GB 41918-2022 Biological safety cabinets
1 Scope
This document specifies the classification, requirements, test methods, labelling, marking, inspection rules, random documentation, packaging, transport and storage of biosafety cabinets.
This document applies to biosafety cabinets.
2 Normative references
The content of the following documents constitutes the essential provisions of this document through the normative references in the text. Among them, note the date of the reference document, only the date of the corresponding version applies to this document; not note the date of the reference document, its latest version (including all the revision of the list) applies to this document.
GB/T 191 Pictorial marking of packaging, storage and transport
GB 4793.1 Safety requirements for electrical equipment for measurement, control and laboratory use Part 1: General requirements
GB/T 14710 Environmental requirements and test methods for medical appliances
GB/T 16273.1 Graphical symbols for equipment Part 1: General symbols
GB/T 18268.1 Electrical equipment for measurement, control and laboratory use ﹑ Electromagnetic compatibility requirements Part 1: General requirements
3 Terminology and definitions
The following terms and definitions apply to this document.
3.1
Biological safety cabinet; BSC
A negative pressure filtered exhaust air cabinet to protect the operator and the environment from exposure to bioaerosols generated during the test.
3.2 Biological agents
Biological agents
Animals, plants, micro-organisms, biological toxins and other biologically active substances.
4 Classification
4.1 Overview
Biological safety cabinets are classified into three levels: Ⅰ, Ⅱ and Ⅲ according to the airflow and isolation barrier design structure.
4.2 Class I Biological Safety Cabinets
Class I biological safety cabinets are biological safety cabinets with a front window opening, through which the operator can operate in the biological safety cabinet operating area. It is used for the protection of personnel and the environment. The negative pressure airflow drawn inwards from the front window is used to protect personnel; the exhaust airflow is filtered through a high efficiency air filter to protect the environment from contamination.
4.3 Class II Biological Safety Cabinets
Class II Biological Safety Cabinets are biological safety cabinets with a front window opening, through which the operator can operate in the operating area of the biological safety cabinet to protect personnel, products and the environment during operation. The negative airflow drawn inwards through the front window is used to protect personnel; the vertical airflow filtered through the high efficiency air filter is used to protect the specimen; the airflow is filtered through the high efficiency air filter and discharged to protect the environment from contamination. Class II biological safety cabinets are divided into four types, A1, A2, B1 and B2, according to the proportion of the total flow of the system and the internal design structure of the discharge airflow.
4.4 Class III Biological Safety Cabinets
Biological safety cabinets with a fully enclosed, non-leaking structure. The personnel are operated in the operating area of the biological safety cabinet by means of gloves that are hermetically connected to the cabinet. The negative pressure inside the biological safety cabinet to the laboratory should be at least 120 Pa. The falling air flow is filtered through a high efficiency air filter and then enters the biological safety cabinet. The exhaust air flow is filtered through two high efficiency air filters and discharged to the outside.
5 Requirements
5.1 Appearance
5.1.1 The surface of the cabinet should be free from obvious scratches, rust spots and indentations, the surface should be smooth and the shape should be flat and regular. 5.1.2 The text and graphic symbols indicating the function should be correct, clear, correct and firm.
5.1.3 The welding shall be firm and the welded surface shall be smooth.
5.2 Materials
5.2.1 All cabinet and decorative materials shall be resistant to normal wear and tear and shall be able to withstand corrosion by gases, liquids, cleaning agents, disinfectants and decontamination operations. The materials shall be structurally stable and shall have strength and resistance to fire and moisture.
5.2.2 All work area surfaces and catch basins shall be made of materials with material properties not less than 300 series stainless steel.
5.2.3 The front window glass should be made of anti-burst toughened or reinforced glass with clear optical transmission and no negative impact on it during cleaning and disinfection, and its thickness should be not less than 5 mm.
5.2.4 The high-efficiency air filter and the outer frame shall meet the requirements of temperature, humidity, corrosion resistance and mechanical strength under normal conditions of use, and the filter material shall not be made of paper. Any substances that may be released from the filter media should not have an adverse effect on personnel, the environment or equipment. The outer frame shall be made of metal with a certain degree of rigidity and strength.
5.2.5 - The gloves of the Class III biological safety cabinet should be made of rubber materials that are resistant to acids and bases and meet the test requirements.
5.3 Structure
5.3.1 Cabinet body
5.3.1.1 Ⅱ level A1, A2, B1, B2 type biological safety cabinet work area should be used four sides (left and right two sides, rear, bottom) double structure. Level I biological safety cabinets, level II A1, A2, B1, B2 biological safety cabinets and level III biological safety cabinets should be in a negative pressure state or surrounded by negative pressure channels and negative pressure ventilation systems.
5.3.1.2 The three side wall panels in the exposed working area of Class II and Class III biological safety cabinets shall be of one-piece structure. The joints on the inner surface should be sealed.
5.3.1.3 The connection between the inner surface and the outer surface of the three wall panels in the exposed working area of the biological safety cabinet, and the connection between the outer wall panel of the negative pressure duct at the bottom and the outer wall panel of the working area shall be sealed. Class III biosafety cabinets should be continuously welded to the airtight part of the cabinet.
5.3.1.4 The fan/motor maintenance and high efficiency air filters should be easy to disassemble and replace. Replaceable circuit components other than fans, non-porous sealed or jacketed wiring and required air speed sensors should not be placed in air contaminated areas. All wiring through air contaminated areas should be sealed and all sockets should be provided with circuit overload protection. Sockets should be installed in the working area. A wiring diagram for all circuit components is to be permanently affixed to the outside area of the pressure ventilation system within a cover that can be opened with a simple tool. Installation instructions for starting current, operating power and circuit requirements are also to be provided.
5.3.1.5 The radius of internal curvature of all two planes in the working area of the biosafety cabinet shall be not less than 3 mm and the radius of internal curvature of the junction of the three planes shall be not less than 6 mm.
5.3.2 Class I and II biological safety cabinets front window opening
The nominal height of the front window opening should be within the range of 160 mm to 250 mm. The opening and closing of the front window should be light, no jamming in any position within the range of travel, no obvious shaking left, right or back and forth, and the sliding should be smooth. In the event of a suspension failure, the sliding front window structure should not fall off to ensure the safety of the operator. There should be an alarm system and interlocking system to ensure that work is only carried out within the specified height of the front window opening. The joints between the sliding front window and the panel to which it is attached, between the window glass and the frame and around the frame, the compression devices, etc., shall be leak-tight.
5.4 Performance
5.4.1 Leak-proof cabinet
Level II biological safety cabinet pressurized to 500 Pa, maintain 10 min after the air pressure should not be less than 450 Pa, or maintain the air pressure in the biological safety cabinet under the condition of 500 Pa to 50 Pa, pressure ventilation system of the external surface of all welds, gaskets, penetrations, sealant seal in this pressure conditions should be no soap bubble reaction.
5.4.2 High efficiency air filter integrity
5.4.2.1 Scannable filters shall have a leakage rate of not more than 0.01% at any point. 5.4.2.2 Non-scannable filters shall have a leakage rate of not more than 0.005% at the point of detection.
5.5 Electrical safety
The requirements of GB 4793.1 should be met.
5.6 Environmental test
Shall comply with the provisions of GB/T 14710 in the climatic environment group I and mechanical environment group I.
5.7 Electromagnetic compatibility
Shall comply with the requirements of GB/T 18268.1.
6 Test methods
6.1 Appearance and materials
Physical inspection to determine whether the results comply with 5.l.
The thickness of the glass shall be measured with a common gauge to determine whether the results comply with 5.2.3. 6.2 Structure
By physical inspection, determine whether the results comply with 5.3.1.1, 5.3.1.2, 5.3.1.3, 5,3.1.4, 5.3.5, 5.3.8, 5.3.9, 5.3.10. Use measuring instruments to determine whether the results comply with 5.3.1.5 and 5.3.2.
7 Labelling and marking
7.1 Labelling
8 Inspection rules
8.1 Inspection classification
The inspection of biosafety cabinets is divided into factory inspection, type inspection, installation inspection and routine maintenance inspection.
9 Random documents
10Packaging, transport and storage
10.1 Packaging markings
Appendix A (normative) Preparation of Bacillus subtilis bacteriophage suspensions
Appendix B (prescriptive) Selection and calibration of aerosol dispensers
Appendix C (prescriptive) Potassium iodide method
Appendix D (prescriptive) Measurement of air volume in circular and rectangular ducts
Bibliography
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Classification
5 Requirements
6 Test methods
7 Labelling and marking
8 Inspection rules
9 Accompanying documents
10 Packaging, transportation and storage
Annex A (Normative) Preparation of bacillus subtilis suspension
Annex B (Normative) Selection and calibration of sprayers
Annex C (Normative) Potassium iodide method
Annex D (Normative) Measurement of air volume in circular and rectangular ducts
Bibliography
