NEN EN ISO 11737-2 : 2009
Withdrawn
View Superseded by
STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS
01-12-2013
06-01-2020
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
Defines the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent that is a fraction of the specified sterilization process.
| DocumentType |
Standard
|
| PublisherName |
Netherlands Standards
|
| Status |
Withdrawn
|
| SupersededBy |
| Standards | Relationship |
| DIN EN ISO 11737-2:2010-04 | Identical |
| NBN EN ISO 11737-2 : 2010 | Identical |
| NS EN ISO 11737-2 : 2009 | Identical |
| NF EN ISO 11737-2 : 2010 | Identical |
| BS EN ISO 11737-2:2009 | Identical |
| ISO 11737-2:2009 | Identical |
| EN ISO 11737-2:2009 | Identical |
| I.S. EN ISO 11737-2:2009 | Identical |
| UNE-EN ISO 11737-2:2010 | Identical |