【英文标准名称】:Sterilizationofhealthcareproducts-Radiation-Part2:Establishingthesterilizationdose(ISO11137-2:2006,correctedversion2006-08-01);EnglishversionofDINENISO11137-2:2007-09
【原文标准名称】:保健产品的灭菌.辐射.第2部分:确定杀菌剂量(ISO11137-2:2006,correctedversion2006-08-01)
【标准号】:DINENISO11137-2-2007
【标准状态】:作废
【国别】:德国
【发布日期】:2007-09
【实施或试行日期】:
【发布单位】:德国标准化学会(DE-DIN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:核对;定义;剂量;效率;电子束;杀菌剂;保健;卫生学;检验;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;辐射剂量;射线处理;规范(验收);辐射灭菌;灭菌;监督(认可);验证;X射线
【英文主题词】:Checks;Definition;Dose;Efficiency;Electronbeams;Germicides;Healthprotection;Hygiene;Inspection;Ionizingradiation;Irradiationapparatus;Medicalequipment;Medicalproducts;Medicalsciences;Medicaltechnology;Methods;Productinformation;Publichealth;Qualitymanagement;Radiation;Radiationdose;Raytreatment;Specification(approval);Sterilizationbyirradiation;Sterilization(hygiene);Surveillance(approval);Verification;X-rays
【摘要】:ThispartofISO11137specifiesmethodsofdeterminingtheminimumdoseneededtoachieveaspecifiedrequirementforsterilityandmethodstosubstantiatetheuseof25kGyor15kGyasthesterilizationdosetoachieveasterilityassurancelevel(SAL)of10-6.ThispartofISO11137alsospecifiesmethodsofdoseauditingtodemonstratethecontinuedeffectivenessofthesterilizationdose.ThispartofISO11137definesproductfamiliesfordoseestablishmentanddoseauditing.
【中国标准分类号】:C50
【国际标准分类号】:11_080_99
【页数】:70P.;A4
【正文语种】:英语