Cleanroom Standards
Also in this section:
The international cleanroom standards 'ISO 14644: Cleanrooms and Associated Controlled Environments' is currently replacing all national standards.
Below is a list of the current sections contained within the ISO 14644 standard:
- ISO 14644-1: Classification of air cleanliness
- ISO 14644-2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1
- ISO 14644-3: Test methods
- ISO 14644-4: Design, construction, and startup
- ISO 14644-5: Operations
- ISO 14644-6: Terms and definitions
- ISO 14644-7: Separative devices (clean air hoods, gloveboxes, isolators, mini-environments)
- ISO 14644-8: Classification of airborne molecular contamination
Below is a list of other commonly used standards within the cleanroom industry:
- US FED 209E (withdrawn)
- BS 5295 (withdrawn)
- EN 12469: 2000 Biotechnology - Performance criteria for microbiological safety cabinets
- BS 7258 (Laboratory Fume Cupboards)
- cGMP guidelines (Good Manufacturing Practice)
- FDA (Food and Drugs Administration)
- GLP guidelines (Good Laboratory Practice)
- MCA approvals (Medical Control Agency)
- MDR regulations (Medical Device Regulations)
- ISPE guidelines (The Society for Pharmaceutical and Medical Device Professionals)
- ACDP (Advisory Committee on Dangerous Pathogens)
Cleanrooms, Products and Servicing acquired from Bassaire will comply with all of the applicable standards shown.