【英文标准名称】:Selfstorage-Specificationforselfstorageservices;EnglishversionofDINEN15696:2009-02
【原文标准名称】:自存储.自存储服务用规范
【标准号】:DINEN15696-2009
【标准状态】:现行
【国别】:德国
【发布日期】:2009-02
【实施或试行日期】:2009-02-01
【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】:售后服务;防偷窃措施;防盗警报;合同协议;合同;消费者满意;危险物质;定义;设备;质量保证;风险管理;安全;安全要求;服务设施;库存;存储;仓储
【英文主题词】:After-salesservices;Anti-burglarmeasures;Burglaralarms;Contractagreement;Contracts;Customersatisfaction;Dangerousmaterials;Definition;Definitions;Equipment;Qualityassurance;Riskmanagement;Safety;Safetyrequirements;Services;Stocks;Storaging;Warehouse;Warehouses
【摘要】:ThisEuropeanStandardspecifiesrequirementsfortheprovisionofselfstoragefacilitiesandrelatedservices,forbothpersonalandbusinesspurposes.
【中国标准分类号】:A12
【国际标准分类号】:03_080_30;55_220
【页数】:16P.;A4
【正文语种】:英语


【英文标准名称】:Sterilizationofhealthcareproducts-Ethyleneoxide-Part1:Requirementsfordevelopment,validationandroutinecontrolofasterilizationprocessformedicaldevices
【原文标准名称】:卫生保健品灭菌.环氧乙烷.第1部分:医疗设备消毒过程的制定、确认和常规控制的要求
【标准号】:ISO11135-1-2007
【标准状态】:现行
【国别】:国际
【发布日期】:2007-05
【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】:验收(鉴定);验收规范;轴承;检查;交付使用;定义;环氧乙烷;评定;检查(质量保证);杀菌剂;卫生学;检验;说明书;维修;医疗设备;医疗产品;医学科学;医疗技术学;方法;微生物分析;操作;操作者(人员);人员;公共卫生;公共卫生防护;合格;质量管理;常规试验;安全;安全工程;安全要求;规范(验收);绝育(节育);灭菌;灭菌器;储存;监督(认可);测试;确认
【英文主题词】:Acceptance(approval);Acceptancespecification;Commissioning;Definitions;Ethyleneoxide;Evaluations;Examination(qualityassurance);Germicides;Hygiene;Inspection;Instructions;Maintenance;Medicaldevices;Medicalequipment;Medicalsciences;Medicaltechnology;Microbiologicalanalysis;Operation;Operators(personnel);Personnel;Publichealth;Publichealthprotection;Qualifications;Qualitymanagement;Routinetests;Safety;Safetyrequirements;Specification(approval);Sterilization(birthcontrol);Sterilization(hygiene);Sterilizers;Storage;Surveillance(approval);Testing;Validation
【摘要】:ThispartofISO11135specifiesrequirementsforthedevelopment,validationandroutinecontrolofanethyleneoxidesterilizationprocessformedicaldevices.NOTE1AlthoughthescopeofthispartofISO11135islimitedtomedicaldevices,itspecifiesrequirementsandprovidesguidancethatmaybeapplicabletootherhealthcareproducts.SterilizationprocessesvalidatedandcontrolledinaccordancewiththerequirementsofthispartofISO11135arenotassumedtobeeffectiveininactivatingthecausativeagentsofspongiformencephalopathiessuchasscrapie,bovinespongiformencephalopathyandCreutzfeldJacobdisease.Specificrecommendationshavebeenproducedinparticularcountriesfortheprocessingofmaterialspotentiallycontaminatedwiththeseagents.NOTE2SeeforexampleISO22442-1,ISO22442-2andISO22442-3.ThispartofISO11135doesnotdetailaspecifiedrequirementfordesignatingamedicaldeviceassterile.NOTE3Attentionisdrawntonationalorregionalrequirementsfordesignatingmedicaldevicesas“sterile”.SeeforexampleEN556-1orANSI/AAMIST67.ThispartofISO11135doesnotspecifyaqualitymanagementsystemforthecontrolofallstagesofproductionofmedicaldevices.NOTE4Theeffectiveimplementationofdefinedanddocumentedproceduresisnecessaryforthedevelopment,validationandroutinecontrolofasterilizationprocessformedicaldevices.Suchproceduresarecommonlyconsideredtobeelementsofaqualitymanagementsystem.ItisnotarequirementofthispartofISO11135tohaveacompletequalitymanagementsystemduringmanufactureorreprocessing,buttheelementsofaqualitymanagementsystemthataretheminimumnecessarytocontrolthesterilizationprocessarenormativelyreferencedatappropriateplacesinthetext(seeinparticularClause4).Nationaland/orregionalregulationsfortheprovisionofmedicaldevicesmightrequireimplementationofacompletequalitymanagementsystemandtheassessmentofthatsystembyathirdparty.ThispartofISO11135doesnotspecifyrequirementsforoccupationalsafetyassociatedwiththedesignandoperationofethyleneoxidesterilizationfacilities.NOTE5Forfurtherinformationonsafety,seeexamplesintheBibliography.Nationalorregionalregulationsmayalsoexist.NOTE6Ethyleneoxideistoxic,flammableandexplosive.Attentionisdrawntothepossibleexistenceinsomecountriesofregulationsgivingsafetyrequirementsforhandlingethyleneoxideandforpremisesinwhichitisused.ThispartofISO11135doesnotcoversterilizationbyinjectingethyleneoxideormixturescontainingethyleneoxidedirectlyintoindividualproductpackages,orcontinuoussterilizationprocesses.
【中国标准分类号】:C47
【国际标准分类号】:11_080_20
【页数】:41P;A4
【正文语种】:英语