ISO 11138-2:2006
Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes

Standard No.

ISO 11138-2:2006

Release Date

2006

Published By

International Organization for Standardization (ISO)

Status

Be replaced

Replace By

ISO 11138-2:2017

Latest

ISO 11138-2:2017

Scope

This part of ISO 11138 provides specific 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. NOTE 2 National or regional regulations could provide requirements for work place safety.

ISO 11138-2:2006 Referenced Document

• ISO 11138-1:2006 Sterilization of health care products - Biological indicators - Part 1: General requirements
• ISO 18472 Sterilization of health care products - Biological and chemical indicators - Test equipment*， 2018-07-31 Update

ISO 11138-2:2006 history

• 2017 ISO 11138-2:2017 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
• 2006 ISO 11138-2:2006 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
• 1994 ISO 11138-2:1994 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization