CSA Preface

This is the first edition of CAN/CSA-ISO 11138-5, Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 11138-5 (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 low-temperature steam and formaldehyde as the sterilizing agent.

NOTE 1 Requirements for validation and control of low-temperature steam and formaldehyde sterilization processes are provided by ISO 14937.

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