BS EN ISO 11138-2:2017
Current
The latest, up-to-date edition.
Sterilization of health care products. Biological indicators Biological indicators for ethylene oxide sterilization processes
Hardcopy , PDF
English
30-04-2017
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
Describes 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 degrees C to 65 degrees C.
| Committee |
CH/198
|
| DevelopmentNote |
Supersedes BS EN 866-2, BS EN 866-8 & 04/30078099 DC (08/2006) Supersedes 15/30321505 DC. (04/2017)
|
| DocumentType |
Standard
|
| Pages |
18
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
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.
NOTE1 Requirements for validation and control of ethylene oxide sterilization processes are provided by ISO11135 and ISO14937 .
NOTE2 National or regional regulations can provide requirements for work place safety.
| Standards | Relationship |
| NEN EN ISO 11138-2 : 2017 | Identical |
| NBN EN ISO 11138-2 : 2009 | Identical |
| NF EN ISO 11138-2 : 2017 | Identical |
| EN ISO 11138-2:2017 | Identical |
| DIN EN ISO 11138-2:2015-10 (Draft) | Identical |
| NS EN ISO 11138-2 : 2017 | Identical |
| I.S. EN ISO 11138-2:2017 | Identical |
| ISO 11138-2:2017 | Identical |
| DIN EN ISO 11138-2:2017-07 | Equivalent |
| UNE-EN ISO 11138-2:2017 | Identical |
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