Tasarım, kurulum, çalıştırma, yeterlilik, yönetim ve bakım.
Standart, tesislerde kontrollü kirlenmeye katkı sağlayan sistem ve parçaların tasarım, kurulum, başlatma, performans kontrol, kabul yönetimi ve spesifik olarak ameliyathane denilen ameliyat gerçekleştirmek için yapılmış birimlerde önceden ayarlı sıcaklık ve nem şartları için talimatları içermektedir.
Standart, ameliyathanelerdeki binalar ve/veya sistemlerle ilgili yeni sistemler ve yenilemeler için geçerlidir ve mevcut olanların kullanım şartlarını teyit etmek için asgari şartları verir.
Aşağıda, çevresel parametreler ve bunlarla ilgili bazı miktarlar için tavsiye edilen değerler bulunmaktadır.
Çeşitli odalarda tasarlanan hava saflık sınıfına ulaşmak için standart ayrıca hava filtreleri için asgari verimliliği de belirler
| 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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