本文件规定了用于以下目的的测试设备的要求: -测试蒸汽、环氧乙烷气体和干热灭菌工艺的生物指示剂是否符合ISO 11138系列中给出的要求； -测试蒸汽、环氧乙烷气体、干热和汽化过氧化氢灭菌过程的化学指示剂是否符合ISO 11140？1:2014中给出的要求。 本文件还提供了有用的信息方法，用于描述预期用途和常规质量控制测试的生物和化学指示剂的性能。 本文件未规定专门用于测试化学和生物指示剂（用于在大气压力下监测隔离器和室内生物去污过程）的过程的测试设备要求。 ISO 11138-2:2017、ISO 11138-3:2017、ISO 11138-4:2017和ISO 11140-1:2014要求使用本文件中规定的电阻计，这些电阻计与ISO 11138系列和ISO 11140系列相应部分中规定的试验方法一起使用。 本文件不包括低温蒸汽和甲醛指示剂的电阻计。ISO 11138-5:2017中包含了使用实验室仪器对低温蒸汽和甲醛进行测试的方法。 ISO 11140-3:2007、ISO 11140-4:2007和ISO 11140-5:2007中规定了用于测试类型2（如Bowie-Dick）化学指示剂的测试设备。

This document specifies the requirements for test equipment to be used to: — test biological indicators for steam, ethylene oxide gas and dry heat sterilization processes for conformity to the requirements given in ISO 11138 series; — test chemical indicators for steam, ethylene oxide gas, dry heat and vaporized hydrogen peroxide sterilization processes for conformity to the requirements given in ISO 11140？1:2014. This document also provides informative methods useful in characterizing the performance of biological and chemical indicators for intended use and for routine quality control testing. This document does not specify requirements for test equipment for processes specifically for testing chemical and biological indicators intended to monitor isolator and room biodecontamination processes at atmospheric pressure. ISO 11138？2:2017, ISO 11138？3:2017, ISO 11138？4:2017 and ISO 11140？1:2014 require the use of resistometers specified in this document, and these resistometers are used in conjunction with the test methods specified in the appropriate parts of ISO 11138 series and ISO 11140 series. Resistometers for low temperature steam and formaldehyde indicators are not included in this document. Test methods using laboratory apparatus for low temperature steam and formaldehyde are included in ISO 11138？5:2017. Test equipment for testing Type 2 (e.g. Bowie Dick) chemical indicators are specified in ISO 11140？3:2007, ISO 11140？4:2007, and ISO 11140？5:2007.