DIN EN ISO 15882-2008 卫生保健产品的灭菌.化学指示剂.选择、使用指南和要求的试验结果(ISO15882-2008).英文版本DINENISO15882-2008

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【英文标准名称】:Sterilizationofhealthcareproducts-Chemicalindicators-Guidanceforselection,useandinterpretationofresults(ISO15882:2008);EnglishversionofDINENISO15882:2008-12
【原文标准名称】:卫生保健产品的灭菌.化学指示剂.选择、使用指南和要求的试验结果(ISO15882-2008).英文版本DINENISO15882-2008
【标准号】:DINENISO15882-2008
【标准状态】:现行
【国别】:德国
【发布日期】:2008-12
【实施或试行日期】:
【发布单位】:德国标准化学会(DE-DIN)
【起草单位】:
【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;作标记;医疗设备;医疗产品;医学科学;公共卫生;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;证实
【英文主题词】:Chemicalindicators;Classification;Definition;Definitions;Developments;Guidebooks;Indicators;Interpretations;Marking;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
【国际标准分类号】:11_080_01
【页数】:39P.;A4
【正文语种】:英语