For project acceptance, an acceptance evaluation team is generally organized by the legal person to conduct on-site inspection. Engineering defects found during on-site inspection are classified into serious defects and general defects: any key items that are incomplete or missing constitute serious defects; any general items that are incomplete or missing constitute general defects.

At the time of acceptance, there should be no serious defects, and the proportion of general defects should generally not exceed 20% of the inspected items.

If there are no serious defects but general defects exceed 20%–40%, or if serious defects do not exceed 3 items and the proportion of general defects does not exceed 20%, rectification within a prescribed time limit will generally be required. If both serious defects and general defects exceed the above values, the possibility of passing no longer exists; only rectification within a prescribed time limit followed by re-testing and re-inspection is possible.

As for specific evaluation criteria, where the competent authority has not formally issued acceptance criteria, the following recommended clauses may be followed Assessment.

There are 19 key items (clauses marked with *), see Table 12.13.

Table 12.13

No. Clause Inspection Content
1 3.03, 10.3.8, 10.3.13 Whether the acceptance inspection values of air cleanliness ($geqslant$0.5μm and $geqslant$5μm) and bacterial concentration (settling or airborne) of each clean operating room and clean auxiliary room meet the standards
2 *4.02 Whether the pressure differential of each clean operating room and clean auxiliary room has changed its positive/negative nature
3 *4.02, 10.3.10 Whether the acceptance inspection values of noise of each clean operating room and of clean auxiliary rooms exceed the standard values
4 *5.2.1 Whether the clean operating department is strictly divided into clean and non-clean areas, and whether buffer rooms or pass-through windows meeting the requirements are provided between them
5 *5.2.5 Whether the purification procedures for people and goods entering the clean operating department are arranged in a continuous pass-through manner conforming to an effective purification process
6 *5.3.6 Whether wood and gypsum are used exposed in the clean operating department
7 *7.1.2 Whether Class Ⅰ～Ⅲ clean operating rooms adopt local centralized air supply, with the operating zone and peripheral zone distinguished
8 *7.1.3 Whether the entire purification air-conditioning system is provided with at least three stages of filtration
9 *7.1.4 Whether ordinary fan coil units or ordinary air conditioners (neither equipped with sub-high-efficiency or higher efficiency filters) are used in the clean operating department
10 *7.1.2 Whether the exhaust air duct outlet is located in the technical mezzanine
11 *7.3.7 Whether an electrostatic dust removal device is used as the final-stage filter
12 *8.1.1 Whether the clean operating department is provided with at least three gas sources and devices: oxygen, compressed air and vacuum suction
13 *8.1.1 Whether the gas source of the central station is supplied through dual lines with automatic and manual switching functions
14 *8.3.1 Where dual power supply is difficult, whether the clean operating department is provided with a backup power source capable of automatic switching within 1min
15 *8.3.4 Whether the grounding system of the cardiac surgery operating room is provided with an isolation transformer
16 *8.3.1 Whether the power supply of clean operating rooms is separated from that of auxiliary rooms, and whether the trunk lines of each operating room are laid separately
17 *8.3.2 Whether there are wireless communication devices in clean operating rooms
18 *9.01 Whether the fire resistance rating of the building housing the clean operating department is not lower than Class II
19 *10.3.4 Whether there is a comprehensive performance overall assessment inspection report issued by a qualified professional engineering quality inspection institution

There are 69 general items, see Table 12.14.

Table 12.14

No. Clause Inspection Content
1 3.02 Whether necessary clean auxiliary rooms of appropriate classes are provided in addition to clean operating rooms
2 *3.05, 5.2.8 If infectious surgery in compliance with the infectious disease management measures is to be performed, whether there are corresponding negative-pressure or positive/negative-pressure convertible operating rooms
3 4.02, 10.3.5 Whether the acceptance inspection value of the cross-sectional air velocity of Class Ⅰ clean rooms meets the requirements
4 4.02, 10.3.6 Whether the acceptance inspection value of the air change rate of Class Ⅱ～Ⅳ clean rooms meets the requirements
5 4.02, 10.3.7 Whether the acceptance inspection value of the pressure differential of each clean operating room meets the requirements
6 4.0.2, 10.3.9 Whether the acceptance inspection values of temperature and humidity of each clean operating room and clean auxiliary room meet the requirements
7 4.02, 10.3.10 Whether the acceptance inspection value of the noise of each clean auxiliary room meets the requirements
8 4.0.2, 10.3.12 Whether the acceptance inspection values of illuminance of each clean operating room and clean auxiliary room meet the requirements; whether the illuminance uniformity of large (inclusive) operating rooms is lower than 0.7
9 4.0.2, 10.3.12 Whether the acceptance inspection values of fresh air volume of each clean operating room and clean auxiliary room meet the requirements
10 5.2.5 Whether medical staff of the operating room pass through the original purification process when exiting the clean operating department; whether they change clothes again when re-entering

Table 12.14 (continued)

No. Clause Inspection Content
11 5.2.6 Whether elevators for people and goods are placed in the clean area, and whether those located in the clean area have buffer rooms
12 5.2.7 Whether there is a cart exchange area, and whether the cart exchange area has a buffer room meeting the requirements
13 5.2.10 Whether a separate scrub room is provided for every 2～4 operating rooms
14 5.2.11 Whether there is a dedicated centralized collection point for soiled items
15 5.2.12 Whether any seismic joints or expansion joints pass through the clean operating department, and whether waterstops are provided
16 5.3.2 Whether the floor of the clean operating department is level, and whether terrazzo floors are cast-in-place
17 5.3.3 Whether the walls of the clean operating department are smooth, level and intact, whether all joints are smoothed, and whether anti-collision bands are installed wherever required
18 5.3.4 Whether the junction between interior walls and floor in the clean operating department is formed as a rounded corner with R≥40mm, and whether the skirting does not protrude from the wall
19 5.3.5 Whether anti-collision boards are provided on corridor walls and at corners in the clean operating department
20 5.3.10 When electric doors are used, whether an automatic delayed-closing device is provided
21 5.3.14～15 In clean operating rooms, whether switches, socket boxes/cabinets, etc. are recessed into the wall, and whether there are exposed pipes and conduits
22 5.3.16 Whether there are access hatches in the ceiling of clean operating rooms
23 6.0.1 Whether the basic equipment of clean operating rooms is complete and correctly positioned
24 7.1.1 Whether clean operating rooms and auxiliary rooms are provided with separate clean air-conditioning systems
25 7.1.8 Whether the system fresh air intake is located in an unpolluted upwind area more than 5m above the ground and more than 3m away from exhaust outlets, whether rain protection measures are provided, and whether the intake air velocity is less than 3m/s
26 7.1.8 Whether the fresh air intake is located inside the machine room
27 7.1.9 Whether the operating room exhaust system is independent and interlocked with the supply air
28 7.1.11 Whether radiators are installed in Class Ⅰ, Ⅱ and Ⅲ operating rooms and Class Ⅰ and Ⅱ clean auxiliary rooms; if radiators are installed in clean rooms of other classes, whether their type is appropriate and whether they have protective covers
29 7.1.11 Whether the heat medium for radiators is hot water not higher than 95℃
30 7.2.1 Whether the area of the centralized air supply outlet complies with the regulations
31 7.2.2 Whether the airflow in Class 100 clean areas (rooms) meets the requirements of unidirectional flow, and whether the full coverage ratio, return air method and velocity uniformity comply with the requirements
32 7.2.5 For clean rooms with a width exceeding 3m, whether lower return air inlets are arranged on both sides in the 3m direction
33 7.2.5 Whether clean rooms with centrally arranged air supply outlets and clean auxiliary rooms with local Class 100 areas use four-corner or four-side return air
34 7.2.6 Whether the return air velocity at indoor return air outlets complies with the regulations, and whether those in Class Ⅰ operating rooms are arranged continuously
35 7.2.6 Whether the upper edge of the return air outlet opening exceeds 0.5m above the floor
36 7.2.7 Whether clean operating rooms adopt corridor return air through return air outlets or excess pressure valves
37 7.2.9 Whether clean operating rooms are provided with top exhaust outlets, whether filters with efficiency equal to or higher than sub-high efficiency are installed along the exhaust airflow direction (the filters have been tested), and whether the exhaust air volume is not less than 200m³/h
38 7.2.9 Whether Class Ⅰ and Ⅱ operating rooms are additionally equipped with purification units
39 7.3.1 Whether condensate from air conditioners is drained smoothly, whether there is water accumulation inside or outside the units, and whether the water pipes are directly connected to the sewer
40 7.3.1 Whether the airflow velocity at the heat exchanger cross-section is greater than 2m/s
41 7.3.1 Whether the humidifier uses water spray humidification
42 7.3.3 Whether glass fiber and its products are used in silencers
43 7.3.4 Whether the flexible duct connections are double-layered with the smooth side facing inward
44 7.3.5 Whether filters of all stages are of the one-time disposable type

Table 12.14 (Continued)

No. Clause Inspection Content
45 7.3.6 Whether the final-stage filters are wooden-framed products; except for Class 100 000 and Class 300 000, whether all are HEPA filters
46 7.3.9 Whether the return air outlets in clean operating rooms have filter layers of roughing grade or above, and whether the blades are vertical
47 7.3.10 Whether the fresh air filtration section of the system is a three-stage combination of roughing, medium-efficiency, and sub-high-efficiency filters (with inspection certificates)
48 7.3.11 Whether the opening angles of the damper blades are marked, and whether the handles are firmly fixed
49 7.3.12 Whether there are exposed untreated metal parts in the system and indoors
50 8.1.1 Whether the gas supply for the operating department has a reserve of no less than 3 days
51 8.1.1 Whether there is a standby set of gas terminals in the operating room
52 8.1.1 Whether the gas supply system for the operating department has overpressure relief safety valves, whether the terminal panels have color markings, and whether the outlets have filters meeting requirements
53 8.1.1 Whether the various gas source connectors are interchangeable and clearly marked
54 8.1.2 Whether the distances of various medical gas pipelines comply with the regulations or are provided with insulation treatment
55 8.1.2 Whether the inlet pipes of medical gases are all grounded, with grounding resistance not higher than $4Omega$
56 8.1.2 Whether concealed pipeline valves are provided with access doors and sealing measures
57 8.1.2 Whether medical gas pipelines share pipe shafts with other gas, electrical, air-conditioning, and other pipelines
58 8.2.1 Whether the water quality supplied to the clean operating department meets drinking water standards, and whether the hot water storage temperature meets the requirements for preventing bacterial growth
59 8.2.1 Whether scrub sinks and washing sinks are equipped with non-manual faucets
60 8.2.1 Whether the connections between water supply pipes and sanitary fixtures and equipment have air breaks
61 8.2.2 Whether the horizontal drainage pipes of the clean operating department are one size larger than conventional ones
62 8.2.2 Whether floor drains are provided in clean operating rooms
63 8.3.1 Whether the power distribution conduits of the clean operating department are laid in metal pipes
64 8.3.2 Whether dedicated distribution cabinets are located inside clean operating rooms, and whether the main distribution cabinet is located in the non-clean area
65 8.3.2 Whether the access openings for the automatic display devices of clean operating rooms are located outside the operating room
66 8.3.2 Whether electrical appliances in clean operating rooms have leakage monitoring and alarm devices, and whether they are well grounded
67 8.3.2 Whether the lighting fixtures in clean operating rooms (except whole-room unidirectional flow) are recessed and arranged outside the air supply outlets
68 9.0.2～9.0.8 Whether the fire protection facilities of the clean operating department comply with the regulations
69 10.2.2 Whether the construction unit has complete construction records, investigation and testing records, and completion reports

Chapter 13 Daily Management and Monitoring