Clean room requirements standards for ISO 13485:2016

ISO organization has following standards dedicated to clean rooms, outlining the practices and procedures required to manage the risk of contamination, and provide the framework for classifying and monitoring the cleanliness of the air in cleanrooms:

• ISO 14644-1:2015, Cleanrooms and associated controlled environments – Part 1: Classification of air cleanliness by particle concentration https://www.iso.org/standard/53394.html
• ISO 14644-2:2015, Cleanrooms and associated controlled environments – Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration https://www.iso.org/standard/53393.html.

More information about managing the cleanliness of a product and contamination control according, you can find on the following link:

• Managing cleanliness of a product and contamination control according to ISO 13485:2016 https://advisera.com/13485academy/blog/2017/07/04/managing-cleanliness-of-a-product-and-contamination-control-according-to-iso-134852016/

Also, the following article may be useful:

• Managing medical device infrastructure requirements according to ISO 13485:2016 https://advisera.com/13485academy/blog/2017/06/28/managing-medical-device-infrastructure-requirements-according-to-iso-13485/