ISO 13485:2016
Resource management – ISO 13485:2016

ISO 13485:2016 6.4.2: Contamination control

As appropriate, the organization plans and documents arrangements for controlling contaminated or potentially contaminated product so it does not contaminate the work environment, personnel or product. For sterile medical devices it documents requirements for controlling contamination with microorganisms or particulate matter and maintains the required cleanliness during assembly or packaging.

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