BS-EN-556-1 › Sterilization of medical devices. Requirements for medical devices to be designated 'STERILE'
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Included in this current edition are the following subparts:
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.
Marking;Sterile equipment;Medical instruments;Quality assurance;Quality control;Sterilization (hygiene);Medical equipment;Microorganisms
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BS EN 556-1:2001
Nov. 30, 2006
BS EN 556:1995