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CSA Z11138-7:21

Current Revision

Sterilization of health care products — Biological indicators — Part 7: Guidance for the selection, use and interpretation of results (Adopted ISO 11138-7:2019, with Canadian deviations)

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Sterilization of health care products — Biological indicators — Part 7: Guidance for the selection, use and interpretation of results (Adopted ISO 11138-7:2019, with Canadian deviations)

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.


SDO CSA: Canadian Standards Association
Document Number
Publication Date Jan. 1, 2021
Language en - English
Page Count
Revision Level
Supercedes
Committee
Publish Date Document Id Type View
Jan. 1, 2021 CSA Z11138-7:21 Revision
Jan. 1, 2021 CSA Z11138-7:F21 Revision