ISO 11137-1-2006 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
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【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】: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
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