RO
SR EN 556-2:2004
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices
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 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).
Status :
Withdrawn
Approval date : 11/20/2004
Publish date : 11/21/2004
Romanian version publish date : 12/4/2009
Withdrawal date : 2/29/2016
Number of pages : 12
ICS : 11.080.01 Sterilization and desinfectation
Technical Committee : 377 - Medical devices
- Normative reference SR EN ISO 13485:2004
- Normative reference SR EN ISO 17665-1:2007
- Normative reference SR EN ISO 11135-1:2007
- Normative reference SR EN ISO 11137-1:2006
- Replaced by SR EN 556-2:2016