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The health care sector requires the setting up of cleanrooms and associated controlled environments in which we endeavour to control the concentration of airborne particles, the temperature, humidity and pressure. This is a very diverse sector in light of its multiple activities (operating suites, central sterilisation areas, resuscitation rooms, sterile rooms, patient's rooms, analysis laboratories, treatment rooms, aseptic areas, etc.).


A clean room is surrounded by its shell, a physical barrier made up of partitions, ceilings, doors and floors separating various (classified and/or unclassified) areas which have to meet a certain number of design criteria or very specific performance requirements (mechanical performance, geometry, ergonomics, fire hazard properties, sound proofing, etc).

In the health care sector, the following contamination risks and areas may be identified:

  • Protecting patients and nursing staff (health care institutions) who could be contaminated by micro-organisms and particles,
  • Protecting manufactured products (sterile medical devices) which could be contaminated by micro-organisms and particles.

A cleanroom's design will have a direct impact on the safety of patients who are subject to nosocomial infections as well as on maintaining the level of sterility of medical devices.

Cleanrooms in this sector may be defined by classifying them into class 1 to 4 risk areas.  These are set out in the standard NF EN ISO 14 698-1 [July 1999] and reiterated in the standard NF S 90-351 [June 2003]. In appendix B of NF S 90-351, four levels, 1 to 4, are proposed in relation to the increasing technical performance of a facility. Risk control, mainly at a microbiological level, applies to level 2 to 4 areas.

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