UNE-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
Spanish, Castilian, English
08-11-2017
This part of ISO 11138 provides specific 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 1Requirements for validation and control of ethylene oxide sterilization processes are provided by ISO 11135.NOTE 2National or regional regulations could provide requirements for work place safety.
| Committee |
CTN 111
|
| DevelopmentNote |
Supersedes UNE EN 866-2 & UNE EN 866-8. (04/2007)
|
| DocumentType |
Standard
|
| Pages |
14
|
| PublisherName |
Asociación Española de Normalización
|
| Status |
Current
|
| Standards | Relationship |
| BS EN ISO 11138-2:2017 | Identical |
| 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 |
| I.S. EN ISO 11138-2:2017 | Identical |
| ISO 11138-2:2017 | Identical |
| NS 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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