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Medical device manufacturers generally perform bioburden testing on samples and environmental monitoring on manufacturing facilities. The result of both tests is a count of the number of microorganisms present. It is important to identify the microorganisms represented by the count. ...
According to AAMI/ISO 11137, medical device manufacturers need to know the “number and types of microorganisms” found on their devices before sterilization. The bioburden test provides the number of microorganisms, and the Gram stain test can determine the types. The Gram...
