DG/TJ 08-307-2002 七氟丙烷灭火系统技术规程(附条文说明)
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基本信息
| 标准名称： | 七氟丙烷灭火系统技术规程(附条文说明) |
| 中标分类： | 工程建设 >> 工程抗震、工程防火、人防工程 >> 工程防火 |
| ICS分类： | 环保、保健与安全 >> 消防 >> 灭火 |
| 发布日期： | 2002-04-05 |
| 实施日期： | 2002-07-01 |
| 首发日期： | |
| 作废日期： | |
| 出版日期： | |
| 页数： | 36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： 工程建设 工程抗震 工程防火 人防工程 工程防火 环保 保健与安全 消防 灭火
下载地址: 点击此处下载
【英文标准名称】:Determinationoftheimagedistortionofelectro-opticalX-rayimageintensifiers
【原文标准名称】:电光X射线影像增强器的影像失真度的测定
【标准号】:IEC60858-1986
【标准状态】:作废
【国别】:国际
【发布日期】:1986
【实施或试行日期】:
【发布单位】:国际电工委员会(IEC)
【起草单位】:IEC/SC62B
【标准类型】:()
【标准水平】:()
【中文主题词】:电光效应;X射线图象增强器;医学放射学;X射线设备;医学科学;电气工程;测定;电器;X射线仪;医疗设备
【英文主题词】:determination;medicalequipment;electricalengineering;x-rayapparatus;electricappliances;medicalsciences;medicalradiology;x-rayequipment;electro-opticaleffects;x-rayimageintensifiers
【摘要】:
【中国标准分类号】:C43
【国际标准分类号】:2340;0755
【页数】:17P;A4
【正文语种】:英语
【英文标准名称】:Sterilizationofhealthcareproducts-Radiation-Part1:Requirementsfordevelopment,validationandroutinecontrolofasterilizationprocessformedicaldevices
【原文标准名称】:保健产品的灭菌.辐射.第1部分:医疗器件消毒过程的制定、确认、和常规控制的要求
【标准号】:ISO11137-1-2006
【标准状态】:现行
【国别】:国际
【发布日期】:2006-04
【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/TC198
【标准类型】:()
【标准水平】:()
【中文主题词】:特性记述;检验;定义;剂量;效率;电子束;杀菌剂;保健;卫生学;电离辐射;辐照器;医疗设备;医疗产品;医学科学;医疗技术学;方法;产品信息;公共卫生;质量管理;辐射;射线处理;规范(验收);辐射灭菌;灭菌;监督(认可);证实;验证;X射线
【英文主题词】:Acceptance(approval);Biologicalhazards;Calibration;Characterisations;Checks;Clearing;Containers;Definitions;Dose;Dosimeters;Dosimetry;Efficiency;Elections;Electronbeams;Evaluations;Gamma-radiation;Germicides;Guidebooks;Healthprotection;Hygiene;Inspection;Ionizingradiation;Irradiationapparatus;Jets;Maintenance;Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Medicaltechnology;Methods;Performance;Personnel;Phototherapy;Plant;Productinformation;Publichealth;Qualifications;Qualitymanagement;Radiation;Raytreatment;Routinetests;Specification(approval);Sterilizationbyirradiation;Sterilization(hygiene);Surveillance(approval);Validation;Verification;X-rays
【摘要】:1.1ThispartofISO11137specifiesrequirementsforthedevelopment,validationandroutinecontrolofaradiationsterilizationprocessformedicaldevices.NOTEAlthoughthescopeofthispartofISO11137islimitedtomedicaldevices,itspecifiesrequirementsandprovidesguidancethatmaybeapplicabletootherproductsandequipment.ThispartofISO11137coversradiationprocessesemployingirradiatorsusing,a)theradionuclide60Coor137Cs,b)abeamfromanelectrongeneratororc)abeamfromanX-raygenerator.1.2ThispartofISO11137doesnotspecifyrequirementsfordevelopment,validationandroutinecontrolofaprocessforinactivatingthecausativeagentsofspongiformencephalopathiessuchasscrapie,bovinespongiformencephalopathyandCreutzfeld-Jakobdisease.Specificrecommendationshavebeenproducedinparticularcountriesfortheprocessingofmaterialspotentiallycontaminatedwiththeseagents.NOTESee,forexample,ISO22442-1,ISO22442-2andISO22442-3.1.2.1ThispartofISO11137doesnotdetailspecifiedrequirementsfordesignatingamedicaldeviceassterile.NOTEAttentionisdrawntoregionalandnationalrequirementsfordesignatingmedicaldevicesas"sterile."See,forexample,EN556-1orANSI/AAMIST67.1.2.2ThispartofISO11137doesnotspecifyaqualitymanagementsystemforthecontrolofallstagesofproductionofmedicaldevices.NOTEItisnotarequirementofthispartofISO11137tohaveacompletequalitymanagementsystemduringmanufacture,buttheelementsofaqualitymanagementsystemthataretheminimumnecessarytocontrolthesterilizationprocessarenormativelyreferencedatappropriateplacesinthetext(see,inparticular,Clause4).Attentionisdrawntothestandardsforqualitymanagementsystems(seeISO13485)thatcontrolallstagesofproductionofmedicaldevices,includingthesterilizationprocess.Regionalandnationalregulationsfortheprovisionofmedicaldevicesmightrequireimplementationofacompletequalitymanagementsystemandtheassessmentofthatsystembyathirdparty.1.2.3ThispartofISO11137doesnotrequirethatbiologicalindicatorsbeusedforvalidationormonitoringofradiationsterilization,nordoesitrequirethatapharmacopoeialtestforsterilitybecarriedoutforproductrelease.1.2.4ThispartofISO11137doesnotspecifyrequirementsforoccupationalsafetyassociatedwiththedesignandoperationofirradiationfacilities.NOTEAttentionisalsodrawntotheexistence,insomecountries,ofregulationslayingdownsafetyrequirementsforoccupationalsafetyrelatedtoradiation.1.2.5ThispartofISO11137doesnotspecifyrequirementsforthesterilizationofusedorreprocesseddevices.
【中国标准分类号】:C04
【国际标准分类号】:11_080_01
【页数】:37P;A4
【正文语种】:英语
【原文标准名称】:电光X射线影像增强器的影像失真度的测定
【标准号】:IEC60858-1986
【标准状态】:作废
【国别】:国际
【发布日期】:1986
【实施或试行日期】:
【发布单位】:国际电工委员会(IEC)
【起草单位】:IEC/SC62B
【标准类型】:()
【标准水平】:()
【中文主题词】:电光效应;X射线图象增强器;医学放射学;X射线设备;医学科学;电气工程;测定;电器;X射线仪;医疗设备
【英文主题词】:determination;medicalequipment;electricalengineering;x-rayapparatus;electricappliances;medicalsciences;medicalradiology;x-rayequipment;electro-opticaleffects;x-rayimageintensifiers
【摘要】:
【中国标准分类号】:C43
【国际标准分类号】:2340;0755
【页数】:17P;A4
【正文语种】:英语
【英文标准名称】:Sterilizationofhealthcareproducts-Radiation-Part1:Requirementsfordevelopment,validationandroutinecontrolofasterilizationprocessformedicaldevices
【原文标准名称】:保健产品的灭菌.辐射.第1部分:医疗器件消毒过程的制定、确认、和常规控制的要求
【标准号】:ISO11137-1-2006
【标准状态】:现行
【国别】:国际
【发布日期】:2006-04
【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/TC198
【标准类型】:()
【标准水平】:()
【中文主题词】:特性记述;检验;定义;剂量;效率;电子束;杀菌剂;保健;卫生学;电离辐射;辐照器;医疗设备;医疗产品;医学科学;医疗技术学;方法;产品信息;公共卫生;质量管理;辐射;射线处理;规范(验收);辐射灭菌;灭菌;监督(认可);证实;验证;X射线
【英文主题词】:Acceptance(approval);Biologicalhazards;Calibration;Characterisations;Checks;Clearing;Containers;Definitions;Dose;Dosimeters;Dosimetry;Efficiency;Elections;Electronbeams;Evaluations;Gamma-radiation;Germicides;Guidebooks;Healthprotection;Hygiene;Inspection;Ionizingradiation;Irradiationapparatus;Jets;Maintenance;Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Medicaltechnology;Methods;Performance;Personnel;Phototherapy;Plant;Productinformation;Publichealth;Qualifications;Qualitymanagement;Radiation;Raytreatment;Routinetests;Specification(approval);Sterilizationbyirradiation;Sterilization(hygiene);Surveillance(approval);Validation;Verification;X-rays
【摘要】:1.1ThispartofISO11137specifiesrequirementsforthedevelopment,validationandroutinecontrolofaradiationsterilizationprocessformedicaldevices.NOTEAlthoughthescopeofthispartofISO11137islimitedtomedicaldevices,itspecifiesrequirementsandprovidesguidancethatmaybeapplicabletootherproductsandequipment.ThispartofISO11137coversradiationprocessesemployingirradiatorsusing,a)theradionuclide60Coor137Cs,b)abeamfromanelectrongeneratororc)abeamfromanX-raygenerator.1.2ThispartofISO11137doesnotspecifyrequirementsfordevelopment,validationandroutinecontrolofaprocessforinactivatingthecausativeagentsofspongiformencephalopathiessuchasscrapie,bovinespongiformencephalopathyandCreutzfeld-Jakobdisease.Specificrecommendationshavebeenproducedinparticularcountriesfortheprocessingofmaterialspotentiallycontaminatedwiththeseagents.NOTESee,forexample,ISO22442-1,ISO22442-2andISO22442-3.1.2.1ThispartofISO11137doesnotdetailspecifiedrequirementsfordesignatingamedicaldeviceassterile.NOTEAttentionisdrawntoregionalandnationalrequirementsfordesignatingmedicaldevicesas"sterile."See,forexample,EN556-1orANSI/AAMIST67.1.2.2ThispartofISO11137doesnotspecifyaqualitymanagementsystemforthecontrolofallstagesofproductionofmedicaldevices.NOTEItisnotarequirementofthispartofISO11137tohaveacompletequalitymanagementsystemduringmanufacture,buttheelementsofaqualitymanagementsystemthataretheminimumnecessarytocontrolthesterilizationprocessarenormativelyreferencedatappropriateplacesinthetext(see,inparticular,Clause4).Attentionisdrawntothestandardsforqualitymanagementsystems(seeISO13485)thatcontrolallstagesofproductionofmedicaldevices,includingthesterilizationprocess.Regionalandnationalregulationsfortheprovisionofmedicaldevicesmightrequireimplementationofacompletequalitymanagementsystemandtheassessmentofthatsystembyathirdparty.1.2.3ThispartofISO11137doesnotrequirethatbiologicalindicatorsbeusedforvalidationormonitoringofradiationsterilization,nordoesitrequirethatapharmacopoeialtestforsterilitybecarriedoutforproductrelease.1.2.4ThispartofISO11137doesnotspecifyrequirementsforoccupationalsafetyassociatedwiththedesignandoperationofirradiationfacilities.NOTEAttentionisalsodrawntotheexistence,insomecountries,ofregulationslayingdownsafetyrequirementsforoccupationalsafetyrelatedtoradiation.1.2.5ThispartofISO11137doesnotspecifyrequirementsforthesterilizationofusedorreprocesseddevices.
【中国标准分类号】:C04
【国际标准分类号】:11_080_01
【页数】:37P;A4
【正文语种】:英语