CAN/CSA-Z11140-1-98 (R2004)

Scope

This 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 1
These 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 2
Relevant test methods and equipment are described in ISO 11140-2.

NOTE 3
Additional requirements for (Class 2) penetration test indicators are given in ISO 11140-3 and ISO 11140-4.