Contamination Control - Class Is medical devices (Clause 6.4.2 ISO 13485:2016 (E))


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I have a question regarding 6.4.2 is 13485 referring to a clean room environment or contamination or product used equipment


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As someone has stated before, you need to demonstrate bioburden control before you can describe a device is sterile (10^-6). With fabric and paper bioburden control is extremely difficult as it often comes in the door with the raw material.

A clean room is by implication necessary. it may be called a CER (Controlled Environment Area) but without IQ, OQ, PQ you cannot demonstrate you are environmentally sampling in the correct areas (ie high particulate flows, max personnel etc). Without this you cannot demonstrate microbiological quality 7.3 of 11135, thus you cannot call you device sterile.

To clarify you do not need a cleanroom, but all the requirements for setting up and monitoring the cleanroom apply. Each study in the cleanroom set up process is used to support the sterility of the product that goes through the clean room.
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