SY/T 5673-1993 油田用防垢剂性能评定方法
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基本信息
| 标准名称： | 油田用防垢剂性能评定方法 |
| 发布日期： | 1993-09-09 |
| 实施日期： | 1994-03-01 |
| 首发日期： | 1900-01-01 |
| 作废日期： | 1900-01-01 |
| 出版日期： | 1900-01-01 |
适用范围
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前言
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目录
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引用标准
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所属分类： 石油 石油勘探 开发与集输 石油钻井
【英文标准名称】:Sterilizationofhealthcareproducts-Ethyleneoxide-Part1:Requirementsforthedevelopment,validationandroutinecontrolofasterilizationprocessformedicaldevices(ISO11135-1:2007);EnglishversionofDINENISO11135-1:2007-08
【原文标准名称】:卫生保健品灭菌.环氧乙烷.第1部分:医疗设备灭菌过程的制定、确认和常规控制的要求(ISO11135-1-2007)
【标准号】:DINENISO11135-1-2007
【标准状态】:现行
【国别】:德国
【发布日期】:2007-08
【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】:验收(鉴定);验收规范;检验;交付使用;定义;环氧乙烷;评定;检查(质量保证);灭菌剂;卫生学;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;公共卫生;公共卫生保护;合格;质量管理;常规试验;安全;安全工程;安全要求;规范(验收);灭菌(绝育);灭菌(卫生学);灭菌器;储存;监督(认可);测试;确认
【英文主题词】:Acceptance(approval);Acceptancespecification;Checks;Commissioning;Definition;Definitions;Ethyleneoxide;Evaluations;Examination(qualityassurance);Germicides;Hygiene;Inspection;Instructions;Maintenance;Medicalequipment;Medicalproducts;Medicalsciences;Medicaltechnology;Methods;Microbiologicalanalysis;Operation;Operators(personnel);Personnel;Publichealth;Publichealthprotection;Qualifications;Qualitymanagement;Routinetests;Safety;Safetyengineering;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.ThispartofISO11135doesnotcoveranalyticalmethodsfordetermininglevelsofresidualethyleneoxideand/oritsreactionproducts.NOTE7ForfurtherinformationseeISO10993-7.NOTE8Attentionisdrawntothepossibleexistenceofregulationsspecifyinglimitsforthelevelofethyleneoxideresiduespresentonorinmedicaldevicesandproducts.
【中国标准分类号】:C47
【国际标准分类号】:11_080_20
【页数】:52P.;A4
【正文语种】:德语
【英文标准名称】:Dataprocessingvocabulary-Computergraphics
【原文标准名称】:数据处理词汇.第13部分:计算机图形
【标准号】:BSISO2382-13-1990
【标准状态】:现行
【国别】:英国
【发布日期】:1990-11-30
【实施或试行日期】:1990-11-30
【发布单位】:英国标准学会(BSI)
【起草单位】:BSI
【标准类型】:()
【标准水平】:()
【中文主题词】:计算机技术;数据处理;计算机制图;词汇
【英文主题词】:
【摘要】:Facilitatestheinternationalcommunicationininformationprocessing.ProvidesselectedEnglishandFrenchtermsandtheirdefinitionsinthefieldofrepresentationandstoringofimages,theaddressingtechniquesandprinciples,thefunctionalunits,theoperationprocessesandprocedures.
【中国标准分类号】:L70;L81
【国际标准分类号】:01_040_35;35_140
【页数】:25P;A4
【正文语种】:英语