EN 556-2:2003
Withdrawn
Withdrawn
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices
Published date
12-17-2003
Publisher
Withdrawn date
06-30-2004
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This European Standard specifies the requirements for an aseptically processed medical device to be designated 'STERILE'.NOTEFor the purpose of the EU Directive(s) for medical devices (see Bibliography), designating that a medical device is 'STERILE' is only permissible when a validated sterilization process has been applied. Requirements for validation and routine control of aseptic processes are specified in prEN 13824 (in preparation).
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Withdrawn
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| Standards | Relationship |
| BS EN 556-2:2003 | Equivalent |
| BS EN 556-2:2003 | Identical |
| UNE-EN 556-2:2004 | Identical |
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