title>WS 233-2002 General principles for biosafety in microbiological and biomedical laboratories - WS 233-2002 - Chinese standardNet - bzxz.net
Home > WS > WS 233-2002 General principles for biosafety in microbiological and biomedical laboratories
WS 233-2002 General principles for biosafety in microbiological and biomedical laboratories

Basic Information

Standard ID: WS 233-2002

Standard Name: General principles for biosafety in microbiological and biomedical laboratories

Chinese Name: 微生物和生物医学实验室生物安全通用准则

Standard category:Sanitary Industry Standards (WS)

state:in force

Date of Release2002-12-03

Date of Implementation:2003-08-01

standard classification number

Standard ICS number:General, Terminology, Standardization, Documentation>>Vocabulary>>01.040.11 Medical and Health Technology (Vocabulary)

Standard Classification Number:Medicine, Health, Labor Protection>>Health>>C50 Health General

associated standards

Publication information

publishing house:China Standards Press

ISBN:155066.2-14980

Publication date:2004-04-23

other information

Publishing department:Ministry of Health of the People's Republic of China

Introduction to standards:

This standard specifies the basic principles of biosafety protection in microbiological and biomedical laboratories, the classification of laboratories, and the basic requirements for laboratories at all levels. This standard is the minimum requirement. This standard is applicable to disease prevention and control institutions, medical and scientific research institutions. WS 233-2002 General Guidelines for Biosafety in Microbiological and Biomedical Laboratories WS233-2002 Standard download decompression password: www.bzxz.net

Some standard content:

1 Scope
Microbiological and biomedical laboratories
General biosafety guidelines
WS233-—2002
This standard specifies the basic principles of biosafety protection in microbiological and biomedical laboratories, the classification of laboratories, and the basic requirements for laboratories at all levels. This standard is the minimum requirement.
This standard is applicable to disease prevention and control institutions, medical care, and scientific research institutions. 2 Normative references
The clauses in the following documents become clauses of this standard through reference in this standard. For any dated referenced document, all subsequent amendments (excluding errata) or revisions are not applicable to this standard. However, parties to an agreement based on this standard are encouraged to study whether the latest versions of these documents can be used. For any undated referenced document, the latest version shall apply to this standard. GB14925—2001 Laboratory animal environment and facilities GB/T16803-1997 Terminology of heating, ventilation, air conditioning and purification equipment GB50073-2001 Clean room design specification JGJ71-1990 Clean room construction and acceptance specification 3 Definitions
This standard adopts the following definitions. :
Laboratory biosafety protection biosafety protection for laboratories When the experimental objects handled by laboratory staff contain pathogenic microorganisms and their toxins, comprehensive measures are taken in terms of laboratory design and construction, use of personal protective equipment, and strict compliance with standardized work and operating procedures and regulations to ensure that laboratory staff are not infected by experimental objects and the surrounding environment is not polluted. 3.2
Hazard assessment for microbes An assessment of the hazards that experimental microorganisms and toxins may bring to humans or the environment. 3.3
Aerosol
A colloid dispersion system formed by solid and liquid microparticles with a particle size of generally 0.001um to 1000μm suspended in a gas medium.
Biosafety cabinetbiosafetycabinet
A box-shaped air purification safety device used when handling dangerous microorganisms. 3.5
Class I biosafety cabinets are equipped with at least one high-efficiency air filter to purify the exhaust gas. When working, the glass sliding window on the front of the cabinet is half open, with the upper part being the observation window and the lower part being the operation window. External air is sucked in through the operation window and cannot escape through the operation window. When working, it ensures that the staff is not harmed, but it does not guarantee that the experimental objects are not contaminated. 3.6
Class I biosafety cabinets are equipped with at least one high-efficiency air filter to purify the exhaust air, and the working space is a one-way flow of air without eddy currents purified by a high-efficiency filter. When working, the front glass sliding window is half open, with the upper part as an observation window and the lower part as an operation window. External air is sucked in through the operation window and it is impossible for it to escape through the operation window. When the operating procedures are followed during working conditions, it is ensured that both the staff and the experimental subjects are not harmed and contaminated.
Class I biosafety cabinets are equipped with at least one high-efficiency air filter to purify the exhaust air, and the working space is a one-way flow of air without eddy currents purified by a high-efficiency filter. The upper part of the front is an observation window, and the lower part is a glove box-style operation port. The box maintains negative pressure to the outside world. It can ensure that the human body is completely isolated from the items in the cabinet.
Physical containment device physical containment device A device that uses physical or mechanical methods to prevent the escape of pathogenic microorganisms. 3.9
High efficiency air filter HEPA (high efficiency particulate air) filter Under rated air volume, the capture efficiency of particles with a particle size greater than or equal to 0.3μm is above 99.97% and the air flow resistance is below 245Pa.
Relative pressure relativepressure
The value of absolute pressure minus atmospheric pressure.
4 Basic principles of laboratory biosafety protection 4.1 General
4.1.1 The content of laboratory biosafety protection includes safety equipment, personal protection devices and measures (primary protection), special design and construction requirements of the laboratory (secondary protection), strict management system and standardized operating procedures and regulations. 4.1.2 The content of comprehensive biosafety protection measures for each specific laboratory from project establishment, construction to use and maintenance should be included in the biosafety manual of each laboratory. A full-time biosafety person in charge must be set up. 4.1.3 Biosafety protection laboratories are divided into four biosafety protection levels according to different microorganisms and protection requirements. 4.2 Safety equipment and personal protection
Safety equipment and personal protection are the first-level barriers to ensure that laboratory workers do not come into direct contact with pathogenic microorganisms and their toxins. 4.2.1 The biosafety cabinet is the most important safety equipment and forms the most important protective barrier. The laboratory should be equipped with Class 1, I, and III biosafety cabinets as required. All operations that may cause pathogenic microorganisms and their toxins to splash or produce aerosols must be carried out in the biosafety cabinet, except for those that are actually impossible to implement. The ultra-clean workbench shall not be used instead of the biosafety cabinet. 4.2.2 When necessary, the laboratory should be equipped with other safety equipment, such as exhaust hoods equipped with exhaust purification devices, etc., or other equipment that does not allow pathogenic microorganisms to escape and ensure safety. 4.2.3 The centrifuge equipped in the laboratory should be used in a biosafety cabinet or other safety equipment referred to in 4.2.2 of this standard, otherwise a special centrifuge cup with a safe seal must be used. 4.2.4 Laboratory workers must be equipped with necessary personal protective equipment. 2
4.3 Special requirements for laboratory design and construction WS233-2002
Includes: special requirements for the design and construction of laboratory site selection, floor plan, enclosure structure, ventilation and air conditioning, safety devices and special equipment.
4.4 Safety operating procedures
4.4.1 The safety operating procedures specified in this standard for different levels of biosafety laboratories, including standard safety operating procedures and special safety operating procedures (see Appendix A), must be clearly listed and implemented in the biosafety manual of each laboratory. 4.4.2 Corresponding special safety operating procedures should be supplemented for different microorganisms and their toxins, which should also be clearly listed and implemented in the biosafety manual of each laboratory.
4.5 The transfer of pathogenic microorganisms and their toxins between laboratories The transfer of pathogenic microorganisms and their toxins between laboratories must be strictly implemented in accordance with the relevant national management measures currently in force. 4.6 Management System
4.6.1 Basic Laboratory Management
4.6.1.1 Layout and Access in the Laboratory
a) Clean areas, semi-contaminated areas and contaminated areas should be reasonably set up in the main laboratory; b) Personnel and items not related to the experiment are not allowed to enter the laboratory; c) Eating and drinking water, or other activities not related to the experiment are not allowed in the laboratory; d) Laboratory staff, external collaborators, trainees and students must obtain approval from the laboratory director before entering the laboratory and their positions.
4.6.1.2 Qualifications and Training of Laboratory Staff a) Laboratory staff must be professionally educated technicians. Before working independently, it is necessary to receive on-the-job training under the guidance of senior or mid-level laboratory technicians and meet the qualification standards before starting work; b) Laboratory staff must be informed of the potential dangers of laboratory work and receive laboratory safety education. They are willing to engage in laboratory work:
c) Laboratory staff must abide by all laboratory systems, regulations and operating procedures; d) Staff in level 3 and level 4 biosafety laboratories must keep background serum for relevant testing before starting work, and conduct regular re-examinations thereafter. If there are vaccines, immunization injections must be performed. 4.6.2 Special laboratory management
In order to avoid and deal with accidents caused by unsafe operations, the following principles must be strictly implemented: 4.6.2.1 Design safe work procedures for possible risk factors. 4.6.2.2 Conduct effective training and simulation training in advance. 4.6.2.3 For accidents, measures including emergency rescue or professional health care treatment must be provided to cope with emergencies. 4.6.2.4. Laboratory accident handling: Accidents that occur during the operation of the staff, such as needle sticks and cuts, skin contamination, infectious specimens splashing on the body surface and inside the mouth, nose and eyes, clothing contamination, and contamination of the test table, are all considered safety accidents. Emergency treatment should be carried out immediately depending on the type of accident and other different situations. Specific measures must be documented and strictly followed. While handling the emergency, it is necessary to report to the relevant experts and leaders and record the accident process and the specific location and degree of injury in detail, and ask experts to evaluate whether preventive treatment is needed. 4.6.2.5 A formal accident registration form should be filled in and reported to the national health authorities at the corresponding level in accordance with regulations. 4.7 Microbial hazard assessment
Before building a laboratory that uses infectious or potentially infectious materials, a microbial hazard assessment must be carried out. The microbial hazard assessment should be carried out based on factors such as the degree of pathogenicity of infectious microorganisms, transmission routes, stability, infection dose, concentration and scale during operation, the source of experimental subjects, whether there are animal experimental data, and whether there are effective prevention and treatment methods. 4.7.1 Determine at which level of biosafety protection laboratory the target microorganism should be operated through microbial hazard assessment. 3
WS233—2002
4.7.2 According to the results of hazard assessment, formulate corresponding operating procedures, laboratory management system and emergency accident handling methods, which must be in written documents and strictly followed.
5 Classification, grading and scope of application of laboratories 5.1 Classification
5.1.1 General biosafety protection laboratory (no experimental vertebrates and insects). 5.1.2 Experimental vertebrate biosafety protection laboratory. 5.2 Grading
Each type of biosafety protection laboratory is divided into four levels according to the degree of hazard of the microorganisms and their toxins handled. The biosafety protection requirements of laboratories at all levels are: level 1 is the lowest and level 4 is the highest. 5.3 Scope of application
5.3.1 General biosafety protection laboratory
5.3.1.1 Level 1 biosafety protection laboratory The laboratory structure and facilities, safe operating procedures, and safety equipment are applicable to microorganisms that are known to have no pathogenic effects on healthy adults, such as ordinary microbiology laboratories used for teaching, etc.
5.3.1.2 Level 2 biosafety protection laboratory The laboratory structure and facilities, safe operating procedures, and safety equipment are applicable to microorganisms with medium potential hazards to humans or the environment. 5.3.1.3 Level 3 biosafety protection laboratory The laboratory structure and facilities, safe operating procedures, and safety equipment are applicable to pathogenic microorganisms and their toxins that mainly infect people with serious or even fatal diseases through the respiratory route, and there are usually vaccines to prevent infection. HIV research (except serological experiments) should be carried out in a level 3 biosafety protection laboratory. 5.3.1.4 Level 4 biosafety protection laboratory The laboratory structure and facilities, safe operating procedures, and safety equipment are applicable to pathogenic microorganisms and their toxins that are highly dangerous to humans, transmitted through aerosol routes or unknown transmission routes, and there are currently no effective vaccines or treatments. Unknown microorganisms similar to the above situation must also be handled in a level 4 biosafety laboratory. After sufficient data is available, it will be decided whether such microorganisms or toxins should be handled in a level 4 or lower level laboratory. 5.3.2 The scope of applicable microorganisms for experimental vertebrate biosafety laboratories is the same as that of general biosafety laboratories of the same level.
6 Basic requirements for general biosafety laboratories 6.1 Level 1 biosafety laboratories
6.1.1 Safety equipment and personal protection
6.1.1.1 Generally, there is no need to use special safety equipment such as biosafety cabinets. 6.1.1.2 Staff should wear work clothes and protective glasses during experiments. 6.1.1.3 Staff should wear gloves when they have skin damage or rashes on their hands. 6.1.2 Special requirements for laboratory design and construction 6.1.2.1 Each laboratory should have a wash basin, which should be located near the exit. 6.1.2.2 The inner surface of the laboratory enclosure structure should be easy to clean. The floor should be non-slip and seamless, and carpets should not be laid. 6.1.2.3 The surface of the laboratory table should be impermeable, corrosion-resistant and heat-resistant. 6.1.2.4 The furniture in the laboratory should be firm. For easy cleaning, a certain gap should be maintained between various furniture and equipment. There should be a table (rack) for placing biological waste containers.
6.1.2.5 If the laboratory has openable windows, screens should be installed. 6.2 Secondary Biosafety Protection Laboratory
6.2.1 Safety Equipment and Personal Protection
WS233—2002
6.2.1.1 Operations that may produce pathogenic microbial aerosols or splashes should be carried out in a biosafety cabinet (preferably a Class I biosafety cabinet) or other physical suppression equipment, and personal protection equipment should be used. 6.2.1.2 Handling of high-concentration or large-volume infectious materials must be carried out in a biosafety cabinet (preferably a Class 1 biosafety cabinet) or other physical suppression equipment, and personal protection equipment should be used. Centrifugation of the above materials can be performed in the laboratory if sealed centrifuge rotors or safety centrifuge cups are used, and they are only opened and closed and loaded with infectious materials in the biosafety cabinet. 6.2.1.3 When microbiological operations cannot be performed in the biosafety cabinet and external operations must be taken, facial protection devices (goggles, masks, personal respiratory protection products or other splash protection equipment) must be used to prevent the splash or atomization hazards of infectious materials. 6.2.1.4 Protective clothing such as work clothes or gowns should be worn in the laboratory. When leaving the laboratory, protective clothing must be taken off and left in the laboratory. It must not be worn outside, let alone taken home. Used work clothes should be disinfected in the laboratory first, and then washed or discarded uniformly. 6.2.1.5 Gloves should be worn when hands may come into contact with infectious materials, contaminated surfaces or equipment. If spillage or splashing of infectious materials may occur, it is advisable to wear two pairs of gloves. Do not leave the laboratory wearing bad gloves. Gloves can only be removed after the work is completely completed. Disposable gloves must not be washed and reused.
6.2.2 Special requirements for laboratory design and construction 6.2.2.1 Biosafety Level 2 laboratories must meet the requirements of each clause in 6.1.2 of this standard. 6.2.2.2 Facilities for implementing various disinfection methods should be set up, such as high-pressure sterilizers, chemical disinfection devices, etc. to treat waste. 6.2.2.3 Eyewash devices should be set up.
The laboratory door should be locked and can be closed automatically. 6.2.2.4
6.2.2.5 There should be luminous signs at the laboratory exit. 6.2.2.6 The laboratory should have a ventilation rate of no less than 3 to 4 times per hour. 6.3 Level 3 Biosafety Laboratory
6.3.1 Safety Equipment and Personal Protection
6.3.1.1 Level I or above biosafety cabinets must be installed in the laboratory. 6.3.1.2 All operations involving infectious materials should be carried out in a biosafety cabinet. When such operations have to be performed outside the biosafety cabinet, comprehensive protective measures must be adopted, including personal protection and the use of physical suppression equipment. 6.3.1.3 Personal protective equipment must be used when conducting infectious tissue culture and operations that may produce infectious aerosols. 6.3.1.4 When aerosols cannot be safely and effectively confined to a certain range, respiratory protection devices should be used. 6.3.1.5 Before entering the laboratory work area, staff should wear back-opening work clothes or other protective clothing in a dedicated locker room (or buffer room). Work clothes must be taken off after work and must not be worn when leaving the laboratory. Reusable work clothes must be disinfected and then washed. 6.3.1.6 Gloves must be worn when working (two pairs are preferred). Disposable gloves must be disinfected and then discarded. 6.3.1.7 Effective disinfectants, eye washes or saline must be available in the laboratory and easily accessible. Emergency medicines can be provided. 6.3.2 Special requirements for laboratory design and construction 6.3.2.1 Site selection
The Class III biosafety laboratory can be located in the same building as other buildings, but it must be a separate area. This area is separated from the public corridor or public area by an isolation door.
6.3.2.2 Plan layout
a) The core area of ​​the Class III biosafety laboratory includes the laboratory room and the buffer room connected to it. b) The buffer room forms the passage into the laboratory room. Two interlocking doors must be set up. When one door is opened, the other door is automatically closed. If an electric interlocking device is used, both doors must be in an openable state when the power is off. Secondary changing of clothes can be carried out in the buffer room.
c) When the laboratory ventilation system is not equipped with an automatic control device, the area of ​​the buffer room should not be too large and should not exceed one eighth of the area of ​​the laboratory room.
WS233—2002
d) The installation location of Class I or Class II biosafety cabinets should be far away from the entrance of the laboratory, away from areas where staff frequently move around, and conducive to the formation of airflow from the "clean" area to the "contaminated" area. 6.3.2.3 Enclosure structure
a) The inner surface of the enclosure structure of the laboratory (including the buffer room) must be smooth, corrosion-resistant and waterproof to facilitate disinfection and cleaning. All gaps must be reliably sealed.
b) All doors in the laboratory can be closed automatically. c) No windows except observation windows shall be installed. The observation window must be a sealed structure and the glass used must be unbreakable glass. d) The floor should be leak-free, smooth but not slippery. Floor tiles, terrazzo and other gap-filled floors shall not be used. e) The intersections between the ceiling, floor and wall are all arc-shaped and reliably sealed. During construction, insects and mice should be prevented from drilling into the foot of the wall. 6.3.2.4 Ventilation and air conditioning
a) An independent ventilation and air conditioning system must be installed to control the airflow direction and pressure gradient of the laboratory. The system must ensure that when the laboratory is in use, the indoor air shall not be discharged to the outside from other parts or gaps of the laboratory except through the exhaust duct after high-efficiency filtration; at the same time, it must ensure that the airflow in the laboratory flows from the "clean" area to the "contaminated" area. The layout of the air inlet and exhaust vents should minimize the dead space in the experimental area.
b) The ventilation and air conditioning system is a direct exhaust system, and a partial return air system shall not be used. c) Environmental parameters: The laboratory interior maintains a negative pressure relative to the outside of the laboratory. The relative pressure of the laboratory room is preferably -30Pa~40Pa, and the relative pressure of the buffer room is preferably -15Pa~-20Pa. The temperature and humidity in the laboratory should be controlled within the human comfort range, or according to the process requirements. The air cleanliness in the laboratory should be level 7 to 8 as defined in GB50073-2001 "Cleanroom Design Specifications". The artificial lighting in the laboratory should be uniform, non-glaring, and the illumination should not be less than 500lx. d) In order to ensure that the airflow in the experimental space flows from the "clean" area to the "contaminated" area, the laboratory should not use a double-sided evenly distributed exhaust vent layout. The ventilation design of top delivery and top exhaust should not be adopted. The air exhausted from the biosafety cabinet after internal high-efficiency filtration can be directly discharged to the atmosphere through the exhaust pipe of the system, or it can be sent to the exhaust system of the building. The pressure balance between the biosafety cabinet and the exhaust system should be ensured.
e) The air intake of the laboratory should be filtered through primary, medium and high-efficiency three levels. f) The exhaust air of the laboratory must be filtered through high-efficiency filtration or treated by other methods, and then discharged directly into the air at a speed of not less than 12m/s. The exhaust port should be far away from the air inlet of the system. The treated exhaust air can also be discharged into the exhaust duct of the building, but it shall not be sent back to any part of the building.
g) The air intake and exhaust high-efficiency filters must be installed in the air outlets of the laboratory on the enclosure structure to avoid contamination of the air duct. h) In the ventilation system of the laboratory, airtight regulating valves should be installed at the air intake and exhaust main pipes, which can be completely closed when necessary for indoor chemical fumigation.
i) All components used in the ventilation system of the laboratory must be airtight. The high-efficiency filters used must not be wooden frames. j) An automatic interlock device for fan start-up should be installed to ensure that the exhaust fan is turned on first and the supply fan is turned on later when the laboratory is started. When shutting down, the supply fan is turned off first and the exhaust fan is turned off later.
k) Split air conditioners shall not be installed in the laboratory. 6.3.2.5 Safety devices and special equipment
a) Class I or Class II biosafety cabinets must be installed in the main laboratory. The installation location should meet the requirements in 6.3.2.5d). b) Continuous flow centrifuges or other equipment that may generate aerosols should be placed in physical suppression equipment, which should be able to filter the aerosols that they may generate through high-efficiency filters and then discharge them. The exhaust of all other exhaust devices (fume hoods, exhaust hoods, etc.) that must be installed in the laboratory must be filtered by high-efficiency filters before being discharged. Its indoor layout should be conducive to the formation of an airflow pattern from the "clean" area to the "contaminated area". c) A high-pressure sterilizer or other disinfection device that does not produce steam must be installed in the laboratory. d) A transfer window should be set between the laboratory and the outside. The double doors of the transfer window must not be opened at the same time, and a physical disinfection device should be installed in the transfer window. Infectious materials must be placed in a closed container before they can be transferred through the transfer window. 6
WS233—2002
e) A pressure display alarm device must be installed in a prominent position at the entrance of the laboratory to display the negative pressure conditions of the laboratory and the buffer room. When the negative pressure indication deviates from the preset interval, it must be able to sound and light segments to alarm personnel inside and outside the laboratory. The display of the air flow resistance of the supply and exhaust high-efficiency filters can be added to the device. f) Laboratory startup work There should be no power outage during operation. A dual power supply should be used. If this is difficult to achieve, a backup power supply or uninterruptible power supply that can automatically switch during power outages should be installed to power key equipment (biosafety cabinets, fume hoods, exhaust hoods, lighting, etc.). g) A washbasin can be installed in the buffer room. The water supply shut-off valve of the washbasin must be a foot-operated, elbow-operated or automatic switch. If the washbasin is located in the main laboratory, the sewer must be separated from the building's sewer line and clearly marked. The sewer must be disinfected. The washbasin is for hand washing only, and no infectious materials should be poured into it. The water supply pipe must be equipped with a backflow prevention device. Floor drains shall not be installed in the laboratory.
6.3.2.6 Others
a) The surface of the laboratory table should be impermeable, corrosion-resistant and heat-resistant. b) The furniture in the laboratory air should be sturdy. For easy cleaning , a certain gap should be maintained between various furniture and equipment. There should be a special table (rack) for placing biological waste containers. The corners and protruding parts of furniture and equipment should be smooth and free of burrs, and arc shape is preferred. c) The required vacuum pump should be placed in the laboratory. The vacuum pipeline must be installed with an online high-efficiency filter. d) Cylinders such as compressed air should be placed outside the laboratory. The pipes passing through the enclosure structure must be sealed with non-shrinking sealing materials between the enclosure structure. The gas pipeline must be installed with an online high-efficiency filter and a backflow prevention device. c) An eyewash device should be installed in the laboratory.
f) There should be a luminous sign at the laboratory exit. g) A communication system must be set up inside and outside the laboratory. h) Experimental records and other information in the laboratory should be sent to the outside of the laboratory via a fax machine. 6.4 Level 4 Biosafety Containment Laboratory
Level 4 biosafety protection laboratories are divided into: safety cabinet type laboratories and positive pressure suit type laboratories. In safety cabinet type laboratories, all microbial operations are carried out in Class III biosafety cabinets. In positive pressure suit type laboratories, workers must wear special positive pressure suit type protective clothing.
6.4.1 Safety equipment and personal protection
6.4.1.1 All operations on infectious materials in the laboratory must be carried out in Class III biosafety cabinets. If the staff wears a whole positive pressure work suit supplied by the life support system, the relevant operations can be carried out in a Class III biosafety cabinet. 6.4.1.2 All staff must change into a full set of laboratory clothing when entering the experimental space, including underwear, underwear, shirts or jumpsuits, shoes and gloves, etc. All these laboratory protective clothing must be taken off in the locker room before taking a shower and leaving the laboratory. 6.4.2 Special requirements for the design and construction of safety cabinet type laboratories 6.4.2.1 Site selection. The laboratory should be built in an independent building or an independent area in the laboratory building. 6.4.2.2 Plan layout
a) The core area of ​​the laboratory consists of a room (safety cabinet room) where a Class III biosafety cabinet is placed and an entrance passage. The entrance passage has at least three parts, namely the outer dressing room, the shower room and the inner dressing room. There is a white interlocking device between any adjacent doors to prevent two adjacent doors from being opened at the same time. For materials, articles and equipment that cannot be brought in and out of the safety cabinet room from the dressing room, a high-pressure sterilizer with a double-door structure should be installed on the wall of the safety cabinet room, and there should be a diffuse disinfection tank, a fumigation room or a ventilation transfer window with a disinfection device for transfer or disinfection. An emergency exit passage with an airlock must be set up. b) A buffer zone can be set up around the safety cabinet room, which is a circular corridor or a buffer room and is part of the core area. The buffer zone construction requirements are the same as those of the Class III biosafety protection laboratory.
6.4.2.3 Enclosure structure
a) The walls, floors, ceilings, etc. of the safety cabinet room and the inner locker room should form a sealed inner shell. The floor should be sealed as a whole, and the corners should be rounded. The inner surface of the room should be waterproof and corrosion-resistant. All gaps in the structure should be sealed. The gaps around the doors of the safety cabinet room and the inner locker room should be minimized and sealed to facilitate disinfection. All sewer pipes on the floor of the safety cabinet room should be directly connected to the liquid disinfection system. The sewer outlets and other service pipelines should be equipped with high-efficiency filters to prevent pests from entering. b) The door to the laboratory can be closed automatically and can be locked. All equipment for transferring items in and out of the laboratory must be a double-door structure, and there must be an automatic interlocking device between the two doors. c) Any window must be shatterproof and sealed. d) A double-door high-pressure sterilization pot for sterilizing items transferred from the Class II biological safety cabinet and the safety cabinet room should be installed on the wall hole of the laboratory. Its outer door opens outside the laboratory. The gap must be well sealed. 6.4.2.4 Ventilation and Air Conditioning
a) A well-designed and constructed direct exhaust ventilation system must be installed. The air intake and exhaust design of the system should ensure directional airflow from the minimum hazard area to the maximum potential hazard area. The layout of the air intake and exhaust vents should minimize the dead space in the experimental area. b) The pressure difference and air flow direction of adjacent areas must be monitored, and alarms must be installed. A pressure instrument panel shall be installed at the entrance of the outer dressing room to display and monitor the pressure or pressure difference of each area in the laboratory and the air intake and exhaust volume. c) Automatic control and alarm devices of the ventilation system must be designed and installed to ensure that there is no positive pressure in the laboratory and to maintain normal pressure and pressure difference in each room. The exhaust of the Class 1 biosafety cabinet must be directly connected to the exhaust duct. The exhaust duct must be set up separately and must not be connected to the building exhaust system.
d) Environmental parameters: The safety cabinet room must maintain the highest negative pressure, and its relative pressure shall not be higher than -60Pa; the relative pressure of the safety cabinet room, inner dressing room, shower room and outer dressing room increases in turn, and there should be a pressure difference between adjacent rooms, which should be maintained between 10Pa and 15Pa. The air cleanliness of the core area should be between level 7 and 8. The artificial lighting of the laboratory should be uniform, non-glare, and the illumination should not be less than 500lx.
e) The air intake is a three-stage filtration system, and the last stage must be filtered by a high-efficiency filter. f) The exhaust air from the entire core area must be processed by two high-efficiency filters in succession. The exhaust outlet should be away from the laboratory area and the air inlet
g) The air intake and exhaust high-efficiency filters must be installed in the air outlets on the enclosure structure of each room in the laboratory to avoid contaminating the air duct. The high-efficiency filter air outlet structure must be disinfected in situ before replacing the high-efficiency filter. Or use a filter structure that can be replaced in an airtight bag, and then disinfect or burn the high-efficiency filter. Each high-efficiency filter must be tested before and after installation, and once a year after operation. 6.4.2.5 Safety devices and special equipment
a) A Class I biological safety cabinet must be installed in the safety cabinet room. b) The door of the autoclave must be automatically controlled, and its outer door can only be opened after the sterilization cycle is completed. c) A double-door liquid immersion tank, fumigation disinfection room or ventilation airlock for disinfection must be provided to disinfect items that cannot be autoclaved from the Class I biological safety cabinet and the safety cabinet room, so that they can enter and exit safely. d) If there is a central vacuum pipeline system, it should not be used in the space outside the safety cabinet room. The online high-efficiency filter should be as close as possible to each point of use or cut-off point. The filter should be easy to disinfect or replace on site. Other gas and liquid pipelines leading to the safety cabinet room are required to be equipped with protective devices to prevent backflow.
e) Liquids flowing out from the inner locker room (including toilets), the water tank of the safety cabinet room, the floor drain, and the autoclave and other sources must be disinfected before being discharged into the sewer, preferably by heating disinfection. The floor drain must have a water seal filled with chemical disinfectants effective for the infectious substances being tested, and they lead directly to the liquid disinfection system. The sewer outlets and other service pipelines should be equipped with high-efficiency filters. The liquid discharged from the shower room, the outer locker room, and the toilet can be discharged directly to the sewer without any treatment. The disinfection effect of liquid waste must be verified.
) The ventilation system, alarm, lighting, access control and biological safety cabinets in the core area of ​​the laboratory (safety cabinet room, inner locker room, shower room and outer locker room) must be equipped with an emergency power supply that can be automatically activated. 6.4.2.6 Others
a) The surface of the workbench should be seamless or sealed. It should be impermeable, corrosion-resistant and heat-resistant. b) The furniture in the laboratory should be simple, open-structured and sturdy. Space should be left between the laboratory bench, safety cabinet and other equipment to enable cleaning and disinfection. The surface of the chair and other facilities should be covered with non-fibrous materials to make it easy to disinfect. The corners and protruding parts of furniture and equipment should be smooth and burr-free, preferably in an arc shape. c) Install non-manually operated or white-acting wash basins near the doors of the safety cabinet room and the inner and outer dressing rooms. d) The laboratory must have a communication system with the outside, and a closed-circuit television system is preferred. e) The experimental records and other materials in the laboratory must be sent to the outside of the laboratory via a fax machine. 6.4.3 Special requirements for the design and construction of laboratories wearing positive pressure suits 6.4.3.1 Site selection: The laboratory should be built in an independent building or an independent area in the laboratory building. 6.4.3.2 Plan layout
a) The core area of ​​the laboratory consists of a room (main laboratory) where a Class I biological safety cabinet is placed and an access passage. The access passage includes a dressing area and a disinfection area. The dressing area is composed of an outer dressing room, a shower room, and an inner dressing room in sequence. The disinfection area is a chemical shower room. When the staff leaves the main laboratory, they first pass through the chemical shower to disinfect the surface of the positive pressure anti-expansion suit. There is an automatic interlocking device between any adjacent doors in the core area to prevent two adjacent doors from being opened at the same time. For materials, articles and equipment that cannot be brought in and out of the main laboratory from the dressing room, a high-pressure sterilizer with a double-door structure, an immersion disinfection tank, a fumigation room or a ventilation transfer window with a disinfection device should be installed on the wall of the main laboratory for transfer or disinfection. An emergency exit passage with an airlock must be set up. b) Same as the requirements in 6.4.2.2b) of this standard. 6.4.3.3 Enclosure structure: Same as the requirements in 6.4.2.3 of this standard. 6.4.3.4 Ventilation and air conditioning
a) The laboratory area must maintain the highest negative pressure, and its relative pressure shall not be higher than -80Pa; the relative pressure of the laboratory area, chemical disinfection shower room, inner dressing room, shower room and outer dressing room increases in sequence, and the pressure difference between adjacent rooms is maintained at 10Pa to 15Pa. The air cleanliness of the core area should be level 7 to 8. b) Except for the above provisions, the other requirements are the same as those in 6.4.2.4 of this standard. 6.4.3.5 Safety devices and special equipment
a) The main laboratory must be equipped with a biological safety cabinet of at least Class II. b) Staff entering the main laboratory must wear positive pressure protective clothing and a life support system protected by a high-efficiency filter to supply breathing gas. The life support system includes a positive pressure gas supply device for providing excess breathing gas, an alarm and an emergency support gas tank. The air pressure inside the work clothes is a continuous positive pressure relative to the surrounding environment. An automatic emergency power supply must be set for the life support system. c) Except for the above clauses, the other requirements are the same as those in 6.4.2.5 of this standard. 6.4.3.6 Others: The same as the requirements in 6.4.2.6 of this standard. 7 Experimental vertebrate biosafety protection laboratory 7.1 When designing an experimental vertebrate biosafety protection laboratory, the requirements of the corresponding level of biosafety protection laboratory in this standard and GB14925-2001 "Experimental Animal Environment and Facilities" must be met at the same time. 7.2 When designing a biosafety laboratory for experimental vertebrates, the dangers caused by animal activities themselves (such as the generation of aerosols, the harm of biting and scratching to humans, etc.) must be fully considered, and necessary measures must be taken in terms of safe operating procedures, safety equipment and personal protection, and laboratory design and construction.
7.3 Biosafety laboratories using experimental vertebrates must be physically isolated from general animal breeding facilities. 7.4 Animals in level 3 experimental vertebrate biosafety laboratories must be placed in a negative pressure cage system with a purification and ventilation device. 7.5 Animals in level 4 experimental vertebrate biosafety laboratories must be placed in a level 1 biosafety cabinet in a safety cabinet type laboratory; in a positive pressure suit type laboratory, staff must wear positive pressure suits, and animals must be placed in a negative pressure cage system with a purification and ventilation device.
8 Biohazard signs and use
8.1 Biohazard signs
WS233—2002
See Figure 1.
8.2 Use of biohazard signs
Biohazard levels
Figure 1 Biohazard signs
8.2.1 Biohazard signs must be posted in obvious locations at the entrance of biosafety containment laboratories above level 2, and the level must be indicated. 8.2.2 Biohazard signs must be posted in obvious locations on the surface of all containers containing infectious substances, and the same level must be indicated according to the level of the biosafety containment laboratory in which they are located.
9 Acceptance of newly built level 3 and level 4 biosafety containment laboratories and testing of existing biosafety containment laboratories 9.1 Acceptance and commissioning of newly built level 3 and level 4 biosafety containment laboratories. It is divided into three stages: project completion acceptance, expert group acceptance, and approval for commissioning. After the project completion acceptance, the newly built level 3 and level 4 biosafety containment laboratories must first be accepted by the expert group and an acceptance report must be submitted, and then they can be put into use after approval by the relevant competent authorities. 9.1.1 Expert Group Acceptance
The expert group must conduct document review, on-site acceptance inspection, spot check and assessment of staff, and submit an acceptance report. 9.1.1.1 Documents that must be reviewed by the expert group during acceptance a) Project establishment report and related documents; b) Experimental microbiological hazard assessment report; c) Design task book, design description and design drawings. If it has been included in the capital construction project, other documents required by the capital construction procedure; d) The completion acceptance and inspection report can be partially referred to JGJ71-1990 Clean Room Construction and Acceptance Specifications; e) Third-party inspection report, including pressure difference, cleanliness, noise and exhaust high-efficiency air filter leak detection in each room; f) Laboratory use and operation technical regulations; g) Laboratory management system; h) Experimental microbiological operation procedures (one copy each); i) Emergency handling procedures; ) Registration form of working personnel (including signature); k) Registration form of instruments in the laboratory; 1) Staff training records; m) Staff physical examination (including serum examination) and immunization registration form: The above (f~m) items should be summarized and bound into one volume, with the cover title "Biosafety Volume". The registration form and record section should leave enough space for subsequent use.
n) Laboratory space use registration book (work log); o) Emergency registration and handling record book. 9.1.1.2 Random inspection and assessment of laboratory staff. During the acceptance process, the staff should be randomly inspected in the form of oral or written examinations, and the number of inspected personnel should not be less than one-fourth of the total number of staff.
9.2 Inspection of existing Class 3 and Class 4 biosafety protection laboratories and Class 4 biosafety cabinets 10
3-2002
9.2.1 After the enclosure structure and ventilation system (including replacement of high-efficiency filters) of the existing Class 3 and Class 4 biosafety protection laboratories are repaired, and after the biosafety cabinets are moved or overhauled, they must be re-inspected (including biosafety cabinets). The inspection is carried out in accordance with the requirements of this standard and JGJ71-1990 and the indicators of the design task book.
9.2.2 Annual inspections are carried out once a year after the existing Class 3 and Class 4 biosafety protection laboratories are put into use. 9.2.3 The Class II biosafety cabinets used in biosafety laboratories at all levels must be inspected on site once a year (see Appendix B).
10 Use and maintenance of existing Class III and Class IV biosafety laboratories 10.1 The use and maintenance of existing Class III and Class IV biosafety laboratories must be carried out in accordance with the requirements of this standard and the laboratory biosafety manual.
10.2 The facilities and equipment related to biosafety in laboratories that have passed acceptance cannot be changed without authorization. 10.3 If the structure and equipment of the laboratory need to be changed, it must be demonstrated by relevant experts and approved by the competent authorities. 10.4 The laboratory should be inspected and maintained by professionals under the condition of ensuring safety. 11
WS233—2002
A.1 Level 1 Biosafety Laboratory
Appendix A
(Normative Appendix)
Safety Operation Procedures
A.1.1 Key points for safety operation in routine microbiological operation proceduresA.1.1.1 Non-staff members are prohibited from entering the laboratory. For special circumstances such as visiting the laboratory, entry must be approved by the laboratory director. A.1.1.2
Wash hands after removing gloves and before leaving the laboratory after contacting microorganisms or items containing microorganisms. A.1.1.3 It is prohibited to eat, smoke, handle contact lenses, apply makeup, or store food in the work area. A.1.1.4 Use a pipette to suck liquids, and do not suck by mouth. A.1.1.5
Establish safe operation procedures for sharp instruments
Operate according to laboratory safety procedures to reduce splashing and aerosol generationA. 1.1.6
A.1.1.7Disinfect the work surface at least once a day, and disinfect it at any time after active substances splash. A, 1.1.8All cultures and waste must be inactivated before being transported out of the laboratory, such as high pressure inactivation. Items that need to be transported out of the laboratory for inactivation must be placed in special sealed containers.
A.1.1.9Establish effective rodent and insect prevention measuresA.1.2Special safety operation procedures
No special safety operation procedures.
A.2 Secondary Biosafety Laboratory
A.2.1 Key points for safe operation in routine microbiological operation proceduresA.2.1.1 Same as A.1.1.1~A.1.1.9 of this appendixA.2.1.2 Biohazard signs must be posted at the entrance of the laboratory, and relevant biohazard information, including the name of the infectious material used, the name and telephone number of the person in charge, must be posted in a prominent position inside.A.2.2 Special safety operation procedures
A.2.2.1 When conducting infectious experiments, no one is allowed to enter the laboratory, or they must obtain the consent of the laboratory director before entering. Immune-tolerant staff or those who are using immunosuppressants must obtain the consent of the laboratory director before working in the laboratory or animal room.A.2.2.2 Biohazard signs must be posted at the entrance of the laboratory, indicating the risk factors, biosafety level, required immunity, name and telephone number of the person in charge, special requirements for entering the laboratory, and procedures for leaving the laboratory.A.2.2.3 Staff should receive necessary vaccinations and tests (such as hepatitis B vaccine, BCG, etc.). A.2.2.4 Collect basic serum from dangerous workers for backup when necessary, and collect serum samples regularly as needed. There should be a test report, and if there is any problem, it should be handled in time.
A.2.2.5 Incorporate biosafety procedures into standard operating procedures or biosafety manuals, which are kept by the laboratory director. Workers should read the specifications before entering the laboratory and operate in accordance with the specifications. A.2.2.6 Workers should receive training on relevant potential hazards and master the procedures for preventing exposure and post-exposure treatment. The latest training should be received once a year.
A.2.2.7 Strictly abide by the following regulations to prevent sharp injuries: A.2.2.7.1 Except for special circumstances (parenteral injection and phlebotomy, etc.), it is prohibited to use needles, syringes and other sharp instruments in the laboratory. Use plastic equipment instead of glass equipment as much as possible. A.2.2.7.2 Use disposable syringes as much as possible. Used needles are prohibited from bending, cutting, breaking, re-capping, or removing from syringes. Direct operation by hand is prohibited. Used needles must be placed directly in a penetration-proof container. Non-disposable sharps must be placed in thick-walled containers and transported for 12 hours.1 Level 1 Biosafety Laboratory
Appendix A
(Normative Appendix)
Safety Operating Procedures
A.1.1 Key points for safe operation in routine microbiological operating proceduresA.1.1.1 Non-staff members are prohibited from entering the laboratory. Visitors to the laboratory and other special circumstances must obtain approval from the laboratory director before entering. A.1.1.2
Wash your hands after contacting microorganisms or items containing microorganisms, taking off gloves and before leaving the laboratory. A.1.1.3 It is prohibited to eat, smoke, handle contact lenses, apply makeup, and store food in the work area. A.1.1.4 Use a pipette to absorb liquids, and do not suck by mouth. A.1.1.5
Formulate safe operating procedures for sharp instruments
Operate in accordance with laboratory safety procedures to reduce splashing and aerosol generationA. 1.1.6
A.1.1.7Disinfect the work surface at least once a day, and disinfect it at any time after active substances are splashed. A, 1.1.8 All cultures and waste must be inactivated before being transported out of the laboratory, such as high pressure inactivation. Items that need to be transported out of the laboratory for inactivation must be placed in special sealed containers.
A.1.1.9 Develop effective rodent and insect prevention measures A.1.2 Special safety operating procedures
No special safety operating procedures.
A.2 Secondary biosafety protection laboratory
A.2.1 Key points for safe operation in routine microbiological operating procedures A.2.1.1 Same as A.1.1.1~A.1.1.9 of this appendix A.2.1.2 Biohazard signs must be posted at the entrance of the laboratory, and relevant biohazard information must be posted in prominent locations inside, including the name of the infectious material used, the name and telephone number of the person in charge. A.2.2 Special safety operating procedures
A.2.2.1 When conducting infectious experiments, others are prohibited from entering the laboratory, or they must obtain the consent of the laboratory director before entering. Staff who are immune-tolerant or currently using immunosuppressants must obtain the consent of the laboratory director before they can work in the laboratory or animal room. A.2.2.2 A biohazard sign must be posted at the entrance of the laboratory, indicating the risk factors, biosafety level, required immunity, name and phone number of the person in charge, special requirements for entering the laboratory, and procedures for leaving the laboratory. A.2.2.3 Staff should receive necessary vaccinations and tests (such as hepatitis B vaccine, BCG, etc.). A.2.2.4 When necessary, collect basic serum from staff engaged in dangerous work and keep it on file, and collect serum samples regularly as needed. There should be a test report, and if there are any problems, they should be dealt with in a timely manner.
A.2.2.5 The biosafety procedures should be included in the standard operating procedures or biosafety manual, which should be kept by the laboratory director. Staff should read the specifications before entering the laboratory and operate in accordance with the specifications. A.2.2.6 Staff should receive training on relevant potential hazards and master the procedures for preventing exposure and post-exposure treatment. The latest training should be received once a year.
A.2.2.7 Strictly comply with the following regulations to prevent sharps injuries: A.2.2.7.1 Except for special circumstances (parenteral injection and phlebotomy, etc.), needles, syringes and other sharps are prohibited in the laboratory. Plastic equipment should be used instead of glass equipment as much as possible. A.2.2.7.2 Disposable syringes should be used as much as possible. Used needles must not be bent, cut, broken, re-capped, or removed from syringes. Direct manipulation by hand is prohibited. Used needles must be placed directly in a penetration-proof container. Non-disposable sharps must be placed in thick-walled containers and transported.1 Level 1 Biosafety LaboratorybzxZ.net
Appendix A
(Normative Appendix)
Safety Operating Procedures
A.1.1 Key points for safe operation in routine microbiological operating proceduresA.1.1.1 Non-staff members are prohibited from entering the laboratory. Visitors to the laboratory and other special circumstances must obtain approval from the laboratory director before entering. A.1.1.2
Wash your hands after contacting microorganisms or items containing microorganisms, taking off gloves and before leaving the laboratory. A.1.1.3 It is prohibited to eat, smoke, handle contact lenses, apply makeup, and store food in the work area. A.1.1.4 Use a pipette to absorb liquids, and do not suck by mouth. A.1.1.5
Formulate safe operating procedures for sharp instruments
Operate in accordance with laboratory safety procedures to reduce splashing and aerosol generationA. 1.1.6
A.1.1.7Disinfect the work surface at least once a day, and disinfect it at any time after active substances are splashed. A, 1.1.8 All cultures and waste must be inactivated before being transported out of the laboratory, such as high pressure inactivation. Items that need to be transported out of the laboratory for inactivation must be placed in special sealed containers.
A.1.1.9 Develop effective rodent and insect prevention measures A.1.2 Special safety operating procedures
No special safety operating procedures.
A.2 Secondary biosafety protection laboratory
A.2.1 Key points for safe operation in routine microbiological operating procedures A.2.1.1 Same as A.1.1.1~A.1.1.9 of this appendix A.2.1.2 Biohazard signs must be posted at the entrance of the laboratory, and relevant biohazard information must be posted in prominent locations inside, including the name of the infectious material used, the name and telephone number of the person in charge. A.2.2 Special safety operating procedures
A.2.2.1 When conducting infectious experiments, others are prohibited from entering the laboratory, or they must obtain the consent of the laboratory director before entering. Staff who are immune-tolerant or currently using immunosuppressants must obtain the consent of the laboratory director before they can work in the laboratory or animal room. A.2.2.2 A biohazard sign must be posted at the entrance of the laboratory, indicating the risk factors, biosafety level, required immunity, name and phone number of the person in charge, special requirements for entering the laboratory, and procedures for leaving the laboratory. A.2.2.3 Staff should receive necessary vaccinations and tests (such as hepatitis B vaccine, BCG, etc.). A.2.2.4 When necessary, collect basic serum from staff engaged in dangerous work and keep it on file, and collect serum samples regularly as needed. There should be a test report, and if there are any problems, they should be dealt with in a timely manner.
A.2.2.5 The biosafety procedures should be included in the standard operating procedures or biosafety manual, which should be kept by the laboratory director. Staff should read the specifications before entering the laboratory and operate in accordance with the specifications. A.2.2.6 Staff should receive training on relevant potential hazards and master the procedures for preventing exposure and post-exposure treatment. The latest training should be received once a year.
A.2.2.7 Strictly comply with the following regulations to prevent sharps injuries: A.2.2.7.1 Except for special circumstances (parenteral injection and phlebotomy, etc.), needles, syringes and other sharps are prohibited in the laboratory. Plastic equipment should be used instead of glass equipment as much as possible. A.2.2.7.2 Disposable syringes should be used as much as possible. Used needles must not be bent, cut, broken, re-capped, or removed from syringes. Direct manipulation by hand is prohibited. Used needles must be placed directly in a penetration-proof container. Non-disposable sharps must be placed in thick-walled containers and transported.
Tip: This standard content only shows part of the intercepted content of the complete standard. If you need the complete standard, please go to the top to download the complete standard document for free.