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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).
Reģistrācijas numurs (WIID)
21434
Darbības sfēra
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).
