Sterilization of health care products - Chemical indicators - Part 1: General requirements

2Scope / Description

This part of ISO 11140 specifies general requirements and test methods for indicators that reveal their exposure to sterilization processes through physical and/or chemical changes in substances and that are used to determine the achievement of one or more process parameters for a sterilization process are (is) to be monitored. Their effect is independent of the presence or absence of a living organism. NOTE 1 Biological test systems are those that depend on evidence of the viability of an organism for their evaluation. Test systems of this type are covered in the ISO 11138 series of standards for biological indicators (BI). The requirements and test methods of this part of ISO 11140 apply to all indicators specified in subsequent parts of ISO 11140, unless the requirement is modified or added to a subsequent part; in this case the requirement of this particular part applies. The corresponding testing devices are described in ISO 18472. NOTE 2 Additional requirements for specific test indicators/indicator systems (Type 2 indicators) are given in ISO 11140-3, ISO 11140-4 and ISO 11140-5.