Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
All contents of this standard are mandatory.
This standard is developed in accordance with the rules given in GB/T 1.1-2009.
This standard replaces WS 233-2002 General Biosafety Standard for Microbiological and Biomedical Laboratories which shall be abolished from the implementation date of this edition.
There are the following main modifications with respect to WS 233-2002:
——"Terms and Definitions" is modified (see Chapter 2; Chapter 3 of Edition 2002);
——The basic principles and requirements for laboratory biosafety protection are modified; detailed provisions regarding laboratory facility, design, environment, apparatus, personnel management, operation specification, disinfection and sterilization and the like are provided (see Chapters 4, 5, 6 and 7; Chapters 4, 5, 6 and 7 of Edition 2002);
——Risk assessment and risk control are modified (see Chapter 5; 4.7 of Edition 2002);
——Enhanced BSL-2 laboratory is added (see 6.3.2);
——Biosafety design principles, basic requirements and the like for vertebrate laboratory are modified (see 6.6.1, 6.6.2, 6.6.3 and 6.6.4; Chapter 7 of Edition 2002);
——Basic requirements for invertebrate laboratory biosafety are added (see 6.6.5);
——"Disinfection and sterilization" is added (see 7.7);
——Annexes of Edition 2002 are deleted (see Annexes A, B and C of Edition 2002);
——Informative Annexes A, B, C and D are added.
The previous edition replaced by this standard is as follows:
——WS 233-2002.
General Biosafety Standard for Causative Bacteria Laboratories
1 Scope
This standard specifies the basic principles, classification and basic requirements for biosafety protection of causative bacteria laboratories.
This standard is applicable to laboratories carrying out activities such as bacteria-related research, teaching, testing and diagnosis.
2 Terms and Definitions
For the purposes of this document, the following terms and definitions apply.
2.1
laboratory biosafety
it refers to that the biosafety conditions and state in the laboratory are not lower than the permissible level; unacceptable damage to laboratory personnel, visitors, communities and environment can be avoided; and requirements of relevant laws, regulations and standards for laboratory biosafety responsibilities can be satisfied
2.2
risk
the integrity of danger occurrence probability and its result severity
2.3
risk assessment
the whole process to assess risk and determine whether it is acceptable
2.4
risk control
the comprehensive measures adopted for reducing risks
2.5
personal protective equipment; PPE
the apparatus and articles that prevent personnel and individual from harm of biological, chemical or physical hazard factor
2.6
biosafety cabinet; BSC
the control cabinet with pneumatic control and high-efficient air filtration unit; which may effectively reduce the hazard of causative bacteria or the harmful aerosols produced during bioexperiment to the operator and environment
2.7
aerosols
the relatively-stable disperse system generally formed by 0.001μm ~ 100μm solid or liquid tiny particles suspending in the gas medium
2.8
biosafety laboratory
the causative bacteria laboratory that meets the biosafety requirements through protective barrier and control measures
2.9
laboratory containment area
the physical zone of the laboratory; in the zone, biohazard risk is relatively large and the plane design of the laboratory, airtightness of enclosing structure, airflow as well as personnel entrance, individual protection and the like shall be controlled
2.10
non-contamination zone
the area with relative small biohazard or the area other than the containment area in biosafety laboratory
2.11
core area
the primary area for carrying out laboratory activities in biosafety laboratory; which generally refers to the room where biosafety cabinet or animal feeding room and operation room exist
2.12
enhanced biosafety level 2 laboratory
the laboratory in which laboratory biosafety protection requirements are enhanced through mechanical ventilation system and other measures based on ordinary biosafety level 2 laboratory
2.13
accident
the unexpected conditions leading to personal and animal infection, injury and death or facility/equipment damage and other losses
2.14
incident
the condition causing or possibly causing accident
2.15
high efficiency particulate air filter
the air filter whose filtration efficiency is greater than 99.97% under specified conditions and generally taking 0.3μm particulates as the test objects
2.16
air lock
the airtight room possessed of mechanical air supply and exhaust system, integral disinfection and sterilization conditions, chemical spraying (if applicable) and monitorable pressure; its doors shall be possessed of interlock function and cannot remain in open state at the same time
3 Classification of Causative Bacteria Hazard Degree
Causative bacteria are divided into four categories according to their infectivity and the hazard degree to individual or group after infection:
a) Category I causative bacteria: the bacteria that will cause very severe human or animal diseases, as well as the bacteria that have not been discovered in China or have already been declared eliminated.
b) Category II causative bacteria: the bacteria that will cause severe human or animal diseases, and are easy to be directly or indirectly transmitted between people, animal and people, as well as animals.
c) Category III causative bacteria: the bacteria that will cause human or animal diseases, but generally will not cause severe hazard to people, animals or environment, with limited transmission risk; after laboratory infection, they will rarely lead to severe disease and there are effective treatment and prevention measures.
d) Category IV causative bacteria: the bacteria that will not cause human or animal diseases normally.
Note 1: Category I and Category II causative bacteria are collectively referred to highly pathogenic causative bacteria.
4 Rating and Classification of Laboratory Biosafety Protection Level
4.1 Rating
4.1.1 Laboratories are divided into Biosafety Level 1 (BSL-1), Biosafety Level 2 (BSL-2), Biosafety Level 3 (BSL-3) and Biosafety Level 4 (BSL-4) according to the biosafety protection level of laboratory for causative bacteria and national standards for laboratory biosafety.
4.1.2 Biosafety level 1 laboratory is applicable to operate the bacteria that will not cause human or animal diseases normally.
4.1.3 Biosafety level 2 laboratory is applicable to the bacteria that will cause human or animal diseases, but generally will not cause severe hazard to people, animals or environment, with limited transmission risk; after laboratory infection, they will rarely lead to severe disease and there are effective treatment and prevention measures. BSL-2 laboratories are divided into ordinary BSL-2 laboratory and enhanced BSL-2 laboratory according to whether the laboratory is provided with mechanical ventilation system.
4.1.4 Biosafety level 3 laboratory is applicable to operate the bacteria that will cause severe human or animal diseases, and are easy to be directly or indirectly transmitted between people, animal and people, as well as animals.
4.1.5 Biosafety level 4 laboratory is applicable to operate the bacteria that will cause very severe human or animal diseases, as well as the bacteria that have not been discovered in China or have already been declared eliminated.
4.2 Classification
4.2.1 BSL-1, BSL-2, BSL-3 and BSL-4 represent the corresponding biosafety protection level of the laboratories only engaged in external operation.
4.2.2 ABSL-1 (Animal Biosafety Level, ABSL-1), ABSL-2, ABSL-3 and ABSL-4 represent the corresponding biosafety protection level of the laboratories engaged in living animal operation.
4.2.3 Animal biosafety laboratories are divided into the laboratory engaged in vertebrate experiment and that engaged in invertebrate experiment.
4.2.4 According to the difference of experiment, adopted PPE and basic isolation facilities, laboratories are divided into:
a) laboratory where the pathogenic biological agents that are generally regarded as non-air-transmitted can be operated;
b) laboratory where safety isolation devices (such as level 2 biosafety cabinet) can be effectively used to operate routine-quantity air-transmitted pathogenic biological agents;
c) laboratory where safety isolation devices (such as level 2 biosafety cabinet) can’t be effectively used to operate routine-quantity air-transmitted pathogenic biological agents;
d) laboratory where positive pressure clothing with life support system can be used to operate routine-quantity air-transmitted pathogenic biological agents;
e) laboratory where the equipment with level 3 biosafety cabinet can be used to operate routine-quantity air-transmitted pathogenic biological agents.
5 Risk Assessment and Risk Control
5.1 General
Risk assessment and risk control systems shall be established and maintained in the laboratory to determine specific requirements for laboratory to continually carry out risk identification, risk assessment and risk control (see Annex A).
5.2 Risk identification
Where pathogenic biological agents are involved in experiment, risk factors including but not limited to those described in a) to j) of 5.2 shall be identified:
a) The known or unknown characteristics of pathogenic biological agents involved in experiment, for example:
1) hazard degree classification;
2) biological characteristics;
3) route of transmission and transmissibility;
4) infectivity and pathogenicity: susceptibility, host range, amount essential for a pathogen, incubation period, clinical symptom, course of disease, prognosis, etc.;
5) interaction with other lives and the environment, relevant experimental data and epidemiological data;
6) stability in environment;
7) preventive, therapeutic and diagnostic measures, including vaccine, therapeutic drugs and the diagnostic reagent used for infection testing.
b) Experiment involving pathogenic biological agents, for example:
1) collection, transfer, preservation and destroy of microorganism strain and infectious substance;
2) separation, cultivation, evaluation, preparation and the like;
3) operation easy to produce aerosols, e.g. centrifugation, grinding, oscillation, homogenate, ultrasound, inoculation, freeze drying;
4) use of sharp instruments such as syringe needle, anatomy instrument, glassware, etc.;
c) Where Genetically Modified Organisms (GMOs) are involved in experiment, the hazard caused by recombinant shall be considered.
d) Animal feeding and experiment involving pathogenic biological agents:
1) scratches or bites;
2) animal dander and aerosols produced from breathing;
3) anatomy, sampling, testing, etc.;
4) treatment of excrement, secretion, tissue/organ/carcass, padding and waste, etc.;
5) possible failure of animal cage, instrument and control system, etc.
e) Risk in infectious waste treatment:
1) waste container, packaging and identification;
2) collection, disinfection, storage and transportation, etc.;
3) leakage of infectious waste;
4) reliability of sterilization;
5) risk of possible contacting with infectious waste by people outside of facilities.
f) Risks of experiment safety management, including, but not limited to:
1) management measures and technical measures to eliminate, reduce or control risk as well as residual or new risk after taking measures;
2) operating experience and risk control measures, including possible risks of management procedure, operation specification, maintenance specification and the like relevant to facilities and equipment;
3) new risk which may be caused by implementing emergency measures.
g) Relevant personnel in experiment involving pathogenic biological agents:
1) professional and biosafety knowledge and operation skill;
2) perception for risk;
3) psychological quality;
4) professional and biosafety training condition;
5) disposal capability for incident/accident;
6) health status;
7) health monitoring, medical security and medical rescue;
8) safety management and provided protective measures for experimenter from other organizations.
h) Laboratory facility and equipment:
1) biosafety cabinet, centrifuge, shaking table and incubator, etc.;
2) waste and wastewater disposal facility and equipment;
3) personal protective equipment;
If applicable, including:
1) airtightness, pressure, temperature and flow control of the containment area;
2) interlocking, air-tight door and access control system;
3) those such as ventilation and air conditioning system as well as water, electrical and gas system associated with containment area;
4) safety monitoring and alarm system;
5) animal feeding and operating facility/equipment;
6) facility/equipment for preservation of microorganism strain and sample;
7) radiation protection device;
8) life support system, positive-pressure protective clothing, chemical shower, etc.;
i) Laboratory biological security system and security measures, mainly for identifying the risk of preserved or used pathogenic biological agents being stolen, misused and maliciously released.
j) Reason analysis for occurred laboratory infection.
5.3 Risk assessment
5.3.1 Risk assessment shall be based on national laws and regulations, standards and codes as well as the guideline, data and the like issued by the authority. The identified risks shall be analyzed to form risk assessment report.
5.3.2 Risk assessment shall be carried out by experienced professional personnel in different fields (not limited to the personnel in the organization).
5.3.3 Risk assessment shall be carried out by the laboratory based on 5.2 and in combination with but not limited to the following conditions:
a) where the biological characteristics or prevention and control strategies of pathogen are changed;
b) new experiments are carried out or experiments are changed (including facilities, equipment, personal, range of activity, regulation, etc.);
c) the operation quantity exceeds routine quantity or specific activity is engaged;
d) the laboratory or similar laboratory has infection incident or infection accident;
e) where relevant policies, laws and regulations, standards and the like are changed.
Foreword i 1 Scope 2 Terms and Definitions 3 Classification of Causative Bacteria Hazard Degree 4 Rating and Classification of Laboratory Biosafety Protection Level 5 Risk Assessment and Risk Control 6 Laboratory Facilities and Equipment Requirements 7 Management Requirements for Laboratory Biosafety Annex A (Informative) Risk Assessment Table for Causative Bacteria Experiment Annex B (Informative) Approval Table for Causative Bacteria Experiment Annex C (Informative) On-site Inspection of Biosafety Isolation Equipment Annex D (Informative) Monitoring of Effect of Pressure Steam Sterilizer Bibliography
Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
All contents of this standard are mandatory.
This standard is developed in accordance with the rules given in GB/T 1.1-2009.
This standard replaces WS 233-2002 General Biosafety Standard for Microbiological and Biomedical Laboratories which shall be abolished from the implementation date of this edition.
There are the following main modifications with respect to WS 233-2002:
——"Terms and Definitions" is modified (see Chapter 2; Chapter 3 of Edition 2002);
——The basic principles and requirements for laboratory biosafety protection are modified; detailed provisions regarding laboratory facility, design, environment, apparatus, personnel management, operation specification, disinfection and sterilization and the like are provided (see Chapters 4, 5, 6 and 7; Chapters 4, 5, 6 and 7 of Edition 2002);
——Risk assessment and risk control are modified (see Chapter 5; 4.7 of Edition 2002);
——Enhanced BSL-2 laboratory is added (see 6.3.2);
——Biosafety design principles, basic requirements and the like for vertebrate laboratory are modified (see 6.6.1, 6.6.2, 6.6.3 and 6.6.4; Chapter 7 of Edition 2002);
——Basic requirements for invertebrate laboratory biosafety are added (see 6.6.5);
——"Disinfection and sterilization" is added (see 7.7);
——Annexes of Edition 2002 are deleted (see Annexes A, B and C of Edition 2002);
——Informative Annexes A, B, C and D are added.
The previous edition replaced by this standard is as follows:
——WS 233-2002.
General Biosafety Standard for Causative Bacteria Laboratories
1 Scope
This standard specifies the basic principles, classification and basic requirements for biosafety protection of causative bacteria laboratories.
This standard is applicable to laboratories carrying out activities such as bacteria-related research, teaching, testing and diagnosis.
2 Terms and Definitions
For the purposes of this document, the following terms and definitions apply.
2.1
laboratory biosafety
it refers to that the biosafety conditions and state in the laboratory are not lower than the permissible level; unacceptable damage to laboratory personnel, visitors, communities and environment can be avoided; and requirements of relevant laws, regulations and standards for laboratory biosafety responsibilities can be satisfied
2.2
risk
the integrity of danger occurrence probability and its result severity
2.3
risk assessment
the whole process to assess risk and determine whether it is acceptable
2.4
risk control
the comprehensive measures adopted for reducing risks
2.5
personal protective equipment; PPE
the apparatus and articles that prevent personnel and individual from harm of biological, chemical or physical hazard factor
2.6
biosafety cabinet; BSC
the control cabinet with pneumatic control and high-efficient air filtration unit; which may effectively reduce the hazard of causative bacteria or the harmful aerosols produced during bioexperiment to the operator and environment
2.7
aerosols
the relatively-stable disperse system generally formed by 0.001μm ~ 100μm solid or liquid tiny particles suspending in the gas medium
2.8
biosafety laboratory
the causative bacteria laboratory that meets the biosafety requirements through protective barrier and control measures
2.9
laboratory containment area
the physical zone of the laboratory; in the zone, biohazard risk is relatively large and the plane design of the laboratory, airtightness of enclosing structure, airflow as well as personnel entrance, individual protection and the like shall be controlled
2.10
non-contamination zone
the area with relative small biohazard or the area other than the containment area in biosafety laboratory
2.11
core area
the primary area for carrying out laboratory activities in biosafety laboratory; which generally refers to the room where biosafety cabinet or animal feeding room and operation room exist
2.12
enhanced biosafety level 2 laboratory
the laboratory in which laboratory biosafety protection requirements are enhanced through mechanical ventilation system and other measures based on ordinary biosafety level 2 laboratory
2.13
accident
the unexpected conditions leading to personal and animal infection, injury and death or facility/equipment damage and other losses
2.14
incident
the condition causing or possibly causing accident
2.15
high efficiency particulate air filter
the air filter whose filtration efficiency is greater than 99.97% under specified conditions and generally taking 0.3μm particulates as the test objects
2.16
air lock
the airtight room possessed of mechanical air supply and exhaust system, integral disinfection and sterilization conditions, chemical spraying (if applicable) and monitorable pressure; its doors shall be possessed of interlock function and cannot remain in open state at the same time
3 Classification of Causative Bacteria Hazard Degree
Causative bacteria are divided into four categories according to their infectivity and the hazard degree to individual or group after infection:
a) Category I causative bacteria: the bacteria that will cause very severe human or animal diseases, as well as the bacteria that have not been discovered in China or have already been declared eliminated.
b) Category II causative bacteria: the bacteria that will cause severe human or animal diseases, and are easy to be directly or indirectly transmitted between people, animal and people, as well as animals.
c) Category III causative bacteria: the bacteria that will cause human or animal diseases, but generally will not cause severe hazard to people, animals or environment, with limited transmission risk; after laboratory infection, they will rarely lead to severe disease and there are effective treatment and prevention measures.
d) Category IV causative bacteria: the bacteria that will not cause human or animal diseases normally.
Note 1: Category I and Category II causative bacteria are collectively referred to highly pathogenic causative bacteria.
4 Rating and Classification of Laboratory Biosafety Protection Level
4.1 Rating
4.1.1 Laboratories are divided into Biosafety Level 1 (BSL-1), Biosafety Level 2 (BSL-2), Biosafety Level 3 (BSL-3) and Biosafety Level 4 (BSL-4) according to the biosafety protection level of laboratory for causative bacteria and national standards for laboratory biosafety.
4.1.2 Biosafety level 1 laboratory is applicable to operate the bacteria that will not cause human or animal diseases normally.
4.1.3 Biosafety level 2 laboratory is applicable to the bacteria that will cause human or animal diseases, but generally will not cause severe hazard to people, animals or environment, with limited transmission risk; after laboratory infection, they will rarely lead to severe disease and there are effective treatment and prevention measures. BSL-2 laboratories are divided into ordinary BSL-2 laboratory and enhanced BSL-2 laboratory according to whether the laboratory is provided with mechanical ventilation system.
4.1.4 Biosafety level 3 laboratory is applicable to operate the bacteria that will cause severe human or animal diseases, and are easy to be directly or indirectly transmitted between people, animal and people, as well as animals.
4.1.5 Biosafety level 4 laboratory is applicable to operate the bacteria that will cause very severe human or animal diseases, as well as the bacteria that have not been discovered in China or have already been declared eliminated.
4.2 Classification
4.2.1 BSL-1, BSL-2, BSL-3 and BSL-4 represent the corresponding biosafety protection level of the laboratories only engaged in external operation.
4.2.2 ABSL-1 (Animal Biosafety Level, ABSL-1), ABSL-2, ABSL-3 and ABSL-4 represent the corresponding biosafety protection level of the laboratories engaged in living animal operation.
4.2.3 Animal biosafety laboratories are divided into the laboratory engaged in vertebrate experiment and that engaged in invertebrate experiment.
4.2.4 According to the difference of experiment, adopted PPE and basic isolation facilities, laboratories are divided into:
a) laboratory where the pathogenic biological agents that are generally regarded as non-air-transmitted can be operated;
b) laboratory where safety isolation devices (such as level 2 biosafety cabinet) can be effectively used to operate routine-quantity air-transmitted pathogenic biological agents;
c) laboratory where safety isolation devices (such as level 2 biosafety cabinet) can’t be effectively used to operate routine-quantity air-transmitted pathogenic biological agents;
d) laboratory where positive pressure clothing with life support system can be used to operate routine-quantity air-transmitted pathogenic biological agents;
e) laboratory where the equipment with level 3 biosafety cabinet can be used to operate routine-quantity air-transmitted pathogenic biological agents.
5 Risk Assessment and Risk Control
5.1 General
Risk assessment and risk control systems shall be established and maintained in the laboratory to determine specific requirements for laboratory to continually carry out risk identification, risk assessment and risk control (see Annex A).
5.2 Risk identification
Where pathogenic biological agents are involved in experiment, risk factors including but not limited to those described in a) to j) of 5.2 shall be identified:
a) The known or unknown characteristics of pathogenic biological agents involved in experiment, for example:
1) hazard degree classification;
2) biological characteristics;
3) route of transmission and transmissibility;
4) infectivity and pathogenicity: susceptibility, host range, amount essential for a pathogen, incubation period, clinical symptom, course of disease, prognosis, etc.;
5) interaction with other lives and the environment, relevant experimental data and epidemiological data;
6) stability in environment;
7) preventive, therapeutic and diagnostic measures, including vaccine, therapeutic drugs and the diagnostic reagent used for infection testing.
b) Experiment involving pathogenic biological agents, for example:
1) collection, transfer, preservation and destroy of microorganism strain and infectious substance;
2) separation, cultivation, evaluation, preparation and the like;
3) operation easy to produce aerosols, e.g. centrifugation, grinding, oscillation, homogenate, ultrasound, inoculation, freeze drying;
4) use of sharp instruments such as syringe needle, anatomy instrument, glassware, etc.;
c) Where Genetically Modified Organisms (GMOs) are involved in experiment, the hazard caused by recombinant shall be considered.
d) Animal feeding and experiment involving pathogenic biological agents:
1) scratches or bites;
2) animal dander and aerosols produced from breathing;
3) anatomy, sampling, testing, etc.;
4) treatment of excrement, secretion, tissue/organ/carcass, padding and waste, etc.;
5) possible failure of animal cage, instrument and control system, etc.
e) Risk in infectious waste treatment:
1) waste container, packaging and identification;
2) collection, disinfection, storage and transportation, etc.;
3) leakage of infectious waste;
4) reliability of sterilization;
5) risk of possible contacting with infectious waste by people outside of facilities.
f) Risks of experiment safety management, including, but not limited to:
1) management measures and technical measures to eliminate, reduce or control risk as well as residual or new risk after taking measures;
2) operating experience and risk control measures, including possible risks of management procedure, operation specification, maintenance specification and the like relevant to facilities and equipment;
3) new risk which may be caused by implementing emergency measures.
g) Relevant personnel in experiment involving pathogenic biological agents:
1) professional and biosafety knowledge and operation skill;
2) perception for risk;
3) psychological quality;
4) professional and biosafety training condition;
5) disposal capability for incident/accident;
6) health status;
7) health monitoring, medical security and medical rescue;
8) safety management and provided protective measures for experimenter from other organizations.
h) Laboratory facility and equipment:
1) biosafety cabinet, centrifuge, shaking table and incubator, etc.;
2) waste and wastewater disposal facility and equipment;
3) personal protective equipment;
If applicable, including:
1) airtightness, pressure, temperature and flow control of the containment area;
2) interlocking, air-tight door and access control system;
3) those such as ventilation and air conditioning system as well as water, electrical and gas system associated with containment area;
4) safety monitoring and alarm system;
5) animal feeding and operating facility/equipment;
6) facility/equipment for preservation of microorganism strain and sample;
7) radiation protection device;
8) life support system, positive-pressure protective clothing, chemical shower, etc.;
i) Laboratory biological security system and security measures, mainly for identifying the risk of preserved or used pathogenic biological agents being stolen, misused and maliciously released.
j) Reason analysis for occurred laboratory infection.
5.3 Risk assessment
5.3.1 Risk assessment shall be based on national laws and regulations, standards and codes as well as the guideline, data and the like issued by the authority. The identified risks shall be analyzed to form risk assessment report.
5.3.2 Risk assessment shall be carried out by experienced professional personnel in different fields (not limited to the personnel in the organization).
5.3.3 Risk assessment shall be carried out by the laboratory based on 5.2 and in combination with but not limited to the following conditions:
a) where the biological characteristics or prevention and control strategies of pathogen are changed;
b) new experiments are carried out or experiments are changed (including facilities, equipment, personal, range of activity, regulation, etc.);
c) the operation quantity exceeds routine quantity or specific activity is engaged;
d) the laboratory or similar laboratory has infection incident or infection accident;
e) where relevant policies, laws and regulations, standards and the like are changed.
Contents of WS 233-2017
Foreword i
1 Scope
2 Terms and Definitions
3 Classification of Causative Bacteria Hazard Degree
4 Rating and Classification of Laboratory Biosafety Protection Level
5 Risk Assessment and Risk Control
6 Laboratory Facilities and Equipment Requirements
7 Management Requirements for Laboratory Biosafety
Annex A (Informative) Risk Assessment Table for Causative Bacteria Experiment
Annex B (Informative) Approval Table for Causative Bacteria Experiment
Annex C (Informative) On-site Inspection of Biosafety Isolation Equipment
Annex D (Informative) Monitoring of Effect of Pressure Steam Sterilizer
Bibliography
