CAN/CSA-ISO 11138-4:17 (R2022) ✓ Most Recent

CSA Preface

This is the first edition of CAN/CSA-ISO 11138-4, Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 11138-4 (second 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 dry heat as the sterilizing agent at sterilizing temperatures within the range of 120 ?C to 180 ?C.

NOTE 1 Requirements for validation and control of dry heat sterilization processes are provided by ISO 20857.

NOTE 2 Requirements for work place safety can be provided by national or regional regulations.