《生物技术安全》（英文版) Chapter 1. Classification of infective

必 实验室 生物安全手册 世界卫生组织

Biosafety Chapter 1. Classification of infective microorganisms by risk group(WHO Risk Groups 1, 2, 3 and 4) for laboratory work

Biosafety Chapter 1. Classification of infective microorganisms by risk group (WHO Risk Groups 1, 2, 3 and 4) for laboratory work

dRisk Group 1(no or low individual and community risk): A microorganism that is unlikely to cause human or animal disease Risk Group 2(moderate individual risk, low community risk): A pathogen that can cause human or animal disease but is unlikely to be a serious hazard to laboratory workers, the community, livestock or the environment. Laboratory exposures may cause serious infection, but effective treatment and preventive measures are available and the risk of spread of infection is limited

❑Risk Group 1 (no or low individual and community risk): A microorganism that is unlikely to cause human or animal disease. ❑Risk Group 2 (moderate individual risk, low community risk): A pathogen that can cause human or animal disease but is unlikely to be a serious hazard to laboratory workers, the community, livestock or the environment. Laboratory exposures may cause serious infection, but effective treatment and preventive measures are available and the risk of spread of infection is limited

dRisk Group 3(high individual risk, low community risk ): A pathogen that usually causes serious human or animal disease but does not ordinarily spread from one infected individual to another, effective treatment and preventive measures are available. Risk Group 4(high individual and community risk ): A pathogen that usually causes serious human or animal disease and that can be readily transmitted from one individual to another, directly or indirectly Effective treatment and preventive measures are not usually available

❑Risk Group 3 (high individual risk, low community risk): A pathogen that usually causes serious human or animal disease but does not ordinarily spread from one infected individual to another. Effective treatment and preventive measures are available. ❑Risk Group 4 (high individual and community risk): A pathogen that usually causes serious human or animal disease and that can be readily transmitted from one individual to another, directly or indirectly. Effective treatment and preventive measures are not usually available

lAboratory facilities are designated as basic Biosafety Level 1, basic Biosafety Level 2, containment- Biosafety Level 3, and maximum containment- Biosafety Level 4 bIosafety level designations are based on a composite of the design features, construction containment facilities equipment, practices and operational procedures required for working with agents from the various risk groups

❑Laboratory facilities are designated as basic – Biosafety Level 1, basic – Biosafety Level 2, containment – Biosafety Level 3, and maximum containment – Biosafety Level 4. ❑Biosafety level designations are based on a composite of the design features, construction, containment facilities, equipment, practices and operational procedures required for working with agents from the various risk groups

RISK BIOSAFETY LABORATORY LABORATORY SAFETY GROUP LEVEL TYPE PRACTICES EQUIPMENT 1 Basic Basic teaching, GMT None: open bench Biosafety research work Level 1 2 Basic Primary health GMT plus protective Open bench plus BSC Biosafety services, diagnostic clothing, biohazard for potential aerosols Level 2 services, research sign 气溶胶 3 Containment Special diagnostic As Level 2 plus BSC and/or other Biosafety services, research special clothing, primary devices for all Level 3 controlled access activities directional airflow 4 Maximum Dangerous pathogen As Level 3 plus Class‖BSC.or containment units airlock entry, shower positive pressure suits Biosafety exit. special waste in conjunction with Level 4 disposal Class‖!BsCs. double GM7:微生物学操作技术规范 ended autoclave BSC, biological safety cabinet; through the wall) GM, good microbiological techniques filtered air

气溶胶 GMT:微生物学操作技术规范

Countries (regions) should draw up a national (regional)classification of microorganisms, by risk group, taking into account 1. Pathogenicity of the organism 02. Mode of transmission and host range of the organism. These may be influenced by existing levels of immunity in the local population, density and movement of the host population, presence of appropriate vectors f 菌者, and standards of environmental hygiene

❑Countries (regions) should draw up a national (regional) classification of microorganisms, by risk group, taking into account: ❑1. Pathogenicity of the organism. ❑2. Mode of transmission and host range of the organism. These may be influenced by existing levels of immunity in the local population, density and movement of the host population, presence of appropriate vectors带 菌者, and standards of environmental hygiene

3. Local availability of effective preventive measures. These may include: prophylaxisfis) by immunization or administration of antisera抗血清 (passive immunization); sanitary measures, e.g. food and water hygiene; control of animal reservoirs or arthropod节肢动物 vectors a4. Local availa bility of effective treatment. This includes passive immunization, postexposure vaccination and use of antimicrobials antivirals and chemotherapeutic agents, and should take into consideration the possibility of the emergence of drug-resistant strains

❑3. Local availability of effective preventive measures. These may include: prophylaxis预防 by immunization or administration of antisera抗血清 (passive immunization); sanitary measures, e.g. food and water hygiene; control of animal reservoirs or arthropod节肢动物vectors. ❑4. Local availability of effective treatment. This includes passive immunization, postexposure vaccination and use of antimicrobials, antivirals and chemotherapeutic agents, and should take into consideration the possibility of the emergence of drug-resistant strains

U The assignment of an agent to a biosafety level for laboratory work must be based on a risk assessment Such an assessment will take the risk group as well as other factors into consideration in establishing the appropriate biosafety level. U For example, an agent that is assigned to risk grou 2 may generally require Biosafety Level 2 facilities,up equipment, practices and procedures for safe conduct of work. However, if particular experiments require the generation of high-concentration aerosols, then Biosafety Level 3 may be more appropriate to provide he necessary degree of safety, since itensures superior containment of aerosols in the laboratory workplace

❑The assignment of an agent to a biosafety level for laboratory work must be based on a risk assessment. Such an assessment will take the risk group as well as other factors into consideration in establishing the appropriate biosafety level. ❑For example, an agent that is assigned to Risk Group 2 may generally require Biosafety Level 2 facilities, equipment, practices and procedures for safe conduct of work. However, if particular experiments require the generation of high-concentration aerosols, then Biosafety Level 3 may be more appropriate to provide the necessary degree of safety, since itensures superior containment of aerosols in the laboratory workplace

Therefore The biosafety level assigned for the specific work to be done is driven by professional judgement based on a risk assessment, rather than by automatic assignment of a laboratory biosafety level according to the particular risk group designation of the pathogenic agent to be used

Therefore, The biosafety level assigned for the specific work to be done is driven by professional judgement based on a risk assessment, rather than by automatic assignment of a laboratory biosafety level according to the particular risk group designation of the pathogenic agent to be used