标准摘要
[中文适用范围]： ISO 11140 的这一部分规定了 2 类指示器的性能，该指示器可用作包装医疗保健物品（仪器等和多孔负载）蒸汽灭菌器的 Bowie 和 Dick 型测试的替代方法。 注：Bowie 和 Dick 型测试用于蒸汽灭菌器的常规测试和蒸汽灭菌过程的验证。 符合 ISO 11140 这一部分的指示器包含用作测试负载的指定材料。 该测试负载可能会也可能不会重复使用。 ISO 11140 的这一部分没有规定测试负载的要求，但规定了指示器的性能与其预期使用的测试负载的结合。 ISO 11140 本部分规定的指标旨在识别蒸汽渗透不良，但不一定表明蒸汽渗透不良的原因。 ISO 11140 的这一部分不包括确定这些指示系统在灭菌器中使用的适用性的测试方法，其中空气去除阶段不包括低于大气压的抽空。 [外文原描述]： ISO 11140-4:2007 specifies the performance for a Class 2 indicator to be used as an alternative to the Bowie and Dick-type test for steam sterilizers for wrapped health care goods (instruments, etc. and porous loads). An indicator complying with ISO 11140-4:2007 incorporates a specified material which is used as a test load. This test load may, or may not, be re-usable. ISO 11140-4:2007 does not specify requirements for the test load, but specifies the performance of the indicator in combination with the test load with which it is intended to be used. The indicator specified in ISO 11140-4:2007 is intended to identify poor steam penetration but does not necessarily indicate the cause of this poor steam penetration. This part of ISO 11140-4:2007 does not include test methods to establish the suitability of these indicators for use in sterilizers in which the air removal stage does not include evacuation below atmospheric pressure.
英文名称Sterilization of health care products — Chemical indicators — Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration