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BS EN ISO 14644-5 Cleanrooms and associated controlled environments: Operations

Basic requirements for cleanrooms and associated controlled environment operations.

BS EN ISO 14644-5 specifies the basic requirements for cleanroom operations. Part 5 of BS EN ISO 14644 is intended for those planning to use and operate a cleanroom. Aspects of safety that have no direct bearing on contamination control are not considered in this part of ISO 14644.

National and local safety regulations have to be observed. This standard considers all classes of cleanrooms used to produce all types of products. Therefore, it is broad in application and does not address specific requirements for individual industries. Methods and programmes for routine monitoring within cleanrooms are not covered in detail in this part of ISO 14644 but reference is made to ISO 14644-2 and ISO 14644-3 for monitoring particles and ISO 14698-1 and ISO 14698-2 for monitoring micro-organisms.

This standard addresses normative and informative operational requirements related to:

  • Providing a system that defines policies and operational procedures
  • Clothing used to isolate human-generated contamination from the cleanroom environment
  • Training of personnel inside the cleanroom and monitoring their compliance to specified procedures and disciplines
  • Transfer, installation and maintenance of stationary equipment (selection criteria is not discussed)
  • Selection and use of materials and portable equipment in the cleanroom
  • Maintaining the cleanliness of the cleanroom through systematic cleaning and monitoring procedures.

BS EN ISO 14644-5 supersedes BS 5295-3:1989 which is withdrawn. Together with BS EN ISO 14644-4:2001, it supersedes DD ENV 1631:1996 which is now withdrawn.

See other cleanrooms standards in the BS EN ISO 14644 series.

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