CEN - EN 556-1
Sterilization of Medical Devices - Requirements for Medical Devices to Be Designated "Sterile" - Part 1: Requirements for Terminally Sterilized Medical Devices
|Publication Date:||1 October 2001|
|ICS Code (Sterilization and disinfection in general):||11.080.01|
This European Standard specifies the requirements for a
NOTE For the purpose of the EU Directive(s) for medical devices (see Bibliography), designation of a medical device as "STERILE" is only permissible when a validated sterilization process has been applied. Requirements for validation and routine control of processes for the sterilization of medical devices are specified in EN 550, EN 552, EN 554, EN ISO 14160 and EN ISO 14937.