GB 50333-2013Architectural technical code for hospital clean operating department (English PDF)

2.0.1 clean operating department

An independent functional area composed of part or all of clean operating room, clean auxiliary room and non-clean auxiliary room.

2.0.2 clean operating room

An operating room that uses air purification technology to reduce the total amount of microbial particles and particulates in the air of the operating environment to the allowable level. The operating room can also be called the operating room.

2.0.3 clean supporting space

Non-operating rooms that require air cleanliness.

2.0.4 non-clean supporting space

Non-operating rooms that do not require air cleanliness.

2.0.5 operating zone

Areas that require special protection include the operating table and its four sides that are pushed out by a certain distance.

2.0.6 Surrounding zone

Clean the operating room to remove other areas other than the operating area.

2.0.7 cleanliness class 5

The number of particles greater than or equal to 0.5 um in the ambient air is greater than 350 particles/m3 (0.35 particles/L) to less than or equal to 3500 particles/m3 (3.5 particles/L); the number of particles greater than or equal to 5 um is 0 particles/ L air cleanliness. Equivalent to the original level 100.

2.0.8 cleanliness class 6

The number of particles greater than or equal to 0.5 um in the ambient air is greater than 3500 particles/m3 (3.5 particles/L) to less than or equal to 35200 particles/m3 (35.2 particles/L); the number of particles greater than or equal to 5 um is less than or equal to 293 particles /m3 (0.3 grains/L) air cleanliness. Equivalent to the original level 1000.

2.0.9 cleanliness class 7

The number of particles greater than or equal to 0.5 um in the ambient air is greater than 35200 particles/m3 (35.2 particles/L) to less than or equal to 352000 particles/m3 (352 particles/L); the number of particles greater than or equal to 5 um is greater than 293 particles/m3 (0.3 grains/L) to less than or equal to 2930 grains/m3 (3 grains/L) air cleanliness. Equivalent to the original 10,000 level.

2.0.10 cleanliness class 8

The number of particles greater than or equal to 0.5 um in the ambient air is greater than 352,000 particles/m3 (352 particles/L) to less than or equal to 3,520,000 particles/m3 (3520 particles/L); the number of particles greater than or equal to 5 um is greater than 2930 particles/m3 (3 particles /L) to less than or equal to 29300 grains/m3 (29 grains/L) of air cleanliness. Equivalent to the original level 100,000.

2.0.11 cleanliness class 8.5 cleanliness class 8.5

The number of particles greater than or equal to 0.5 um in the ambient air is greater than 3520000 particles/m3 (3520 particles/L) to less than or equal to 11120000 particles/m3 (11120 particles/L); the number of particles greater than or equal to 5 um is greater than 29300 particles/m3 (29 particles /L) to less than or equal to 92500 grains/m3 (93 grains/L) of air cleanliness. Equivalent to the original 300,000 level.

2.0.12 Empty as-built

The indoor purification and air conditioning facilities and functions are complete but not in operation, but there is no medical equipment and personnel in the room.

2.0.13 Static at-rest

Indoor purification and air-conditioning facilities and functions are complete and operating. If there is medical equipment, the medical equipment has been installed and is operational, but there is no staff status.

2.0.14 airborne bacterial concentration by planktonic method

Referred to as the concentration of planktonic bacteria. The air is randomly sampled with a planktonic sampler, and the number of colony-forming units per unit air volume obtained through culture represents the number of planktonic bacteria in the air (cfu/m3).

2.0.15 Depositing bacterial concentration

Referred to as sedimentation bacteria concentration. The sedimentation method is also called the plate exposure method. Use a Petri dish to expose the sample in the air, and the number of colony-forming units obtained after the culture of the Petri dish is covered, which represents the number of bacteria that can settle down in the air (cfu/dish).

2.0.16 Recovery time between operations

Under the condition of the number of air changes in normal operation, the time required to reduce the air dust concentration in the operating room after the postoperative waste has been removed by about 90% or within the upper limit concentration of the design cleanliness level.

2.0.17 clean zone

All areas with cleanliness requirements of Class IV and above are clean areas.

2.0.18 air cleaning and conditioning system

The air conditioning system is adopted to control the concentration of suspended dust and microorganisms in the controlled area to the required level by taking filter sterilization and dust removal as the main measures.

2.0.19 exogenous infection

An infection in a patient caused by microorganisms outside the body, such as other people or the environment.

2.0.20 Endogenous infection

An infection caused by a patient's own flora.

2.0.21 Multifunctional hybrid operating room hybrid operating room

It is a special operating room that can perform imaging diagnosis, interventional therapy and surgical operation at the same time.

2.0.22 Non-aspirating supply diffusers

Specifically refers to the airflow distribution device installed in the clean operating room to guide the air supply airflow to flow downward from the air outlets arranged on the ceiling (ceiling) and rarely induce indoor air. Usually, the outlet wind speed is low and the cross-sectional wind speed is uniform. Commonly known as air supply ceiling or air supply ceiling.

3.0.3 The auxiliary rooms set up in the clean operation department should meet the requirements in Table 3.0.3.

Table 3.0.3 Classification of main auxiliary buildings

3.0.4 For hospitals that need to build clean operating rooms, clean operating rooms of different levels should be selected according to the types of operations that can be performed, and auxiliary rooms should be reasonably allocated.

5.1 Scale of clean operation department

5.1.1 The number of clean operating rooms set up in the clean operation department should be approved according to the type of hospital, the number of beds and the number of annual operations.

5.1.2 The clean operating room shall specify and control the set number of medical personnel in the room, and the design load shall be based on the set number. When the set number of people cannot be proposed, the design load can be calculated according to the following number of people. 12 to 14 people for Class I, 10 to 12 people for Class II, and 6 to 10 people for Class III and IV.

5.2 Hygienic requirements for clean operating department

5.2.1 The functional layout of the clean operating department should be reasonable and in line with the principles of surgical aseptic techniques, and should be easy to communicate and clean and dirty.

5.2.2 The static air bacterial concentration in the clean operating room and the cleaning and disinfection status of the equipment surface are the basic requirements of hygiene, and should meet the provisions of this specification and the current national standard "Hospital Disinfection Hygienic Standard" GB 15982.

5.2.3 The flow of people and logistics in the clean operating department from the unclean area to the clean area should undergo sanitation, and personnel should change their shoes and clothes. The import and export of medical personnel (including medical technology, sanitation, management, etc.) and patients should be separated.

5.2.4 Reusable instruments after surgery should be sealed and sent to the disinfection supply center for centralized processing. Medical waste should be packaged on site, sealed and transported for disposal.

5.3 Medical procedures in clean operating department

5.3.1 The medical staff should strictly implement the hygienic pass, and should strictly implement the aseptic technique operating procedures. Medical staff should enter the clean area after changing shoes and clothes in the unclean area. Medical staff should enter the operating room after hand hygiene, wear surgical gowns and gloves before the operation, and exit the operating room by the same route after the operation.

5.3.2 After the patient enters from the unclean area, he should change to a clean vehicle or clean the vehicle in the clean area, and perform anesthesia, surgery and recovery in the clean area, and exit the operation department to the ward or ICU after the operation.

5.3.3 Sterile items should be sterilized in the supply center, then enter the clean area through closed transfer or special clean channel, and should be stored aseptically in the clean area, and should be sent to the operating room as needed.

5.3.4 The entry and exit process of items after operation should meet the following regulations.

1 Reusable devices should be recovered in a closed manner in the disinfection supply center, and should be counted, sorted, cleaned, disinfected, dried, inspected and packaged in the decontamination area, and the sterilized reusable devices should be sent to the sterile storage room. And should be sent to the surgery department as required.

2 Reusable cloth surgical materials should be recycled in a closed laundry room, and should be cleaned, disinfected, and sent back to the disinfection supply center for inspection, packaging and sterilization, and sent to the sterile storage room after sterilization, and should be sent to the surgery department as required.

5.4 Functional plane of clean operating department

5.4.1 The plane layout of the clean operating department should be conducive to improving medical efficiency, and should be divided into clean areas and unclean areas according to room functions.

5.4.2 The changing room should be divided into shoe-changing and changing areas; toilets and showers should be located in the front half of the changing area.

5.4.3 The total area of the dressing area for medical staff should not be less than 1m2 per person according to the actual number of users, and the dressing room should not be less than 6m2.

5.4.4 The vehicle sanitation passing area or changing room should be set at the main entrance of the operation department, and its area should meet the requirements of the vehicle turning scale and parking and transfer.

5.4.5 When the pathological quick examination room is adjacent to the clean operation department, it is advisable to set up a transfer window connected with the corridor of the clean area.

5.4.6 The unpacking room should be located in the non-clean area adjacent to the clean area, and the items after unpacking should be transferred to the unpacking inner room or clean area immediately.

5.4.7 The nurse station should be located at the main entrance.

5.4.8 The centerline of the operating table should coincide with the long axis of the operating room, the center point of the operating table installation base should be the intersection of the long axis and short axis of the operating room, and the distance from the bedside of the operating bed on the head side to the wall should not be less than 1.8m. The main operating field should be located in the central area of the air supply surface.

7.1 Built environment

7.1.1 The new clean operation department should avoid pollution sources.

7.1.2 The clean operation department should not be located on the first floor and the top floor of high-rise buildings.

5 An exhaust filter should be installed at the exhaust inlet or outlet of the clean room.

8.1.5 The purification air-conditioning system can be centralized or return air self-circulation treatment. For Class IV clean operating rooms and Class III and Class IV clean auxiliary rooms, clean fan coil units or vertical cabinet air conditioners with high-efficiency and higher filtration efficiency filters can be used.

8.1.6 When the whole clean operating department is equipped with centralized fresh air cooling and heat treatment facilities, the fresh air treatment unit shall treat the fresh air to an enthalpy value not greater than the required indoor air state point during the cooling season. When conditions permit, it is advisable to adopt fresh air humidity priority control...