ISO 14644

The EN ISO 14644 is a standard for cleanrooms and associated controlled room areas. Parts 1 and 2 of the standard replace the old U.S. Federal Standard 209E from. This has been used in previous years to determine a cleanroom classification. For this reason, the EN ISO 14644 builds on him, and the clean room classifications are comparable with those of the Federal Standard.

In Germany the standard as DIN standard DIN EN ISO 14644 is published.

The standard deals with the theme cleanrooms for the semiconductor region ( protect your product from the human and environmental conditions ), as well as for biological hazardous substances (protection of people and the environment from the product), but is also binding for the pharmaceutical industry, as parenteral (injection drug ) have to be produced as well under strict clean room conditions.

List the parts of the standard:

  • Part 1 Classification of air cleanliness
  • Part 2 Specifications for testing and monitoring to prove continued compliance with ISO 14644-1
  • Part 3 test methods
  • Part 4 Planning, implementation and start-up
  • Part 5 operating
  • Part 6 terms
  • Part 7 SD Module ( clean air hoods, gloveboxes, isolators and mini-environments )
  • Part 8 Classification of airborne molecular contamination
  • Part 9 Classification of surface particle cleanliness (currently draft, Booth 2.2010 )
309900
de