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Clean room requirements standards for ISO 13485:2016

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Guest user Created:   Sep 14, 2020 Last commented:   Sep 15, 2020

Clean room requirements standards for ISO 13485:2016

What are the cleanroom requirements standards for ISO13485:2016?

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Kristina Zvonar Brkić Sep 15, 2020

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:

Also, the following article may be useful:

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Sep 14, 2020

Sep 15, 2020