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DIN EN 556-1:2002
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; English version of DIN EN 556-1
This European Standard specifies the requirements for a terminally-sterilized medical device to be designated 'STERILE'. NOTE: For the purpose of the EC Directives 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.
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Deutsches Institut für Normung [din]
Deutsches Institut für Normung [din]