AS/NZS 2243.3:2022
Safety in laboratories - Part 3: Microbiological safety and containment
Standard specifies requirements and gives recommended practices relating to safety in laboratories in which microorganisms are handled. Includes descriptions of risk group categories for microorganisms and requirements for facilities of corresponding containment levels.
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AS/NZS 2243.3:2022 Safety in laboratories Microbiological safety and containment
Preface
Introduction
Section 1 Scope and general
1.1 Scope
1.2 Application
1.3 Normative references
1.4 Terms and definitions
1.5 Abbreviations
Section 2 Organizational responsibility
2.1 Responsibility
2.1.1 Risk assessment
2.1.2 Establishment and management of a biosafety committee
2.1.3 Biological safety officer
2.1.4 Person with responsibility for the operation of the laboratory or facility
2.1.5 Responsibility of laboratory personnel
2.2 Biosecurity material
2.2.1 Australia
2.2.2 New Zealand
2.3 Laboratories using genetically modified organisms
2.3.1 Australia
2.3.2 New Zealand
2.4 Laboratory and facility biosecurity
2.5 Commissioning
2.6 Health management
2.6.1 General
2.6.2 Injuries and infections
2.6.3 Blood samples
2.6.4 Vaccination of workers
2.6.5 At-risk persons
2.6.6 Risks to pregnant women and the unborn child
2.7 Incident management and reporting
2.8 Emergency response plans
2.8.1 Emergency plan
2.8.2 First aid kit
Section 3 Degree of hazard from microorganisms
3.1 General
3.2 Classification of microorganisms by risk group
3.2.1 General
3.2.2 Human and terrestrial animal infectious microorganisms
3.2.3 Plant infectious microorganisms
3.2.4 Invertebrates carrying microorganisms
3.2.5 Aquatic infectious microorganisms
3.3 Risk-grouping of microorganisms by type
3.3.1 General
3.3.2 Human and animal infectious microorganism risk group examples
3.3.3 Plant risk group examples
3.3.4 Invertebrate risk group examples
3.3.5 Aquatic risk group examples
3.4 Human and animal clinical and diagnostic specimens
3.5 Quality assurance of cultures and materials
3.6 Work with human, animal or plant cells
3.7 Prions
3.8 Scale of cultures
Section 4 Principles of containment
4.1 General
4.2 Containment measures
4.2.1 General
4.2.2 Primary containment measures
4.2.3 Secondary containment measures
4.2.4 Tertiary containment measures
4.3 Physical containment classifications
4.3.1 General
4.3.2 Physical containment level 1 (PC1)
4.3.3 Physical containment level 2 (PC2)
4.3.4 Physical containment level 3 (PC3)
4.3.5 Physical containment level 4 (PC4)
4.4 Design
Section 5 Laboratory containment facilities
5.1 Laboratory physical containment
5.2 Requirements for Laboratory PC1 facilities
5.2.1 General
5.2.2 Construction
5.2.3 Work practices
5.3 Requirements for Laboratory PC2 facilities
5.3.1 General
5.3.2 Multiple room PC2 facilities
5.3.3 Construction
5.3.4 Ventilation
5.3.5 Containment equipment
5.3.6 Work practices
5.4 Requirements for Laboratory PC3 facilities
5.4.1 General
5.4.2 Construction
5.4.3 Ventilation
5.4.4 Access to services
5.4.5 Containment equipment
5.4.6 Work practices
5.4.7 Health monitoring
5.5 Requirements for Laboratory PC4 facilities
5.5.1 General
5.5.2 Construction
5.5.3 Ventilation
5.5.4 Containment equipment
5.5.5 Work practices
5.5.6 Health monitoring
Section 6 Terrestrial animal containment facilities
6.1 Requirements for terrestrial animal containment facilities
6.2 Principles of terrestrial animal containment
6.3 Other considerations associated with terrestrial animal containment
6.3.1 Designing facilities for different aspects of terrestrial animal handling
6.3.2 The occurrence of allergic reactions in personnel handling terrestrial animals
6.3.3 Air change rates for terrestrial animal containment facilities
6.3.4 Decontamination and disposal of terrestrial animal waste
6.3.5 Transport of terrestrial animals and animal tissues between facilities
6.3.6 Dissection and post-mortem examinations
6.4 Requirements for Terrestrial Animal PC1 facilities
6.4.1 General
6.4.2 Construction
6.4.3 Work practices
6.5 Requirements for Terrestrial Animal PC2 facilities
6.5.1 General
6.5.2 Construction
6.5.3 Ventilation
6.5.4 Containment equipment
6.5.5 Work practices
6.6 Requirements for Terrestrial Animal PC3 facilities
6.6.1 General
6.6.2 Construction
6.6.3 Ventilation
6.6.4 Access to services
6.6.5 Containment equipment
6.6.6 Work practices
6.6.7 Health monitoring
6.7 Requirements for Terrestrial Animal PC4 facilities
6.7.1 General
6.7.2 Alternative locations for animal work
6.7.3 Construction
6.7.4 Ventilation
6.7.5 Containment equipment
6.7.6 Work practices
6.7.7 Health monitoring
Section 7 Plant containment facilities
7.1 General
7.2 Requirements for Plant PC1 facilities
7.2.1 General
7.2.2 Location
7.2.3 Construction
7.2.4 Work practices
7.3 Requirements for Plant PC2 facilities
7.3.1 General
7.3.2 Location
7.3.3 Construction
7.3.4 Containment equipment
7.3.5 Work practices
7.4 Requirements for Plant PC3 facilities
7.4.1 General
7.4.2 Location
7.4.3 Construction
7.4.4 Ventilation
7.4.5 Access to services
7.4.6 Work practices
Section 8 Invertebrate containment facilities
8.1 General
8.2 Requirements for Invertebrate PC1 facilities
8.2.1 General
8.2.2 Location
8.2.3 Construction
8.2.4 Work practices
8.3 Requirements for Invertebrate PC2 facilities
8.3.1 General
8.3.2 Location
8.3.3 Construction
8.3.4 Containment equipment
8.3.5 Work practices
8.4 Requirements for Invertebrate PC3 facilities
8.4.1 General
8.4.2 Location
8.4.3 Construction
8.4.4 Ventilation
8.4.5 Access to services
8.4.6 Containment equipment
8.4.7 Work practices
8.5 Requirements for Invertebrate PC4 facilities
8.5.1 General
8.5.2 Construction
8.5.3 Ventilation
8.5.4 Work practices
8.5.5 Health monitoring
Section 9 Aquatic organism containment facilities
9.1 General
9.2 Principles of aquatic organism containment
9.3 Other considerations associated with aquatic organism containment
9.3.1 Designing facilities for different aspects of aquatic organism handling
9.3.2 The occurrence of allergic reactions in personnel handling aquatic organisms
9.3.3 Air change rates for aquatic organism containment facilities
9.3.4 Decontamination and disposal of aquatic organism waste
9.3.5 Transport of aquatic organisms and organism tissues between facilities
9.3.6 Dissection and post-mortem examinations
9.4 Requirements for Aquatic Organism PC1 facilities
9.4.1 General
9.4.2 Construction
9.4.3 Work practices
9.5 Requirements for Aquatic Organism PC2 facilities
9.5.1 General
9.5.2 Construction
9.5.3 Ventilation
9.5.4 Containment equipment
9.5.5 Work practices
9.6 Requirements for Aquatic Organism PC3 facilities
9.6.1 General
9.6.2 Construction
9.6.3 Ventilation
9.6.4 Access to services
9.6.5 Containment equipment
9.6.6 Work practices
9.6.7 Health monitoring
Section 10 Microbiological spills
10.1 General
10.2 Planning
10.2.1 General
10.2.2 Emergency provisions for personnel
10.2.3 Clean-up materials and equipment
10.3 Spills inside biological safety cabinets
10.3.1 General
10.3.2 Small spills
10.3.3 Larger spills
10.4 Spills outside biological safety cabinets
10.4.1 General
10.4.2 Spills in PC1 and PC2 facilities that can be cleaned up by the worker
10.4.3 Spills in PC2 facilities that should be cleaned up by a dedicated spills clean-up team
10.4.4 Spills in PC3 facilities
10.4.5 Spills in PC4 facilities where positive pressure suits are not worn
10.4.6 Spills in PC4 facilities where positive pressure suits are worn
10.5 Centrifuge spills
Section 11 Chemicals, personal protective equipment and special equipment
11.1 Chemicals
11.1.1 General
11.1.2 Dunk tanks, footbaths and disinfectant dispensers
11.2 Personal protective equipment
11.2.1 General
11.2.2 Laboratory coats, gowns, coveralls and aprons
11.2.3 Footwear
11.2.4 Eye and face protection
11.2.5 Respiratory protection
11.2.6 Gloves
11.3 Centrifuges
11.3.1 General
11.3.2 Centrifuge use and maintenance
11.3.3 Centrifuges lacking aerosol containment
11.3.4 Centrifuge rooms
11.4 Freeze-drying and reconstitution of cultures
11.5 Liquid nitrogen
11.6 Pressure steam sterilizers
11.6.1 General
11.6.2 Air removal methods for steam sterilizers
11.6.3 Downward-displacement steam sterilizers
11.6.4 Pre-vacuum (porous load) steam sterilizers
11.6.5 Times for sterilization
11.6.6 Monitoring of sterilization cycles
11.6.7 Chamber pressure relief valves
11.6.8 Barrier wall steam sterilizers
11.7 Biological safety cabinets
11.7.1 Classes I and II biological safety cabinets
11.7.2 Class III biological safety cabinets
11.8 Laminar flow cytotoxic drug safety cabinets
11.9 Vacuum systems
11.10 HEPA filters
11.10.1 Specification
11.10.2 Installation and maintenance
11.11 Liquid effluent decontamination systems
11.11.1 General
11.11.2 Safety considerations
11.11.3 Methods of liquid effluent decontamination
11.11.4 Requirements for liquid effluent decontamination systems
11.11.5 Storage and handling of chemicals
11.11.6 Pressure relief valves
11.11.7 Biological indicators for heat-based liquid effluent decontamination systems
Section 12 Cleaning
12.1 General
12.2 Cleaning personnel handling infectious material
12.3 Cleaning of equipment
12.4 Walls and shelves
12.5 Floor cleaning
Section 13 Contaminated materials and waste
13.1 Collection
13.2 Decontamination and disposal of wastes
13.2.1 General
13.2.2 Validation of waste decontamination processes
13.2.3 Decontamination methods
13.2.4 Prions
13.2.5 Secondary contamination considerations
13.2.6 Uncontaminated waste
13.3 Decontamination of liquid wastes
Section 14 Transport of infectious and other biological materials
14.1 General
14.2 Transport regulations
14.3 Transport definitions of biological materials
14.4 Classification and packaging
14.4.1 General
14.4.2 Infectious substances
14.4.3 Biological products
14.4.4 Genetically modified microorganisms and organisms
14.4.5 Medical or clinical wastes
14.5 Transport of infected animals
14.6 Documentation
Appendix A (normative) Additional containment requirements for poliovirus
Appendix B (normative) Biological hazard signs
Appendix C (normative) Water and gas supplies to containment facilities
Appendix D (informative) Chemical disinfectants
Appendix E (informative) Examples of recommended layouts for PC3 and PC4 facilities
Appendix F (informative) Recommendations for achieving acceptable room airtightness
Appendix G (normative) Safe use of Class I and Class II biological safety cabinets
Bibliography
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References
Pressure equipment
Safety, protective and occupational footwear - Guide to selection, care and use
Occupational protective footwear - Test methods
Occupational protective footwear - Specification for safety footwear
Occupational protective footwear - Specification for protective footwear
Occupational protective footwear - Specification for occupational footwear
Occupational protective footwear - Additional requirements and test methods
Occupational protective footwear - Additional specifications for safety footwear
Occupational protective footwear - Additional specifications for protective footwear
Occupational protective footwear - Additional specifications for occupational footwear
Related Information
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AS/NZS 2243.1:2005
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AS/NZS 2243.10:2004
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AS/NZS 2243.2:2006
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AS/NZS 2243.3:2022 Safety in laboratories Microbiological safety and containment
Preface
Introduction
Section 1 Scope and general
1.1 Scope
1.2 Application
1.3 Normative references
1.4 Terms and definitions
1.5 Abbreviations
Section 2 Organizational responsibility
2.1 Responsibility
2.1.1 Risk assessment
2.1.2 Establishment and management of a biosafety committee
2.1.3 Biological safety officer
2.1.4 Person with responsibility for the operation of the laboratory or facility
2.1.5 Responsibility of laboratory personnel
2.2 Biosecurity material
2.2.1 Australia
2.2.2 New Zealand
2.3 Laboratories using genetically modified organisms
2.3.1 Australia
2.3.2 New Zealand
2.4 Laboratory and facility biosecurity
2.5 Commissioning
2.6 Health management
2.6.1 General
2.6.2 Injuries and infections
2.6.3 Blood samples
2.6.4 Vaccination of workers
2.6.5 At-risk persons
2.6.6 Risks to pregnant women and the unborn child
2.7 Incident management and reporting
2.8 Emergency response plans
2.8.1 Emergency plan
2.8.2 First aid kit
Section 3 Degree of hazard from microorganisms
3.1 General
3.2 Classification of microorganisms by risk group
3.2.1 General
3.2.2 Human and terrestrial animal infectious microorganisms
3.2.3 Plant infectious microorganisms
3.2.4 Invertebrates carrying microorganisms
3.2.5 Aquatic infectious microorganisms
3.3 Risk-grouping of microorganisms by type
3.3.1 General
3.3.2 Human and animal infectious microorganism risk group examples
3.3.3 Plant risk group examples
3.3.4 Invertebrate risk group examples
3.3.5 Aquatic risk group examples
3.4 Human and animal clinical and diagnostic specimens
3.5 Quality assurance of cultures and materials
3.6 Work with human, animal or plant cells
3.7 Prions
3.8 Scale of cultures
Section 4 Principles of containment
4.1 General
4.2 Containment measures
4.2.1 General
4.2.2 Primary containment measures
4.2.3 Secondary containment measures
4.2.4 Tertiary containment measures
4.3 Physical containment classifications
4.3.1 General
4.3.2 Physical containment level 1 (PC1)
4.3.3 Physical containment level 2 (PC2)
4.3.4 Physical containment level 3 (PC3)
4.3.5 Physical containment level 4 (PC4)
4.4 Design
Section 5 Laboratory containment facilities
5.1 Laboratory physical containment
5.2 Requirements for Laboratory PC1 facilities
5.2.1 General
5.2.2 Construction
5.2.3 Work practices
5.3 Requirements for Laboratory PC2 facilities
5.3.1 General
5.3.2 Multiple room PC2 facilities
5.3.3 Construction
5.3.4 Ventilation
5.3.5 Containment equipment
5.3.6 Work practices
5.4 Requirements for Laboratory PC3 facilities
5.4.1 General
5.4.2 Construction
5.4.3 Ventilation
5.4.4 Access to services
5.4.5 Containment equipment
5.4.6 Work practices
5.4.7 Health monitoring
5.5 Requirements for Laboratory PC4 facilities
5.5.1 General
5.5.2 Construction
5.5.3 Ventilation
5.5.4 Containment equipment
5.5.5 Work practices
5.5.6 Health monitoring
Section 6 Terrestrial animal containment facilities
6.1 Requirements for terrestrial animal containment facilities
6.2 Principles of terrestrial animal containment
6.3 Other considerations associated with terrestrial animal containment
6.3.1 Designing facilities for different aspects of terrestrial animal handling
6.3.2 The occurrence of allergic reactions in personnel handling terrestrial animals
6.3.3 Air change rates for terrestrial animal containment facilities
6.3.4 Decontamination and disposal of terrestrial animal waste
6.3.5 Transport of terrestrial animals and animal tissues between facilities
6.3.6 Dissection and post-mortem examinations
6.4 Requirements for Terrestrial Animal PC1 facilities
6.4.1 General
6.4.2 Construction
6.4.3 Work practices
6.5 Requirements for Terrestrial Animal PC2 facilities
6.5.1 General
6.5.2 Construction
6.5.3 Ventilation
6.5.4 Containment equipment
6.5.5 Work practices
6.6 Requirements for Terrestrial Animal PC3 facilities
6.6.1 General
6.6.2 Construction
6.6.3 Ventilation
6.6.4 Access to services
6.6.5 Containment equipment
6.6.6 Work practices
6.6.7 Health monitoring
6.7 Requirements for Terrestrial Animal PC4 facilities
6.7.1 General
6.7.2 Alternative locations for animal work
6.7.3 Construction
6.7.4 Ventilation
6.7.5 Containment equipment
6.7.6 Work practices
6.7.7 Health monitoring
Section 7 Plant containment facilities
7.1 General
7.2 Requirements for Plant PC1 facilities
7.2.1 General
7.2.2 Location
7.2.3 Construction
7.2.4 Work practices
7.3 Requirements for Plant PC2 facilities
7.3.1 General
7.3.2 Location
7.3.3 Construction
7.3.4 Containment equipment
7.3.5 Work practices
7.4 Requirements for Plant PC3 facilities
7.4.1 General
7.4.2 Location
7.4.3 Construction
7.4.4 Ventilation
7.4.5 Access to services
7.4.6 Work practices
Section 8 Invertebrate containment facilities
8.1 General
8.2 Requirements for Invertebrate PC1 facilities
8.2.1 General
8.2.2 Location
8.2.3 Construction
8.2.4 Work practices
8.3 Requirements for Invertebrate PC2 facilities
8.3.1 General
8.3.2 Location
8.3.3 Construction
8.3.4 Containment equipment
8.3.5 Work practices
8.4 Requirements for Invertebrate PC3 facilities
8.4.1 General
8.4.2 Location
8.4.3 Construction
8.4.4 Ventilation
8.4.5 Access to services
8.4.6 Containment equipment
8.4.7 Work practices
8.5 Requirements for Invertebrate PC4 facilities
8.5.1 General
8.5.2 Construction
8.5.3 Ventilation
8.5.4 Work practices
8.5.5 Health monitoring
Section 9 Aquatic organism containment facilities
9.1 General
9.2 Principles of aquatic organism containment
9.3 Other considerations associated with aquatic organism containment
9.3.1 Designing facilities for different aspects of aquatic organism handling
9.3.2 The occurrence of allergic reactions in personnel handling aquatic organisms
9.3.3 Air change rates for aquatic organism containment facilities
9.3.4 Decontamination and disposal of aquatic organism waste
9.3.5 Transport of aquatic organisms and organism tissues between facilities
9.3.6 Dissection and post-mortem examinations
9.4 Requirements for Aquatic Organism PC1 facilities
9.4.1 General
9.4.2 Construction
9.4.3 Work practices
9.5 Requirements for Aquatic Organism PC2 facilities
9.5.1 General
9.5.2 Construction
9.5.3 Ventilation
9.5.4 Containment equipment
9.5.5 Work practices
9.6 Requirements for Aquatic Organism PC3 facilities
9.6.1 General
9.6.2 Construction
9.6.3 Ventilation
9.6.4 Access to services
9.6.5 Containment equipment
9.6.6 Work practices
9.6.7 Health monitoring
Section 10 Microbiological spills
10.1 General
10.2 Planning
10.2.1 General
10.2.2 Emergency provisions for personnel
10.2.3 Clean-up materials and equipment
10.3 Spills inside biological safety cabinets
10.3.1 General
10.3.2 Small spills
10.3.3 Larger spills
10.4 Spills outside biological safety cabinets
10.4.1 General
10.4.2 Spills in PC1 and PC2 facilities that can be cleaned up by the worker
10.4.3 Spills in PC2 facilities that should be cleaned up by a dedicated spills clean-up team
10.4.4 Spills in PC3 facilities
10.4.5 Spills in PC4 facilities where positive pressure suits are not worn
10.4.6 Spills in PC4 facilities where positive pressure suits are worn
10.5 Centrifuge spills
Section 11 Chemicals, personal protective equipment and special equipment
11.1 Chemicals
11.1.1 General
11.1.2 Dunk tanks, footbaths and disinfectant dispensers
11.2 Personal protective equipment
11.2.1 General
11.2.2 Laboratory coats, gowns, coveralls and aprons
11.2.3 Footwear
11.2.4 Eye and face protection
11.2.5 Respiratory protection
11.2.6 Gloves
11.3 Centrifuges
11.3.1 General
11.3.2 Centrifuge use and maintenance
11.3.3 Centrifuges lacking aerosol containment
11.3.4 Centrifuge rooms
11.4 Freeze-drying and reconstitution of cultures
11.5 Liquid nitrogen
11.6 Pressure steam sterilizers
11.6.1 General
11.6.2 Air removal methods for steam sterilizers
11.6.3 Downward-displacement steam sterilizers
11.6.4 Pre-vacuum (porous load) steam sterilizers
11.6.5 Times for sterilization
11.6.6 Monitoring of sterilization cycles
11.6.7 Chamber pressure relief valves
11.6.8 Barrier wall steam sterilizers
11.7 Biological safety cabinets
11.7.1 Classes I and II biological safety cabinets
11.7.2 Class III biological safety cabinets
11.8 Laminar flow cytotoxic drug safety cabinets
11.9 Vacuum systems
11.10 HEPA filters
11.10.1 Specification
11.10.2 Installation and maintenance
11.11 Liquid effluent decontamination systems
11.11.1 General
11.11.2 Safety considerations
11.11.3 Methods of liquid effluent decontamination
11.11.4 Requirements for liquid effluent decontamination systems
11.11.5 Storage and handling of chemicals
11.11.6 Pressure relief valves
11.11.7 Biological indicators for heat-based liquid effluent decontamination systems
Section 12 Cleaning
12.1 General
12.2 Cleaning personnel handling infectious material
12.3 Cleaning of equipment
12.4 Walls and shelves
12.5 Floor cleaning
Section 13 Contaminated materials and waste
13.1 Collection
13.2 Decontamination and disposal of wastes
13.2.1 General
13.2.2 Validation of waste decontamination processes
13.2.3 Decontamination methods
13.2.4 Prions
13.2.5 Secondary contamination considerations
13.2.6 Uncontaminated waste
13.3 Decontamination of liquid wastes
Section 14 Transport of infectious and other biological materials
14.1 General
14.2 Transport regulations
14.3 Transport definitions of biological materials
14.4 Classification and packaging
14.4.1 General
14.4.2 Infectious substances
14.4.3 Biological products
14.4.4 Genetically modified microorganisms and organisms
14.4.5 Medical or clinical wastes
14.5 Transport of infected animals
14.6 Documentation
Appendix A (normative) Additional containment requirements for poliovirus
Appendix B (normative) Biological hazard signs
Appendix C (normative) Water and gas supplies to containment facilities
Appendix D (informative) Chemical disinfectants
Appendix E (informative) Examples of recommended layouts for PC3 and PC4 facilities
Appendix F (informative) Recommendations for achieving acceptable room airtightness
Appendix G (normative) Safe use of Class I and Class II biological safety cabinets
Bibliography
Previous versions
AS/NZS 2243.3:2022
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