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

Designation Number:
CAN/CSA-ISO 11140-1:16
Standard Type:
National Standard of Canada - Domestic
Standard Development Activity:
Reaffirmation
ICS code(s):
11.080.01
Status:
Proceeding to development
SDO Comment Period Start Date:
SDO Comment Period End Date:
Posted On:

Scope:

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.

Project need:

To review the Standard within the required 5 year period.

Note: The information provided above was obtained by the Standards Council of Canada (SCC) and is provided as part of a centralized, transparent notification system for new standards development. The system allows SCC-accredited Standards Development Organizations (SDOs), and members of the public, to be informed of new work in Canadian standards development, and allows SCC-accredited SDOs to identify and resolve potential duplication of standards and effort.

Individual SDOs are responsible for the content and accuracy of the information presented here. The text is presented in the language in which it was provided to SCC.