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Terminology and Definitions
Lipopolysaccharide component of the cell wall of Gram-negative bacteria that is heat stable and elicits a variety of inflammatory responses in animals and humans.
Endotoxin
Application of engineering and/or procedural systems to maintain conditions in a defined space within specified limits.
Environmental control
Expiry date
Date by which product should be used.
Specified actions for putting on protective garments in a manner commensurate with the cleanliness level of the room.
Gowning procedure
Measure of water vapour in the air expressed as a percentage of the maximum for a given temperature.
Relative humidity (rh)
Portion of the accompanying information that is essential for the safe and effective intended use of a medical device or accessory directed to the user of the medical device.
Instructions for Use (IFU)
The term includes microorganisms and other transmissible agents e.g. abnormal proteins.
Infectious Agents
Patients who have a deficient immune system, whether caused by disease or treatment, rendering them more susceptible to infection.
Immuno-Compromised
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