Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test

Designation Number:
CAN/CSA-ISO 11140-3
Standard Type:
National Standard of Canada - Adoption of International Standard
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 the requirements for chemical indicators to be used in the steam penetration 
test for steam sterilizers for wrapped goods, e.g. instruments and porous materials. The indicator for this 
purpose is a Class 2 indicator as described in ISO 11140-1. 
Indicators complying with this part of ISO 11140 are intended for use in combination with the standard test 
pack as described in EN 285. This part of ISO 11140 does not consider the performance of the standard test 
pack, but does specify the performance of the indicator systems. 

Project need:

To review the Standard within the required 5 year period.

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