BS EN ISO 11140-1-2009 保健产品的灭菌.化学指示剂.一般要求

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                   【英文标准名称】:     Sterilization of health care products - Chemical indicators - General requirements            【原文标准名称】:     保健产品的灭菌.化学指示剂.一般要求            【标准号】:     BS EN ISO 11140-1-2009            【标准状态】:     现行            【国别】:     英国            【发布日期】:     2009-11-30    【实施或试行日期】: 2009-11-30【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】: 生物危害;化学指示剂;等级;分类;分类系统;定义;可处置物;干热;干燥度;英语;设备;环氧乙烷;甲醛;保健;热学;热处理;指示器;使用说明;电离;致电离辐射;文字书写;标志;道路标记;医疗器械;医疗产品;医学科学;医疗技术学;非生物的;包装件;性能;性能要求;光线疗法;过程;辐射;储存期限;规范;规范(验收);蒸汽灭菌;蒸汽灭菌器;灭菌;灭菌器;监督(认可);系统;测试;示踪法;使用;蒸气【英文主题词】: Biological hazards;Chemical indicators;Classes;Classification;Classification systems;Definitions;Disposables;Dry heat;Dryness;English language;Equipment;Ethylene oxide;Formaldehyde;Health protection;Heat;Heat treatment;Indicators;Instructions for use;Ionizing;Ionizing radiation;Letterings;Marking;Marking of roads;Medical devices;Medical products;Medical sciences;Medical technology;Non-biologicalackageserformanceerformance requirementshototherapyrocess;Radiation;Shelf life;Specification;Specification (approval);Steam sterilization;Steam sterilizers;Sterilization (hygiene);Sterilizers;Surveillance (approval);Systems;Testing;Tracer methods;Use;Vapours【摘要】: 1.1 This part of ISO 11140 specifies general requirements and test methods for indicators that show exposure to sterilization processes by means of physical and/or chemical change of substances, and which are used to monitor the attainment of one or more of the variables required for a sterilization process. They are not dependent for their action on the presence or absence of a living organism.NOTE Biological test systems are regarded as those tests which are dependent for their interpretation on the demonstration of the viability of an organism. Test systems of this type are considered in the ISO 11138 series for biological indicators (BIs).1.2 The requirements and test methods of this part of ISO 11140 apply to all indicators specified insubsequent parts of ISO 11140, unless the requirement is modified or added to by a subsequent part, in which case the requirement of that particular part will apply.Relevant test equipment is described in ISO 18472.NOTE Additional requirements for specific test indicators (Class 2 indicators) are given in ISO 11140-3, ISO 11140-4 and ISO 11140-5.【中国标准分类号】: C05【国际标准分类号】: 11_080_20【页数】: 38P.;A4【正文语种】: 英语