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【英文标准名称】:Sterilizationofhealthcareproducts-Chemicalindicators-Part4:Class2indicatorsasanalternativetotheBowieandDick-typetestfordetectionofsteampenetration
【原文标准名称】:卫生保健品的灭菌.化学指示剂.第4部分:蒸汽穿透检测布维-狄(BowieandDick)形式试验的2级指示剂
【标准号】:ISO11140-4-2007
【标准状态】:现行
【国别】:国际
【发布日期】:2007-03
【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/TC198
【标准类型】:()
【标准水平】:()
【中文主题词】:空气;布维-狄克试验;化学指示剂;分类体系;定义;距离;设备;保健;指示器;作标记;医疗产品;医学科学;医疗技术学;非生物的;包装;穿透;个人保健;过程;规范;规范(验收);蒸汽灭菌;蒸汽灭菌器;灭菌;灭菌器;监督(认可);试验;示踪法;蒸汽
【英文主题词】:Aeration;Ageing(materials);Air;Biologicalhazards;Bodies;BowieandDicktest;Calibration;Checkingequipment;Chemicalindicators;Classificationsystems;Conditions;Control;Controlcharts;Cycle;Defects;Definitions;Density;Determinations;Distance;Equipment;Geometry;Healthprotection;Heat;Indications;Indicators;Information;Leakage;Lightingsystems;Limits(mathematics);Lowpressure;Marking;Measurement;Measuringinstruments;Medicaldevices;Medicalproducts;Medicalsciences;Medicaltechnology;Methods;Non-biological;Optics;Packages;Penetrations;Performance;Personalhealth;Process;Productinformation;Qualityassurance;References;Reflection;Sensitivity;Sensors;Sequenceofoperations;Signals;Specification;Specification(approval);Standards;Statistics;Steamsterilization;Steamsterilizers;Sterilization(hygiene);Sterilizers;Supply;Surveillance(approval);Systems;Testcycle;Testing;Testingconditions;Tracermethods;Use;Vapours;Verification;Wavelengths
【摘要】:ThispartofISO11140specifiestheperformanceforaClass2indicatortobeusedasanalternativetotheBowieandDick-typetestforsteamsterilizersforwrappedhealthcaregoods(instruments,etc.,andporousloads).NOTETheBowieandDick-typetestisusedforroutinetestingofsteamsterilizersandvalidationofsteamsterilizationprocesses.AnindicatorcomplyingwiththispartofISO11140incorporatesaspecifiedmaterialwhichisusedasatestload.Thistestloadmay,ormaynot,bere-usable.ThispartofISO11140doesnotspecifyrequirementsforthetestload,butspecifiestheperformanceoftheindicatorincombinationwiththetestloadwithwhichitisintendedtobeused.TheindicatorspecifiedinthispartofISO11140isintendedtoidentifypoorsteampenetrationbutdoesnotnecessarilyindicatethecauseofthispoorsteampenetration.ThispartofISO11140doesnotincludetestmethodstoestablishthesuitabilityoftheseindicatorsystemsforuseinsterilizersinwhichtheairremovalstagedoesnotincludeevacuationbelowatmosphericpressure.
【中国标准分类号】:C50
【国际标准分类号】:11_080_01;11_080_20
【页数】:35P;A4
【正文语种】:英语