ISO/TR 15844-1998 医疗保健产品灭菌辐射灭菌单个生产批用灭菌剂量的选择

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【英文标准名称】:Sterilizationofhealthcareproducts-Radiationsterilization-Selectionofsterilizationdoseforasingleproductionbatch
【原文标准名称】:医疗保健产品灭菌辐射灭菌单个生产批用灭菌剂量的选择
【标准号】:ISO/TR15844-1998
【标准状态】:作废
【国别】:国际
【发布日期】:1998-12
【实施或试行日期】:
【发布单位】:国际标准化组织(ISO)
【起草单位】:ISO/TC198
【标准类型】:()
【标准水平】:()
【中文主题词】:医疗设备;辐射剂量;选择;电子束;规范(验收);定义;定义;辐射灭菌;医疗产品;灭菌
【英文主题词】:Definition;Definitions;Electronbeams;Medicalequipment;Medicalproducts;Radiationdose;Selection;Specification(approval);Sterilizationbyirradiation;Sterilization(hygiene)
【摘要】:ThisTechnicalReportdescribesamethodofselectingasterilizationdosetobeusedforradiationsterilizationofasingleproductionbatchofhealthcareproducts.Thesterilizationdoseestablishedthroughtheuseofthismethodforaparticularbatchcannotbeusedforotherbatches.NOTE1ApplicationofthemethodofdoseselectiondescribedinthisTechnicalReportmaybeusedtomeettherequirementsspecifiedunder6.2.2relatingtoproductqualificationinISO11137:1995.NOTE2ThisTechnicalReportisconsideredinformative,anduseoftheterms"shall,""should,"etc.shouldbeconsideredwithinthecontextofthisTechnicalReportonly.Thatis,ifthedecisionismadetousethismethodofdoseselection,thenthemethodshouldbefollowedinadherencewiththerequirements("shall")andrecommendations("should")assetforthinthisTechnicalReport.
【中国标准分类号】:C04
【国际标准分类号】:11_080_01
【页数】:11P;A4
【正文语种】:英语