ISO 11737-1-2006 医疗器械灭菌.微生物学方法.第1部分:产品上微生物群落的测定

sigh007

                   【英文标准名称】:     Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products            【原文标准名称】:     医疗器械灭菌.微生物学方法.第1部分:产品上微生物群落的测定            【标准号】:     ISO 11737-1-2006            【标准状态】:     现行            【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/TC 198【标准类型】: ()【标准水平】: ()【中文主题词】: 细菌纲;细菌计数;细菌学质量;特性;污染;计数;定义;测定;估计;卫生学;检验;医疗设备;医疗器械;医疗产品;医学科学;微生物分析;微生物;包装件;种群;质量保证;质量管理;原材料;安全;规范(验收);无菌;灭菌;证实【英文主题词】: Analysis;Applications;Assessment;Bacteria;Bacterial count;Bacteriological quality;Biological hazards;Characteristics;Colony count;Concentration;Conditions;Contamination;Corrrections;Counting;Culture;Culture media;Definitions;Determination;EDP;Elections;Equipment;Estimation;Evaluations;Filtration;Germs;Guide books;Hygiene;Incubation;Inspection;Instruments;Laboratories;Laboratory testing;Limits (mathematics);Loading;Materials;Mathematical calculations;Media;Medical devices;Medical equipment;Medical instruments;Medical products;Medical sciences;Membranes;Methods;Methods of manufacture;Microbiological;Microbiological analysis;Microbiology;Micro-organisms;Microorganisms;Operationackagesatternsersonnelopulationroducts;Quality assurance;Quality management;Raw materials;Reclamation;Release;Safety;Samples;Sampling methods;Selection;Solutions;Specification (approval);Sterile;Sterility;Sterilization (hygiene);Substances;Testing;Transfer;Transport;Treatment;Validation;Verification【摘要】: This part of ISO 11737 specifies requirements and provides guidance for the enumeration and microbialcharacterization of the population of viable microorganisms on or in a medical device, component, rawmaterial or package.This part of ISO 11737 does not specify requirements for the enumeration or identification of viral or protozoancontaminants.This part of ISO 11737 does not specify requirements for the microbiological monitoring of the environment inwhich medical devices are manufactured.【中国标准分类号】: C30【国际标准分类号】: 07_100_10;11_080_01【页数】: 35P;A4【正文语种】: 英语         
         

nimo_chen

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sue2022

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wisemedical

下载链接呢，咋么看不到