Superseded
Draft standard
Historical
DIN EN 556-2:2014-02
Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE'' - Part 2: Requirements for aseptically processed medical devices; German version prEN 556-2:2014
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Summary
This European Standard specifies the requirements for an aseptically processed medical device to be designated 'STERILE'. NOTE For the purpose of the EU Directive (s) for medical devices (see Bibliography), designating that a medical device is 'STERILE' is permissible when a validated manufacturing and sterilization process has been applied. Requirements for validation and routine control of aseptic processes are specified in EN ISO 13408-1. Specific requirements for the aseptic processing of solid medical devices and combination products are specified in EN ISO 13408-7 (in preparation).
Notes
Prévu pour remplacer DIN EN 556-2 (2004-03).
Technical characteristics
| Publisher | Deutsche Institut für Normung e.V. (DIN) |
| Publication Date | 02/01/2014 |
| Cancellation Date | 11/01/2015 |
| Page Count | 17 |
| EAN | --- |
| ISBN | --- |
| Weight (in grams) | --- |
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