保健产品的消毒.生物和化学指示剂.试验器械

[中文适用范围]： 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过程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标是否符合 ISO 11140-1:2014 中给出的要求。 本文件还提供了有用的信息方法，可用于表征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。 本文件没有规定专门用于测试化学和生物指示剂的过程的测试设备的要求，这些指示剂旨在监测大气压下的隔离器和房间生物净化过程。 本文件中指定的电阻计，这些电阻计与 ISO 11138 系列和 ISO 11140 系列相应部分中指定的测试方法结合使用。 本文件不包括用于低温蒸汽和甲醛指示器的电阻计。 ISO 11138-5:2017 中包含使用实验室设备进行低温蒸汽和甲醛的测试方法。 ISO 11140-3:2007 中规定了用于测试 2 型（例如 Bowie Dick）化学指标的测试设备， [外文原描述]： 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.