Conception, installation, mise en marche, qualification, gestion et entretien.
La norme fournit des indications pour la conception, l’installation, la mise en marche, le contrôle des prestations, l’acceptation, la gestion des installations et des composants concourant au contrôle de la contamination environnementale et au maintien des conditions thermo-hygrométriques établies dans les services spécifiques de chirurgie, appelés blocs opératoires.
La norme s’applique aux nouvelles réalisations et à la restauration de bâtiments et/ou aux installations de blocs opératoires. Elle fournit les exigences minimums pour vérifier les conditions d’utilisation des blocs existants.
Nous reportons ci-dessous les valeurs recommandées par la norme UNI 11425 des paramètres environnementaux et des certaines grandeurs leurs étant associées;
Pour atteindre la classe de purification de l’air souhaitée dans les différents lieux, la norme indique également le stade d’efficacité minimum des filtres d’air:
Rooms | Temperature [°C] | U.R. [%] | Overpressure compared to outdoors [Pa] | Outdoor air [vol/h] | Recirculation air [-] | Cleanliness classes in accordance with UNI EN ISO 14644-1 | Final filtering levele | Sound pressure level [dBA] | ||
---|---|---|---|---|---|---|---|---|---|---|
Winter | Summer | Winter | Summer | |||||||
Operating theatres with very high air quality | ≥22 | ≤24 | ≥40 | ≤60 | 15 (1) | 15 | SI (2) | ISO5 | H14 | 45 (3) |
Operating theatres with high air quality | 15 (1) | 15 | SI (2) | ISO7 | H14 | 45 (3) | ||||
Operating theatres with standard air quality | 15 (1) | 15 | – (4) | ISO8 | H14 | 45 (3) | ||||
Sterile deposits | ≥22 | ≤26 | ≥40 | ≤60 | 15 | ≥2 (5) | – (4) | – | H14 | 45 |
Preparation of patients undergoing surgery | 10 | ≥2 (5) | – (4) | – | ≥H12 | – | ||||
Staff preparation | 10 | ≥2 (5) | – (4) | – | ≥H12 | – | ||||
Waking up patients who have undergone surgery | 10 | ≥2 (5) | – (4) | – | ≥H12 | – | ||||
Clean / sterile corridor | 10 | ≥2 (5) | – (4) | – | ≥H12 | – | ||||
Spaces for filters used for patients undergoing surgery | 5 | ≥2 (5) | – (4) | – | ≥F9 | – | ||||
Spaces for filters used for staff | 5 | ≥2 (5) | – (4) | – | ≥F9 | – | ||||
Sub-sterilization | 10 | ≥2 (5) | – (4) | – | ≥H12 | – | ||||
Clean deposits | ≥18 | ≤26 | ≥40 | ≤60 | 10 | ≥2 (5) | – (4) | – | ≥H12 | – |
Dirty deposits | 5 | ≥2 (5) | NO | – | ≥HF9 | – | ||||
(1) The pressure in operating theatres used for infected patient is lower compared to adjacent rooms (2) Please refer to the examples in annex D (3) In the event of renovation works where it is necessary to create class IOS5 operating theatres using room recirculation systems, the max noise level that can be reached is 48 dB(A9) and the project must contain the reason for the decision (4) Depending on how clean the air needs to be, as well as the monitoring (5) Minimum value if there are no other values that, set in relation to the specific crowding needs, sources of pollutants and based on a risk analysis Values required by current laws (Decree of the President of the Republic dated 14/1/1997) |
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