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CSA ISO 11140-1:16 (R2021)
Sterilization of health care products — Chemical indicators — Part 1: General requirements
WARNING — The use of this part of ISO 11140 can involve hazardous materials, operations and equipment. This part of ISO 11140 does not purport to address all of the safety problems associated with their use. It is the responsibility of the user of this part of ISO 11140 to determine the applicability of national or regional regulatory requirements and to establish appropriate occupational health and safety practices prior to use of any hazardous materials, operations and/or equipment.
This is the third edition of CAN/CSA-ISO 11140-1, Sterilization of health care products — Chemical indicators — Part 1: General requirements, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 11140-1 (third edition, 2014-11-01). It supersedes the previous edition published in 2007 as CAN/CSA-Z11140-1 (adopted ISO 11140-1:2005). For brevity, this Standard will be referred to as CAN/CSA-ISO 11140-1 throughout.
This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group.
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.