I.S. EN ISO 11138-2:2017
Current
The latest, up-to-date edition.
STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 2: BIOLOGICAL INDICATORS FOR ETHYLENE OXIDE STERILIZATION PROCESSES (ISO 11138-2:2017)
Hardcopy , PDF
English
01-01-2017
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National Foreword
European foreword
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.
| DevelopmentNote |
Supersedes I.S. EN 866-2 and I.S. EN 866-8. (09/2006)
|
| DocumentType |
Standard
|
| Pages |
24
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| BS EN ISO 11138-2:2017 | Identical |
| NEN EN ISO 11138-2 : 2017 | Identical |
| UNE-EN ISO 11138-2:2009 | 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 |
| UNI EN ISO 11138-2 : 2009 | Identical |
| SN EN ISO 11138-2:2017 | Identical |
| ISO 11138-2:2017 | Identical |
| UNE-EN ISO 11138-2:2017 | Identical |
| ISO 11135:2014 | Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ISO 14937:2009 | Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices |
| ISO 18472:2006 | Sterilization of health care products Biological and chemical indicators Test equipment |
| ISO 11138-1:2017 | Sterilization of health care products — Biological indicators — Part 1: General requirements |
| ISO 14161:2009 | Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results |
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