CAN/CSA-ISO 11138-3:17 (R2022) ✓ Most Recent

CSA Preface

This is the first edition of CAN/CSA-ISO 11138-3, Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 11138-3 (third edition, 2017-03).

Scope

This document specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing moist heat as the sterilizing agent.

NOTE 1 Requirements for validation and control of moist heat sterilization processes are provided by the ISO 17665 series.

NOTE 2 National or regional regulations can provide requirements for work place safety.

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