Diseño, instalación, puesta en marcha, cualificación, gestión y mantenimiento
La norma proporciona las indicaciones para el diseño, la instalación, la puesta en marcha, el control de las prestaciones, la aceptación, la gestión de los equipos y de los componentes, usados para el control de la contaminación ambiental y el mantenimiento de condiciones termo-higrométricas predeterminadas en las secciones específicamente destinadas al desarrollo de actividades quirúrgicas, denominados módulo quirófano.
La norma se aplica a las nuevas realizaciones y a las remodelaciones de las construcciones y/o de instalaciones de los módulos quirófanos e indica los requisitos mínimos para verificar las condiciones de uso de los existentes.
A continuación, facilitamos los valores recomendados por la UNI 11425 para los valores ambientales y algunas grandezas relacionadas con ellos;
Para alcanzar la clase de pureza del aire deseada en los varios ambientes, la norma indica también el grado mínimo de eficiencia de los filtros de aire:
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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