This standard specifies the basic requirements for facilities, equipments and safety management of laboratories at different biosafety protection classes.
Chapter 5, Sections 6.1 and 6.2 are the basic requirements for biosafety laboratory; if required, they are applicable to biosafety laboratories and biosafety laboratories with higher protection class.
As for the relevant laboratory activities related to infectious animal feeding, this standard specifies the basic requirements for animal feeding facilities and environment in the laboratory. If required, Sections 6.3 and 6.4 are applicable to the animal biosafety laboratories with corresponding protection class.
This standard is applicable to the laboratory related to biological agent operation.
2 Terms and Definitions
The following terms and definitions are applicable to this standard.
2.1
Aerosols
Relatively-stable disperse system generally formed by 0.001 μm ~ 100 μm solid or liquid tiny particles suspending in the gas medium
2.2
Accident
Fortuitous event causing death, disease, harm, damage and other loss
2.3
Airlock
As for the airtight room possessed of mechanical air supply and exhaust system, integral sterilization conditions, chemical spraying (if applicable) and monitoring pressure, its doors shall be possessed of interlock function and can not be open at the same time.
2.4
Biological agents
Microorganism and bioactivator
2.5
Biological safety cabinet, BSC
The control cabinet with pneumatic control and high-efficient air filtration unit may effectively reduce the hazard of harmful aerosols to the operator and environment during the process of experiment.
2.6
Buffer room
The sealed room installed between the laboratories with different contamination probability. If necessary, it shall be equipped with mechanical ventilation system. Its doors shall be possessed of interlock function and can not be open at the same time.
2.7
Directional airflow
The controlled airflow from the area with small contamination probability to the area with large contamination probability
2.8
Hazard
Sources or states that may cause death, harm, disease, property loss, working environment damage or their combination
2.9
Hazard identification
The process to identify potential hazard and determine its characteristics
2.10
High efficiency particulate air filter (HEPA filter)
The air filter whose filtering efficiency is greater than 99.97 under specified conditions, generally adopting 0.3 μm particles as the testing objects
2.11
Incident
The conditions resulting in or may result in accidents
2.12
Laboratory
Laboratory related to biological agent operation
2.13
Laboratory biosafety
Biosafety conditions and state in the laboratory are not lower than the permissible level, can avoid laboratory workers, visitors, communities and environment receiving unacceptable damage, as well as meet the requirements of relevant laws, regulations and standards for laboratory biosafety responsibilities.
2.14
Laboratory containment area
The physical area of the laboratory, biohazard risk in this area is relatively large, the area that shall control the plane design of the laboratory, tightness of building enclosure, air flow, personnel entrance and individual protection
2.15
Material safety data sheet, MSDS
Technical bulletin that provides the hazard and precautions of some materials in details
2.16
Personal protective equipment, PPE
Equipment and appliance that prevent personnel and individual from biological, chemical and physical risk agent harm.
2.17
Risk
Integrity of hazard occurrence probability and its consequence severity
2.18
Risk assessment
The overall process to evaluate risk and determine whether it is acceptable
2.19
Risk control
Comprehensive measures adopted for reducing risks
3 Risk Assessment and Risk Control
3.1 Risk assessment and risk control procedures shall be established and maintained in the laboratory to continually carry out hazard identification, risk assessment and necessary control measures. To-be-considered contents include:
3.1.1 If the laboratory activities involve pathogenic biological agents, the biological risk assessment shall be carried out for the laboratory. The following contents shall be considered (but not limited to) for the risk assessment:
a) Known or unknown characteristics of biological agents, such as variety, source, infectiousness, transmission route, susceptivity, incubation period, dosage effect (reaction) relationship, pathogenicity (including acute and chronic), variability, stability in the environment, interaction with other organisms and environment, relevant experimental data, epidemiologic data, and prevention and treatment schemes, etc.
b) If applicable, accident analysis of the laboratory or relevant laboratories;
c) Risk (not limited to biological factors) in the laboratory during the process of conventional and unconventional activities, including activities of all laboratory personnel and other relevant personnel (such as: personnel of the contract part);
d) Risks related to facilities and equipments;
e) If applicable, risks related to laboratory animals;
f) Risks related to personnel, such as physical conditions, ability and pressure that may influence work;
g) Risks caused by incidents and accidents;
h) Misused and maliciously-used risks;
i) Scope, performance and time limitation of risks;
j) Probability assessment of hazard occurrence;
k) Potential hazard and consequence analysis;
l) Acceptable risks;
m) If applicable, control measures and technical measures that eliminate, reduce or control risks, as well as residual risk or new risk assessment after adopting these measures;
n) If applicable, adaptable degree assessment of operating experience and adopted risk control measures;
o) If applicable, emergency measure and anticipated effect assessment;
p) If applicable, input message provided for determining facility and equipment requirements, identifying training requirements and developing operating control;
q) If applicable, assessment for information and resource (including external resource) required for reducing risks and controlling hazard;
r) Comprehensive assessment for risks, requirements, resources, feasibility and applicability.
3.1.2 Risks of activities to be carried out shall be assessed in advance, including chemical hazard, physical hazard, radiation, electrical hazard, flood, fire and natural disaster.
3.1.3 Risk assessment shall be carried out by experienced professional personnel (not limited to the personnel in the organization).
Contents Foreword i Introduction iii 1 Scope 2 Terms and Definitions 3 Risk Assessment and Risk Control 4 Classification of Laboratory Biosafety Protection 5 Design Principles and Basic Requirements of Laboratory 6 Laboratory Facilities and Equipment Requirements 6.1 BSL-1 Laboratory 6.2 BSL-2 Laboratory 6.3 BSL-3 Laboratory 6.4 BSL-4 Laboratory 6.5 Animal Biosafety Laboratory 7 Management Requirements 7.1 Organization and Management 7.2 Management Responsibilities 7.3 Personal Responsibilities 7.4 Documents for Safety Management System 7.5 Documentation Control 7.6 Safety Program 7.7 Safety Inspection 7.8 Identification and Control of Nonconformity 7.9 Corrective Measures 7.10 Preventive Measures 7.11 Continuous Improvement 7.12 Internal Check 7.13 Management Review 7.14 Laboratory Personnel Management 7.15 Laboratory Material Management 7.16 Laboratory Activities Management 7.17 Laboratory Housekeeping Management 7.18 Laboratory Facility/Equipment Management 7.19 Waste Disposal 7.20 Hazardous Material Transportation 7.21 Emergency Measures 7.22 Fire-fighting Safety 7.23 Accident Report Appendix A (Informative) Guideline for the Tightness Testing of Laboratory Building Enclosure and the Leakage Detection Method of Air-Exhaust HEPA Filter Appendix B (Informative) Manual on Good Working Behaviors in Biosafety Laboratory Appendix C (Informative) Guidance on the Handling of the Overflow and Sprinkle of Biohazard Substances in Laboratory Bibliography
1 Scope
This standard specifies the basic requirements for facilities, equipments and safety management of laboratories at different biosafety protection classes.
Chapter 5, Sections 6.1 and 6.2 are the basic requirements for biosafety laboratory; if required, they are applicable to biosafety laboratories and biosafety laboratories with higher protection class.
As for the relevant laboratory activities related to infectious animal feeding, this standard specifies the basic requirements for animal feeding facilities and environment in the laboratory. If required, Sections 6.3 and 6.4 are applicable to the animal biosafety laboratories with corresponding protection class.
This standard is applicable to the laboratory related to biological agent operation.
2 Terms and Definitions
The following terms and definitions are applicable to this standard.
2.1
Aerosols
Relatively-stable disperse system generally formed by 0.001 μm ~ 100 μm solid or liquid tiny particles suspending in the gas medium
2.2
Accident
Fortuitous event causing death, disease, harm, damage and other loss
2.3
Airlock
As for the airtight room possessed of mechanical air supply and exhaust system, integral sterilization conditions, chemical spraying (if applicable) and monitoring pressure, its doors shall be possessed of interlock function and can not be open at the same time.
2.4
Biological agents
Microorganism and bioactivator
2.5
Biological safety cabinet, BSC
The control cabinet with pneumatic control and high-efficient air filtration unit may effectively reduce the hazard of harmful aerosols to the operator and environment during the process of experiment.
2.6
Buffer room
The sealed room installed between the laboratories with different contamination probability. If necessary, it shall be equipped with mechanical ventilation system. Its doors shall be possessed of interlock function and can not be open at the same time.
2.7
Directional airflow
The controlled airflow from the area with small contamination probability to the area with large contamination probability
2.8
Hazard
Sources or states that may cause death, harm, disease, property loss, working environment damage or their combination
2.9
Hazard identification
The process to identify potential hazard and determine its characteristics
2.10
High efficiency particulate air filter (HEPA filter)
The air filter whose filtering efficiency is greater than 99.97 under specified conditions, generally adopting 0.3 μm particles as the testing objects
2.11
Incident
The conditions resulting in or may result in accidents
2.12
Laboratory
Laboratory related to biological agent operation
2.13
Laboratory biosafety
Biosafety conditions and state in the laboratory are not lower than the permissible level, can avoid laboratory workers, visitors, communities and environment receiving unacceptable damage, as well as meet the requirements of relevant laws, regulations and standards for laboratory biosafety responsibilities.
2.14
Laboratory containment area
The physical area of the laboratory, biohazard risk in this area is relatively large, the area that shall control the plane design of the laboratory, tightness of building enclosure, air flow, personnel entrance and individual protection
2.15
Material safety data sheet, MSDS
Technical bulletin that provides the hazard and precautions of some materials in details
2.16
Personal protective equipment, PPE
Equipment and appliance that prevent personnel and individual from biological, chemical and physical risk agent harm.
2.17
Risk
Integrity of hazard occurrence probability and its consequence severity
2.18
Risk assessment
The overall process to evaluate risk and determine whether it is acceptable
2.19
Risk control
Comprehensive measures adopted for reducing risks
3 Risk Assessment and Risk Control
3.1 Risk assessment and risk control procedures shall be established and maintained in the laboratory to continually carry out hazard identification, risk assessment and necessary control measures. To-be-considered contents include:
3.1.1 If the laboratory activities involve pathogenic biological agents, the biological risk assessment shall be carried out for the laboratory. The following contents shall be considered (but not limited to) for the risk assessment:
a) Known or unknown characteristics of biological agents, such as variety, source, infectiousness, transmission route, susceptivity, incubation period, dosage effect (reaction) relationship, pathogenicity (including acute and chronic), variability, stability in the environment, interaction with other organisms and environment, relevant experimental data, epidemiologic data, and prevention and treatment schemes, etc.
b) If applicable, accident analysis of the laboratory or relevant laboratories;
c) Risk (not limited to biological factors) in the laboratory during the process of conventional and unconventional activities, including activities of all laboratory personnel and other relevant personnel (such as: personnel of the contract part);
d) Risks related to facilities and equipments;
e) If applicable, risks related to laboratory animals;
f) Risks related to personnel, such as physical conditions, ability and pressure that may influence work;
g) Risks caused by incidents and accidents;
h) Misused and maliciously-used risks;
i) Scope, performance and time limitation of risks;
j) Probability assessment of hazard occurrence;
k) Potential hazard and consequence analysis;
l) Acceptable risks;
m) If applicable, control measures and technical measures that eliminate, reduce or control risks, as well as residual risk or new risk assessment after adopting these measures;
n) If applicable, adaptable degree assessment of operating experience and adopted risk control measures;
o) If applicable, emergency measure and anticipated effect assessment;
p) If applicable, input message provided for determining facility and equipment requirements, identifying training requirements and developing operating control;
q) If applicable, assessment for information and resource (including external resource) required for reducing risks and controlling hazard;
r) Comprehensive assessment for risks, requirements, resources, feasibility and applicability.
3.1.2 Risks of activities to be carried out shall be assessed in advance, including chemical hazard, physical hazard, radiation, electrical hazard, flood, fire and natural disaster.
3.1.3 Risk assessment shall be carried out by experienced professional personnel (not limited to the personnel in the organization).
Contents of GB 19489-2008
Contents
Foreword i
Introduction iii
1 Scope
2 Terms and Definitions
3 Risk Assessment and Risk Control
4 Classification of Laboratory Biosafety Protection
5 Design Principles and Basic Requirements of Laboratory
6 Laboratory Facilities and Equipment Requirements
6.1 BSL-1 Laboratory
6.2 BSL-2 Laboratory
6.3 BSL-3 Laboratory
6.4 BSL-4 Laboratory
6.5 Animal Biosafety Laboratory
7 Management Requirements
7.1 Organization and Management
7.2 Management Responsibilities
7.3 Personal Responsibilities
7.4 Documents for Safety Management System
7.5 Documentation Control
7.6 Safety Program
7.7 Safety Inspection
7.8 Identification and Control of Nonconformity
7.9 Corrective Measures
7.10 Preventive Measures
7.11 Continuous Improvement
7.12 Internal Check
7.13 Management Review
7.14 Laboratory Personnel Management
7.15 Laboratory Material Management
7.16 Laboratory Activities Management
7.17 Laboratory Housekeeping Management
7.18 Laboratory Facility/Equipment Management
7.19 Waste Disposal
7.20 Hazardous Material Transportation
7.21 Emergency Measures
7.22 Fire-fighting Safety
7.23 Accident Report
Appendix A (Informative) Guideline for the Tightness Testing of Laboratory Building Enclosure and the Leakage Detection Method of Air-Exhaust HEPA Filter
Appendix B (Informative) Manual on Good Working Behaviors in Biosafety Laboratory
Appendix C (Informative) Guidance on the Handling of the Overflow and Sprinkle of Biohazard Substances in Laboratory
Bibliography
