【英文标准名称】:Sterilizationofhealthcareproducts-Radiation-Part2:Establishingthesterilizationdose
【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
【标准号】:ISO11137-2-2006
【标准状态】:作废
【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】: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】:Acceptance(approval);Biologicalhazards;Calibration;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;Radiationdose;Raytreatment;Routinetests;Specification(approval);Sterilizationbyirradiation;Sterilization(hygiene);Surveillance(approval);Validation;Verification;X-rays
【摘要】:ThispartofISO11137specifiesmethodsofdeterminingtheminimumdoseneededtoachieveaspecifiedrequirementforsterilityandmethodstosubstantiatetheuseof25kGyor15kGyasthesterilizationdosetoachieveasterilityassurancelevel,SAL,of10–6.ThispartofISO11137alsospecifiesmethodsofdoseauditinginordertodemonstratethecontinuedeffectivenessofthesterilizationdose.ThispartofISO11137definesproductfamiliesfordoseestablishmentanddoseauditing.
【中国标准分类号】:C04
【国际标准分类号】:11_080_01
【页数】:60P;A4
【正文语种】:英语