【英文标准名称】:Sterilizationofhealthcareproducts-Radiation-Establishingthesterilizationdose
【原文标准名称】:卫生保健品灭菌.辐射.确定灭菌剂量
【标准号】:BSENISO11137-2-2007
【标准状态】:作废
【国别】:英国
【发布日期】:2007-06-29
【实施或试行日期】:2007-06-29
【发布单位】:英国标准学会(GB-BSI)
【起草单位】:BSI
【标准类型】:()
【标准水平】:()
【中文主题词】: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;辐射剂量;射线处理;规范(验收);辐射灭菌;灭菌(卫生学);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】:ISO11137-2:2006specifiesmethodsofdeterminingtheminimumdoseneededtoachieveaspecifiedrequirementforsterilityandmethodstosubstantiatetheuseof25kGyor15kGyasthesterilizationdosetoachieveasterilityassurancelevel(SAL)of10-6.Italsospecifiesmethodsofdoseauditinginordertodemonstratethecontinuedeffectivenessofthesterilizationdose.ISO11137-2:2006definesproductfamiliesfordoseestablishmentanddoseauditing.
【中国标准分类号】:C47
【国际标准分类号】:11_080_01
【页数】:72P;A4
【正文语种】:英语