ISO 11138-2:2017 (R2022)
Active , Reaffirmed Standard
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ISO 11138-2:2017 (R2022)

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

Summary

ISO 11138-2:2017 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.

Notes

90.93 : Norme internationale confirmée

Technical characteristics

Publisher International Organization for Standardization (ISO)
Publication Date 03/03/2017
Confirmation Date 12/09/2022
Edition 3
Page Count 6
EAN ---
ISBN ---
Weight (in grams) ---
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