Summary

Specifies the classification of air cleanliness in cleanrooms and clean zones in terms of concentration of airborne particles. Defines ISO Classes 1 through 9. Essential for medical device manufacturers with cleanroom manufacturing requirements.

Standard Details

Standard Number: ISO 14644-1:2015
Type: ISO Standard
Published by: ISO
Official Link: https://www.iso.org/standard/53394.html

This standard is referenced in the harmonized standards lists for the EU Medical Device Regulation (MDR) 2017/745, EU In Vitro Diagnostic Regulation (IVDR) 2017/746, and is recognized by regulatory authorities worldwide including the FDA, Health Canada, and TGA.

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ISO 14644-1:2015 — Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness by particle concentration

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