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【英文标准名称】:Sterilizationofhealthcareproducts-Radiation-Requirementsfordevelopment,validationandroutinecontrolofasterilizationprocessformedicaldevices
【原文标准名称】:保健产品的灭菌.辐射.医疗器械消毒程序的建立、确认、和常规控制的要求
【标准号】:BSENISO11137-1-2006
【标准状态】:现行
【国别】:英国
【发布日期】:2006-08-31
【实施或试行日期】:2006-08-31
【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】:特性记述;检验;定义;剂量;效率;电子束;杀菌剂;保健;卫生学;监督;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);确认;验证;X射线
【英文主题词】:
【摘要】:ISO11137-1:2006specifiesrequirementsforthedevelopment,validationandroutinecontrolofaradiationsterilizationprocessformedicaldevices.AlthoughthescopeofISO11137-1:2006islimitedtomedicaldevices,itspecifiesrequirementsandprovidesguidancethatmaybeapplicabletootherproductsandequipment.ISO11137-1:2006coversradiationprocessesemployingirradiatorsusingtheradionuclide60Coor137Cs,abeamfromanelectrongeneratororabeamfromanX-raygenerator.ISO11137-1:2006doesnot:specifyrequirementsfordevelopment,validationandroutinecontrolofaprocessforinactivatingthecausativeagentsofspongiformencephalopathiessuchasscrapie,bovinespongiformencephalopathyandCreutzfeldt-Jakobdisease;detailspecifiedrequirementsfordesignatingamedicaldeviceassterile;specifyaqualitymanagementsystemforthecontrolofallstagesofproductionofmedicaldevices;specifyrequirementsforoccupationalsafetyassociatedwiththedesignandoperationofirradiationfacilities;specifyrequirementsforthesterilizationofusedorreprocesseddevices.
【中国标准分类号】:C30
【国际标准分类号】:11_080_01
【页数】:50P;A4
【正文语种】:英语