Search result: WS 233-2017 (WS/T 233-2017 Older version)
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General biosafety standard for causative bacteria laboratories
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WS 233-2017
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WS/T 233-2017 | English | RFQ |
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(General guidelines for biosafety in pathogenic microbiology laboratories)
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WS/T 233-2017
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General biosafety standard for microbiological and biomedical laboratories
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Standard ID | WS 233-2017 (WS233-2017) | Description (Translated English) | General biosafety standard for causative bacteria laboratories | Sector / Industry | Health Industry Standard | Classification of Chinese Standard | C59 | Date of Issue | 2017-07-24 | Date of Implementation | 2018-02-01 | Older Standard (superseded by this standard) | WS 233-2002 | Regulation (derived from) | State-Health-Communication (2017) 7 |
WS 233-2017
(Common guidelines for biosafety of pathogenic microorganisms)
ICS 11.020
C 59
WS
People's Republic of China health industry standards
Replace WS 233-2002
Pathogenic microorganisms - Laboratory biosafety guidelines
General biosafety standard for causative bacteria laboratories
2017 - 07 - 24 Posted
2018 - 02 - 01 implementation
People's Republic of China National Health and Family Planning Commission released
Directory
Preface v
1 range .1
2 Terms and definitions .1
3 pathogenic microorganism hazard classification .2
Laboratory biosafety level classification and classification 3
5 Risk Assessment and Risk Control .3
6 Laboratory facilities and equipment requirements 5
7 Laboratory Biosafety Management Requirements
Appendix A (informative) pathogenic microorganisms experimental activity risk assessment table
Appendix B (Informative) Pathogenic microorganisms experimental activity approval table 27
Appendix C (informative) site inspection of biosecurity isolation equipment .29
Appendix D (informative) pressure steam sterilizer effect monitoring
References .34
Foreword
This standard is mandatory.
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces WS 233-2002 "Microbiological and Biomedical Laboratory Biosafety General Guidelines." Since the implementation of this standard date,
WS 233-2002 Repealed at the same time.
This standard compared with WS 233-2002, the main changes are as follows.
- revised terms and definitions (see Chapter 2, Chapter 2 of the.2002 edition);
- Revised the basic principles of laboratory bio-safety protection, requirements, from the laboratory facilities, design, environment, equipment, people
Staff management, practices, sterilization and other detailed specifications (see Chapter 4,5,6,7,.2002 edition of 4,5,6,7
chapter);
- revised risk assessment and risk control (see Chapter 5, version 4.7 of.2002);
- Added enhanced BSL-2 laboratory (see 6.3.2);
- Revised biosafety design principles, basic requirements, etc. for vertebrate laboratories (see 6.6.1, 6.6.2, 6.6.3, 6.6.4,
2002 edition of Chapter 7);
- Increased basic requirements for biological safety of invertebrates in laboratories (see 6.6.5);
- Added disinfection and sterilization (see 7.7);
- The.2002 edition of the Appendix was deleted (see the.2002 edition of Appendix A, Appendix B, Appendix C);
- Added informative Appendix A, Appendix B, Appendix C, Appendix D.
This standard was drafted. China Center for Disease Control and Prevention virus prevention and control, China Center for Disease Control and Prevention, China disease pre
Prevention and Control Center of Infectious Diseases Prevention and Control, Institute of Medical Laboratory Animal, Chinese Academy of Medical Sciences, Chinese Academy of Medical Sciences, Pathogenic Biology
Institute of Microbiology and Epidemiology, Fudan University, Academy of Military Medical Sciences, Wuhan Institute of Virology, Chinese Academy of Sciences, Tianjin National Institute for Biological Protection
Equipment Engineering Technology Research Center, Shandong Provincial Center for Disease Control and Prevention, Fujian Provincial Center for Disease Control and Prevention, Jiangsu Province Disease Prevention and Control
Heart, China National Accreditation Center for Conformity Assessment.
The main drafters of this standard. Wu Guizhen, Zhao Che-hung, Han Jun, Wang Guijie, Qu Di, Wei Qiang, Li Zhenjun, Qin Chuan, Wei Qiang,
Qi Jiancheng, Bi Zhenqiang, Liang Mi Fang, Lin Zhong, Shi Zhiyang, Chen Zongsheng, Zhai Peijun, Wang Rong, Zhang Shuxia.
This standard replaces the standard historical version released as follows.
- WS 233-2002.
Pathogenic microorganisms - Laboratory biosafety guidelines
1 Scope
This standard specifies the basic principles, grading and basic requirements for biological safety of pathogenic microorganisms in laboratories.
This standard applies to carry out microbial related research, teaching, testing, diagnosis and other activities laboratory.
2 Terms and definitions
The following terms and definitions apply to this document.
2.1
Laboratory biosafety
Laboratory biosafety conditions and conditions are not below allowable levels to avoid exposure of laboratory personnel, visitors, communities and the environment
Acceptable damage, in line with relevant laws and regulations, standards and other laboratory biosafety requirements.
2.2
Risk
The probability of the occurrence of the danger and the consequences of the severity of the combination.
2.3
Risk assessment
Assess the size of the risk and determine if it is acceptable.
2.4
Risk control
Comprehensive measures to reduce risk.
2.5
Personal protective equipment; PPE
Equipment and supplies that prevent personal injury to individuals such as biological, chemical or physical hazards.
2.6
Biosafety cabinet; BSC
Control cabinet with air flow control and high efficiency air filtration device can effectively reduce the harmful effects of pathogenic microorganisms or biological experiments
Hazards of aerosols to operators and the environment.
2.7
Aerosols aerosols
The particle size suspended in the gas medium is generally relatively stable dispersion of solid or liquid fine particles of 0.001 μm to 100 μm
system.
2.8
Biosafety laboratory
Through the protective barriers and management measures to meet the biosafety requirements of the pathogenic microorganism laboratory.
2.9
Laboratory containment area
Laboratory physical partitions, the biological risk in this area is relatively large, the need for laboratory graphic design, confinement of the envelope, gas
Flow, as well as personnel access, personal protection and other control of the area.
2.10
Laboratory auxiliary work area non-contamination zone
Refers to a region with a relatively small biological risk and also refers to a region outside a protected area in a biosafety laboratory.
2.11
Core workplace
Is the main area for conducting laboratory activities in the Biosafety Laboratory, and usually refers to the area where the Biosafety Cabinets or Animal Rearing and Operations Room
room.
2.12
Enhanced biosafety level 2 laboratory
On the basis of the ordinary biosafety level-2 laboratory, measures such as mechanical ventilation are required to enhance the laboratory's biosafety requirements
laboratory.
2.13
Accident
Accidental human or animal infections, injuries, deaths, or damage to facilities and equipment, and other unforeseen circumstances.
2.14
Incident
A situation that may or may cause an accident.
2.15
High efficiency air filter (HEPA filter)
Usually 0.3 μm particles for the test object, under the conditions specified filter efficiency of more than 99.97% of the air filter.
2.16
Air lock air lock
With mechanical ventilation system, the overall disinfection conditions, chemical spray (when applicable) and the pressure can be monitored airtight, the door has
Interlock function, can not be on at the same time.
3 pathogenic microorganism hazard classification
According to the infectious of pathogenic microorganisms, the degree of harm to individuals or groups after infection, the pathogenic microorganisms are divided into four categories.
a) The first type of pathogenic microorganisms, refers to microorganisms that cause very serious diseases in humans or animals, as well as our country has not yet found or
Those who have declared the destroyed microbes;
b) The second type of pathogenic microorganisms, is able to cause serious human or animal diseases, more easily, directly or indirectly, in humans,
Animals and humans, animals and animals spread between microorganisms;
c) The third type of pathogenic microorganisms, refers to the human or animal disease can cause, but under normal circumstances, no human or animal or environment
Seriously harmful, limited risk of transmission, few post-laboratory infection serious illnesses, and effective treatment and preventative measures
Of microorganisms;
d) The fourth type of pathogenic microorganisms refers to microorganisms that normally do not cause disease in humans or animals.
Note 1. The first and second types of pathogenic microorganisms are collectively referred to as highly pathogenic microorganisms.
4 Laboratory biosafety level classification and classification
4.1 classification
4.1.1 According to the laboratory on the level of biological safety of pathogenic microorganisms, and in accordance with the provisions of the national laboratory biosafety standards will be
The laboratory is divided into 1 levels (Biosafety Level 1, BSL-1), Level 2 (BSL-2), Level 3 (BSL-3) and Level 4 (BSL-4).
4.1.2 Biosafety level 1 laboratories are suitable for the operation of microorganisms that normally do not cause disease in humans or animals
Things.
4.1.3 biosafety level two laboratories suitable for operation can cause human or animal diseases, but in general, the human,
Animals or the environment do not pose a serious risk, have limited risk of transmission, rarely cause serious illness after a laboratory infection, and have effective treatment and
Preventive measures of microorganisms. According to whether the laboratory has a mechanical ventilation system, the BSL-2 laboratory is divided into ordinary type BSL-2 laboratory, plus
Strong BSL-2 laboratory.
4.1.4 biosafety level three laboratories suitable for operation can cause serious human or animal disease, relatively easy direct
Or indirectly between humans, animals and people, animals and animals spread between microorganisms.
4.1.5 Biosafety level four laboratories are suitable for the operation of microorganisms that cause very serious human or animal diseases,
My country has not yet discovered or has announced the elimination of microorganisms.
4.2 Classification
4.2.1 The BSL-1, BSL-2, BSL-3 and BSL-4 indicate the corresponding biosafety level of laboratories operating in vitro only.
4.2.2 Indicated by ABSL-1 (Animal Biosafety Level 1, ABSL-1), ABSL-2, ABSL-3, ABSL-
The corresponding biosafety level of the living laboratory.
4.2.3 Animal Biosafety Laboratory is divided into laboratories engaged in experimental activities of vertebrates and invertebrates.
4.2.4 According to the experimental activities, the use of individual protective equipment and basic isolation facilities are different, the laboratory is divided into.
a) laboratories that operate on non-airborne pathogenic biological agents;
b) The effective use of safety isolating devices (eg Class II biological safety cabinets) to operate conventional airborne pathogenic biological agents
laboratory;
c) laboratories that can not effectively use conventional safety isolators to operate conventional airborne pathogenic biological agents;
d) Use of positive pressure service with a life support system to operate conventional airborne PAH laboratories;
e) Use of laboratories with conventional levels of airborne pathogenic biological agents with Class III biological safety cabinets.
5 risk assessment and risk control
5.1 General
Laboratories should establish and maintain a risk assessment and risk control system that clearly identifies the laboratory's ongoing risk identification, risk assessment and risk
Specific requirements for control (see Appendix A).
5.2 Risk Identification
When experimental activities involve pathogenic biological agents, the risk factors described in 5.2.a) to 5.2.j) should be identified but not limited to.
a) Experimental activities involve known or unknown characteristics of pathogenic biological agents, such as.
1) Degree of hazard classification;
2) Biological characteristics;
3) Transmission and transmission;
4) Infectivity and pathogenicity. Susceptibility, host range, the amount of disease required, latency, clinical symptoms, duration, prognosis;
5) Interactions with other organisms and the environment, relevant experimental data, epidemiological data;
6) stability in the environment;
7) Prevention, treatment and diagnostic measures, including diagnostic reagents for vaccines, therapeutic drugs and infections.
b) Experimental activities involving pathogenic biological agents, such as.
1) collection, transfer, storage and destruction of bacteria (poisonous) species and infectious substances;
2) separation, culture, identification, preparation and other operations;
3) easy to produce aerosol operations, such as centrifugation, grinding, shaking, homogenization, ultrasound, inoculation, freeze-drying, etc .;
4) The use of sharps, such as injection needles, anatomical equipment, glassware and so on.
c) Consideration should be given to the hazards posed by the recombinants when the experimental activity involves GMOs.
d) Animal feeding and testing activities involving pathogenic biological agents.
1) scratching, bite
2) animal dander, breathable aerosol;
3) Anatomy, sampling, testing, etc.
4) excrement, secretions, tissue/organ/body, litter, waste treatment, etc .;
5) animal cage, equipment, control system may be malfunctioning.
e) Risks of infectious waste disposal.
1) waste containers, packaging, labeling;
2) Collection, disinfection, storage, transportation and so on;
3) Leakage of infectious waste;
4) the reliability of sterilization;
5) There is a risk that out-of-facility populations may be exposed to infectious waste.
f) Risk of safety management in experimental activities, including but not limited to.
1) Management measures and technical measures to eliminate, reduce or control risks and new risks resulting from or after the measures are taken;
2) Operating experience and risk control measures, including management procedures related to facilities and equipment, operating procedures, maintenance procedures
Potential risks;
3) New risks that may arise when implementing emergency measures.
g) Relevant persons involved in the experimental activities of pathogenic biological factors.
1) professional and biosafety knowledge, operation skills;
2) awareness of risk;
3) Psychological quality;
4) professional and biosafety training status;
5) Accident/incident handling capacity;
6) Health status;
7) Health monitoring, medical insurance and medical treatment;
8) Safety management of external laboratory personnel and protection measures provided.
h) Laboratory facilities, equipment.
1) biological safety cabinets, centrifuges, shaker, incubator, etc .;
2) waste, waste water treatment facilities, equipment;
3) personal protective equipment;
Where applicable, include.
1) Protected area of the hermetic, pressure, temperature and air flow control;
2) interlocking, closed doors and access control systems;
3) Ventilation and air conditioning systems and water, electricity and gas systems associated with protection zones;
4) safety monitoring and alarm system;
5) animal husbandry and operation of facilities and equipment;
6) bacteria (poison) species and sample preservation facilities and equipment;
7) radiation protection device;
8) life support system, pressure protective clothing, chemical showers and more.
i) laboratory biosecurity and security measures that focus on the identification of stolen, abused and evils of deposited or used pathogenic biological agents
Risk of release.
j) Analysis of the cause of a laboratory infection that has occurred.
5.3 Risk Assessment
5.3.1 Risk assessment should be based on national laws, regulations, standards, norms, guidelines and data released by the authority. Right
Identify the risk analysis to form a risk assessment report.
5.3.2 Risk assessment should be conducted by experienced professionals in different fields (not limited to people within the organization).
5.3.3 The laboratory shall conduct a risk assessment on the basis of 5.2 with but not limited to the following cases.
a) changes in the biological characteristics or control strategies of pathogens;
b) carry out new experimental activities or change experimental activities (including facilities, equipment, personnel, scope of activities, procedures, etc.);
c) Operation of extraordinary capacity or special activities;
d) An incident of infection or infection in our laboratory or similar laboratory;
e) Relevant policies, regulations, standards and other changes.
5.4 Risk Assessment Report
5.4.1 The contents of the risk assessment report shall include at least. an introduction to the experimental activity (project plan), the purpose of the assessment, the basis for the assessment,
Law/Procedure, Assessment Content, Assessment Conclusion.
5.4.2 Risk assessment report should indicate the assessment time and review staff.
5.4.3 risk assessment report should be approved by the establishment of laboratories.
5.5 Risk Control
5.5.1 According to the risk assessment conclusions to take the appropriate risk control measures.
5.5.2 Risk control measures should first give priority to the control of risk sources, and then consider other measures to reduce the risk.
6 Laboratory facilities and equipment requirements
6.1 Laboratory design principles and basic requirements
6.1.1 Laboratory location, design and construction should be consistent with national and local construction planning, biosafety, environmental protection and building technical specifications
Regulations and requirements.
6.1.2 Laboratory design should ensure that the level of protection against biological, chemical, radiation and physical hazards is controlled at an acceptable
Degree, to prevent endangering the environment.
6.1.3 Laboratory building structure should be consistent with the relevant state building regulations.
6.1.4 In the full consideration of biosafety laboratory ground, walls, roofs, pipes, cabinets and other disinfection, cleaning, non-slip, anti-seepage,
Anti-dust and other special requirements on the basis of the energy-saving, environmental protection, safety and economy, and many other aspects of comprehensive consideration, the appropriate choice of countries
Home standard requirements of building materials.
6.1.5 Laboratory design should give full consideration to the convenience of work, the process is reasonable, staff comfort and other issues.
6.1.6 Laboratory indoor temperature, humidity, illumination, noise and cleanliness and other indoor environmental parameters should be consistent with job requirements, as well as personnel comfort,
Hygiene and other requirements.
6.1.7 Laboratory design, to meet the job requirements, safety requirements, should give full consideration to energy saving and redundancy.
6.1.8 Laboratory corridors and access should not impede the passage of personnel and items.
6.1.9 An emergency evacuation route should be designed and the emergency exit should be clearly marked.
6.1.10 Room doors Door locks are installed as required, and the door locks should be quick to open internally.
6.1.11 The laboratory should be based on room or laboratory in use, deactivation, disinfection, maintenance and other different needs of the state, to take appropriate warnings and
Enter restrictions such as warning signs, warning lights, warning lines, access control and more.
6.1.12 Laboratory safety and security should be consistent with the relevant state departments on the level of laboratory safety management requirements and requirements.
6.1.13 Risk assessment that should be misused, stolen and misused, based on biological materials, samples, pharmaceuticals, chemicals and confidential information,
Take appropriate physical precautionary measures.
6.1.14 There should be a special design to ensure the safety of storing, transferring, collecting, handling and disposing of hazardous materials.
6.2 BSL-1 laboratory
6.2.1 should provide sufficient space for the installation, cleaning and maintenance of laboratory equipment, safe operation.
6.2.2 The laboratory should have enough space and cabinet display laboratory equipment and articles.
6.2.3 Outside the work area of the laboratory there shall be facilities for storing outerwear and personal belongings, separate personal clothing from lab coveralls
Set.
6.2.4 Places to eat, drink and rest should be located outside the work area of the laboratory.
6.2.5 Laboratory walls, roofs and floors should be smooth, easy to clean, leak-proof and resistant to chemicals and disinfectants. The ground should be non-slip,
Do not lay carpets in the lab.
6.2.6 Laboratory table (table) cabinets and seats should be solid and solid, the corners should be smooth. The test bench should be waterproof and able to withstand moderate levels
Heat, organic solvents, acids and bases, disinfectants and other chemicals.
6.2.7 should be based on the nature of work and process reasonable placement of laboratory equipment, cabinets, items, etc., to avoid mutual interference, cross-contamination, and should
Do not impede escape and first aid. The table (table) cabinet and equipment should be sufficient spacing between, in order to facilitate cleaning.
6.2.8 The laboratory should set the sink, faucet switch should be non-manual, should be set near the exit.
6.2.9 Laboratory doors should have visible windows and can be locked and reach the appropriate fire rating, door locks and door opening direction should not interfere with the indoor
Staff escape.
6.2.10 Laboratory can use natural ventilation, open the windows should be installed mosquito screens. If mechanical ventilation is used, air flow should be avoided
The resulting pollution and avoidance of contamination airflow can cause cross-contamination between laboratories or with other areas.
6.2.11 should ensure that sufficient laboratory lighting, to avoid unnecessary reflection and flash.
6.2.12 laboratory involving irritating or corrosive substances operation, eyewash device should be set within 30 m, the risk should be larger emergency sprinkler device.
6.2.13 When it comes to the use of toxic, irritating, volatile substances, a suitable fume hood (hood) should be fitted.
6.2.14 If involving the use of highly toxic, radioactive substances, should be equipped with the appropriate safety equipment and personal protective equipment should be consistent with national,
Local regulations and requirements.
6.2.15 If the use of high-pressure gas and combustible gas, there should be safety measures should be consistent with the relevant national and local requirements and requirements.
6.2.16 There should be a reliable and sufficient supply of electricity to ensure safe use of electricity.
6.2.17 emergency lighting devices should be set, taking into account the appropriate installation location to ensure that staff leave the laboratory safely.
6.2.18 should be equipped with enough fixed power outlet, to avoid multiple devices use a common electrical outlet. There should be a reliable grounding system should be
The key nodes to install leakage protection or monitoring alarm device.
6.2.19 should meet the laboratory required water.
6.2.20 Water supply pipe should be set back to prevent backflow or other devices to prevent pollution back to the drain should not leak, the water should be
With anti-reflux design.
6.2.21 should be equipped with suitable emergency equipment, such as fire equipment, accident handling equipment, first aid equipment.
6.2.22 should be equipped with suitable communication equipment.
6.2.23 If necessary, can be equipped with appropriate disinfection, sterilization equipment.
6.3 BSL-2 laboratory
6.3.1 Common type BSL-2 laboratory
6.3.1.1 When applicable, the requirements of 6.2 shall be met.
6.3.1.2 laboratory main entrance door, biological safety cabinet placed in the test room should be closed automatically; laboratory main entrance door should have entered
Control measures.
6.3.1.3 Outside the work area of the laboratory, there shall be conditions for storing spares.
6.3.1.4 A pressure steam sterilizer or other suitable disinfection and sterilization equipment shall be provided in the laboratory or in the building in which it is installed
Disinfection, sterilization equipment should be based on risk assessment.
6.3.1.5 Eyewash devices should be provided in the laboratory work area and eyewash units should be provided in each workplace where necessary.
6.3.1.6 Secondary biological safety cabinets shall be equipped in the experimental area for the operation of pathogenic microorganisms and samples.
6.3.1.7 should be the product design, instructions for the installation and use of biological safety cabinets.
6.3.1.8 In the case of biological safety cabinets that use duct ventilation, they shall be discharged through ducts independent of other public ventilation systems in buildings.
6.3.1.9 Laboratory entrance should be biohazard logo, exit should have signs of escape light.
6.3.2 Enhanced BSL-2 labor......
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