EJ/T 755-1993 黑云母钾、氩同位素地质年令测定
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基本信息
| 标准名称： | 黑云母钾、氩同位素地质年令测定 |
| 中标分类： | 矿业 >> 非金属矿 >> 建材原料矿 |
| ICS分类： | 采矿和矿产品 >> 非金属矿 |
| 发布日期： | 1993-04-14 |
| 实施日期： | 1993-10-01 |
| 首发日期： | |
| 作废日期： | |
| 出版日期： | |
| 页数： | 7页 |
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： 矿业 非金属矿 建材原料矿 采矿和矿产品 非金属矿
下载地址: 点击此处下载
【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】:Castorsandwheels-Requirementsforcastorsforhospitalbeds
【原文标准名称】:脚轮和轮子.医院床用脚轮的要求
【标准号】:ISO22882-2004
【标准状态】:现行
【国别】:国际
【发布日期】:2004-04
【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/TC110
【标准类型】:()
【标准水平】:()
【中文主题词】:脚轮;锁紧装置;床;轮子;试验;医院;试验要求;规范(验收);尺寸
【英文主题词】:wheels;hospitals;testing;beds;castors;specification(approval);dimensions;lockingdevice;testingrequirements
【摘要】:ThisInternationalStandardspecifiesthetechnicalrequirements,theappropriatedimensionsandtherequirementsfortestingofswivelcastorsforhospitalbedswithawheeldiameterof100mmormore,andwhichhaveacentrallockingdevice.Swivelcastorsmaybeusedwiththemainprincipaldimensions.
【中国标准分类号】:Y82
【国际标准分类号】:11_140
【页数】:12P.;A4
【正文语种】:英语
【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】:Castorsandwheels-Requirementsforcastorsforhospitalbeds
【原文标准名称】:脚轮和轮子.医院床用脚轮的要求
【标准号】:ISO22882-2004
【标准状态】:现行
【国别】:国际
【发布日期】:2004-04
【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/TC110
【标准类型】:()
【标准水平】:()
【中文主题词】:脚轮;锁紧装置;床;轮子;试验;医院;试验要求;规范(验收);尺寸
【英文主题词】:wheels;hospitals;testing;beds;castors;specification(approval);dimensions;lockingdevice;testingrequirements
【摘要】:ThisInternationalStandardspecifiesthetechnicalrequirements,theappropriatedimensionsandtherequirementsfortestingofswivelcastorsforhospitalbedswithawheeldiameterof100mmormore,andwhichhaveacentrallockingdevice.Swivelcastorsmaybeusedwiththemainprincipaldimensions.
【中国标准分类号】:Y82
【国际标准分类号】:11_140
【页数】:12P.;A4
【正文语种】:英语