BS EN ISO 11138-2:2017
$102.76
Sterilization of health care products. Biological indicators – Biological indicators for ethylene oxide sterilization processes
| Published By | Publication Date | Number of Pages |
| BSI | 2017 | 18 |
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.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 4 | European foreword |
| 5 | Endorsement notice |
| 7 | Foreword |
| 8 | Introduction |
| 10 | 1 Scope 2 Normative references 3 Terms and definitions 4 General requirements 5 Test organism |
| 11 | 6 Suspension 7 Carrier and primary packaging 8 Inoculated carriers and biological indicators 9 Population and resistance |
| 13 | Annex A (normative) Method for determination of resistance to ethylene oxide sterilization |
| 14 | 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 °C |
| 15 | Bibliography |
