BS-EN-556-2 › Sterilization of medical devices. Requirements for medical devices to be designated STERILE. Requirements for aseptically processed medical devices
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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.
Medical equipment, Medical instruments, Sterile equipment, Sterilization (hygiene), Quality control, Controlled-atmosphere rooms, Environment (working), Microorganisms, Particulate materials, Contaminants, Contamination
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BS EN 556-2:2015
Sept. 30, 2015
BS EN 556-2:2003