SS-EN-ISO-11138-2 › Historical Revision Information
Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006)

SS-EN-ISO-11138-2 - 2009 EDITION - SUPERSEDED
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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.

To find similar documents by classification:

11.080 (Sterilization and disinfection)

11.080.01 (Sterilization and disinfection in general Including sterilization methods, air quality of surgery rooms, etc.)

11.080.20 (Disinfectants and antiseptics Chemicals for industrial and domestic disinfection purposes, see 71.100.35)


Medical devices

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Designation Name

SS-EN ISO 11138-2:2009

Revision Level

2009 EDITION

Status

Superseded

Publication Date

May 18, 2009

Language(s)

English

Page Count

20

International Equivalent

EN ISO 11138-2:2009(IDT); ISO 11138-2:2006(IDT)