1 Scope
This standard specifies basic biosafety principles for microbiological and biomedical laboratories, laboratory classification and basic requirements for laboratories. The requirements in this standard shall be followed at least.
This standard is applicable to disease control and medical care bodies and scientific institutions.
2 Normative References
The following standards contain provisions which, through reference in this standard, constitute provisions of this standard. For dated reference, subsequent amendments to (excluding corrigendum), or revisions of, any of these publications do not apply. However, all parties coming to agreements based on this standard are encouraged to investigate the possibility of applying the most recent editions of the standards. For undated references, the latest edition of the normative document referred to applies.
GB 14925-2001 Laboratory Animal - Requirements of Environment and Housing Facilities
GB/T 16803-1997 Equipment of Heating, Ventilating, Air Conditioning and Air Cleaning - Terminology
GB 50073-2001 Code for Design of Clean Room
JGJ 71-1990 Code for Construction and Acceptance of Cleanroom
3 Terms and Definitions
For the purpose of this standard, the following definitions apply.
3.1
Biosafety protection for laboratories
In case of the experimental subject to handle by laboratory workers in which pathogenic microbe and toxin are contained, comprehensive measures shall be taken by means of design and construction of personnel protection facilities to use in the laboratories and strict adhesion to standard operating program and specification, to ensure that the laboratory workers and ambient environment are not exposed to the contamination of experimental subject.
3.2
Hazard assessment for microbes
The assessment for the hazards which the microbe and toxin potentially bring to the human or environment.
3.3
Aerosol
Colloid of fine solid particles or liquid droplets, in dispersed state, suspended in gas medium, with particle diameter generally between 0.001μm and 1000μm.
3.4
Biosafety cabinet
Safety cabinet for air purification when handling hazardous microbe.
3.5
Class I biosafety cabinet
With at least one HEPA filter to purify the exhaust, during the operating, pull the front glass sliding window half, the upper window is used for observing and the lower part is for operating. The outside air is sucked by and will not escape from the operating window. During the operating, the workers shall not be prejudiced but the experimental subject may be contaminated.
3.6
Class II biosafety cabinet
With at least one HEPA filter to purify the exhaust and the workspace is high efficient filter-purified nonvortex uniflow air. During the operating, pull the front glass sliding window half, the upper window is used for observing and the lower part is for operating. The outside air is sucked by and will not escape from the operating window. The workers and experimental subject shall not be contaminated when the operation specifications are followed during the operating.
3.7
Class III biosafety cabinet
With at least one HEPA filter to purify the exhaust and the workspace is high efficient filter-purified nonvortex uniflow air. The upper front window is used for observing and the lower part is a glove box operation window. The box keeps negative pressure relative to outside. The human body shall be totally isolated from the articles in the cabinet.
3.8
Physical containment device
Equipment which prevents the pathogenic organism from being escaped by physical or mechanical method.
3.9
HEPA (high efficiency particulate air) filter
Air filter which is equipped with particle collection efficiency above 99.97% for particle diameter equal to or larger than 0.3μm at rated air flow and airflow resistance below 245Pa.
3.10
Relative pressure
The value calculated as absolute pressure minus atmospheric pressure.
4 Basic Principles of Biosafety Protection for Laboratories
4.1 General
4.1.1 Biosafety protection for laboratories consists of safety equipment, personnel protection facilities and measures (primary barrier), special requirements for design and construction of laboratories (secondary barrier), strict management system and standardized operating program and specification.
1 Scope
2 Normative References
3 Terms and Definitions
4 Basic Principles of Biosafety Protection for Laboratories
4.1 General
4.2 Safety equipment and personnel protection
4.3 Specific requirements for laboratory design and construction
4.4 Safety operation specification
4.5 Transfer of pathogenic organism and toxin among laboratories
4.6 Management system
4.7 Hazard assessment for microbes
5 Category, Classification and Application Scope of Laboratory
5.1 Category
5.2 Classification
5.3 Application Scope
6 Basic requirements for ordinary biosafety laboratory
6.1 Class I biosafety laboratory
6.2 Class II biosafety laboratory
6.3 Class III biosafety laboratory
6.4 Class IV biosafety laboratory
7 Biosafety Laboratory for Experimental Vertebrate
8 Biohazard Mark and Its Application
8.1 Biohazard Mark
8.2 Application of Biohazard Mark
9 Acceptance of Newly-built Class III and Class IV Biosafety Laboratories and Testing of Existing Biosafety Laboratory
10 Use and Maintenance of Existing Class III and Class IV Biosafety Laboratories
Appendix A (Normative) Safety Operation Specification
A.1 Class I Biosafety Laboratory
A.2 Class II Biosafety Laboratory
A.3 Class III Biosafety Laboratory
A.4 Class IV Biosafety Laboratory
Appendix B (Normative) Site Testing for Class II Biosafety Cabinet
Appendix C (Informative) Biosafety Protection Levels for Microbiological and Biological Laboratories in Various Countries
