Chapter I General
In order to meet the needs of hospital clean operating room construction, to meet the requirements of the medical development and technological progress, improve the effectiveness of investment, the development of this construction standards.
Article II of the construction standards for the use of the hospital's new or remodeled clean surgical department project and built in the non-clean surgical department (district) of the put clean operating room and its auxiliary rooms project. The use of ventilation and air conditioning of the general operating room (room) projects can refer to the implementation
Article 3 of the Ministry of Clean Surgery of the construction, must comply with national laws and regulations relating to economic construction and health, in line with the relevant hygienic standards and clean technology standards are now determined.
Article 4 The construction of clean surgery department should adhere to the principle of comprehensive performance to meet the standards, focusing on air purification, strengthen the protection of the surgical area, the construction of the quasi-practical, economic principles, to avoid one-sided pursuit of performance.
Article V clean surgical department construction, in addition to the implementation of the construction standards, should also comply with the current national standards, norms and regulations.
Chapter II scale and composition of the Department of clean surgery
Article VI of the hospital clean surgery by the clean operating room and auxiliary rooms, can be built to all clean operating room as the center and includes the necessary auxiliary rooms, self-contained functional areas; can also be built to part of the clean operating room as the center and includes the necessary auxiliary rooms, and the ordinary operating room coexisting with the Department of the independence of the functional areas. Functional area.
Article VII of the clean surgical department of various types of clean rooms should be based on its air or static conditions of bacterial concentration and air cleanliness level according to Table 1 class.
The clean rooms of the clean operation department shall be classified according to their air state or static condition and air cleanliness level.
The clean rooms of the clean operation department shall be classified according to their air state or static condition and the clean room of the clean operation department shall be classified according to their air state or static condition and the clean room of the clean operation department shall be classified according to their air state or static condition and the clean room of the clean operation department.
Peripheral area 0.4/30min?Φ90 dishes (10/m3)
Operating area class 100,
Peripheral area class 1000
Clean auxiliary room
Local class 100 area 0.2/30min?Φ90 dishes (5/m3),
Peripheral area 0.4/30min?Φ90 dishes (10/m3),
Peripheral area 0.4/30min? 90 dishes (10/m3),
Class 1000
(local class 100)
II
Clean operating room
Operating area 0.75/30min?Φ90 dishes (25/m3),
Peripheral 1.5/30min?Φ90 dishes (50/m3)
Operating area class 1000,
Peripheral area class 10,000
Clean auxiliary rooms
1.5/30min?Φ90 dishes (50/m3)
Class 10,000
III
Clean operating rooms
Operating area 2/30min?Φ90 dishes (75 dishes/m3),
peripheral area 4/30min?Φ90 dishes (50 dishes/m3)
Operating area class 10000,
Peripheral area class 100000
Clean auxiliary room
4/30min?Φ90 dishes (50 dishes/m3)
Class 100000<
IV
Clean operation room
5/30min?Φ90 dishes (50/m3)
300000
Clean auxiliary room
Article VIII: The scope of surgery applicable to different grades of clean operation rooms is as follows:
I. Grade I special clean operation room: applicable to joint replacement surgery, organ transplant surgery and brain surgery. I special clean operating room: for joint replacement surgery, organ transplantation surgery and brain surgery, cardiac surgery, gynecology and other aseptic surgery;
II II standard clean operating room: for thoracic surgery, plastic surgery, urology; liver, gallbladder and pancreas surgery, orthopedic surgery, and egg retrieval and support surgery and a class of aseptic surgery in general surgery;
III III general clean operating room for general surgery (remove), obstetrics and gynecology, etc. III general clean operating room for general surgery (remove a class of surgery), obstetrics and gynecology and other surgery;
IV quasi-clean operating room; for anal and intestinal surgery and contamination and other surgeries.
Article IX clean surgical auxiliary rooms should include clean auxiliary rooms and non-clean auxiliary rooms, the scope of application is as follows:
I I clean auxiliary rooms: for reproductive laboratories and other special laboratories needing aseptic operation of the room;
II II clean transfusion auxiliary rooms; for extracorporeal circulation perfusion preparation of the room;
III, Class III clean auxiliary room; applicable to brush hands, surgical preparation, sterile dressings and instruments, disposable items and precision instrument storage rooms, nurses' stations and clean corridors;
IV Class IV clean auxiliary room: applicable to recovery rooms, clean corridors and other quasi-clean places;
V. Non-clean auxiliary room: applicable to the doctor's and nurses' lounges, on-duty room, anesthesia Office, frozen section room, dark room, teaching rooms and family waiting place, changing shoes, changing outerwear, bathrooms and purification of air-conditioning and other equipment rooms.
Article X of the main technical indicators of various types of clean rooms must comply with the provisions of Table 2.
The main technical indicators table
Name
Minimum static pressure (Pa)
Ventilation
Number of times
(times/h)
Surgical giant surgical combined (or local 100 work area) work surface height cross-section of the average wind speed (m/s)
Temperature (℃)
Relative
Humidity
(%RH)
Minimum fresh air volume
Noise
Minimum illumination
To neighboring low-level cleanrooms
(m3h/person)
(times/h)
dB(A)
(lx)
Specially clean
Operating room
+8
/
0.25~0.30
22~25
40~60
60
6
≤52
350
Standard clean
operating room
+ 8
30~36
/
22~25
40~60
60
6
≤50
350
General clean
Surgery room
+5
20~24
22~25
35~60
60
4
≤50
350
Quasi-clean
Operating room
+5
12~15
/
22~25
35~60
60
4
≤50
350
Extracorporeal Circulation Perfusion Preparation Room
+5
17~20
/
21~27
≤60
/
3
.≤60
150
Sterile dressings,
Instruments, disposable
Sexual goods room
and TM
Technical confidentiality equipment storage space
+5
10~13
/
21~27
≤60
.
3
≤60
150
Nurse's Station
+5
10~13
/
21~27
≤60
60
3
≤60
150
Preparation room
(Sterilization)
+5
10~13
/
21~27
≤60
30
3
≤60
200
Pre-anesthesia room
-8 <
10~13
/
22~25
30~60
60
4
≤55
150
Brushroom
>0
10~13
/
. 21~27
≤65
/
3
≤55
150
Clean Corridor
0~+5
10~13
/
21~27
≤65
/
. 3
≤52
150
Dressing room
0~+5
8~10
/
21~27
30~60
/
3
≤60
200
Restoration
0
8~10
/
22~25
30~60
/
4
≤50
200
Clean corridors
0~+5
8~10
/
/
<21~27
≤65
/
3
≤52
150
Note: ①Clean area should maintain a positive pressure of not less than 10Pa on the non-clean area connected with it, and the clean area should maintain a positive pressure of not less than 15Pa on the outdoor area or on the area directly connected with the outdoor area, and the difference of all the squeezes should not be more than 30Pa. Difference should not be greater than 30Pa.
② brushing hand room without a door or located in a clean corridor, the minimum static pressure can be greater than zero.
③ The number of air changes and cross-section of the average air velocity design value should be within the table.
④ Winter temperature extremes can be taken not less than the lower limit value in the table, the summer can be taken not higher than the upper limit value in the table.
⑤ Table 2 does not list the name of the room can refer to the use of similar rooms to determine the value of its indicators.
⑤ The technical indicators of the project, value, precision and other special to come to the room, should be designed according to the actual requirements
Article 11 of the Department of Clean Surgery in the number of clean operating rooms, the size and air cleanliness level, according to the nature of the hospital, scale, level and financial resources to decide. For general hospitals, the need to build Class I clean operating room, the number of such clean operating room should not exceed 15% of the total number of clean operating room, at least one; conditions can be set up according to the need for a negative pressure clean operating room. For specialized hospitals, special clean operating room should be based on the actual need to determine the number of construction.
Article XII of the Department of Clean Surgery in the clean operating room according to Table 3 is divided into four scales, various scales of clean operating room net area should not exceed the value of the provisions of Table 3, must be more than there should be a specific technical description, and more than the area should not be greater than the maximum net area of Table 3 in 25%.
Clean operating room plan scale Table 3
Scale category
Net area expansion
Reference length x width m
Extremely large
40 ~ 45
7.5x5.7
Large
30 ~ 35
5.7x5.4
Medium
The net area of the clean operating room should not exceed the value specified in Table 3, and if it must be exceeded, there should be specific technical instructions, and the area exceeded should not be greater than 25% of the maximum net area in Table 3. >Medium-sized
25～30
5.4x4.8
Small
20～25
4
Chapter III Architecture
Article 13 The location of the clean surgical procedures within the hospital shall be far away from the sources of high contamination, and located on the upwind side of the direction of the most winds of the city or region in which it is located; and when there are the most and near the When there are the most and close to the most of the two prevailing wind direction, the clean surgical department should be located in all the wind direction with the smallest wind frequency of wind direction of the opposite side of the location.
Article 14 of the Department of clean surgery should not be located in the first floor and the top floor, when set up in the equipment (may not include large refrigeration units) layer of the next layer, effective measures must be taken to carry out waterproofing, vibration and acoustic treatment.
Article 15 of the clean area and non-clean area should be set up between the buffer room with an area of not less than 3m2, the cleanliness level should be high with the clean side of the same level, and should not be higher than 1000. There shall be transfer windows for logistics. Clean area in the different air cleanliness levels between areas should be set up partition door.
Article 16 The internal layout of the Department of Clean Surgery and channel forms should be in line with the principle of short functional processes and clean and dirty clearly, generally can choose the end of the arrangement, the center of the arrangement, lateral arrangement or ring arrangement of a. The dirt has a local disinfection and packaging. Dirt with in situ disinfection and packaging measures can be used in a single channel, otherwise can be used to separate the clean and dirty dual-channel; when the conditions of diversion, can be used in a multi-channel; when there is a corridor, the outer corridor should be designed as a clean corridor.
Article XVII of the clean operating room net height of 2.8-3m.
Article XVIII of the people and things with elevators should not be located in the clean area. Restricted by the conditions must be located in the clean area, it must be set up in the exit buffer room.
Article XIX brush room should be decentralized, every 2-4 operating rooms should be set up a separate brush room. When the conditions are available, the theater can also be located in the clean corridor.
Article 20 The floor of the Department of Clean Surgery should be used wear-resistant, corrosion-resistant, dust-free, easy to clean and prevent the generation of static electricity materials. Under normal circumstances can be used to cast copper embedded terrazzo floor and paint, coil floor.
Article 21 of the clean surgical department of the wall should be used without dust, flat and easy to clean materials. Generally can be used as a whole or assembled wall panels, level IV (not included) below the clean room can be used large tiles or paint.
Article 22 The net width of the door of the clean operating room should not be less than 1.4m, it is appropriate to use an automatic delay closing device with an automatic sliding door of electric suspension.
Article 23 The clean operating room and I, II clean auxiliary rooms should not be equipped with external windows, III, IV clean auxiliary rooms can be equipped with double-closed external windows.
Chapter IV clean operating room basic equipment
Article 14 of the clean operating room and operating room layout and building installation
basic equipment (excluding special mobile medical instruments and equipment) configuration, should be consistent with the requirements of Table 4
.
Basic equipment Table 4
Name of equipment
Minimum number of configurations
Shadowless lamps
Operating tables
Timers
Medical gas supply units
Anesthesia gas venting unit
Hands-free intercom telephones
Pharmaceutical cabinets (built-in)
Instrument Cabinet (Recessed)
Anesthesia Cabinet (Recessed)
Viewing Lamp
Record Board
Infusion Rails (Including 4 Hooks)
l Sets/Each Room
1 Set/Each Room
1 Unit/Each Room
1 Unit/Each Room
2 Sets/Each Room
1 Set/Each Room
1 Part
1/per room
1/per room
1/per room
1/per room
3 joints/small per room, A joint/medium per room,
6 joints/large per room
1 piece per room
five sets/per room
Chapter V: Air Conditioning and Air Purification
Article 25 Clean surgical treasure should be separated from auxiliary rooms opened through the purification of air-conditioning system; clean operating rooms should be used to clean air-conditioning unit set up independently, III, IV clean operating room allows 2-3 rooms to share a system, should be used for self-circulating return air; fresh air can be used to centralize the air supply system; exhaust system should be set up independently.
Article 26 The purified air conditioning system should be at least three air filtration. The first level of air filtration should be set up in the new air, the second level should be set up in the positive pressure section of the system, the third level should be set up at the end of the air supply or its vicinity.
Article 27 The quasi-clean operating room can be used with sub-high-efficiency filters or high-efficiency filters purification fan coil unit or indoor cabinet-type purification air conditioning unit, shall not be used ordinary fan coil unit or air conditioner.
Article 28 I, II, III clean operating rooms and I, II clean auxiliary rooms, shall not be set up in the indoor radiator, but can be used as a radiant radiator plate heating on duty. Class IV clean operating room and see, Class IV clean auxiliary rooms, such as the need to set up radiators, should be used not easy to accumulate dust and easy to clean the type, and set up protective cover. Radiator heat medium should not be higher than 95 ℃ hot water.
Article 29 I, II, III clean operating room should be used in a localized centralized air supply, centralized layout of the air supply area that the size of the surgical area should be compatible with the level of the operating room, I level of not less than 6.2 expansion (of which the head of the dedicated not less than 1.4m2), IV level of not less than 4.6m2, III level of not less than 3.6m2. According to the needs of clean auxiliary rooms can be equipped with a local 100 level of the room. As needed, clean auxiliary room can be set up in a local 100-class area.
Article 30 of the electrostatic air purification device shall not be used as a purification air-conditioning system for the final level of purification facilities, and shall not be used as a stand-alone unit directly in the clean operating room and clean auxiliary rooms.
Chapter VI medical gas, water supply and drainage, power distribution
Article 31 of the Department of Clean Surgery must be set up oxygen, compressed air and negative pressure to attract three kinds of gas and devices. Nitrous oxide (nitrous oxide that laughs), nitrogen, argon gas and exhaust gas recycling and emission devices when needed. Medical gas must have no less than three days of spare capacity. Clean operating room medical gas terminal must have a set of spare.
Article 32 The water supply system in the clean operating department should have two imports, and there should be no hot and cold water system at the same time.
Article 33 The quality of water supplied to the Department of Clean Surgery must meet the drinking water standards; brushing water is appropriate to carry out sterilization treatment; hot water storage should be prevented from breeding bacteria measures.
Article 34 The Department of Clean Surgery should be equipped with direct fire hydrant water supply system and portable gas extinguishers. Clean surgical department need to set up automatic sprinkler system, the nozzle should not be located in the operating room. Smoke detectors should be provided in the clean operating room. Clean surgical department of the technical mezzanine should be set up at the same time the fire fighting facilities.
Article 35 The Department of Clean Surgery must be set up to automatically switch the dual-channel power supply, from the building where the power distribution center dedicated line supply.
Article 36 The clean operating room electricity should be separated from the auxiliary room electricity, each operating room trunk line must be laid separately.
Article 37 The total load of the distribution of medical equipment and devices in the clean operating room should not be less than 8kVA in addition to meet the design requirements.
Article 36 The power supply of the clean operating room should be separated from the power supply of auxiliary rooms.