【英文标准名称】:Sterilizationofhealthcareproducts-Liquidchemicalsterilizingagentsforsingle-usemedicaldevicesutilizinganimaltissuesandtheirderivatives-Requirementsforcharacterization,development,validationandroutinecontrolofasterilizationpro
【原文标准名称】:保健品灭菌.利用动物组织及其衍生物的一次使用性医疗器械所用液体化学灭菌剂.医疗器械灭菌过程的特征,开发,验证和常规控制要求
【标准号】:ANSI/AAMI/ISO14160-2011
【标准状态】:现行
【国别】:美国
【发布日期】:2011
【实施或试行日期】:
【发布单位】:美国国家标准学会(US-ANSI)
【起草单位】:ANSI
【标准类型】:()
【标准水平】:()
【中文主题词】:
【英文主题词】:Animal;Animalproducts;Aseptic;Bacterialcount;Biologicalhazards;Calibration;Certification;Characterisations;Checks;Chemical;Chemicals;Clearing;Compatibility;Contamination;Definitions;Derivatives;Developments;Disposable;Disposables;Efficiency;Equipmentforsingleuse;Evaluations;Fabrics;Germicides;Germs;Guidebooks;Incubation;Information;Insulations;Kinetics;Liquid;Liquidmaterials;Liquids;Loading;Media;Medicaldevices;Medicalproducts;Methods;Microbiological;Micro-organisms;Neutralization;Performance;Personnel;Production;Products;Publichealth;Screening-method;Sterileequipment;Sterilization(hygiene);Surveillance(approval);Training;Use;Validation
【摘要】:Specifiesrequirementsforthedevelopment,validation,processcontrolandmonitoringofthesterilization,bytheuseofliquidchemicalsterilants,ofsingle-usemedicaldevicescomprising,inwholeorinpart,materialsofanimalorigin.
【中国标准分类号】:C47
【国际标准分类号】:11_080_20
【页数】:
【正文语种】:英语