ONORM EN ISO 11737-2 : 2010
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by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
15-06-2020
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.
| Committee |
TC 215
|
| DocumentType |
Standard
|
| PublisherName |
Osterreichisches Normungsinstitut/Austrian Standards
|
| Status |
Withdrawn
|
| SupersededBy |
| Standards | Relationship |
| ISO 11737-2:2009 | Identical |
| NBN EN ISO 11737-2 : 2010 | Identical |
| NEN EN ISO 11737-2 : 2009 | Identical |
| NS EN ISO 11737-2 : 2009 | Identical |
| I.S. EN ISO 11737-2:2009 | Identical |
| SN EN ISO 11737-2 : 2010 | Identical |
| UNI EN ISO 11737-2 : 2010 | Identical |
| UNE-EN ISO 11737-2:2010 | Identical |
| BS EN ISO 11737-2:2009 | Identical |
| EN ISO 11737-2:2009 | Identical |
| NF EN ISO 11737-2 : 2010 | Identical |
| DIN EN ISO 11737-2:2010-04 | Identical |
| ONORM EN ISO 25424 : 2011 | STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| ISO 10012:2003 | Measurement management systems — Requirements for measurement processes and measuring equipment |
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