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CAN/CSA-ISO 11138-5:17:2017 Edition

CAN/CSA-ISO 11138-5:17:2017 Edition

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Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes

Published By Publication Date Number of Pages
CSA 2017-08-01 27
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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.

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