CSA Z11138-7:21

1 Scope The CAN/CSA-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, this Standard 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 this Standard in a manner that can be easily interpreted and to address common questions about the use of biological indicators. This Standard consists of 16 main clauses and seven annexes. These provide general information on biological indicators and their use in process development, validation, and routine monitoring. For ease of reference, the clause numbers and clause titles of this Annex parallel the arrangement in this Standard. The format employed by many of the clauses of this Annex is to present quotations from this Standard in italic type followed by one or more paragraphs of commentary in roman (non-italic) type. Clauses CA.2, CA.3, CA.7, CA.8, CA.11, and CA.13 provide general information or commentary without quoted material. This Annex also includes two attachments. Attachment A addresses D-values. Attachment B provides answers to frequently asked questions on biological indicators.