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GB 27421-2015: Mobile laboratories -- General requirements for biosafety
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, ope...