1.0.1 This code is prepared with a view to making the biosafety laboratory meet the biosafety protection requirements for laboratories in aspects of design, construction and acceptance.
1.0.2 This code is applicable to the design, construction and acceptance of newly-built, renovated and extended biosafety laboratories.
1.0.3 The construction of biosafety laboratory shall earnestly comply with the building technology principle of physical isolation, center on the biosafety, ensure the safety of the experiment personnel and the laboratory ambient environment, meet the environmental requirements of experimental subjects and achieve practicality and economy. Equipment and materials used for the biosafety laboratory shall be provided with valid quality certificate and inspection report. The newly-developed products and processes shall be provided with appraisal certificate or test certificate materials.
1.0.4 The design, construction and acceptance of biosafety laboratory shall not only comply with the requirements of this code, but also comply with those in the current relevant ones of the nation.
2 Terms
2.0.1 Primary barrier
The isolation between the operator and the operated object, also referred to as primary isolation.
2.0.2 Secondary barrier
The isolation between the biosafety laboratory and the external environment, also referred to as secondary isolation.
2.0.3 Biosafety laboratory
The microbiological laboratory and animal laboratory (including main room and its auxiliary room) that reach the requirements of biosafety through protective barrier and control measures.
2.0.4 Laboratory containment area
The area with relatively big biohazard and required tightness and air flow direction for building envelope.
2.0.5 Non-contamination zone
The area with relatively small biohazard, also refers to areas except the containment area in biosafety laboratory.
2.0.6 Main room
The room with the highest contamination risk in the biosafety laboratory, including experiment operation room, animal feed room, zootomy room, etc. Main room is also referred to as core workshop.
2.0.7 Buffer room
The closed room arranged between different laboratory areas with different contamination probability. Mechanical ventilation system may be arranged if required; thereof, the doors shall be equipped with interlock function, and cannot be open simultaneously.
2.0.8 Individually ventilated cage (IVC)
A kind of individually ventilated barrier equipment with feeding box as unit. Clean air is respectively supplied to each individual cage to maintain certain pressure and cleanliness of the feeding environment so as to avoid environmental contamination for the animal (positive pressure) or the animal contamination for the environment (negative pressure); all experiment operations shall be conducted in equipment such as biosafety cabinet. This equipment is used to feed clean animals without SPF or infection (negative pressure).
2.0.9 Animal isolated equipment
A general term for the isolation devices adopted for animal rearing in biosafety laboratory. The internal environment of this equipment for animal rearing is negative pressure and single-direction air flow so as to avoid pathogen leakage to the environment and animal escape. Common animal isolated equipment are isolator, laminar flow cabinet, etc.
2.0.10 Airtight door
A kind of airtight door generally possessed of integrated door leaf and door frame; the gap is sealed with mechanical hold-down device or inflatable ring.
2.0.11 Waste water of biohazard
Hazardous waste water contaminated by injurious organisms.
2.0.12 Cleanliness class 7
In the air, the density of dust particles ≥0.5μm is greater than 35200pcs/m3 and less than or equal to 352000pcs/m3; the density of dust particles≥1μm is greater than 8320pcs/m3 and less than or equal to 83200pcs/m3; the density of dust particles ≥5μm is greater than 293pcs/m3 and less than or equal to 2930pcs/m3.
2.0.13 Cleanliness class 8
In the air, the density of dust particles ≥0.5μm is greater than 352000pcs/m3 and less than or equal to 3520000pcs/m3; the density of dust particles ≥1μm is greater than 83200pcs/m3 and less than or equal to 832000pcs/m3; the density of dust particles ≥5μm is greater than 2930pcs/m3 and less than or equal to 29300pcs/m3.
2.0.14 At-rest
The state of laboratory where facilities have been built up, process equipment has been installed, and the ventilation and air conditioning system and equipment are in normal operation; but there is no operator and experimental subject.
2.0.15 Comprehensive performance judgment
Comprehensive inspection and judgment for engineering indexes of the completed and accepted biosafety laboratory.
Foreword I 1 General Provisions 2 Terms 3 Classification, Type and Technical Index of Biosafety Laboratories 3.1 Classification of Biosafety Laboratories 3.2 Type of Biosafety Laboratories 3.3 Technical Indexes for Biosafety Laboratories 4 Architecture, Decoration and Structure 4.1 Architecture Requirements 4.2 Decoration Requirements 4.3 Structural Requirements 5 Air Conditioning, Ventilating and Air Cleaning 5.1 General Requirements 5.2 Air Supply System 5.3 Air Exhaust System 5.4 Air-flow Distribution 5.5 Components and Materials of Air Cleaning System 6 Water Supply, Drainage and Gas Supply 6.1 General Requirements 6.2 Water Supply 6.3 Drainage 6.4 Gas Supply 7 Electrical System 7.1 Power Distribution 7.2 Lighting 7.3 Automatic Control 7.4 Security System 7.5 Communication 8 Fire Prevention 9 Construction Requirements 9.1 General Requirements 9.2 Building Decoration 9.3 Air Conditioning and Cleaning 9.4 Laboratory Equipment 10 Testing and Acceptance 10.1 Testing of Project 10.2 Site Testing of Biosafety Equipment 10.3 Acceptance of Project Appendix A Record Chart for Biosafety Laboratory Test Appendix B Record Chart for Biosafety Equipment On-Site Testing Appendix C Evaluation Items for Acceptance of Biosafety Laboratory Project Appendix D Leakage Detection of High Efficiency Filter by In-situ Efficiency Method Explanation of Wording in This Code List of Quoted Standards
1 General Provisions
1.0.1 This code is prepared with a view to making the biosafety laboratory meet the biosafety protection requirements for laboratories in aspects of design, construction and acceptance.
1.0.2 This code is applicable to the design, construction and acceptance of newly-built, renovated and extended biosafety laboratories.
1.0.3 The construction of biosafety laboratory shall earnestly comply with the building technology principle of physical isolation, center on the biosafety, ensure the safety of the experiment personnel and the laboratory ambient environment, meet the environmental requirements of experimental subjects and achieve practicality and economy. Equipment and materials used for the biosafety laboratory shall be provided with valid quality certificate and inspection report. The newly-developed products and processes shall be provided with appraisal certificate or test certificate materials.
1.0.4 The design, construction and acceptance of biosafety laboratory shall not only comply with the requirements of this code, but also comply with those in the current relevant ones of the nation.
2 Terms
2.0.1 Primary barrier
The isolation between the operator and the operated object, also referred to as primary isolation.
2.0.2 Secondary barrier
The isolation between the biosafety laboratory and the external environment, also referred to as secondary isolation.
2.0.3 Biosafety laboratory
The microbiological laboratory and animal laboratory (including main room and its auxiliary room) that reach the requirements of biosafety through protective barrier and control measures.
2.0.4 Laboratory containment area
The area with relatively big biohazard and required tightness and air flow direction for building envelope.
2.0.5 Non-contamination zone
The area with relatively small biohazard, also refers to areas except the containment area in biosafety laboratory.
2.0.6 Main room
The room with the highest contamination risk in the biosafety laboratory, including experiment operation room, animal feed room, zootomy room, etc. Main room is also referred to as core workshop.
2.0.7 Buffer room
The closed room arranged between different laboratory areas with different contamination probability. Mechanical ventilation system may be arranged if required; thereof, the doors shall be equipped with interlock function, and cannot be open simultaneously.
2.0.8 Individually ventilated cage (IVC)
A kind of individually ventilated barrier equipment with feeding box as unit. Clean air is respectively supplied to each individual cage to maintain certain pressure and cleanliness of the feeding environment so as to avoid environmental contamination for the animal (positive pressure) or the animal contamination for the environment (negative pressure); all experiment operations shall be conducted in equipment such as biosafety cabinet. This equipment is used to feed clean animals without SPF or infection (negative pressure).
2.0.9 Animal isolated equipment
A general term for the isolation devices adopted for animal rearing in biosafety laboratory. The internal environment of this equipment for animal rearing is negative pressure and single-direction air flow so as to avoid pathogen leakage to the environment and animal escape. Common animal isolated equipment are isolator, laminar flow cabinet, etc.
2.0.10 Airtight door
A kind of airtight door generally possessed of integrated door leaf and door frame; the gap is sealed with mechanical hold-down device or inflatable ring.
2.0.11 Waste water of biohazard
Hazardous waste water contaminated by injurious organisms.
2.0.12 Cleanliness class 7
In the air, the density of dust particles ≥0.5μm is greater than 35200pcs/m3 and less than or equal to 352000pcs/m3; the density of dust particles≥1μm is greater than 8320pcs/m3 and less than or equal to 83200pcs/m3; the density of dust particles ≥5μm is greater than 293pcs/m3 and less than or equal to 2930pcs/m3.
2.0.13 Cleanliness class 8
In the air, the density of dust particles ≥0.5μm is greater than 352000pcs/m3 and less than or equal to 3520000pcs/m3; the density of dust particles ≥1μm is greater than 83200pcs/m3 and less than or equal to 832000pcs/m3; the density of dust particles ≥5μm is greater than 2930pcs/m3 and less than or equal to 29300pcs/m3.
2.0.14 At-rest
The state of laboratory where facilities have been built up, process equipment has been installed, and the ventilation and air conditioning system and equipment are in normal operation; but there is no operator and experimental subject.
2.0.15 Comprehensive performance judgment
Comprehensive inspection and judgment for engineering indexes of the completed and accepted biosafety laboratory.
Contents of GB 50346-2011
Foreword I
1 General Provisions
2 Terms
3 Classification, Type and Technical Index of Biosafety Laboratories
3.1 Classification of Biosafety Laboratories
3.2 Type of Biosafety Laboratories
3.3 Technical Indexes for Biosafety Laboratories
4 Architecture, Decoration and Structure
4.1 Architecture Requirements
4.2 Decoration Requirements
4.3 Structural Requirements
5 Air Conditioning, Ventilating and Air Cleaning
5.1 General Requirements
5.2 Air Supply System
5.3 Air Exhaust System
5.4 Air-flow Distribution
5.5 Components and Materials of Air Cleaning System
6 Water Supply, Drainage and Gas Supply
6.1 General Requirements
6.2 Water Supply
6.3 Drainage
6.4 Gas Supply
7 Electrical System
7.1 Power Distribution
7.2 Lighting
7.3 Automatic Control
7.4 Security System
7.5 Communication
8 Fire Prevention
9 Construction Requirements
9.1 General Requirements
9.2 Building Decoration
9.3 Air Conditioning and Cleaning
9.4 Laboratory Equipment
10 Testing and Acceptance
10.1 Testing of Project
10.2 Site Testing of Biosafety Equipment
10.3 Acceptance of Project
Appendix A Record Chart for Biosafety Laboratory Test
Appendix B Record Chart for Biosafety Equipment On-Site Testing
Appendix C Evaluation Items for Acceptance of Biosafety Laboratory Project
Appendix D Leakage Detection of High Efficiency Filter by In-situ Efficiency Method
Explanation of Wording in This Code
List of Quoted Standards
