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CAN/CSA-ISO 11138-2:17

Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes (Adopted ISO 11138-2:2017, third edition, 2017-03)

SKU: 2704215 Published by CSA Group Publication Year 2017

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Preface/Scope
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This is the first edition of CAN/CSA-ISO 11138-2, Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 11138-2 (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 sterilizers and sterilization processes employing ethylene oxide gas as the sterilizing agent, either as pure ethylene oxide gas or mixtures of this gas with diluent gases, at sterilizing temperatures within the range of 29 °C to 65 °C.

NOTE 1 Requirements for validation and control of ethylene oxide sterilization processes are provided by ISO 11135 and ISO 14937.

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

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CAN/CSA-ISO 11138-2:17

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CAN/CSA-ISO 11138-2:17

Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes (Adopted ISO 11138-2:2017, third edition, 2017-03)

CAN/CSA-ISO 11138-2:F17

Stérilisation des produits de santé — Indicateurs biologiques — Partie 2 : Indicateurs biologiques pour la stérilisation à l’oxyde d’éthylène (norme ISO 11138-2:2017 adoptée, troisième édition, 2017-03)

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CAN/CSA-ISO 11138-2:17

Product Details

CAN/CSA-ISO 11138-2:17

Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes (Adopted ISO 11138-2:2017, third edition, 2017-03)

CAN/CSA-ISO 11138-2:F17

Stérilisation des produits de santé — Indicateurs biologiques — Partie 2 : Indicateurs biologiques pour la stérilisation à l’oxyde d’éthylène (norme ISO 11138-2:2017 adoptée, troisième édition, 2017-03)