Some standard content:
GL 19489—2004
The preparation of this standard mainly refers to the WHO Laboratory Biosafety Manual (15190:2003 (upper) Medical Laboratory Safety Requirements and the WHO Laboratory Biosafety Manual (revised edition), 2003). The difference between this standard and the WHO Laboratory Biosafety Manual (15190:2003 (lower) is that this standard is not only applicable to medical laboratories, but also to various laboratories that operate biological factors. In addition, the requirements for laboratory biosafety are added. The standard incorporates the relevant contents of the WHO Laboratory Biosafety Manual for laboratories operating hazardous substances. However, this version takes into account the overall status of laboratory safety and management in my country, and specifies the requirements for the establishment of such laboratories. To ensure safety, this standard was proposed by the National Accreditation and Certification Administration of the Ministry of Science and Technology of the People's Republic of China. This standard is under the jurisdiction of the National Accreditation and Certification Standardization Committee. The sponsor of this standard is the China National Accreditation Committee for Laboratory Accreditation. The participating units of this standard are: the Chinese Academy of Military Medical Sciences, China Center for Disease Control and Prevention, Beijing Military Region General Hospital, Guangdong Inspection Bureau, National Animal Husbandry and Veterinary Station of the Ministry of Agriculture of the People's Republic of China. The main contributors of this standard are: Che Fengxiang, Tu Gengchan, He Kuaichun, Lin Zhiwei, Tian Kezhuang, Qi Peijun, Chuan Zhaowei, m
1 Qianwei
General requirements for laboratory biosafety
GB 19489—2004
This standard defines the principles for the establishment of a safe laboratory for laboratory safety. It also stipulates the requirements for safety classification of biological equipment, configuration of test and detection equipment, personal protection and laboratory safety behavior. This standard is a minimum requirement. Such laboratories should also comply with the requirements of other relevant national regulations.
2 Technical and Definitions
The following technical specifications and definitions apply to this standard: 2.1
Biological Agents
-Microorganisms and biological hazards,
Pathogens
Biological agents that can cause disease in humans, animals or plants, 2.3
Hazards Hazardous waste
hazardouswaste
Potential biological hazards, flammable, corrosive, toxic, radioactive and destructive to humans and the environment. 2.4
Hazard Hisk
Comprehensive incidence and severity of the hazards. 2.5
Aerosolswww.bzxz.net
A stable dispersion system formed by a total number of tiny particles with a diameter of 0.COun--10m suspended in a gas medium.
Life safety waste
Comprehensive measures to prevent hazardous organisms from causing harm to laboratory personnel, spreading outside the laboratory and causing harm. 2. 7
High Efficiency Particulate Air (HEPA) filter with a filter capacity of greater than or equal to 3000 particles per month, and the removal efficiency is required for the cabinet. 2.B
Safety Equipment
Negative pressure exhaust is placed on the workbench or equipment in the laboratory to reduce the risk of laboratory workers. 2.9
Biological Safety Cabinet (BSC) Negative zone ultra-high pressure exhaust cabinet to prevent the operator and the environment from being exposed to biological gases generated during the experiment. 2.10
Personal Protective Equipment PRE is used to prevent personnel from being injured by chemical and biological harmful substances. GU19489-2304
Laboratory partitionslabarntoryarea
Technical laboratory can be divided into reasonable zones according to the frequency and size of pollution. 2.12
Buff error
A closed room set between the living area, semi-contaminated area and contaminated area, with a ventilation system, and its two doors have five functions and cannot be opened at the same time. 2. 13
Air lock girloch
The air seat with adjustable air pressure is used to adjust the air pressure of adjacent areas, and its two doors have interlocking function and cannot be opened at the same time. Used as a special test in the laboratory, 2.14
Directional airflow
In the laboratory where the main air pressure is lower than the external environment, the airflow is controlled to flow from the place with low contamination rate and high relative pressure to the place with high relative pressure.
Material Safety Data Sheet: Ass Provides detailed technical information on risks and business matters. 3 Hazard Classification
Based on the risk level to individuals and groups, it can be divided into 4 levels 3.1 Hazard Level [(low individual hazard, low group hazard) will not cause pathogenic bacteria, bacteria, pathogens and parasites to humans and animals. 2 Hazard level: Can cause disease in humans or animals - minor hazards to households, limited populations, livestock or the environment. Pathogens are allowed to cause small infections and cause serious diseases. There are limited risk of natural treatment and prevention measures. 3.3 Hazard level: Can cause serious disease in humans or animals, low hazard) - cannot be transmitted naturally between individuals, cannot be linked to the old chain, or cannot be treated with antibiotics. 3.4 Hazard level: individual hazard, group hazard (hazard level), can cause very stressful diseases in humans or animals, generally cannot be cured, and is transmitted directly, indirectly or accidentally between people, between animals and people, or between people and animals, or between animals and animals. 4 Biological hazard assessment
When determining whether a pathogen is infectious or a carrier of biological materials, a hazard extent assessment and hazard rate assessment should be carried out. The hazard rate assessment should include the following: biological agent type (known, unknown, genetically modified or unknown biological materials with negative transmission potential), pathogenicity, tumorigenicity, transmission route, identification of agents in the environment, degree of exposure, animal experimental data, prevention and treatment. The assessment should be based on appropriate professional experience! 5. Protection barriers and biosafety level classification for personnel conducting experiments
5.1 Protection barriers
5.1.1 "Level 1 protection barriers
The biosafety barrier composed of experimental biosafety barriers and personal protective equipment. 2
5.1.2 Secondary protective barrier
The laboratory's logistical facilities and ventilation systems or other protective barriers 5.2 Biosafety level classification
GB 19489-20C4
According to the degree of risk of the biological factors being handled and the protective measures taken, the biosafety protection level (BSL) is divided into 4 levels: BSL-1, BSL2, BSL3, BSL4, and ABSL-1, BSL2, BSL3, BSL4 represent the corresponding biosafety protection level of the laboratory, and ABSL-2, BSL3, ABSL-4 represent the corresponding biosafety protection level of the animal laboratory. 6 Facility and equipment requirements
All laboratory facilities, equipment and materials (including protective barriers) should comply with relevant national standards and requirements. 6.1 BS1-1 Laboratory
1) No special requirements are required, ordinary buildings can be used. There should be a design to prevent animals and rodents from passing through. 2) Each laboratory should be equipped with a hand basin, which should be installed near the exit. 3) A clothing holding device should be installed at the door of the laboratory. Personal casual clothes and safety work clothes should be separately placed: The walls, ceilings and floors of the laboratory should be flat, easy to clean, and not susceptible to corrosion by water, chemicals and toxic agents. The floor should be non-slip and no floor paint should be laid.
5 The experimental surface should be waterproof, resistant to dust and strong sunlight. S) The cabinets and experimental tables in the experiment should be of solid quality. A certain distance should be maintained between the cabinets and experimental tables to facilitate cleaning. 7) If the laboratory has windows that can be opened, screens should be installed. 8) The lighting in the laboratory should be kept away from the outside to avoid unnecessary reflections and strong light. 9) It should be equipped with appropriate fire-fighting equipment.
E.2KSL-2 Laboratory
1) Meet 5.1.
2) The laboratory door should be locked and can be closed automatically. The door of the laboratory should have a visible seat. There should be a certain storage space for items to be used. There should be a storage space for long-term use outside the laboratory work area.
Special work clothes should be used in the laboratory; latex condoms should be used. 4
3) There should be conditions for storing personal items outside the working area of the laboratory. 5) The building in the laboratory should be equipped with high-pressure steam sterilization equipment, and the technology should be checked and verified regularly to ensure that it meets the safety requirements. 7) Semi-automatic safety equipment should be equipped in the laboratory. It should be equipped with a limited space, and there should be an emergency spray device when necessary. 8
3》 There should be ventilation. If the door is not open for ventilation, there should be insect-proof windows. 10) There should be reliable lighting and lighting. If necessary, important equipment such as incubators, biological safety cabinets, refrigerators, etc. should be equipped with power supplies.
11) The experimental equipment should be identifiable in the dark. 5.3 BSL-3 experimental facilities should be isolated in the building (with access control) or be independent buildings. 6.3.1 Layout
1) It consists of clean area, semi-contaminated area and contaminated area. A flushing room should be set between the contaminated area and semi-contaminated area. If necessary, a flushing room should be set between the semi-contaminated area and the clean area.
2) There should be a safety door in the semi-contaminated area. 3) There should be a pass-through door between the contaminated area and the semi-contaminated area, and between the semi-contaminated area and the clean area. The double doors cannot be in the open state at the same time. A physical disinfection device should be set in the pass-through. tiB 19489-2094
Enclosure structure
The surface of the laboratory structure should be smooth, corrosion-resistant, waterproof, and easy to clean; all shelters should be non-toxic. The walls should have appropriate pits and fireproof structures. 3) The corners of the cabinets and floors should be rounded and sealed. 1 The floor should be anti-bacterial, non-contact, light-resistant, and anti-corrosive. All automatic closures in the laboratory space: the exit should have a clear and identifiable mark, and the external structure should not have windows; the internal enclosure should be anti-shatter, anti-gas and safe. 6
All exits and entrances should be equipped with devices to prevent animals and humans from entering the room. 6.3.3 Ventilation system
1) A dedicated ventilation system should be installed to control the airflow direction: it should be ensured that the airflow in the laboratory flows from the clean area to the contaminated area, and the air in the laboratory can only be discharged through the dedicated duct after high-efficiency filtration. 2) The layout of the ventilation outlet and the exhaust outlet should be parallel, with the upper ventilation and the lower exhaust, and the air flow angle and width in the contaminated area and the semi-contaminated area should be minimized.
3) The ventilation system should be a direct exhaust type or a return air system. The air discharged from the biological safety cabinet after internal activation can be directly discharged through the exhaust duct of the system, and the pressure of the biological safety cabinet and the exhaust system should be equal.
5) The air supply of the test room should be filtered by three filters to ensure that the static cleanliness rate of the pollution area reaches level 7 to level 3. The exhaust of the experimental room should be discharged to the open air after high-efficiency filtration. The external exhaust air should be set in the downwind direction of the main air supply outlet, at least higher than the base of the rainproof and insect-proof design. The gas should be directly discharged to the open air. The high-efficiency air filter should be installed at the water end of the air supply duct and the front end of the exhaust duct. 8) The installation of the high-efficiency air filter in the wine area system should be solid and meet the air tightness requirements. The high-efficiency filter should be disinfected before replacement: or the filter should be replaced in an airtight package. After connection, it should be disinfected or incinerated immediately. After installation and replacement of the low-efficiency filter, it should be tested according to the final confirmation method after maintenance. After operation, it should be inspected at least once a year to ensure its performance. 3》Install airtight valves at the supply and exhaust mains. When necessary, they can be fully closed to conduct indoor chemical vacuum. Each fan and biosafety cabinet start-up port or interlock device should be installed to ensure that there is no positive proportionality in the laboratory and ensure that there is no abnormal flow of biosafety air. Exhaust fans should be installed in each state.
) No external air conditioning, heating and electric fan rooms, etc. should be installed in contaminated restricted areas and semi-contaminated areas. 6.3.4 Environmental registration
1) Relative to the outside atmospheric pressure. The contaminated area is -10Pa (nominal value). Maintain a safe and reasonable pressure with the biosafety cabinet and other equipment, maintain a directional air system and keep the air point difference between the allowed areas uniform. Inspect the source of the house and the humidity meets the work requirements and is suitable for employees. 2) The artificial service quality of the laboratory shall meet the above working requirements: The actual isolation and noise level shall meet the relevant standards: 6.3.5 Special equipment requirements
1) There shall be II and III level biological safety equipment that meet the safety and work requirements, and the installation position shall be away from the contaminated area and the suspected walking area:
2) Low temperature and high temperature air conditioners and other equipment that may generate gases shall be placed in negative hoods or their exhaust devices (ventilation and exhaust hoods, etc.), and the gases that may be generated shall be filtered out after being efficiently filtered. A non-exhaust high-pressure steam sterilizer or other disinfection devices shall be installed in the contaminated area: 3) An indoor pressure display device with alarm function shall be installed at a prominent position at the entrance of the laboratory to display the negative pressure status of the contaminated area and semi-contaminated area. When the negative pressure value deviates from the control interval, an alarm shall be issued to the personnel inside and outside the laboratory through sound, light and other means. A high-efficiency filtration resistance display shall also be set. There should be a backup power supply to ensure uninterrupted power supply during the working period of the laboratory. 53
GB 194892CC4
6) A manual switch should be installed at the entrance of the contaminated area and the semi-contaminated area. The water supply of the manual switch should be a non-manual switch. The supply should be equipped with a backflow prevention device. No ground bacteria should be installed in the laboratory. The sewer should be completely separated from the sewer pipes of the building and have obvious signs. The sewer should be directly collected by an independent liquid disinfection system and disposed after effective disinfection. 5.3.6 Others
13 The surface of the test bench should be resistant to water corrosion and heat. 21 The furniture in the laboratory should be firm. In order to facilitate disinfection, the laboratory equipment should be kept at a certain distance from each other. The pressure equipment required in the laboratory (such as recording, compressed gas, etc.) should not affect the effective gradient of the indoor negative pressure. 31
The laboratory should be equipped with a communication system.
The experimental records should be sent to the laboratory through a transmitter, a computer, etc.: 51
The disinfection area should be equipped with a shower. If necessary, an emergency disinfection shower device should be installed in the semi-contaminated area. 6. 4 BSL-4 laboratory
HST.1 The laboratory can be divided into a safety cabinet type, a full-suit type and a mixed whole laboratory according to the type of the biological safety cabinet used and the protective clothing worn.
5.4. 1 Safety cabinet type B5L-4
5.4.1.1 Site selection
The construction of the sealed room should be within the scope of the production or construction of the enterprise. The two zones of the building should be far away from the commercial operation area. 6.4.1.2 After the layout
1! It consists of a disinfection area, a semi-contaminated area and a contaminated area with a level of biological safety: the clean area includes an outdoor dressing room, a shower room and an indoor dressing room. The shower room is connected by a level of cleaning room. 2 A double-air sterilizer and a high-efficiency filter or a separation disinfectant should be installed on the wall of the semi-contaminated area and the contaminated area. 3) The contaminated area and semi-contaminated area shall be equipped with double non-commercial sterilizers without exhaust steam on the wall. The sterilizer shall be directly connected to the 111 biological safety cabinet. The semi-contaminated area shall be equipped with emergency exits. The emergency exit shall be equipped with a buffer room and a total disinfection treatment plan. 6.4.1.3 Enclosure structure
According to the provisions of 5.3.2
6, 4.1.4 Exhaust system
The exhaust air shall pass through two commercial processes in accordance with the requirements. Its fast requirements shall be in accordance with the provisions of 6.3.2. 6.4.1.5 Environmental rating
According to the thermal requirements of 5.3.4
6.4.1.6 Safety devices and special equipment
Should have Class 100 biosafety that meets safety and work requirements: Other requirements shall be in accordance with the provisions of 6.3.5.
6.4.1.7 Others
According to the provisions of 6.3.6:
6.4.2 Positive pressure strict type RSI-4 safety test box
It consists of BSI-I level experimental facilities, Class II biological safety cabinets and positive pressure protection shades with life support gas supply systems, 6.4.2.F site
According to the provisions of 6.4.1.1.
6.4.2.2 Distribution
1) It consists of a clean area, a semi-contaminated area and a contaminated area where a Class II biological safety cabinet is placed. The cabinet adjacent area is connected to the shower room: the clean area includes an external changing room, a shower room, an internal changing room (which can also be a shower room) + the contaminated area.A chemical shower device should be installed between the towers in the semi-polluted areas according to GB 19489—2004. When the staff is in the experiment, the surface of the protective layer shall be subjected to the chemical deionization bath for poisoning. 2) Other responsibilities shall comply with the provisions of 6.4.1.2, 6.4.2.3, 6.3.>, 6.4.2.4, 6.1.1.4, 6.4.2.5, 6.3.1, 6.4.2.5, 6.4.2.6, 6.4.2.7, 6.4.2.8, 6.4.2.9, 6.4.3.10, 6.4.3.11, 6.4.3.12, 6.4.3.13, 6.4.3.14, 6.4.3.15, 6.4.3.16, 6.4.3.17, 6.4.3.18, 6.4.3.19, 6.4.3.20, 6.4.3.21, 6.4.3.22, 6.4.3.23, 6.4.3.24, 6.4.3.25, 6.4.3.26, 6.4.3.27, 6.4.3.38, 6.4.3.39, 6.4.4 1) Biosafety protection with ventilation should be used; 2) Non-infected workers should wear protective clothing; the air supply system should include a super-quick breather device; the air supply device should provide emergency air for the surrounding environment; the air supply should be continuous and meet the requirements. The life support system should have an automatic emergency power supply. 3) Other requirements shall be as specified in 6.3.5.
5.4.2.7 Others
Including the provisions of 6.3.6
5.4.3 Hybrid R5I-4 laboratory
When using high-quality biological safety equipment and good biological support gas supply system (positive pressure protection limit), it should also meet all the requirements of the biological safety standards i.4.1 and 6..2. The biological safety of animal experiment room
The biological safety protection measures for animal experiment should be implemented according to the corresponding requirements of BSL-1~BSL4 laboratories (see Chapter 6>), and the animal respiration, excretion, main absorption, squeeze, escape, animal average rate (such as toxicity, sent to school for inspection, sampling) should be considered. The animals must be kept, and the hazardous materials produced by the animals must be handled, such as the body and the area where they are kept, and the hazardous materials must be handled. Special attention should be paid to the protection of animals. For example, the animals must be protected according to the species, body size, and living conditions of the animals, and the light and water suitable for the experiment must be selected and conform to the relevant national standards for animal safety. The animal breeding facilities, animal temporary facilities and decorations must be selected. The experimental building should ensure that the experimental animals cannot escape, and non-experimental animals (such as mice, insects, etc.) cannot enter. The laboratory design (such as space, access routes, etc.) should meet the needs of the animals used. The air in the animal laboratory should not be adjusted. Animal-derived sols should be properly filtered and (or>) discharged after disinfection, and should not be discharged against the human indoor chain. If animals need to obtain water, the supply system cannot be safely disinfected. The temperature, humidity, clothing, noise, cleanliness and other environmental components of the animal laboratory should meet the requirements of relevant national standards. 7.1 In addition to meeting the safety requirements of 6.+, the ADSL-1 laboratory should also meet the following requirements: 1. Temporary facilities in the building should be separated from the activities of people who are on duty. 2. Automatic Automatic door closers should be kept locked when there are experimental activities. 3
The floor should always be sealed with water or disinfectant: 4 The selection of animal samples should meet the cleaning requirements. 7.2ABSL-2 Laboratory
In addition to meeting the requirements of 6.2 and 7, the following requirements are applicable: 1) The entrance should be equipped with a vertical flushing room, the door of the animal laboratory should have a visual signal, can be automatically closed, and have an appropriate fire alarm, 2)
GB 19489-2CC4
3" In order to ensure the requirements of animal laboratory transfer and pollution control, high-efficiency incinerators used to treat solid waste should be specially designed and reasonably volatile, and maintenance should be strengthened. The incinerator should be specially designed and equipped with supplementary heat and smoke elimination equipment. The polluted wastewater must be treated with smoke elimination.
7.34BSL-3 laboratories
In addition to meeting the requirements of 6.3 and 7.2, they should also meet the following requirements; 1) The building should have the required anti-rat, anti-escape, and anti-theft capabilities, and it should be composed of the smear area, the contaminated area and the infection area (before the animals are allowed to enter), and a buffer room should be set between the special area and the semi-contaminated area. When necessary, the semi-infected area should be swept with a certain amount of wind to ensure that the air in the room is clean and the contaminated area is 60P (nominal value). The air in the biosafety panel and other devices should be kept safe and reasonable. Maintain directional airflow and keep the air pressure difference between the zones uniform. Indoor blood circulation equipment (such as disinfection sprayer, oxygen disinfector) should be equipped with disinfectants. When there are infected animals in the room, protective masks should be worn. 7.4AB5L-4 The experimental rate should meet the requirements of 6.4 and 7.3, and meet the following requirements; 1) The passage for animals to enter the room should be increased; 2) Infected animals should be kept in an isolator with [11 biosafety cabinet recharge function; 3] The animal housing method should ensure that the air retention of animals is effective and cannot enter the room. 4] Generally speaking, operations on infected animals, including blood collection, dissection, changing bedding, and transfer, must be carried out under physical protection conditions. Those that can be carried out in a biosafety panel must be carried out in it: In special cases, large animals or animals that are not kept in a biosafety cabinet should be designed according to the specific situation, such as setting up relatively safe and operable physical protection equipment, and as far as possible, carry out operations that are not infected. Personal protective equipment
Any personal protective equipment used in the laboratory should meet the requirements of relevant national standards. Based on the hazard assessment, appropriate personal protective equipment should be selected according to the protection requirements of different levels. The laboratory should have clear written regulations on the selection, use, maintenance, selection, and use of personal protective equipment.
8.1 Laboratory protective clothing
The laboratory should have sufficient clean protective clothing with an appropriate level of protection for use. When not in use, the clean protective clothing should be placed in a special storage place. The protective clothing should be properly marked and placed in the open area. The protective clothing should be changed at appropriate intervals to ensure that it is clean. When it is known that the protective clothing has been contaminated by hazardous materials, it should be changed immediately: take off the protective clothing before leaving the experimental space.
When the equipment is exposed to dangerous substances that can be absorbed by the workers, the long oxygen mask should be used. In this working environment, if necessary, other personal protective equipment should be worn, such as protective goggles, masks, head and face protection masks, etc. 8.2 Face and body protection
If aerosols containing biological factors may be generated during the handling of samples, the operation should be carried out in an appropriate biosafety cabinet. When handling hazardous materials, approved safety glasses, face shields or other face protection should be available for use. 8.3 Gloves
Gloves should be available for use during experimental work to prevent animal hazards, chemicals, vehicle spray, cold and heat product contamination, punctures, stabs and animal bites, etc.
Gloves should meet the requirements of fit, flexibility, neatness, resistance to puncture and tearing according to the nature of the work being performed. Adequate protection should be provided for the hazards involved. Training should be provided to laboratory staff on the selection, use, and preparation and removal of gloves after use. This should be ensured.
1) The gloves should not be removed,
GB19489—2554
2) After being put on, they can completely cover the body and the skin. If necessary, they can be replaced with long clothes or outer garments. 5) Gloves should be replaced when they are torn, damaged or damaged. The gloves are for laboratory work only and should be disinfected, removed and safely placed after the work is completed or stopped. 8.4 Shoes
Shoes should be comfortable, source-proof, and made of non-toxic materials. When performing work that may cause leakage, disposable waterproof covers should be used. In special areas of the laboratory (for example, areas with anti-static requirements or ISSI.-F and BSL-4 laboratories require the use of special shoes (such as disposable or rubber boots): E.5 Respiratory protection
When respiratory protective equipment (such as masks, personal respirators, proper clothing, etc.) is required, the work instructions for its position and maintenance should include the safe operation of the corresponding activities. Respirators can only be used as required by the work instructions and training requirements. Workplace monitoring and multi-disciplinary assessment of respirator users should be arranged to ensure that they use such equipment correctly and that respiratory equipment is required. Physical fitness test.
When performing operations that are likely to generate highly hazardous gases, it is required to use appropriate personal protective equipment, a safety cabinet and (or) other physical protection equipment.
9 Management requirements
9.1 Management of toxic gases
The management of the laboratory is responsible for the safety of all employees and visitors to the laboratory. The final responsibility is the laboratory director or a designated person of equivalent status. A laboratory safety officer with appropriate qualifications and experience should be appointed to assist the management in safety management matters. Safety personnel should develop, maintain and supervise an effective laboratory safety plan. An effective laboratory safety management plan should include training.The laboratory safety manager should have the authority to stop unsafe activities. If there is a safety committee, the laboratory safety manager should be the leader of the committee, at least one of the members of the committee. The person in charge of the laboratory project should formulate the observation and procedures! Ensure that the laboratory equipment, personal protective equipment, and other equipment meet the relevant safety requirements of the laboratory, and are regularly inspected, selected, and updated to ensure that their design performance is not reduced: 9.2 Employee management
All personnel should have documents to prove that they have been trained on the potential risks in their work and laboratory facilities: All personnel should be required to receive immunization or vaccination according to the situation. Make-up records should be kept. 9.3 Safety Design
When designing a new laboratory building, the corresponding national and local building laws and building safety standards for laboratories should be followed when constructing a laboratory space that has already violated the standards: it is prohibited to carry out construction or engineering operations in the laboratory space without the permission of the responsible person.
The design of the laboratory should ensure that the protection level against biological, chemical, biological and physical hazards in the technical area is controlled within the corresponding evaluated risk management process, provide a safe secondary environment for the associated office area and the adjacent public air, and prevent the risk of people entering the surrounding community. The passages and corridors should be regularly monitored to ensure adequate ventilation and prevent the spread of potentially infectious and harmful gases. Each product entrance and population of the laboratory should be separable and marked at the entrance. The markings should include danger signs indicating the passage (such as biological hazard signs, fire hazard signs and radioactive signs as well as other relevant regulations). An emergency exit should be set and marked to be in line with the general exit area. The emergency exit route should be clearly identifiable even in the dark. The laboratory entrance should have a lockable door. The door should be tightly closed. Entrance to the laboratory should be limited to authorized personnel. Doors in the room should be equipped with locks as needed. There should be access restrictions when handling high-risk test samples. When storing high-risk samples, cultures, chemical test structures or supplies, other security measures should be taken, such as lockable doors, lockable cold boxes, access restrictions for special personnel, etc. The risks of theft and improper use of biological materials, samples, drugs, chemicals and confidential information should be evaluated, and appropriate measures should be taken to prevent their occurrence: there should be a specially designed storage, transportation, collection, processing and disposal of hazardous materials. The internal environment of the laboratory, such as temperature, pressure, humidity, atmosphere, noise and cleanliness, meets the work requirements and relevant requirements. 9.4 Procedure
B 1948920C4
The corresponding standard working procedures should be formulated according to the experimental objects, biological hazard assessment, research content, facility characteristics, and specific work procedures. The laboratory's labeling of the working procedures should include detailed instructions on what to test and how to carry out the next work in the event of a risk failure. The person in charge of the work activities should review and update these activities once a year. A written plan should be formulated. At least the following contents should be included: 1) Employee supervision
Implementation of hazard assessment, recording of results and safety measures taken; 2) Confirmation of chemicals and other hazardous materials, including appropriate training requirements, safe storage and handling and monitoring procedures; 3) Procedures for safe behavior of hazardous materials; 4) Procedures for safe behavior of hazardous materials; 5) Procedures for safety inspection and disposal of hazardous materials. Confirm training needs and methods for materials.
Procedure for obtaining, maintaining and distributing the safety data sheet (VSDS) for all laboratory materials. Procedure for safe decontamination and maintenance of laboratory equipment, emergency procedures, including operation and exit procedures. S
1) Incident records, reports and investigations:
11) Waste treatment and disposal.
9.5 Review of the safety plan
9.5.1 Review of the safety plan
The safety plan should be reviewed and inspected at least once a year by [personnel who have received appropriate training]: including but not limited to the following elements: safety, health and environmental regulations!
Written work order covers safety work behavior; 3
Education and training:
Supervision of staff;
Regulation and control:
Hazardous materials and substances;
Energy monitoring:
First aid services and equipment
Efficiency and efficiency of medical treatment!
Promote a friendly and safe attitude Safety review:
11>Discussion and statistics:
12 Ensure the implementation of the audit plan for all the contributions that need to be taken. Special checklists for each area can effectively assist the audit work, 9.5.2 Safety review
The implementation of the room is qualified to ensure the implementation of safety changes. The workplace should be inspected at least once a year to ensure: 1) the function and status of emergency equipment, alarm systems and evacuation procedures; 2) the status of hazardous materials control procedures and materials, including special care; 3) the status of the protection and control of flammable, infectious, radioactive and hazardous materials; 5) the status of laboratory facilities, equipment and personnel; 9.5.3 Safety Manual All employees are required to have a safety manual available in the work area at all times: the manual should be targeted at the needs of the laboratory, mainly including but not limited to 1. 19489—2004
For the following aspects:
1) Biological hazards;
2) Fire protection
3) Gas safety
4) Chemical safety;
5]: Radiation:
Hazardous waste product handling and disposal:
Safety personnel should have detailed instructions for removal from the work area and door handling procedures. Laboratory management should update the safety register at least once a year.
Useful information sources for other experimental areas also include (but are not limited to) safety data sheets, technical manuals and quality reports of all materials involved in the experiment.
9.6 Records
9.6.1 Occupational illness, injury and adverse event records. There should be a mechanism to record and report occupational illness, injury, adverse event and the corresponding actions taken, while respecting personal confidentiality.
Records of personnel training should be maintained. Safety instructions and safety preparedness status for each employee should be updated annually. 9.6.2 Hazard assessment records
There should be a formal hazard assessment system, which can use safety form to record and document the hazard assessment process: Safety audit records and incident situation analysis records to assist in the formulation and implementation of corrective measures: 9.5.3 Hazard disposal records
Hazard disposal and treatment records should be a component or part of the enterprise safety plan. Hazard disposal plans and treatment, hazard assessment safety investigation records and records of the actions taken should be kept and available at the relevant specified time. 9.6.4 Hazard identification
Hazard areas shall be clearly and systematically marked and, where applicable, the relevant hazards shall be identified by markings and physical barriers.
Hazardous materials used in the laboratory or laboratory shall be clearly marked. All entrances and exits to work areas shall be marked with the hazards present, particularly fire hazards and flammable, toxic, radioactive, hazardous and biohazardous materials. The laboratory manager shall be responsible for regularly reviewing and updating the hazard identification system to ensure that it is appropriate for existing hazards. This activity shall be carried out at least once a year.
Non-laboratory personnel involved in production (such as maintenance personnel, including contractors) shall be aware of any hazards to which they may be exposed. Employees should be familiar with the specific written instructions for the implementation procedures. Potential hazards to pregnant women and susceptible personnel should be identified and evaluated. Hazard assessments should be performed and recorded. 9.6.5 Reporting of incidents, injuries, accidents and occupational diseases The laboratory should have a procedure for reporting incidents, injuries, accidents, occupational diseases and potential hazards. All incident reports (including injuries) should be documented and should include a detailed description of the event, an evaluation of the causes, and the preventive measures taken to support the implementation of the equipment. This report (including corrective measures) should be reviewed by senior management, the safety committee, and the laboratory safety manager.7 Training The laboratory manager shall ensure that the safety training program is implemented for all relevant laboratory personnel, including transport and cleaning staff. Training should focus on safe work behaviors. A comprehensive training program begins with a written plan and should include the orientation of new employees and periodic retraining of some experienced employees. Employees should be required to read the applicable safety manual before working in the laboratory. Employees should confirm in writing that they have received appropriate training and understand the safety manual, including its implementation date. A safety training program should at least include fire and storage conditions, chemical and radiation safety, and biological hazards and infection prevention. The curriculum should be tailored to the employee's position and should take into account pregnancy, immunization deficiencies and physical disabilities as appropriate. There should be a system to assess individual employees' understanding of the information provided to them.
The laboratory shall ensure that all personnel are trained in emergency procedures. Procedures shall be provided to reduce the occurrence of incidents and events involving hazardous materials, chemicals or harmful substances. There shall be a management guide and, where necessary, emergency and semi-management measures appropriate to the hazards encountered in the laboratory. All responsible persons shall be familiar with the procedures to be followed after an accident. 9.8 Personal Responsibilities
9.8.1 Food, Beverages and Similar Items
Food, beverages and similar items shall only be prepared and consumed in designated areas. Food and beverages shall only be stored in designated areas outside the laboratory. Ice shall be appropriately marked to indicate their presence. Smoking is prohibited in the laboratory. 8.2. Cosmetics, Hair, Jewelry
The use of cosmetics and eyeglasses is prohibited in the work area. Long hair should be tied back. Fingers, earrings, watches, bracelets, chains and other jewelry should not be worn in the work area. 9.8.3 Immunization status
All laboratory workers should be responsible for the protection of their laboratory from the possible exposure to biomass. Immunization records should be maintained in accordance with relevant regulations.
The immunization plan for a specific laboratory should be developed based on the documented laboratory infectious hazard assessment and the recommendations of the local public health authorities.
9.8.4 Personal belongings
Personal belongings, packaging and cosmetics should not be placed in designated areas or areas where contamination may occur. 1 Good housekeeping behavior
Provisions should be made to monitor and maintain good housekeeping behavior. The work area should be kept clean and tidy at all times. Storage of disposable materials that may cause blockage and spillage hazards is prohibited in the workplace. All equipment and working surfaces that handle contaminated materials should be filtered and disinfected with appropriate reagents at the end of each shift, after any spill or when contamination occurs.
Samples, chemicals, radioactive materials or culture media that have been contaminated should be cleared and the area involved should be decontaminated after risk assessment. Safety precautions, safety methods and personal protective equipment should be used during cleaning. Changes in housekeeping behavior should be reported to the laboratory manager to ensure that unidentified risks or hazards are avoided. Changes in laboratory behavior, work habits and materials that may pose a potential hazard to housekeeping and maintenance personnel should be reported to the laboratory manager and the supervisor and maintenance personnel should be informed in writing. Special procedures for decontamination, purification and disinfection of each piece of equipment should be prepared before maintenance or disposal in the event of an accident or leak that may lead to biological, chemical or radioactive contamination.
11 Safe work plan
11.1 Hand washing
Laboratory personnel should wash their hands immediately after actual or potential contact with contaminated materials, even if they are wearing gloves. Wash hands routinely after removing gloves, before and after using sanitary ware, before leaving the laboratory, before eating or breathing, and before and after contact with each patient. The laboratory should provide alternative hand sanitizers for workers who are allergic or have other reactions to the specific compounds in these anti-toxic agents.
The full sink should not be used for other days. In places where the use of hand sanitizers is restricted, the use of ethanol-based "no-technique" for internal cleaning products is acceptable.
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