Sterilization of health care products — Chemical indicators — Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration

CSA Group
Standards Development Organisation:
Canadian Standards Association (operating as CSA Group)
Working Program:
View the CSA work program
Designation Number:
CAN/CSA-ISO 11140-4
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 performance for a Class 2 indicator to be used as an alternative to the 
Bowie and Dick-type test for steam sterilizers for wrapped health care goods (instruments, etc., and porous 
loads). 
NOTE The Bowie and Dick-type test is used for routine testing of steam sterilizers and validation of steam 
sterilization processes. 
An indicator complying with this part of ISO 11140 incorporates a specified material which is used as a test 
load. This test load may, or may not, be re-usable. This part of ISO 11140 does not specify requirements for 
the test load, but specifies the performance of the indicator in combination with the test load with which it is 
intended to be used. The indicator specified in this part of ISO 11140 is intended to identify poor steam 
penetration but does not necessarily indicate the cause of this poor steam penetration. 
This part of ISO 11140 does not include test methods to establish the suitability of these indicator systems for 
use in sterilizers in which the air removal stage does not include evacuation below atmospheric pressure.

Project need:

To review the Standard within the required 5 year period.

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