GB 50333: Evolution and historical versions
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| GB 50333-2013 | English | RFQ |
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Architectural technical code for hospital clean operating department
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GB 50333-2013
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| GB 50333-2002 | English | RFQ |
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Architectural technical code for hospital clean operating department
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GB 50333-2002
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PDF similar to GB 50333-2013
Basic data | Standard ID | GB 50333-2013 (GB50333-2013) | | Description (Translated English) | Architectural technical code for hospital clean operating department | | Sector / Industry | National Standard | | Classification of Chinese Standard | P33 | | Classification of International Standard | 91.040.10 | | Word Count Estimation | 156,153 | | Older Standard (superseded by this standard) | GB 50333-2002 | | Quoted Standard | GB 50140; GB 50325; GB 50591; GB 50736; GB 5749; GB 50751; GB/T 14549; GB 15982; GB/T 19862; DL/T 1028 | | Regulation (derived from) | Announcement of the Ministry of Housing and Urban-Rural Development, No. 238 | | Issuing agency(ies) | Ministry of Housing and Urban-Rural Development of the People's Republic of China; General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China | | Summary | This standard applies to hospital construction, reconstruction, expansion of the cleansing operation of the engineering design, construction and acceptance. | GB 50333-2013: Architectural technical code for hospital clean operating department---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
1 General
1.0.1 In order to standardize the design, construction and acceptance of the clean operation department of the hospital, improve the medical environment control ability of the clean operation department of the hospital, meet the requirements of safety, hygiene, economy, applicability, energy saving, environmental protection, etc., and meet the functional needs of medical services, this document is formulated specification.
1.0.2 This specification is applicable to the design, construction and acceptance of clean operation department projects for new construction, reconstruction and expansion of hospitals.
1.0.3 The construction of the hospital's clean operating department should focus on air purification technical measures, strengthen the protection of the operating area, and reduce the risk of infection. In terms of building facilities, the principles of practicality and economy should be adhered to.
1.0.4 The design of the clean operating room should leave room for development, focusing on the flexibility and versatility of the design, so as to meet the needs of future reconstruction or expansion.
1.0.5 The construction of the hospital's clean operation department should not only meet the requirements of this specification, but also meet the relevant current national standards and regulations.
2 terms
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 μm 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 μm 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 μm 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 μm 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 μm 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 μm 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 μm 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 μm 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 μm 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 μm 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 Classification of clean operating room
3.0.1 The clean rooms of the clean operation department should be graded according to the bacterial concentration under empty or static conditions.
3.0.2 The grading standards for clean operating rooms shall comply with the provisions in Table 3.0.2-1, and the grading standards for clean auxiliary rooms shall comply with the provisions in Table 3.0.2-2.
Table 3.0.2-1 Classification Standards for Clean Operating Room
Note. 1 The maximum average concentration of bacteria in the planktonic method adopts the value in brackets. Bacterial concentration is the result of direct measurement, not the result of mutual conversion between sedimentation method and planktonic method.
2 The cleanliness level of the peripheral area of the special ophthalmic operating room may be 2 levels lower than that of the operating area.
Table 3.0.2-2 Classification standards for clean auxiliary rooms
Note. The maximum average concentration of bacteria in the planktonic method adopts the value in brackets. Bacterial concentration is the result of direct measurement, not the result of mutual conversion between sedimentation method and planktonic method.
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.
4 Technical indicators of clean operating room
4.0.1 In addition to the bacterial concentration and cleanliness level of various clean rooms in the clean operating department, the other main technical indicators of various clean rooms should be designed according to the provisions of Table 4.0.1.
Table 4.0.1 The main technical indicators of clean operating room
Note. 1 The column of negative pressure operating room pressure should be "negative".
2 The average wind speed refers to the average wind speed of the section 1.2m above the ground in the centralized air supply area.
3 The average wind speed of the section of the ophthalmic operating room should be controlled at 0.15m/s~0.2m/s.
4 The lower limit of the temperature and humidity range is the lowest value in winter, and the upper limit is the highest value in summer.
5 The value of fresh air volume in the operating room should be increased or decreased according to whether there is anesthesia or electric knife that emits harmful gas during the operation.
4.0.2 The selection of technical indicators for various clean rooms in the clean operation department shall meet the following requirements.
1 Between the interconnected clean rooms of different cleanliness levels, the rooms with high cleanliness should maintain a relatively positive pressure for the rooms with low cleanliness. The minimum static pressure difference should be greater than or equal to 5Pa, the maximum static pressure difference should be less than 20Pa, and the whistle should not be generated or affect the opening of the door due to the pressure difference.
2 There should be an appropriate pressure difference between connected clean rooms of the same cleanliness level to maintain the required airflow direction.
3 The heavily polluted room should maintain negative pressure to the connected adjacent room, and the minimum static pressure difference should be greater than or equal to 5Pa. The operating room used to control air infection should be a negative pressure operating room, and the negative pressure operating room should maintain a negative pressure difference slightly lower than "0" on the technical interlayer on the ceiling.
4 The clean area should maintain a positive pressure on the non-clean area connected to it, and the minimum static pressure difference should be greater than or equal to 5Pa.
5 In addition to the requirements in Table 4.0.1, the number of air changes and fresh air volume should also meet the requirements of pressure difference, compensation exhaust, air-conditioning load and special service conditions.
6 The temperature and humidity should not reach the standard for more than 5 days/year, and the failure for 2 consecutive days should not exceed 2 times/year.
7 The rooms with special requirements for the items, values, precision and change rules of technical indicators shall be designed according to actual requirements.
8 For the rooms whose names are not listed in Table 4.0.1 of this code, their index values can be determined by referring to the rooms with similar purposes in the table.
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.
6 Basic equipment of clean operating room
6.0.1 The basic equipment related to the layout and building installation of each clean operating room should meet the requirements in Table 6.0.1.
Table 6.0.1 Basic Equipment of Clean Operating Room
Note. The required equipment can be adjusted according to medical requirements.
6.0.2 The shadowless lamp should be configured according to the operation requirements and the size of the operating room. It is advisable to use a multi-head shadowless lamp; The shadowless lamp base shield should not be installed under the tuyere.
6.0.3 The operating room timer should have the functions of anesthesia timing, operation timing and general clock timing. It should be clearly marked with hours, minutes and seconds, and should be equipped with a timing controller; The battery power supply time should not be less than 10h. The timer should be set above the wall where the patient cannot easily see it.
6.0.4 The medical gas source device should be installed on the anesthesia pendant on the right side of the patient's head on the operating table and on the wall close to the anesthesia machine, with a height of 1.0m to 1.2m from the ground. (or wall gas terminal).
6.0.5 The number of film viewing lights can be configured according to the size and type of the operating room, and the film viewing lights or terminal display screens should be set on the wall opposite to the chief surgeon.
6.0.6 Instrument cabinets and medicine cabinets should be embedded in the foot end wall of the operating table for easy access, and anesthesia cabinets should be embedded in the easy-to-operate position on the patient's head wall of the operating table.
6.0.7 The parameter display and control panel of the purification air conditioner should be set on the side wall of the entrance door of the operating vehicle.
6.0.8 The micromanometer should be set at the visible height on the outer wall of the entrance door of the operating cart.
6.0.9 The recording board that can place the computer workstation should be concealed, and it should be flush with the wall when folded.
6.0.10 For new operating rooms such as multifunctional compound operating rooms, the configuration of medical and imaging equipment can be adjusted according to actual medical needs.
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...
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