other information
drafter:Li Jinsong, Li Na, Zhang Wenge, He Chunlei, Li Zhaojun, Zou Yaxiong, Liu Wei, Zhou Lan, Zou Zongyong, Chen Zhonghui, Hu Kongxin, Ma Xuezheng, Yu Mingzhou, Yan Zhenghui, Zhao Xiaoning, Li Chengzhi, Sui Guodong, Xiong Shengjun, etc.
Drafting unit:Military Medical Research Institute, China Institute of Metrology, Qingdao Zhongrui Intelligent Instrument Co., Ltd., Institute of Process Engineering, Chinese Academy of Sciences, Qingdao Metrology Technology Research Institute, Zhejiang Doppler Env
Focal point unit:National Technical Committee for Particle Characterization and Sorting and Sieve Standardization (SAC/TC 168)
Proposing unit:National Technical Committee for Particle Characterization and Sorting and Sieve Standardization (SAC/TC 168)
Publishing department:State Administration for Market Regulation National Standardization Administration
Introduction to standards:
GB/T 39990-2021. Particulate-Bioaerosol sampler-Technical specification.
1 Scope
GB/T 39990 specifies the classification, composition, working conditions, technical requirements, test conditions, test methods, inspection rules, marking, packaging, transportation and storage of bioaerosol samplers.
GB/T 39990 applies to the development, production and inspection of bioaerosol samplers.
2 Normative references
The contents of the following documents constitute the essential clauses of this document through normative references in the text. Among them, for dated references, only the version corresponding to that date applies to this document; for undated references, the latest version (including all amendments) applies to this document.
GB/T 3768 Acoustics Sound pressure method for determination of sound power level and sound energy level of noise source Simple method using envelope measuring surface above reflecting surface
GB/T 11463 Reliability test for electronic measuring instruments
GB/T 38517-2020 General rules for sampling and analysis of particulate bioaerosols
3 Terms and definitions
GB/T 38517-2020 The following terms and definitions defined in and to GB/T 38517-2020 apply to this document.
3.1
Sampling airflow ratio
The volume of gas passing through the bioaerosol sampler per minute under normal working conditions.
3.2
Sampling efficiency
The percentage of aerosol particles that can be collected during the sampling process to the total number of aerosol particles passing through the sampler.
3.3
Survival rate of microbial
The ratio of the bioaerosol sampler to maintain the activity of microorganisms in aerosol particles during the sampling process and to have the ability to cultivate and reproduce microorganisms.
This document specifies the classification, composition, working conditions, technical requirements, test conditions, test methods, inspection rules, marking, packaging, transportation and storage of bioaerosol samplers.
This document is applicable to the development, production and inspection of bioaerosol samplers.
Some standard content:
ICS19.120
CCS A 28
National Standard of the People's Republic of China
GB/T 39990—2021
Bioaerosol sampler
Technical conditions
Particulate-Bioaerosol sampler-Technical specification2021-04-30 Issued
State Administration for Market Regulation
National Standardization Administration
2021-08-01 Implementation
People's Republic of China
National Standard
Bioaerosol sampler
Technical conditions
GB/T393002021
Published and distributed by China Standard Publishing House
Chaoyang, Beijing No. 2, West Hepingli Street, Beijing (100029) No. 16, Sanlihe North Street, Xicheng District, Beijing (100043) Website: apc.org.cn
Service hotline: 4001580010
First edition in April 2021
Book number: 155066·1-67142
Copyright reserved
Infringements must be investigated
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Normative references
3 Terms and definitions
Classification, composition and working conditions,
Working conditions
5 Technical requirements
Sampling efficiency
Microbial survival rate
Sampling flow
Gas path air tightness
Mean time between failures (MT13F)
Timing error
Test conditions
Test environment
Test instruments and equipment
Reagents or materials
Test Method
Sampling efficiency
Microorganism survival rate
Sampling flow
Gas path airtightness
Mean time between failures
Timing error
Inspection rules
Inspection types and inspection items
Factory inspection
Type inspection
Maintenance inspection
9Marking, packaging, transportation and storage
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GB/T 39990—2021
GB/T39990—2021
References
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GB/T 39990—2021
This document is drafted in accordance with the provisions of GB/T1.12020% Guidelines for Standardization Work Part 1: Structure and Drafting Rules for Standardization Documents.
Please note that some of the contents of this document may involve patents. The issuing agency of this document does not assume the responsibility for identifying patents. This document was proposed and managed by the National Technical Committee for Particle Characterization and Sorting and Screen Standardization (SAC/TC168). The drafting units of this document are: Military Medical Research Institute, China Institute of Metrology, Qingdao Zhongrui Intelligent Instrument Co., Ltd., Institute of Process Engineering, Chinese Academy of Sciences, Qingdao Institute of Metrology Technology, Jianjiang Doppler Bad Protection Technology Co., Ltd., Qingdao Laoying Environmental Technology Co., Ltd., China Institute of Inspection and Quarantine, China University of Metrology, Shanghai Qikang Regenerative Medicine Technology Co., Ltd., Beijing Institute of Metrology and Testing Science, Fu Ri University, Beijing Huatai Nuoan Detection Technology Co., Ltd., Dandong Hute Instrument Co., Ltd., Kunshan Shanghai Institute of Technology Optoelectronic Information Application Technology Research Institute Co., Ltd.
The main drafters of this document are: Li Jinsong, Li Na, Zhang Wenge, He Chunlei, Li Zhaojun, Zou Yaxiong, Liu Wei, Zhou Lan, Zou Zongnan, Chen Zhonghui, Hu Kongxin, Ma Xuezheng, Yu Mingzhou, Yan Zhenghui, Zhao Xiaoning, Li Chengzhi, Sui Guodong, Xiong Shengjun, Dong Qingyun, Lu Bing, Yuan Xujun. -riKacerkAca-
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Particles, Technical conditions for bioaerosol samplers GB/T39990—2021
Warning: Hazardous biological components, operations and equipment may be involved in the use of this document. This document does not contain biosafety issues that should be paid attention to when using this document. Before using this document, the user should take appropriate biosafety protection measures based on the performance of the sampler, the collection object and the biological hazard risks of the sampling environment. 1 Scope
This document specifies the classification, composition, working conditions, technical requirements, test conditions, test methods, inspection rules, marking, packaging, transportation and storage of bioaerosol samplers. This support is applicable to the development, production and inspection of bioaerosol samplers. 2 Normative reference documents
The contents of the following documents constitute the indispensable terms of this document through normative references in the text. Among them, for dated references, the versions corresponding to such dates apply to this document; for undated references, the latest versions (including all amendments) apply to this document
Method for determining noise source power level and energy level by sound pressure method using the envelope measurement surface above the reflecting surface GB/T 3768
GB/T11463Reliability test for electronic measuring instruments GB/T38517-2020General rules for sampling and analysis of particulate and bioaerosols 3 Terms and definitions
GB/T38517-2020 and the following terms and definitions apply to this document: 3.1
Sampling airflow rate The volume of gas passing through the bioaerosol sampler per minute under normal working conditions. 3.2
Sampling efficiency sampling efficiency The fraction of the number of aerosol particles that can be collected during the sampling process to the total number of aerosol particles passing through the sampler. 3.3
Survival rate of microbialThe ratio of the microbial activity in the aerosol particles maintained by the bioaerosol sampler during the sampling process and the ability to cultivate and reproduce microorganisms.
Note: Considering the impact of the sampling process and the analysis process on microorganisms, the survival rate of microorganisms is not a relative value. Generally, the relative survival rate is used to replace the survival rate of microorganisms. It is internationally recognized that the Andersc six-stage sampler or AGI-3 sampler is used as the standard sampler. The biological sampling efficiency of other samplers is compared with these two samplers to obtain the relative survival rate. 3.4
Aerosol generator
aerosolgenerator
An apparatus that generates aerosols with stable concentration and appropriate particle size range by hydraulic, pneumatic, ultrasonic, electrostatic and other means. 1
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GB/T39990—2021
4 Classification, composition and working conditions
4.1 Classification
Biological aerosol samplers (hereinafter referred to as samplers) are mainly divided into seven categories according to the sampling method: impact samplers, impact samplers, filter samplers, centrifugal samplers, large flow samplers, electrostatic adsorption samplers and natural sedimentation samplers. All types of samplers and their working principles shall comply with the provisions of 4.4.2 of (G[3/1385172020. 4.2 CompositionbzxZ.net
4.2.1 Overview
Except for the natural sedimentation sampler, the sampler shall at least consist of a sample list, a gas flow control unit, a time control list and a sampling information recording and storage unit. As shown in Figure 1, the natural sedimentation sampler is only composed of a sampling unit. Sampling unit
Gas flow control unit
Time control unit
Sampling information recording and storage unit
Schematic diagram of the composition of the bioaerosol sampler
4.2.2 Sampling unit
The sampling list mainly includes a sample head, a sample medium and a sample medium carrier. 4.2.2.2 Sampling media include solid media and liquid media. Solid media, solid media are divided into gel solids and filter membranes. They are usually configured before the sampling work begins.
The sampling medium composition meets the requirements of 4.5.2 in GB/T38517-2020, 4.2.2.3
4.2.2.4 The sampling medium carriers of gel solids and liquids are generally glass or plastic containers. 4.2.2.5 The sampling medium carrier supporting the filter membrane is generally a rigid structure. The filter membrane should be kept flat, the support surface should be evenly stressed, and the edges should not leak. 4.2.3 Gas flow control unit
4.2.3.1 The gas flow control unit includes a vacuum pump, flow control and connecting gas lines. 4.2.3.2 The flow of the sampler can be set and adjusted. When the flow measured by the sampler deviates from the set working flow by more than 10% and the duration exceeds 108.It should be able to automatically stop sampling. 4.2.4 Time control unit
The time control unit should at least have the function of setting the sampling duration, automatically controlling the start and stop of sampling, and the time control should be accurate to seconds. The sampling time information should be stored in the sampling information recording storage unit, 2
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4.2.5 Sampling information recording storage unit
GB/T39990—2021
4.2.5.1 The sampler should be able to automatically measure and display the flow rate and sampling time. The display update time should not exceed 5s. The cumulative upper condition sampling volume and standard condition sampling volume should be calculated at least once. 4.2.5.2 The sampling information recording storage unit should at least be able to record and store the sampling period, sampling time, ambient temperature, ambient air pressure, sampling number, sampling flow, sampling volume and standard condition sampling volume. 4.2.5.3 The stored record information should be able to be transferred to a computer or other carrier for query or printing. The data should be stored for at least 3 months. 4.3 Working conditions
4.3.1 Ambient temperature: -10℃~50℃
4.3.2 Ambient humidity: Relative humidity is not more than 85%. Atmospheric pressure: 80kPa-106kPa.
5 Technical requirements
Sampling efficiency
The result should not be less than 70%, and the corresponding particle size range should be marked. 5.2
Microbial survival rate
Should not be less than 70%. And mark the test reference sampler type. 5.3 Sample flow
5.3.1 The sampling flow indication error should not exceed +5%. 5.3.2 The sampling flow repeatability should not be less than 2%. 5.3.3 The sampling flow rate stability should not exceed 5%. 5.4 The air tightness of the gas path
The pressure change within 1 minute should not exceed 0.15kPal. 5 The noise
should not exceed 62dB(A).
The mean time between failures (MTBF)
should be greater than or equal to 800h.
5.7 Timing error
Should not exceed ±1%:
6 Test conditions
6.1 Test environment
6.1.1 Ambient temperature: 15℃~-30℃,
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GB/T 39990—2021
6.1.2 Relative humidity: not more than 85%
6.1.3 Power supply: (220122)V.(5011)Hz Test instruments and equipment
6.2.1 Standard flow meter
Flow range 0.1L/min~1000L/min. Accuracy not less than 0.5 level. 6.2.2 Vacuum pressure gauge
0MPa~60MPa. Accuracy not less than 2.5 level. 6.2.3 Stopwatch
Precision is 1ms:
6.2.4 Sound level meter
Measurement range: 50 dB~100 dB. Precision is ±1dB. Resolution is 1dB, with "A" weighting mode Aerosol test chamber
The temperature in the chamber is maintained at (25_2)℃, the relative humidity is maintained at (50+10)%, and the aerosol particle concentration distribution is uniform: 6.2.6 Aerodynamic particle size spectrometer
The maximum allowable error of the indication value: -30%FS.
6.2.7 Fluorescence spectrophotometer
The maximum allowable error of the wavelength indication value: +2nm
6. 2.8 Aerosol generator
Can generate particles of 0.5um~15μm.
6.2.9 Constant temperature biochemical incubator
Temperature deviation: -1.0℃.
Reference standard sampler
Anderscn6-level air microbial sampler or AGl-30 air microbial sampler, sampling efficiency is not less than 70%6.3 Reagents or materials
6.3.1 Monodisperse fluorescent polystyrene microspheres
The microsphere sizes are: 1μm, 3μm, 5μm and 10μm. The coefficient of variation is 3%-~5%. 6.3.2 Indicator microorganisms for testing
Certified standard substance for Salmonella glutinis, certified standard substance for bacteriophage PhiX171, certified standard substance for Bacillus thuringiensis, 4
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7 Test method
7.1 Sampling efficiency
GB/T39990—2021
7.1.1 In the aerosol test chamber, the sampling ports of the sampler to be tested and the membrane filter sampler are at the same height and are 0.5m~1m away from the aerosol inlet. Use an aerosol generator to generate 1um monodisperse fluorescent microsphere aerosol. After 5 minutes of generation, use an aerodynamic particle counter to measure the aerosol particle concentrations at the sampling ports of the sampler to be tested and the membrane filter sampler respectively. 7.1.2 When the two measured concentrations are consistent, open the sampler to be tested and the membrane filter sampler at the same time to trace the aerosol. Sampling for 5 minutes: 7.1.3 After the sampling is completed, use 30ml of deionized water to elute the particles collected in the sampler to be tested and the membrane filter sampler, and use a fluorescence spectrophotometer to measure their fluorescence concentrations, which are recorded as Cu and C respectively. According to formula (1), calculate the sampling efficiency (ntn) of the sampler to be tested:
Where:
Co×Sx100%
1rm=Cih*Q
Sampling efficiency of the sampler to be tested; ||t t||——fluorescence concentration of the sampler to be tested;
Cinl——fluorescence concentration of the membrane filter sampler;Ql—sample flow rate of the membrane filter sampler, in liters per minute (L/min);Qa——sampling flow rate of the sampler to be tested, in liters per minute (L/min):7.1.4 Repeat the measurement three times, 7-take the average value7.*+(1)
7.1.5 Also follow the steps of 7.1.17.1.4 to test the sample efficiency at other particle sizes , take the minimum value of the four sampling efficiencies of mm, m, 710 as the sampling efficiency,
7.2 Microbial survival rate
7.2.1 Set the concentration of the indicator microbial solution to 10*cfu/ml~10°cfu/mL7.2.2 In the aerosol test chamber, the sampling ports of the sampler to be tested and the reference standard sampler are at the same height and are 0.5m~1ml away from the aerosol population. Connect a membrane filter sampler to the gas path of the sampler to be tested and the reference standard sampler respectively. 7.2.3 Add the indicator microbial liquid into the aerosol generator. 5 minutes after the bioaerosol is generated, use an aerodynamic particle counter to measure the aerosol particle concentrations at the sampling ports of the sampler to be tested and the reference standard sampler respectively. When the two particle concentrations are consistent, start the sampler to be tested and the reference standard sampler at the same time. The sampling time is 1 minute. 7.2.4 After the sampling is completed, use the average culture counting method to culture the collected samples to obtain the number of live microorganisms collected by each sampler. The number of biological particles collected by the sampler to be tested is H, the sum of the number of biological particles collected by the filter type sampler on the gas path is the total number of biological particles in the gas path is NexE, the number of biological particles collected by the reference standard sampler is Ner, the sum of the number of biological particles collected by the filter type sampler on the gas path is Ner, the total number of biological particles in the gas path is N: 7.2.5 According to formula (2) and formula (3), calculate the microbial survival rate Stalu of the sampler to be tested and the microbial survival rate Swten of the reference standard sampler respectively:
Where:
Nrest e
Nest te
N×100%
SeNel
Microbial survival rate of the sampler to be tested;
The number of biological sperm collected by the sampler to be tested; The total number of biological particles in the gas path of the sampler to be tested. rKaeerkAca-
.. (2)
GB/T39990—2021
Where:
Nr×100%
The microbial survival rate of the reference standard sampler; The number of biological particles collected by the reference standard sampler: The total number of biological particles in the gas path of the reference standard sampler. 7.2.6 Calculate the relative survival rate (relativesurvivaltllici) according to formula (4) cency, Sre), which is the microbial survival rate: S.
Wu Zhong:
7.3 Sampling flow
Relative survival rate:
Microbial survival rate of the sampler to be tested:
S×100%
Reference to the microbial survival rate of the standard sampler Sampling flow indication error
(3)
..(4)
After the sampler to be tested is installed with the sampling medium and runs stably, use the standard flowmeter to measure the flow of the sampler to be tested. Measure 3 times. Calculate the flow indication error (AQ) according to formula (5) and formula (6): Q:
Q: -Q:+Q:
Formula:
Average flow rate of the sampler under test, in liters per minute (L/tmin); 3 measured values of the flow rate of the sampler under test, in liters per minute (1./min); Set value of the flow rate of the sampler under test, in liters per minute (L/rmin); Flow indication error.
(See JJF1826-2020, 7.1)
Flow repeatability
(5)
+ (6)
Measure 10 times according to the method in 7.3.1. Repeatability is expressed as the experimental standard deviation of a single measurement. Calculate the flow repeatability (s.) according to formula (7):
Wherein:
-Flow repeatability:
×100%
The average value of the measured flow of the sampler under test [0 times, in liters per minute (L./min); -The measured value of the flow of the sampler under test each time, in liters per minute (L/min): Number of measurements,
(See JJF1826-2020, 7.2)
7.3.3 Flow stability
After the sampler under test is installed with the sampling medium and runs stably, use a standard flowmeter to measure the flow of the sampler under test (Q.) and start timing, every 6
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