BS-EN-556-2 › Sterilization of medical devices. Requirements for medical devices to be designated 'STERILE'
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Part 2 of BS EN 556 specifies the requirements for an aseptically processed medical device to be designated “STERILE”.
Designation of a medical device as “STERILE” is only permissible when a validated sterilization process has been applied.
Particulate materials;Contaminants;Quality control;Microorganisms;Medical instruments;Sterilization (hygiene);Medical equipment;Contamination;Controlled-atmosphere rooms;Sterile equipment;Environment (working)
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BS EN 556-2:2015
Sept. 30, 2015
BS EN 556-2:2003