ISO 18472-2006 保健产品的消毒.生物和化学指示剂.试验器械

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                   【英文标准名称】:     Sterilization of health care products - Biological and chemical indicators - Test equipment            【原文标准名称】:     保健产品的消毒.生物和化学指示剂.试验器械            【标准号】:     ISO 18472-2006            【标准状态】:     现行            【国别】:     国际            【发布日期】:     2006-06    【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】: 生物指示剂;特性;检验设备;化学指示剂;定义;文献工作;特点;医疗卫生事业;指示器;医学科学;性能要求;记录;规范(验收);灭菌;杀菌器具;试验设备;试验;试验装置【英文主题词】: Biochemicals;Bio-indicators;Biological hazards;Biological systems;Characteristics;Checking equipment;Chemical indicators;Definitions;Documentations;Efficiency;Ethylene oxide;Features;Germs;Health services;Heat;Hot air sterilizers;Indicators;Inoculation;Marking of roads;Medical equipment;Medical sciences;Methods;Microbiological analysis;Microorganisms;Operationackageserformance requirementsopulation;Qualifications;Rating tests;Recording;Recording equipment;Recording systems;Resistance;Sequence of operations;Specification (approval);Steam sterilizers;Sterilization (hygiene);Sterilizers;Sterilizing apparatus;Sterilizing gases;Surveillance (approval);Survival characteristics;Systems;Test equipment;Test germs;Testing;Testing devices;Use;Validation;Vapours【摘要】: 1.1      This International Standard specifies the requirements for test equipment to be used to test chemical and biological indicators for steam, ethylene oxide, dry heat and vaporized hydrogen peroxide processes for conformity to the requirements given in ISO 11140-1 for chemical indicators, or the requirements given in the ISO 11138 series for biological indicators. This International Standard also provides informative methods useful in characterizing the performance of biological and chemical indicators for intended use and for routine quality control testing.ISO 11138-2, ISO 11138-3, ISO 11138-4, and ISO 11140-1 require the use of resistometers specified in this International Standard, and these resistometers are used in conjunction with the test methods specified in the appropriate parts of ISO 11138 and ISO 11140.NOTE         Resistometers for formaldehyde indicators are not included in this International Standard. Test methods usinglaboratory apparatus for steam-formaldehyde are included in ISO 11138-5, ISO 11140-3 and ISO 11140-4.1.2      This International Standard does not address the methods used to demonstrate compliance of biological or chemical indicators to ISO 11138 and ISO 11140, as these are covered in the appropriate parts of these standards. Indicators used with combination processes, such as washer-disinfection, are not covered by this International Standard.NOTE         Test equipment and methods necessary for ISO 11140-3, ISO 11140-4 or ISO 11140-5 are specified in thosestandards.1.3      This International Standard does not address safety aspects of the test equipment because these are usually covered by specific regional, national or local regulations.【中国标准分类号】: C47【国际标准分类号】: 11_080_20【页数】: 28P;A4【正文语种】: 英语