Stérilisation des produits de santé - Indicateurs chimiques - Partie 1: Exigences générales

This part of ISO 11140 specifies general requirements and test methods for indicators that show exposure 
to sterilization processes by means of physical and/or chemical change of substances, and which are 
used to monitor the attainment of one or more of the process parameter(s) specified for a sterilization 
process. They are not dependent for their action on the presence or absence of a living organism.

NOTE 1 Biological test systems are regarded as those test systems which are dependent for their interpretation on the demonstration of the viability of an organism. Test systems of this type are considered in the ISO 11138- series for biological indicators (BIs).
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 by a subsequent part, in 
which case the requirement of that particular part will apply. Relevant test equipment is 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.