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ISO 14644 Series

ISO 14644 Series

ISO 14644 Series

ISO 14644 consists of the following parts, under the general title “Cleanrooms and associated controlled environments”:
Published: 23 April 2024

Each part is sold separately and can be purchased through BSI in the UK

  • Part 1: (2015) Classification of air cleanliness by particle concentration
  • Part 2: (2015) Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration.
  • Part 3: (2019) Test methods
  • Part 4: (2022) Design, construction, and start-up
  • Part 5: (2004)* Operations
  • Part 6: (2007) Vocabulary
  • Part 7: (2004)* Separative devices (clean air hoods, gloveboxes, isolators and mini environments)
  • Part 8: (2022)** Assessment of air cleanliness by chemical concentration
  • Part 9: (2022)** Assessment of surface cleanliness for particle concentration
  • Part 10: (2022)** Assessment of surface cleanliness by chemical concentration
  • Part 11: Number not used
  • Part 12: (2018) Classification of air cleanliness by nanoscale particle concentration
  • Part 13: (2017)* Cleaning of surfaces to achieve defined levels of cleanliness in terms of particle and chemical classifications.
  • Part 14: (2016)* Assessment of suitability for use of equipment by airborne particle concentration
  • Part 15: (2017)* Assessment of suitability for use of equipment and materials by airborne chemical and surface chemical concentration
  • Part 16: (2019) Energy considerations (replaced BS8568:2013)
  • Part 17: (2021) Particle deposition rate applications
  • Part 18: (2023) Assessment of suitability of consumables
  • Part 19: General technical requirements of modular isolation units for emergency medical use UNDER DEVELOPMENT
  • Part 20: Microbiological contamination control UNDER DEVELOPMENT
  • Part 21: (2023) Airborne particle sampling techniques

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Peter Phillips

I knew of Toni and her team from around 2003 and the days of their Clean Tent business. With a small new business that needed a clean room, I went straight back. Very helpful discussion with Toni led me to choosing a custom lamina flow hood (cheaper!) which was delivered bang on time, immediately passed an ISO 1385 audit and has been cheerfully maintained ever since. I'd go back to ISOClean because they know their stuff and do what they say.


ISO Cleanroom were very easy and practical to work with. Both Toni and Amaleed were knowledgeable and very flexible - looking forward to working with them in for future projects.

Siobhan Carey

I recently contracted Iso Cleanroom to design and build two modular ISO Class 6 cleanrooms so that our small orthobiologics company could implement in-house manufacture. They delivered on all of their commitments on cost, schedule and quality with no fuss. They showed up they day they said the would and finished up the day they said they would. They were extremely organised and meticulous, and helped us to address some unforeseen issues that cropped up during the installation.

Gareth Evans

We contracted ISO Cleanroom to design, build and validate a large cleanroom in our new facility. Toni really knows her business, and was very helpful through the design process, enabling us to make the most of the available space. When it came to installation, Anthony and his team did an exceptional job, keeping the install to schedule. We are very happy with the professional service we have had from ISO Cleanroom and would not hesitate in recommending others to use them for any cleanroom requirements.