NF EN ISO 14 644:

Clean rooms and related controlled environments.

  • 14 644-1: The classification of cleanliness of the air.
  • 14 644-2: Specification for testing and monitoring to demonstrate continued compliance with ISO 14 644-1.
  • 14 644-3: Metrology and test methods.

Annex 1 of the EU GMPs  (Good Manufacturing Practice).

 

EUROVENT 4.8:

  • In situ test method for leak detection of THE filters in controlled dust chambers.

 

FD S 98-113:

  • Medical devices, guide for their preparation in clean room.

 

NF EN 1632-4:

  • Clean room technology.
  • Part 4: Methods of analysis and measurement of aerobiocontamination in risk areas.

 

X 44-102:

  • Pregnant with controlled dust.
  • Definitions - classifications introduction to the procedure of reception and periodic inspection.

 

NF S 90-351:

  • Medical-surgical equipment.
  • Procedures for reception and control of operating rooms.

 

 

 



Normes