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GB 27421-2015: Mobile laboratories - General requirements for biosafety
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GB 27421-2015
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 13.100
C 52
Mobile laboratories - General requirements for biosafety
ISSUED ON: SEPTEMBER 11, 2015
IMPLEMENTED ON: DECEMBER 15, 2015
Issued by: General Administration of Quality Supervision, Inspection and
Quarantine;
Standardization Administration of the People’s Republic of China.
Table of Contents
FOREWORD ... 3 
INTRODUCTION ... 4 
1 Scope ... 5 
2 Normative references ... 5 
3 Terms and definitions... 5 
4 Risk assessment and risk control of mobile laboratories ... 6 
5 Basic technical form and safety protection level classification of mobile laboratories
... 7 
6 Design principles and basic requirements of mobile laboratories ... 7 
6.1 Design principles ... 7 
6.2 Basic requirements ... 8 
7 Requirements for mobile laboratory facilities and equipment ... 10 
7.1 BSL-1 laboratory ... 10 
7.2 BSL-2 laboratory ... 11 
7.3 BSL-3 laboratory ... 12 
7.4 ABSL-1 laboratory ... 14 
7.5 ABSL-2 laboratory ... 14 
7.6 ABSL-3 laboratory ... 15 
7.7 Requirements for laboratory facilities engaged in invertebrate manipulation ... 15 
8 Management requirements ... 15 
Appendix A (Informative) Comparison of terms between this Standard and GB 19489-
2008 ... 18 
Appendix B (Informative) Mobile biosafety level 3 laboratory action plan and on-site
work plan ... 20 
Appendix C (Informative) Guidelines for on-site testing of safety performance of
mobile biosafety level 3 laboratories ... 25 
Appendix D (Informative) Guidelines for mobile biosafety level 3 laboratory spare
parts ... 29 
Appendix E (Informative) Outline of on-site emergency response plan for mobile
biosafety level 3 laboratories ... 34 
References ... 39 
Mobile laboratories - General requirements for biosafety
1 Scope
This Standard specifies the basic requirements for the facilities, equipment and safety
management of the level 1, level 2 and level 3 biosafety protection level mobile
laboratories, excluding the requirements for mobile biosafety level 4 laboratories and
biosafety level 3 laboratories with open or semi-open animal rearing.
Chapter 6, 7.1 and 7.2 are the basic requirements for mobile laboratory biosafety
protection facilities and equipment. When necessary, they are applicable to mobile
laboratories with higher protection levels.
For laboratory activities related to the breeding of infected animals, this Standard
specifies the basic requirements for animal breeding facilities and environments in
mobile laboratories. When necessary, 7.3 is applicable to the animal biosafety mobile
laboratory of the corresponding protection level.
This Standard applies to mobile laboratories involved in the operation of biological
factors.
2 Normative references
The following referenced documents are indispensable for the application of this
document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
GB 14925-2010, Laboratory animal - Requirements of environment and housing
facilities
GB 19489-2008, Laboratories - General Requirements for Biosafety
3 Terms and definitions
The following terms and definitions are applicable to this document.
3.1
mobile laboratory
Laboratory that can be used in different locations.
3.2
directional airflow
Airflow that is directionally controlled.
3.3
primary barrier
A physical barrier or isolation between the operator and the action object.
Note: Personal protective equipment is also considered a primary barrier. When it is not
specified in this Standard, the primary barrier refers to protective equipment
such as biological safety cabinet or isolator.
3.4
secondary barrier
A physical barrier or isolation between the public environment and the action object.
Note: The enclosure structure of the laboratory is a secondary barrier.
4 Risk assessment and risk control of mobile laboratories
4.1 It shall meet the applicable requirements in Chapter 3 of GB 19489-2008.
4.2 The method of laboratory movement and the risks during the movement shall be
assessed, and appropriate control measures shall be taken.
4.3 The risks of the environment to the mobile laboratory (not limited to biological risks)
shall be assessed, and appropriate control measures shall be taken.
4.4 The environmental risks of mobile laboratories and experimental activities (not
limited to biological risks) shall be assessed, and appropriate control measures shall be
taken.
4.5 Before and after the maintenance, repair, modification or decommissioning of the
laboratory, a risk assessment shall be carried out and appropriate control measures shall
be taken.
4.6 The activities undertaken by the laboratory shall be determined, on the basis of risk
assessment, in accordance with the classification list of pathogenic microorganisms
issued by the relevant national competent authorities.
6.1.3 It shall be safe, reliable, durable, easy to use, meet the requirements of biosafety
protection, and meet the requirements of occupational hygiene, environmental
protection and energy saving.
6.1.4 If applicable, it shall meet the corresponding requirements of GB 19489-2008.
6.1.5 When test animals are involved, if applicable, the corresponding requirements of
GB 14925-2010 shall be met.
6.1.6 If there are no special requirements, it shall meet the design requirements and
manufacturing requirements for motorized running devices or transported devices in
relevant national regulations or standards.
6.1.7 For a mobile laboratory that is designed and manufactured according to the
specific requirements of the customer, if the technical indicators conflict with the
requirements of the relevant national regulations or standards, the relevant competent
authorities shall be consulted for advice in advance.
6.1.8 Driving positioning system and driving recording system shall be installed.
6.2 Basic requirements
6.2.1 It shall be easy to reach or to be transported to the designated place.
6.2.2 The parts to be transported shall have suitable loading and unloading, handling
and fixing devices to meet the requirements of handling and transportation tools. Lifting
devices and supporting wheels should be provided to achieve short-distance movement.
6.2.3 The maximum overall dimensions of the laboratory and removable parts should
be designed and manufactured with reference to the relevant national standards for
removable facilities.
6.2.4 Design and model selection shall be carried out according to the principles and
requirements of modularization, integration and standardization, so as to ensure
universality and ease of maintenance.
6.2.5 If applicable, maintenance-free equipment shall be selected.
6.2.6 The layout of facilities and equipment, the working space, and the equipment
operating mode shall be reasonable, so as to ensure smooth work flow and comply with
the principles and requirements of ergonomics.
6.2.7 The implementability of all maintenance works shall be ensured, and the work
station space shall be suitable for the needs of human body measurement, posture and
use of tools. Mechanical and electrical equipment, if installed, shall not affect the
maintenance work.
j) sand and dust;
k) smog (including salt fog);
l) pests (such as fungi, arthropods, rodents).
6.2.16 Documents such as schematic diagrams, operation instructions, maintenance
manuals and safety manuals that meet the needs of on-site use, maintenance and repair
shall be provided.
6.2.17 The self-propelled laboratory shall be provided with relevant documents of the
motorized driving part, which shall meet the requirements of 6.2.16.
6.2.18 When applicable, documents such as good manufacturing practices for mobile
laboratories and on-site emergency response plans shall be provided.
7 Requirements for mobile laboratory facilities and
equipment
7.1 BSL-1 laboratory
7.1.1 The laboratory may consist of a single laboratory room. The primary barrier mode
can be open, but it shall be based on risk assessment, including the content of
experimental quality control requirements.
7.1.2 The fixed equipment, table cabinets and wall cabinets of the laboratory shall be
firm and connected with the cabin reliably, and the connection shall be smooth and easy
to clean.
7.1.3 When the laboratory is moved, there shall be reliable mechanisms and measures
to fix items such as instruments and equipment, experimental equipment and seats.
7.1.4 The height of the laboratory shall meet the requirements for equipment installation,
and there shall be space for maintenance and cleaning.
7.1.5 The laboratory shall be ventilated. If natural ventilation is used, openable windows
and/or ventilation fans may be provided, and the air inlets of openable windows and/or
ventilation fans shall be installed with screens that can prevent mosquitoes.
7.1.6 If mechanical ventilation is used, an air-conditioning system with circulating air
may be used. The laboratory air-conditioning system shall be reasonably designed
according to the area and climatic conditions where the laboratory is used.
7.1.7 A municipal water supply interface should be reserved for the laboratory, and a
sewer collection device can be set up. The effluent discharge, if any, shall be based on
risk assessment.
7.1.8 In the case of handling irritating or corrosive substances, an eyewash device or an
eyewash bottle shall be provided in the laboratory. If a large amount of irritating or
corrosive substances are used, an emergency spraying device shall be set up.
7.1.9 UV disinfection lamps and portable disinfection and sterilization devices (such as
disinfection sprayers) shall be installed in the laboratory.
7.1.10 When necessary, it shall be equipped with high pressure steam sterilizer or other
appropriate disinfection and sterilization equipment.
7.1.11 The average illuminance of the laboratory working area shall not be less than
300 lx.
7.1.12 There shall be a mechanism to maintain smooth communication.
7.2 BSL-2 laboratory
7.2.1 Where applicable, the requirements of 7.1 shall be met.
7.2.2 A buffer room shall be set up at the entrance of the core laboratory room, and the
buffer room can also be used as a dressing room for protective clothing.
7.2.3 The doors of the buffer room should be interlocked. If an interlocking door is used,
an emergency manual release interlocking switch shall be set near the interlocking door,
and, when necessary, the interlocking of the laboratory door shall be released
immediately.
7.2.4 During the experiment, the conspicuous position at the entrance of the core
laboratory room shall have internationally accepted biohazard warning signs and
related information.
7.2.5 The laboratory can adopt natural ventilation or negative pressure ventilation. If a
negative pressure ventilation air conditioning system is used, it shall comply with the
principle of directional airflow.
7.2.6 The fresh air vents and exhaust vents of the negative pressure ventilation air
conditioning system shall be designed to prevent wind, rain, rodents and insects, and
the specifications of the air filters shall be determined according to the results of the
risk assessment. The fresh air vent shall be 2.5 m higher than the outdoor ground
(removable structure can be used); the new air vent shall be set as far away as possible
from the exhaust vent.
7.2.7 The core laboratory room shall be equipped with biosafety cabinets or other
biosafety isolation devices.
7.2.8 If the exhaust air from biosafety cabinets or other biosafety isolation devices
circulates indoors, the laboratory shall be equipped with ventilation conditions.
7.3.8 A non-manual hand washing device or an automatic hand sanitizing device shall
be installed near the exit of the core working area of the laboratory.
7.3.9 The core working room of the laboratory should be equipped with a collection
and inactivation device for activated toxic wastewater.
7.3.10 The exhaust high-efficiency air filter (or HEPA filter) in the core working room
of the level 2 biosafety cabinet laboratory shall have the conditions for in-situ
disinfection and leak detection.
7.3.11 The design of the air-conditioning system shall consider the adaptability of the
natural environment conditions in the region of use and the heat and humidity load of
various equipment; the design of the air supply and exhaust system shall consider the
air supply and exhaust of ventilation equipment such as biosafety cabinets and
biological isolators.
7.3.12 The air vents, doors, and equipment shall be reasonably arranged to avoid
interference and reduce eddy currents and dead ends of airflow in the room.
7.3.13 The supply air of the laboratory shall be filtered through a HEPA filter, and
primary- and medium-efficiency filters shall be installed at the same time.
7.3.14 The laboratory shall be provided with a municipal water supply interface and a
water storage tank; a backflow prevention device shall be set up between the laboratory
water supply and the water storage tank.
7.3.15 The gas supply cylinders or water storage tanks, if any, shall be placed outside
the laboratory protection area where they are easy to be replaced and maintained, and
installed firmly.
7.3.16 If the experimental operation requires a vacuum device, the vacuum device shall
be installed in the core working room, and a high-efficiency filter device shall be
installed for the exhaust of the vacuum device.
7.3.17 The conditions for disinfection and sterilization of the laboratory protection area
and the ventilation pipes directly connected with it, laboratory equipment and safety
isolation devices (including the pipes directly connected with them) shall be provided.
7.3.18 The laboratory shall be equipped with generators for independent power supply,
to ensure reliable and sufficient power supply. The power and fuel capacity shall be
designed with r...