CAN/CSA-ISO 11138-2:17
Current
The latest, up-to-date edition.
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)
Hardcopy , PDF
English, French
01-01-2017
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Test organism
6 Suspension
7 Carrier and primary packaging
8 Inoculated carriers and biological indicators
9 Population and resistance
Annex A (normative) - Method for determination of
resistance to ethylene oxide sterilization
Annex B (informative) - Rationale for the inclusion
of a second minimum D value specification as a
result of changes to the test gas used to evaluate
resistance and deletion of the requirement for a
minimum D value at 30 degrees C
Bibliography
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