Preface:

This is the first edition of CSA Z11138-7, Sterilization of health care products — Biological indicators — Part 7: Guidance for the selection, use and interpretation of results, which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard 11138-7 (first edition, 2019-03). It replaces CAN/CSA-Z14161:11 (adopted ISO 14161:2009), Sterilization of health care products — Biological indicators — Guidance for the selection, use and interpretation of results.

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.

Scope:

This document provides guidance for the selection, use and interpretation of results from application of biological indicators when used in the development, validation and routine monitoring of sterilization processes.

It does not consider those processes that rely solely on physical removal of microorganisms, e.g. filtration.

It is not applicable to combination processes using, for example, washer-disinfectors or flushing and steaming of pipelines.

It does not specify requirements for the selection and use of biological indicators intended to monitor vaporised hydrogen peroxide processes for isolator and room biodecontamination processes at atmospheric pressure.

It is not applicable to liquid immersion sterilization processes.