BS EN ISO 14937-2009 保健产品灭菌.医疗器械用消毒剂的特性和消毒方法的研发、验证及常规控制的一般要求
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【英文标准名称】:Sterilizationofhealthcareproducts-Generalrequirementsforcharacterizationofasterilizingagentandthedevelopment,validationandroutinecontrolofasterilizationprocessformedicaldevices
【原文标准名称】:保健产品灭菌.医疗器械用消毒剂的特性和消毒方法的研发、验证及常规控制的一般要求
【标准号】:BSENISO14937-2009
【标准状态】:现行
【国别】:英国
【发布日期】:2010-03-31
【实施或试行日期】:2010-03-31
【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】:试剂;特性记述;定义;开发;γ辐射;保健;卫生学;检验;电离辐射;医疗器械;医疗设备;医疗产品;医学科学;医疗技术学;方法;工艺;合格;质量保证体系;辐射;规范;规范(验收);绝育;辐射灭菌;灭菌;灭菌器;杀菌器具;监督(认可);使用;证实
【英文主题词】:Agents;Characterisations;Definitions;Developments;Gamma-radiation;Healthprotection;Hygiene;Inspection;Ionizingradiation;Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Medicaltechnology;Methods;Processes;Qualifications;Qualityassurancesystems;Radiation;Specification;Specification(approval);Sterilization(birthcontrol);Sterilizationbyirradiation;Sterilization(hygiene);Sterilizers;Sterilizingapparatus;Surveillance(approval);Use;Validation
【摘要】:1.1.1ThisInternationalStandardspecifiesgeneralrequirementsforthecharacterizationofasterilizingagentandforthedevelopment,validationandroutinemonitoringandcontrolofasterilizationprocessformedicaldevices.1.1.2ThisInternationalStandardappliestosterilizationprocessesinwhichmicroorganismsareinactivatedbyphysicaland/orchemicalmeans.1.1.3ThisInternationalStandardisintendedtobeappliedbyprocessdevelopers,manufacturersofsterilizationequipment,manufacturersofmedicaldevicestobesterilized,andorganizationsresponsibleforsterilizingmedicaldevices.1.1.4ThisInternationalStandardspecifiestheelementsofaQualityManagementSystemwhicharenecessarytoassuretheappropriatecharacterizationofthesterilizingagent,development,validationandroutinemonitoringandcontrolofasterilizationprocess.
【中国标准分类号】:C04
【国际标准分类号】:11_080_01
【页数】:52P;A4
【正文语种】:英语
【原文标准名称】:保健产品灭菌.医疗器械用消毒剂的特性和消毒方法的研发、验证及常规控制的一般要求
【标准号】:BSENISO14937-2009
【标准状态】:现行
【国别】:英国
【发布日期】:2010-03-31
【实施或试行日期】:2010-03-31
【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】:试剂;特性记述;定义;开发;γ辐射;保健;卫生学;检验;电离辐射;医疗器械;医疗设备;医疗产品;医学科学;医疗技术学;方法;工艺;合格;质量保证体系;辐射;规范;规范(验收);绝育;辐射灭菌;灭菌;灭菌器;杀菌器具;监督(认可);使用;证实
【英文主题词】:Agents;Characterisations;Definitions;Developments;Gamma-radiation;Healthprotection;Hygiene;Inspection;Ionizingradiation;Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Medicaltechnology;Methods;Processes;Qualifications;Qualityassurancesystems;Radiation;Specification;Specification(approval);Sterilization(birthcontrol);Sterilizationbyirradiation;Sterilization(hygiene);Sterilizers;Sterilizingapparatus;Surveillance(approval);Use;Validation
【摘要】:1.1.1ThisInternationalStandardspecifiesgeneralrequirementsforthecharacterizationofasterilizingagentandforthedevelopment,validationandroutinemonitoringandcontrolofasterilizationprocessformedicaldevices.1.1.2ThisInternationalStandardappliestosterilizationprocessesinwhichmicroorganismsareinactivatedbyphysicaland/orchemicalmeans.1.1.3ThisInternationalStandardisintendedtobeappliedbyprocessdevelopers,manufacturersofsterilizationequipment,manufacturersofmedicaldevicestobesterilized,andorganizationsresponsibleforsterilizingmedicaldevices.1.1.4ThisInternationalStandardspecifiestheelementsofaQualityManagementSystemwhicharenecessarytoassuretheappropriatecharacterizationofthesterilizingagent,development,validationandroutinemonitoringandcontrolofasterilizationprocess.
【中国标准分类号】:C04
【国际标准分类号】:11_080_01
【页数】:52P;A4
【正文语种】:英语
下载地址: 点击此处下载
