1范围ISO 11140的本部分规定了通过物质的物理和/或化学变化显示暴露于灭菌过程的指示器的性能要求。注1:这些指示器用于监测一个或多个令人满意的灭菌过程所需参数的存在或实现情况，或用于灭菌设备的特定测试。ISO 11140的本部分还包括用于确定指标是否符合要求的验收标准。注2 ISO 11140-2中描述了相关试验方法和设备。注3:ISO 11140-3和ISO 11140-4中给出了（2级）渗透测试指示器的附加要求。

1ScopeThis part of ISO 11140 specifies performance requirements for indicators that show exposure to sterilization processes by means of physical and/or chemical change of substances.NOTE 1These indicators are used to monitor the presence or attainment of one or more of the parameters required for a satisfactory sterilization process, or are used in specific tests of sterilization equipment.This part of ISO 11140 also includes acceptance criteria used to establish whether or not an indicator complies with it.NOTE 2Relevant test methods and equipment are described in ISO 11140-2.NOTE 3Additional requirements for (Class 2) penetration test indicators are given in ISO 11140-3 and ISO 11140-4.