NBN EN ISO 11737-2 : 2010
Current
The latest, up-to-date edition.
STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS
12-01-2013
1 Scope
2 Normative references
3 Terms and definitions
4 General
5 Selection and preparation of product units for
testing
6 Tests of sterility
7 Assessment of method for test of sterility
Annex A (informative) Guidance on tests of sterility
performed in validation of a
sterilization process
Bibliography
Establishes the general requirements for tests on medical devices that have been exposed to a treatment with the sterilizing agent that is a fraction of the specified sterilization process. These tests are intended to be carried out when validating a sterilization process. Does not apply to sterility testing for routine release of product that has been subjected to a sterilization process, nor to performance of a pharmacopoeial sterility test.
| DocumentType |
Standard
|
| PublisherName |
Belgian Standards
|
| Status |
Current
|
| Standards | Relationship |
| EN ISO 11737-2:2009 | Identical |
| NS EN ISO 11737-2 : 2009 | Identical |
| BS EN ISO 11737-2:2009 | Identical |
| UNE-EN ISO 11737-2:2010 | Identical |
| ISO 11737-2:2009 | Identical |
| SN EN ISO 11737-2 : 2010 | Identical |
| I.S. EN ISO 11737-2:2009 | Identical |
| NEN EN ISO 11737-2 : 2009 | Identical |
| DIN EN ISO 11737-2:2010-04 | Identical |
| NF EN ISO 11737-2 : 2010 | Identical |
| UNI EN ISO 11737-2 : 2010 | Identical |
| ONORM EN ISO 11737-2 : 2010 | Identical |
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