12.3.1 Mandatory Test Items for Engineering Inspection

The mandatory test items are as specified in the Code and listed in Table 12.11.

Table 12.11 Mandatory Test Items

Completion acceptance Comprehensive performance evaluation
Air volume and rotational speed of the fans Cross-sectional velocity at the working plane of the operating zone of each Class Ⅰ clean operating room and of the local Class 100 zone of Class Ⅰ auxiliary rooms
Air volume of systems and rooms and its balancing Air change rate of clean operating rooms of other classes and auxiliary rooms
Static pressure of systems and rooms and its adjustment Static pressure difference
Joint operation of the automatic control system Cleanliness class
HEPA filter leak test Temperature and humidity
Cleanliness class Noise
Cleanliness class Illuminance
Cleanliness class Fresh air volume
Cleanliness class Bacterial concentration

12.3.2 Test Items for Appraisal Acceptance

The test items required for the appraisal acceptance of the clean operating department project are listed in Table 12.12.

Table 12.12 Test Items for Appraisal Acceptance

Item Unit Instrument Height of measuring points Number and position of measuring points Measurement method Formula Requirements Remarks
Average cross-sectional velocity in the working zone of the Class 100 area of Class Ⅰ operating rooms and Class Ⅰ auxiliary rooms m/s Rod-type hot-bulb anemometer (0～10m/s) 0.8m above the floor or 0.25m above the operating table ① Evenly distributed over the area within 0.12m inside the boundary of the orthogonal projection of the concentrated air supply face ② Measuring points, with spacing between adjacent points not greater than 0.3m Extend the measuring rod and place the probe at each measuring point $bar{v}=dfrac{sum v_i}{K}$ $bar{v}$ is the cross-sectional velocity of the working zone, $v_i$ is the velocity at each point, $K$ is the number of measuring points $0.275leqslantbar{v}leqslant0.36$ $0.185leqslantbar{v}leqslant0.24$ (ophthalmology-dedicated operating room)
Air velocity uniformity in the working zone of the Class 100 area of Class Ⅰ operating rooms and Class Ⅰ auxiliary rooms m/s Rod-type hot-bulb anemometer (0～10m/s) 0.8m above the floor or 0.25m above the operating table ① Evenly distributed over the area within 0.12m inside the boundary of the orthogonal projection of the concentrated air supply face ② Measuring points, with spacing between adjacent points not greater than 0.3m Extend the measuring rod and place the probe at each measuring point $beta=dfrac{sqrt{dfrac{sum bar{v}-v_i}{K-1}}}{bar{v}}$ $beta$ is the non-uniformity of air velocity $betaleqslant0.25$
Air change rate of Class Ⅱ and Class Ⅲ operating rooms times/h Rod-type hot-bulb anemometer (0～10m/s) 0.1m below the concentrated air supply face ① 0.1m below the concentrated air supply face ② Boundary of the measurement range, 0.05m from the boundary of the air supply face ③ Measuring points, with spacing between adjacent points not greater than 0.3m Extend the measuring rod and place the probe at each measuring point $Q=bar{v}F3600$ $n=dfrac{Q}{V}$ $Q$ is the room supply air volume, $N$ is the air change rate, $V$ is the room volume, $bar{v}$ is the average velocity of the air supply face, $F$ is the area of the air supply face Class Ⅱ operating room: $33.0leqslant nleqslant43.2$ Class Ⅲ operating room: $20.0leqslant nleqslant26.4$ To be determined separately for extra-large operating rooms

Table 12.12 (continued)

Item Unit Instrument Measurement point height Number and location of measurement points Measurement method Formula Requirements Remarks
Air change rate of Class Ⅳ operating rooms and Class Ⅱ～Ⅳ auxiliary rooms times/h Rod-type hot-bulb anemometer (0～10m/s) Outlet plane of the air-measuring sleeve On the outlet plane of the sleeve, divide it into grids of about 0.3m per side, with the midpoint of each grid as a measurement point, but the minimum number of measurement points shall be 6 Sleeve: shall be able to cover the air outlet, being a rectangular duct with a length of no less than 1.2m. Measure the air velocity at each point on the outlet plane $q_i=bar{v}_i F,3600$ $Q=sum q_i$ $n=dfrac{Q}{V}$ $bar{v}_i$ is the average air velocity at the sleeve outlet $q_i$ is the supply air volume of each outlet $F$ is the area of the sleeve outlet Class Ⅳ operating room: $13.5leqslant nleqslant 18$ Class Ⅱ auxiliary room: $18.5leqslant nleqslant 24$ Class Ⅲ auxiliary room: $11.5leqslant nleqslant 15.6$ Class Ⅳ auxiliary room $9leqslant nleqslant 12$ Especially large operating rooms and auxiliary rooms shall be determined separately
Static pressure difference Pa Micromanometer with a resolution of 1Pa 0.8m above the floor (measured on site) or at the height of the already installed instrument 1 point (avoid vortex zones, avoid facing the airflow directly) Extend a thin rubber tube into the room (measured on site), or install the instrument at the doorway 1.5m above the floor for observation Code or design value ＜$Delta Pleqslant 30$ ($Delta P$ is the absolute value of the pressure difference) All doors shall be closed
Cleanliness class Particle counter 0.8m above the floor or 0.25m above the operating table surface Operating zone of Class Ⅰ operating rooms and local Class 100 zone of Class Ⅰ auxiliary rooms: minimum 5 measurement points Peripheral zone of Class Ⅰ operating rooms and Class Ⅰ auxiliary rooms: minimum 8 measurement points (2 points evenly distributed on each side) ① No more than 2 persons shall perform the measurement, wearing clean work garments and staying downwind of the measurement point ② Minimum sampling volume: Class Ⅰ: 5.66L Class Ⅱ～Ⅳ: 2.83L ③ Horizontal sampling tube length $geqslant 0.5$m ④ At each point, take the average of 3 consecutive readings that are close to one another $N=overline{N}+tsigma_N$ $sigma_N=sqrt{dfrac{sum(C_i-bar{v})^2}{K(K-1)}}$ $overline{N}$ is the average concentration of the room $C_i$ is the average concentration at a point $t$ is the one-sided $t$ distribution coefficient 2 points $t=6.31$, 3 points $t=2.92$ 4 points $t=2.35$ 5 points $t=2.3$ 6 points $t=2.02$ 7 points $t=1.94$ 8 points $t=1.90$ 9 points $t=1.86$ Simultaneously satisfy: $C{max}leqslant$ upper limit concentration of the class $C{max}$ is the maximum of the concentrations at all points $Nleqslant$ upper limit concentration of the class
Operating zone of Class Ⅰ and Ⅲ operating rooms: minimum 3 measurement points Peripheral zone of Class Ⅰ operating rooms: minimum 6 measurement points (2 points on the long side, 1 point on the short side) Peripheral zone of Class Ⅲ operating rooms: minimum 4 measurement points (1 point on each side) Cleanrooms with dispersedly arranged air outlets: $geqslant 30,mathrm{m}^2$ minimum 4 points $<30,mathrm{m}^2$ minimum 2 points
Temperature Relative humidity ℃ % Handheld digital thermo-hygrometer 0.8m above the floor 1 point at the room center Take readings after the instrument stabilizes Comply with the code or design requirements; the values measured in the hottest or coldest month shall prevail, and values measured at other times are for reference

Table 12.12 (continued)

Item Unit Instrument Measuring point height Number and location of measuring points Measurement method Formula Requirements Remarks
Illuminance lx Illuminance meter 0.8m above the floor Random point placement, not deliberately under lamps or avoiding lamps, 0.5m from walls, approximately one point every 2m Hold the illuminance meter by hand; the person should not block it The lowest illuminance value among all points shall meet the code or design requirements
Noise dB(A) Portable sound level meter 1.1m above the floor For room area ≤15m², 1 point at the center; for room area ＞15m², 1 point at each of the four corners and the center Hold the sound level meter level in the hand, away from the body Measure in the evening after work; if there is local purification equipment, the test operating conditions are: ① main system and local Class 100 both fully on ② main system off with only local purification equipment on ③ background with all systems off
Settling bacteria concentration CFU/(φ90 dish·0.5h) Petri dishes, incubator Average at floor level or at any height below 0.8m from the floor ① No fewer than the number of cleanliness measuring points (excluding 1 control dish), arranged the same as for cleanliness measurement ② Minimum number of Petri dishes: Class 100: 13, Class 1000: 4, Class 10 000: 2, Class 100 000: 2 ① First carry out routine disinfection of indoor surfaces ② The person placing the dishes shall wear a sterile suit with tight trouser cuffs (a lab gown is not allowed) ③ A control dish should be prepared when pouring the culture medium, and a control dish should also be present during sampling Comply with code requirements
Fresh air volume m³/h Rod-type hot-bulb anemometer No fewer than 9 points on the fresh air inlet plane. When the louvers are wide, measure once every other louver, with no fewer than 6 points per louver; or no fewer than 9 points on a cross-section of the fresh air duct ① Measure when the outdoor wind is not strong ② When measuring on the fresh air duct, select a cross-section on a straight duct section, divide it into grids in both the longitudinal and transverse directions with side lengths not exceeding 30cm, and drill holes at the grid centers through which the measuring rod can be inserted Comply with code or design requirements