JIS A8909-2012 土方机械.防护结构的实验室评价.偏差极限容量规格
作者:标准资料网 时间:2024-05-08 19:31:05 浏览:8726
来源:标准资料网
【英文标准名称】:Earth-movingmachinery--Laboratoryevaluationsofprotectivestructures--Specificationsfordeflection-limitingvolume
【原文标准名称】:土方机械.防护结构的实验室评价.偏差极限容量规格
【标准号】:JISA8909-2012
【标准状态】:现行
【国别】:
【发布日期】:2012-11-20
【实施或试行日期】:
【发布单位】:日本工业标准调查会(JP-JISC)
【起草单位】:TechnicalCommitteeonIndustrialMachinery
【标准类型】:()
【标准水平】:()
【中文主题词】:
【英文主题词】:
【摘要】:
【中国标准分类号】:P97
【国际标准分类号】:53_100
【页数】:6P;A4
【正文语种】:日语
【英文标准名称】:CircuitRepresentations;Definitions,Classification
【原文标准名称】:电路图；概念；分类
【标准号】:DIN40719-1-1973
【标准状态】:作废
【国别】:德国
【发布日期】:1973-06
【实施或试行日期】:
【发布单位】:德国标准化学会(DIN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:定义;表(数据);线路图;布置;图示;仪器
【英文主题词】:layout;instruments;tables(data);circuitdiagrams;definitions;diagrams
【摘要】:
【中国标准分类号】:K04
【国际标准分类号】:01_080_30
【页数】:4P;A4
【正文语种】:德语
【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
