DIN EN ISO 11140-1-2009 保健产品的消毒.化学指示剂.第1部分:一般要求(ISO 11140-1-2005).英文版本DIN EN ISO 11140-1-2009-09

标准号：DIN EN ISO 11140-1-2009
中文标准名称：保健产品的消毒.化学指示剂.第1部分:一般要求(ISO 11140-1-2005).英文版本DIN EN ISO 11140-1-2009-09
英文标准名称：Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005); English version of DIN EN ISO 11140-1:2009-09
标准类型：C05
发布日期：1999/12/31 12:00:00
实施日期：2009/9/1 12:00:00
中国标准分类号：C05
国际标准分类号：11.080.20
引用标准：ISO 8601;ISO 11138;ISO 11607;ISO 18472
适用范围：1.1 This part of ISO 11140 specifies general requirements and test methods for indicators that showexposure to sterilization processes by means of physical and/or chemical change of substances, and whichare used to monitor the attainment of one or more of the variables required for a sterilization process. Theyare 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 thedemonstration of the viability of an organism. Test systems of this type are considered in the ISO 11138 sedes forbiological 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 whichcase 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 11140-4and ISO 11140-5.