Planung, Installation, Inbetriebnahme, Qualifizierung, Betrieb und Wartung
Die Norm enthält Hinweise für die Planung, Installation, Inbetriebnahme, Leistungskontrolle, Abnahme und Verwaltung von Systemen und Komponenten, die zur Kontrolle der Umweltkontamination und zur Aufrechterhaltung vorgegebener thermohygrometrischer Bedingungen in den Abteilungen beitragen, die speziell für die Durchführung von chirurgischen Operationen, in sogenannten Operationsblöcken zur Anwendung kommen.
Die Norm gilt für Neubauten und Gebäude- und/oder Anlagensanierungen von Operationsblöcken und enthält die Mindestanforderungen zur Überprüfung der Betriebsbedingungen bestehender Anlagen.
Nachfolgend sind die von der Norm UNI 11425 empfohlenen Werte für die Umgebungsparameter und einige zugehörige Größen aufgeführt.
Um die gewünschte Luftreinheitsklasse in den verschiedenen Umgebungen zu erreichen, gibt die Norm auch den Mindestwirkungsgrad der Luftfilter an:
| 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) |
||||||||||
This website uses cookies to improve your experience while you navigate through the website. Out of these cookies, the cookies that are categorized as necessary are stored on your browser as they are as essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may have an effect on your browsing experience.
This website uses cookies to improve your experience while you navigate through the website. Out of these cookies, the cookies that are categorized as necessary are stored on your browser as they are as essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may have an effect on your browsing experience.
Necessary cookies are absolutely essential for the website to function properly. This category only includes cookies that ensures basic functionalities and security features of the website. These cookies do not store any personal information.
Any cookies that may not be particularly necessary for the website to function and is used specifically to collect user personal data via analytics, ads, other embedded contents are termed as non-necessary cookies. It is mandatory to procure user consent prior to running these cookies on your website.