Journal of Biosafety and Biosecurity 1 (2019) 39–45

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Journal of Biosafety and Biosecurity

journal homepage: www.elsevier.com/locate/jobb

Research Article

Studies on developing a safe-management standard system for Chinese

biosafety laboratories
Feng W a,⇑, Haixia Ma b, Amei Deng a, ZongSheng C b, Zhiming Y b
a
Wuhan Library and Intelligence Center, CAS, WuHan 430071, China
b
Wuhan Institute of Virology, CAS, WuHan 430071, China

a r t i c l e i n f o a b s t r a c t

Article history: Standardization management is one of the key prerequisites to guarantee the effective and safe function-
Received 26 October 2018 ing of high-level biosafety laboratories. Since the outbreak of SARS, increasing numbers of biosafety lab-
Accepted 11 December 2018 oratory levels have been established in China. Therefore, creating a specialized and standardized
management system for biosafety laboratories has become necessary and is a core concern. This paper
describes the current status of Chinese standards for biosafety management and analyzes its relation
Keywords: to other laboratory biosafety standard systems in developed countries. Based on the analysis on develop-
Biosafety laboratories
ing a biosafety laboratory, a laboratory biosafety standard system framework was developed, and a policy
Standard system
Management frame
environment for building the system was suggested with the aim of promoting the promulgation of
Safety running specific biosafety standards and securing the effective functioning of high-level biosafety laboratories.
Ó 2018 Published by Elsevier B.V. on behalf of KeAi Communications Co., Ltd.
This is an open access article under CC BY-NC-ND license.
(http://creativecommons.org/licenses/by-nc-nd/4.0/)

1. Standardized management is the key to ensuring safe With the number of biological laboratories in China increasing, it
operation of biosafety laboratories has become urgent for China to ensure the safe operation of labo-
ratories by researching, developing, and implementing standard-
A biosafety laboratory is an experimental site for research on ized professional management of biological laboratories.
the prevention and control of infectious diseases and invasion of
biological viruses and on biosafety protection. It provides an
2. The status of a standardized management system for foreign
important safety platform that protects experimental personnel
biosafety laboratories
from pathogenic infections and prevents the pathogenic sources
from leaking to the environment. This is crucial to social stability
The WHO has been paying close attention to the safe operation
and national security [1].
and management of biosafety laboratories. From 1983 to 2003, the
In the 1980s, the World Health Organization (WHO) had already
WHO and the United States Centers for Disease Control and
rated biosafety laboratories from level 1 to level 4 depending on
Prevention jointly issued three editions of the Laboratory Biosafety
the degree of hazards such as pathogenicity, toxicity, infectious-
Manual. The Manual graded the biosafety protection into four
ness, transmission, stability, induction of allergies, and the extent
levels and regulated their operational procedures separately, thus
of the infection source [2,3]. Since then, many countries have
providing useful reference and guidance worldwide.
established biosafety laboratories with different biosafety levels.
The United States attaches great importance to laboratory bio-
Since 2003, China has planned to establish a nationwide system
safety management. It is not only the first country in the world
consisting of a number of high-level biosafety laboratories. So far,
to build biosafety laboratories but also the country with the high-
China has successfully established at least 26 high-level biosafety
est number and largest total area of top-level biosafety laborato-
laboratories and thousands of laboratories with lower levels and
ries. At present, the United States has more than 22 Protection
has successfully formulated and promulgated a number of laws,
Level 4 laboratories with rich experience in laboratory manage-
regulations, and standards for biosafety management [4,5]. How-
ment. The United States was also the first country to publish the
ever, due to the lack of practical experience, the scientific manage-
Biosafety manual in Microbiology and Biomedical Laboratories,
ment of biosafety laboratories remains at the exploratory stage.
which is recognized and adopted by the WHO.
The world’s most advanced high-risk virus laboratory is located
⇑ Corresponding author. in Lyon, France. It was brought into operation in 1999. Its main task
E-mail address: weif@mail.whlib.ac.cn (F. W). is to study the world’s newest and most virulent viruses, carry out

https://doi.org/10.1016/j.jobb.2018.12.007
2588-9338/Ó 2018 Published by Elsevier B.V. on behalf of KeAi Communications Co., Ltd.
This is an open access article under CC BY-NC-ND license. (http://creativecommons.org/licenses/by-nc-nd/4.0/)
40 F. W et al. / Journal of Biosafety and Biosecurity 1 (2019) 39–45
Fig. 1. Standard system of French biosafety laboratories.
in-depth research and documentation on old and variant viruses in
history, and find ways to treat them. To ensure smooth operation,
the laboratory in Lyon established a solid system in 11 areas (as
shown in Fig. 1)—management and quality assurance; product
and company certification and conformity assessment; biology,
botany, and zoology; microbiology; sterilization; experimental
medicine; environmental management; workplace ventilation
controlling; clean rooms and related environment controlling;
occupational safety and laborers’ sanitation; and special waste dis-
posal—all centrally monitored by computers.
3. Comparison and analysis of biosafety standards between
China and France
3.1. Comparison of total amounts of standards and situation of
internationalization
Detailed survey on the current status of the management stan-
dards system adopted by the biosafety laboratories of the two
countries has revealed that these systems mainly consist of inter-
national (ISO, IEC) and national standards. The specific distribution
Fig. 2. The number of (international) standards adopted by Chinese and French
biosafety laboratories.
is shown in Fig. 2. There are currently 49 standards in China for
biosafety laboratory management, including 24 international stan-
dards and 25 Chinese national standards; thus, the percentage of
international standards is 49%. Meanwhile, in France, there are
79 standards, including 45 international standards and 34 French
national standards; thus the percentage of international standards
is 57%. This shows that France attaches great importance to the
adoption of international standards in addition to adopting more
national standards. Moreover, the survey also revealed that, among
the 45 international standards adopted by France, 24 are also
adopted by China. Please refer to the author’s previous study for
details [6–8].
3.2. Status and comparison of standard systems
After investigating the management standards for biosafety lab-
oratories in the two countries, the standards are considered to be
mainly distributed in seven categories: safety, quality manage-
ment, environmental management, laboratory capability building
and evaluation, waste disposal, construction engineering, and
experimental test, as shown in Table 1. France has a relatively large
number of standards for environmental management, capability
building assessment, safety methods, and experimental tests while
China has a relatively large number of standards for waste treat-
ment and construction engineering. This indicates that France
has richer experience in the areas of laboratory environment, capa-
bility building, safety, and testing technology while China has more
explicit regulations on waste treatment and construction
engineering.
To further analyze the specific content of classification for bio-
safety laboratory standards systems between China and France, the
status of equivalent use of international standards, and the adop-
tion of national standards, an in-depth analysis was carried out
based on the comparisons shown in Fig. 3. The result of classifica-
tion analysis is shown in Table 1. In terms of laboratory quality
management standards, laboratory environmental management,
and laboratory capability building assessment and management,
both countries adopt ISO standards; in terms of content, the two
countries show consistency in adopting quality management stan-
dards. In terms of environmental management and capability
building assessment and management, China adopts fewer ISO
standards than France; as for how the two countries adopt those
standards, France directly adopts ISO standards while China con-
verts the ISO standards into national standards before adoption.
This difference might have something to do with the different
management of the two countries when using ISO standards.
From the aspects of waste treatment and construction engineer-
ing, China’s biosafety laboratories use more standards, mainly Chi-
nese national standards and equivalent conversion of ISO
 F. W et al. / Journal of Biosafety and Biosecurity 1 (2019) 39–45 41

Table 1
Application and content comparison between Chinese and French secondary classification standards for biosafety laboratory systems.

Category France China

Quality Directly adopts ISO standards. Includes quality management system Converts the ISO standards into equivalent national standards with
management requirements, sustainable quality management methods for same content as in France
organizations, project quality management guidelines, quality system
structure management guidelines, and quality management
documentation guidelines
Environmental Directly adopts ISO standards including environmental management Converts the ISO standards into equivalent national standards
management system requirements, usage guidelines, and technical corrigenda; including environmental management system requirements and usage
environmental management system principles, systems, and guidelines; environmental management system principles, systems,
supporting technical guidelines; and environmental performance and supporting technical guidelines; and environmental performance
evaluation guidelines evaluation guidelines
Capability building Directly adopts ISO standards and equivalent conversions of EU Converts the ISO standards into equivalent national standards
assessment and standards including supplier conformity assessment requirements; including supplier conformity assessment requirements, specialized
management specialized requirements for quality and competence of medical requirements for quality and competence of medical laboratories,
laboratories; general competence requirements and technical general competence requirements for the examination and calibration
corrigenda for the experimental and calibration laboratories; risk laboratories, clean rooms and related environmental air pollution
management, continuously improving technologies and corrigenda rating, regulations on clean room and related controlled environment
sheet of medical laboratories; clean rooms and related environmental monitoring and supervision, principles and methods for clean rooms
air pollution rating; regulations on clean room and related controlled and related environmental biological pollution control, and operation
environment monitoring and supervision; principles and methods for of clean rooms and related controlled environments
biological pollution control; operation of clean rooms and related
controlled environments; and biological laboratory operation
guidelines
Waste treatment Directly adopts ISO standards and equivalent conversions of EU Mainly China’s national standards including odor pollutant discharge
standards including assessments and instructions (ISO) for standards, wastewater discharge standards, biological safety
biocontamination data for clean rooms and related controlled treatment procedures for diseased animals and products, control
environments, guidelines for waste treatment, and inactivation and standards for hazardous waste incineration pollution discharge
examination of biological laboratories (EU) requirements for water pollutants from medical institutions, and
environmental protection signs for landfill pollution control of
hazardous wastes—solid waste storage (disposal) field
Construction Direct or equivalent adoption of ISO standards including the design, Mainly national standards and equivalent conversion of ISO standards
engineering construction, and start-up of clean rooms and related controlled including the design specifications of clean workshops; design
environments and the design principles of a protective paddock specifications for heating, ventilation, and air-conditioning;
specifications for construction and acceptance of clean rooms;
specifications for construction and acceptance of infectious disease
hospitals; acceptance criteria for construction quality of ventilation
and air-conditioning engineering; and design, construction, and start-
up of clean rooms and related controlled environments
Safety methodology Directly adopts IEC* standards and equivalent conversions of EU Mainly adopts national standards including the general requirements
standards including laboratory in vitro diagnostic medical equipment of laboratory biosafety, medical laboratory safety requirements, design
special safety requirements; EMC requirements and technical specifications of building fire extinguishers, design specifications of
corrigenda for laboratory electrical equipment (special requirements building fire extinguishing, and environmental protection graphic
for in vitro diagnostic medical instruments); leakage rating of signs—solid waste storage (disposal) sites
biosafety zones and related detection methods; requirements for
protection levels, hazardous area, location, and physical safety of
microbiology laboratories; guidelines for inoculation of microbial
animal protection in biological laboratories; selection of hazard
equipment in biological laboratory; and characteristics and
assessment of ultra-fine aerosol respiratory exposure in workplaces
Experimental tests Directly adopts ISO standards and equivalent conversions of EU Adopts national standards including hospital hygiene standards, high-
standards including the determination of the quantity of efficiency air filter permeability and resistance performance test
microorganisms in medical products and technical corrigenda; the methods, identification of toxicity of hazardous waste leaching,
definition of the sterilization process for medical devices; the general requirements for the invasion of plant pathogens, and
effectiveness of sterilization experiments and the test methods for examination procedures of West Nile virus laboratory
clean rooms and related controlled environments; the requirements
and detection of thermal disinfection equipment; the requirements for
the disinfection of waste containers for humans and the methods for
detecting and testing the effects of cleaning treatments; the
development of sterilization procedures for the medical sterilization
devices of health products and the requirements for daily
maintenance; the guidelines for the sterilization of health
products and the biological and chemical indicator test equipment for
the sterilization of health products; classification and performance
testing of high-efficiency air filters; aerosol generation of high-
efficiency air filters; measurement equipment; particle count
statistical methods; flat filter media detection methods of high-
efficiency air filter; high-efficiency air filters unit leak-scanning
method; high-efficiency air filter efficiency test; performance
examination of ordinary air-vented particulate air filters; method and
requirements for quantitative suspension testing of human medical
chemical sterilizing agents and fungicides; airborne surface
sterilization methods—bacterial bactericides, fungal bactericides, yeast
killer agent, and sporicidal agent activity assay; anti-particle half mask
requirements; detection and labeling; determination of bactericidal
activity in the presence of interfering substances; determination of

(continued on next page)

42 F. W et al. / Journal of Biosafety and Biosecurity 1 (2019) 39–45

Table 1 (continued)

Category France China

viricidal activity of vertebrate viruses; determination of viricidal
activity of phage virus; determination of bactericidal fungicides and
sporicides (microbial loss method); determination of fungicide activity
(dilution method); determination of fungicide activity (film filtration
method); determination of the activity of bactericides in the presence
or absence of interfering substances (dilution); determination of
bactericidal activity in the presence or absence of interfering
substances (membrane filtration); air diffusion surface disinfection;
and test methods and requirements for quantitative suspension testing
of preservatives and chemical disinfectants used in human medicine
*
Note: IEC is short for International Electrotechnical Commission.

Fig. 3. Secondary classification measurement comparison of Chinese and French biosafety laboratory methodology standards.

standards. The waste treatment standards include standards for
sewage emission, odor pollutants, hazardous waste, and diseased
animals and products. The construction engineering standards
include the design, construction, and acceptance of clean rooms;
the design and construction of heating, ventilation, and air condi-
tioning; and the construction and acceptance of infectious disease
hospitals. France mainly adopts ISO directly and equivalently
adopts European standards. Its waste treatment standards include
the evaluation of biological pollutants, biological laboratory waste
disposal, inactivation and detection, and so on. The standards for
construction engineering include the design, construction, and
start-up of clean rooms and related environments. From the com-
parison above, although France has fewer standards in these two
areas than China, the standards adopted by France are specialized
for biological laboratories.
In terms of safety standards, France has adopted more stan-
dards, mainly direct adoption of IEC and equivalent adoption of
European standards, including laboratory in vitro diagnostics for
special safety requirements for electrical equipment; electromag-
netic compatibility requirements; biosafety protection zone levels;
hazards, location, and physical safety requirements; leak detec-
tion; and laboratory respiratory safety. China mainly adopts
national standards, including general requirements for laboratory
biosafety, safety requirements for medical laboratories, fire extin-
guishers for buildings, and fire extinguishing design for buildings.
In terms of experimental test methods, France has more standards
for application of biosafety laboratories. See Table 1 for details. This
is related to the longer running time and the work scope of French
biosafety laboratories.
4. Analysis of problems in the management system standards
for biosafety laboratory in China
Problems have long been found in the management of biosafety
laboratories. Fortunately, during the past decade, a series of man-
agement regulations, laws, and standards has been developed
and promulgated to guide the management of the laboratories in
China, which play an important role in the prevention and control
of biosafety in the whole country.
Nowadays, management system standards have been developed
in the seven areas of laboratory construction: environmental impact
assessment, certification, and accreditation and qualification
assessment for experimental activities, supervision, culture preser-
vation, and personnel training. Moreover, other important regula-
tions have been promulgated such as the national catalogue of
hazardous wastes, catalogue for classification of medical wastes,
laboratory biosafety guidance, technical specifications for central-
ized medical wastes treatment, highly pathogenic animal and
pathogenic microorganisms (drug), and packaging for sample trans-
port. These may provide guidance for future work on the manage-
ment of biosafety laboratories, including the administrative
 F. W et al. / Journal of Biosafety and Biosecurity 1 (2019) 39–45 43

management, culture preservation, transportation, and medical (3) There is an absence of quantifiable standards for assessment
waste pathogen disposal. of waste, disinfectant, preservative treatment, biological pol-
At the same time, China also released four basic and compre- lution data analysis, and air condition derived from the
hensive management standards including the general principles biotechnology experiment.
of biosafety in microbiological and biomedical laboratories, general (4) In terms of safety, there is a lack of feasible standards for the
requirements for laboratory biosafety, five construction stan- safety requirements of different protection zones and for the
dards—laboratory construction technology, design, construction, inoculation of microbiological animals and equipment selec-
acceptance, and fire prevention—and seven facilities quality stan- tion under different risk degrees in biosafety laboratories.
dards including biological safety cabinets, heating and ventilation (5) There is a lack of professional methods that can be applied to
acceptance, air filter, and waste transport vehicles as well as nine the determination of microbial populations, instrument ster-
laboratory testing methods standards such as the competence of ilization, environmental testing, product sterilization, high-
calibration and testing laboratories and laboratory tests such as efficiency air filter test, all kinds of fungicides virus quantita-
etiology tests, etiology classification, safety operation, animal tive detection, and determination of activity, all of which are
quarantine, gene inspection on entry, and exit organism laborato- necessary for the safety operation of biosafety laboratories.
ries, the promulgation of which may provide concrete plans and
For this aim, under the guidance of the existing management
basis for the implementation of regulations.
laws and regulations system on biosafety laboratories, China must
Compared with high-level biosafety laboratories that possess
gradually establish applicable, operational, and propagable stan-
standardized management systems in foreign countries, 80% of
dard management systems on biosafety laboratories to guide the
the relevant specification/standard of biosafety laboratories in
planning, design, evaluation, verification, testing and acceptance,
China belong to the specification and quality standards under the
operation, and maintenance of biosafety laboratories. These will
macro guidance, and only a small fraction are operational method
provide standardized professional technical support for biosafety
standards, making it difficult to ensure the security of the biosafety
laboratory safety and effective management.
laboratory due to lack of operational technical support. Here are
the main aspects:
5. Construction of the standardized management system for
biosafety laboratories in China
(1) The existing biosafety laboratory standards are mainly on
laboratory construction requirements and general guidance
As a kind of highly professional laboratory, the construction of a
such as evaluation, environment, safety, personal health,
standard system for biosafety laboratories not only must consider
and so on, lacking professional instructions for biosafety
some general application standards but also should be character-
laboratory.
ized by professional construction, management, function, and
(2) Although China has developed some professional methods
operation that are specifically shown in biosafety laboratories.
for detecting pathogenic bacteria, there is still a lack of
Then, in combination with conventional standard system analysis
enough operable technical standards for the standards of
methods and the characteristics of the professional laboratory,
the biotechnology laboratory.
through analyzing and constructing biosafety laboratory standard

Fig. 4. The overall framework of the standard systems for biosafety laboratories in China.
44 F. W et al. / Journal of Biosafety and Biosecurity 1 (2019) 39–45
systems including planning, location, construction and acceptance,
assessment, operation, management, and activity abilities at differ-
ent stages, the overall framework of the standard systems of bio-
safety laboratories in China is simplified in Fig. 4.
Fig. 4 reflects that our biosafety laboratory standard system
framework includes planning, design, construction and acceptance,
certification, qualification evaluation, daily activities and manage-
ment of science and technology, and maintenance and evaluation
of the nine stages. Meanwhile, to maintain the consistency and
coordination of the standard system, the professional nouns, com-
monly used terms, concepts, and classifications of the nine phased
standards involved are based on common standards (Fig. 5).
According to the above classifications, further specific analysis
on the existing standards were conducted, and we found that same
standards may be repeatedly used in biosafety laboratories in dif-
ferent stages—for example, the same GB/T 22576-2008 testing and
calibration laboratory capacity of general requirements may be
employed at both building acceptance and laboratory evaluation
stages—even that certain standards in specific implementation
stage may be missing. To solve this problem, based on the thinking
shown in Fig. 2, we combined the traditional construction of stan-
dard system methods with a more detailed frame for a biosafety
laboratory standard system, as shown in Fig. 3.
Also as shown in Fig. 3, a standard system framework for biosafety
laboratories in China includes nine categories: basic standards; lab-
oratory planning and design standards; construction standards;
acceptance, certification and evaluation standards; safe operation
and management standards; equipment standards; scientific
research standards; competency verification and training standards;
and repair and maintenance standards. According to different appli-
cation areas, each category is divided into several small categories:
Fig. 5. The standard system framework for biosafety laboratories in China.
(1) Basic standards, including professional nouns, terms, expla-
nations, classifications, and identifications.
(2) Biosafety laboratory planning and design standards, includ-
ing three aspects: the design of various laboratories consist-
ing of veterinary, microbiology, medical, and so on; the
planning and design of buildings; and the function planning
for buildings, such as heating and ventilation, air condition-
ing, and so on.
(3) Biosafety laboratory construction standards, including two
aspects: construction technology standards for laboratory
and clean rooms and building standards for functional archi-
tectures, comprising heating, ventilation, air conditioning,
and so on.
(4) Acceptance, certification, and evaluation standards in biosaf-
ety, including building acceptance, laboratory accreditation,
and technical evaluation.
(5) Operation and management standards, including quality
management, environment, risk management, pollutant
control and waste management, work environment, occupa-
tional safety, and laborer hygiene.
(6) Device and technology standards, including standards for
laboratory applications and operating methods.
(7) Scientific research standards, including sterilization, equip-
ment operation, and related research work on biology,
plants, and animals.
(8) Competency verification and training standards, including
operation and management of laboratories, dissemination
of standards, and training.
(9) Repair and maintenance standards, including laboratory
heating, ventilation, laboratory technical facilities, and
sterilization.
 F. W et al. / Journal of Biosafety and Biosecurity 1 (2019) 39–45
6. Measures for the standardized management of biosafety
laboratories in China
The biosafety laboratory is a double-edged sword; it can be
used for the benefit of humanity but can also lead to a ‘‘disaster.”
With increasing numbers of high-level biosafety laboratories con-
structed in China, it is urgent to establish and implement standard-
ized management measures for biosafety laboratories. Of course,
the implementation of standardized management measures
requires system planning, comprehensive blueprints, effective
means, and establishment of specific management standards for
biosafety laboratory. Furthermore, these standardized manage-
ment measures should be implemented as soon as possible to
ensure the effective operation of biosafety laboratories. Thus, we
put forward several suggestions:
(1) A Standardization Technical Committee on operational man-
agement of biosafety laboratories should be established as
soon as possible led by high-level biosafety laboratory pro-
fessionals for the secretariat work to effectively promote
the construction and operation of biosafety laboratories in
China.
(2) A systematic analysis of a standard system for biosafety lab-
oratories at home and abroad should be launched to investi-
gate and establish a standardized system of biosafety
management system in China in order to promote the imple-
mentation of a national biosafety strategy more substan-
tially and effectively.
(3) In the absence of a standardized management system for
biosafety laboratories in China at present, we propose that,
in biotechnology areas that are in urgent need, vacant, and
of key development, technical specifications and standards
may be formulated in priority in the core and key biotech-
nology to cope with the current problems.
(4) Importance should be attached to the increased investment
in professional technological research and development and
standardization in biosafety laboratories. In this field, com-
pared with other developed countries, China has shortcom-
ings of later start times, shorter development cycle, less
experience, inadequate technology research, and develop-
ment capacity. From the perspective of national security
and social stability, it is necessary to strengthen the planning
and layout, increase research and development, provide pol-
icy and financial support, and so on, aiming at shortening the
gap with developed countries.
45
(5) At present, China should accelerate the construction of a uni-
fied, general, standardized evaluation system in biosafety
laboratories. In addition, China should reference, investigate,
and promulgated a number of operational standards on the
design, evaluation, acceptance verification, testing, and
operation of biosafety laboratories as soon as possible.
(6) The equivalence and universality of our standards with
international standards should be enhanced. In promulga-
tion of the technology standards for the security of biosafety
laboratories, we should consider not only national condi-
tions but also the equivalence with international standards,
because, in aspects such as international trade, technology
transfer, and international certification, the international
standards of ISO and IEC have incomparable advantages.
Acknowledgments
This work was supported by the International Science and
Technology Cooperation Project (2009DFB33040), ‘‘Twelfth
Five-Year Plan” Special Project (2012ZX10004403), National
Natural Science Foundation Project (71103178) and Excellent
Talents Project of Chinese Academy of Sciences.
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