BS-EN-556-1 › Sterilization of medical devices. Requirements for medical devices to be designated STERILE. Requirements for terminally sterilized medical devices
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AMD 16728 - Oct. 31, 2006
BS EN 556-1 is the standard that specifies the requirements for a terminally sterilized medical device to be designated “STERILE”.
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 assurance, Quality control, Marking, Microorganisms
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BS EN 556-1:2001
Dec. 11, 2001
BS EN 556:1995