认可);示踪法;使用;有校性
【英文主题词】:Chemicalindicators;Classification;Definitions;Developments;Guidebooks;Indicators;Interpretations;Marking;Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Publichealth;Qualityassurance;Results;Selection;Specification(approval);Sterilization(birthcontrol);Sterilization(hygiene);Sterilizingapparatus;Surveillance(approval);Tracermethods;Use;Validation
【摘要】:1.1ThisInternationalStandardprovidesguidancefortheselection,useandinterpretationofresultsofchemicalindicatorsusedinprocessdefinition,validationandroutinemonitoringandoverallcontrolofsterilizationprocesses.ThisInternationalStandardappliestoindicatorsthatshowexposuretosterilizationprocessesbymeansofphysicaland/orchemicalchangeofsubstances,andwhichareusedtomonitoroneormoreofthevariablesrequiredofasterilizationprocess.Thesechemicalindicatorsarenotdependentfortheiractiononthepresenceorabsenceofalivingorganism.1.2ThisInternationalStandarddoesnotconsiderindicatorsforuseinthoseprocessesthatrelyonphysicalremovalofmicroorganisms,e.g.filtration.1.3ThisInternationalStandardisnotintendedtoapplytoindicatorsforuseincombinationprocesses,forexample,washerdisinfectorsorCIP(cleaninginplace)andSIP(sterilizationinplace).
【中国标准分类号】:C04;G65
【国际标准分类号】:11_080_01
【页数】:31P;A4
【正文语种】:英语