Draft Details

Designation:ISO 11138-7 (with Canadian deviations)
Review start date:Nov 13, 2020
Review end date:Jan 13, 2021
Contact email:jelena.vulovic(at)csagroup.org
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Draft Scope/Description:

The ISO 11138 series of Standards specifies general production, labelling, and performance requirements for the manufacture of biological indicators. These Standards provide detailed information on the qualification of biological indicators, but only limited information for the health care professional on the use of biological indicators.

In contrast, CAN/CSA-Z11138-7 contains much useful information on the use of biological indicators, although this information is presented in a manner that might not be easily understood by the health care professional.

Accordingly, this Annex attempts to present the information contained in CAN/CSA-Z11138-7 in a manner that can be easily interpreted and to address common questions about the use of biological indicators

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