NF 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
12-01-2013
Defines the 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 |
Indice de classement: S98-004-2. PR NF EN ISO 11138-2 October 2004. (10/2004) Supersedes NF EN 866-2 and NF EN 866-8. (11/2006) PR NF EN ISO 11138-2 February 2009. (02/2009)
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| DocumentType |
Standard
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| PublisherName |
Association Francaise de Normalisation
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| Status |
Current
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| Standards | Relationship |
| SN EN ISO 11138-2:2017 | Identical |
| EN ISO 11138-2:2017 | Identical |
| DIN EN ISO 11138-2:2015-10 (Draft) | Identical |
| ISO 11138-2:2017 | Identical |
| I.S. EN ISO 11138-2:2017 | Identical |
| UNE-EN ISO 11138-2:2017 | Identical |
| UNI EN ISO 11138-2 : 2009 | Identical |
| BS EN ISO 11138-2:2017 | Identical |
| NF EN ISO 11135-1 : 2007 | STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| NF CEN ISO/TS 11135-2 : 2008 | STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1 |
| NF EN ISO 18472 : 2006 | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL AND CHEMICAL INDICATORS - TEST EQUIPMENT |
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