【英文标准名称】:Sterilizationofhealthcareproducts-Ethyleneoxide-Requirementsfordevelopment,validationandroutinecontrolofasterilizationprocessformedicaldevices
【原文标准名称】:卫生保健品灭菌.环氧乙烷.医疗设备灭菌过程的制定、确认和常规控制的要求
【标准号】:BSENISO11135-1-2007
【标准状态】:现行
【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】:验收(鉴定);验收规范;检验;交付使用;定义;环氧乙烷;评定;检验(质量保证);杀菌剂;卫生学;说明书;维修;医疗设备;医疗产品;医学科学;医疗技术学;方法;微生物分析;操作;操作者(人员);人员;公共卫生;公共卫生保护;合格;质量管理;常规试验;安全;安全工程;安全要求;规范(验收);灭菌(绝育);灭菌(卫生学);灭菌器;储存;监督(认可);测试;确认
【英文主题词】:Acceptance(approval);Acceptancespecification;Checks;Commissioning;Definitions;Ethyleneoxide;Evaluations;Examination(qualityassurance);Germicides;Hygiene;Inspection;Instructions;Maintenance;Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Medicaltechnology;Methods;Microbiologicalanalysis;Operation;Operators(personnel);Personnel;Publichealth;Publichealthprotection;Qualifications;Qualitymanagement;Routinetests;Safety;Safetyengineering;Safetyrequirements;Specification(approval);Sterilization(birthcontrol);Sterilization(hygiene);Sterilizers;Storage;Surveillance(approval);Testing;Validation
【摘要】:ISO11135-1:2007specifiesrequirementsforthedevelopment,validationandroutinecontrolofanethyleneoxidesterilizationprocessformedicaldevices.SterilizationprocessesvalidatedandcontrolledinaccordancewiththerequirementsofISO11135-1:2007arenotassumedtobeeffectiveininactivatingthecausativeagentsofspongiformencephalopathiessuchasscrapie,bovinespongiformencephalopathyandCreutzfeldJacobdisease.Specificrecommendationshavebeenproducedinparticularcountriesfortheprocessingofmaterialspotentiallycontaminatedwiththeseagents.
【中国标准分类号】:C47
【国际标准分类号】:11_080_20
【页数】:54P.;A4
【正文语种】:英语