Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes

Designation Number:
CAN/CSA-ISO 11138-2:17
Standard Type:
National Standard of Canada - Adoption of International Standard
Standard Development Activity:
Reaffirmation
ICS code(s):
11.080.01
Status:
Proceeding to development
SDO Comment Period Start Date:
SDO Comment Period End Date:
Posted On:

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.

Project need:

To review the Standard within the required 5 year period

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Individual SDOs are responsible for the content and accuracy of the information presented here. The text is presented in the language in which it was provided to SCC.