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GB/T 39990-2021 English PDF (GBT39990-2021)

GB/T 39990-2021 English PDF (GBT39990-2021)

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GB/T 39990-2021: Particulate -- Bioaerosol sampler -- Technical specification

This Standard specifies the classification, composition, working conditions, technical requirements, test conditions, test methods, inspection regulations, marking, packaging, transportation and storage of bioaerosol sampler. This Standard is applicable to development, production and inspection of bioaerosol sampler.
GB/T 39990-2021
GB
NATIONAL STANDARD OF THE
PEOPLE REPUBLIC OF CHINA
ICS 19.120
CCS A 28
Particulate - Bioaerosol Sampler - Technical
Specification
ISSUED ON: APRIL 30, 2021
IMPLEMENTED ON: AUGUST 1, 2021
Issued by: State Administration for Market Regulation;
Standardization Administration of the PEOPLE Republic of
China.
Table of Contents
Foreword ... 4
1 Scope ... 5
2 Normative References ... 5
3 Terms and Definitions ... 5
4 Classification, Composition and Working Conditions ... 6
4.1 Classification ... 6
4.2 Composition ... 6
4.3 Working Conditions ... 8
5 Technical Requirements ... 8
5.1 Sampling Efficiency ... 8
5.2 Survival Rate of Microbial ... 8
5.3 Sampling Airflow Ratio ... 8
5.4 Air-tightness of Gas Circuit ... 9
5.5 Noise ... 9
5.6 Mean Time Between Failures (MTBF) ... 9
5.7 Timing Error ... 9
6 Test Conditions ... 9
6.1 Test Environment ... 9
6.2 Test Instruments and Equipment... 9
6.3 Reagents or Materials ... 10
7 Test Methods ... 10
7.1 Sampling Efficiency ... 10
7.2 Survival Rate of Microbial ... 11
7.3 Sampling Airflow Ratio ... 13
7.4 Air-tightness of Gas Circuit ... 14
7.5 Noise ... 15
7.6 Mean Time Between Failures ... 15
7.7 Timing Error ... 15
8 Inspection Rules ... 15
8.1 Inspection Types and Inspection Items ... 15
8.2 Exit-factory Inspection ... 16
8.3 Type Inspection ... 16
8.4 Maintenance Inspection ... 17
9 Marking, Packaging, Transportation and Storage ... 17
9.1 Marking ... 17
9.2 Packaging ... 17
9.3 Transportation ... 18
9.4 Storage ... 18
Bibliography ... 19
Particulate - Bioaerosol Sampler - Technical
Specification
WARNING : hazardous biological components, operations and equipment may be involved during the use of this document. This document does not include the biosafety issues that shall be paid attention to when using this document. Before using this document, the user shall take appropriate biosafety protection measures in accordance with the performance of the sampler, and the biohazard risks of the sample collection object and the sampling environment.
1 Scope
This Standard specifies the classification, composition, working conditions, technical requirements, test conditions, test methods, inspection regulations, marking, packaging, transportation and storage of bioaerosol sampler.
This Standard is applicable to development, production and inspection of bioaerosol sampler.
2 Normative References
The contents of the following documents constitute the indispensable clauses of this document through normative references in the text. In terms of references with a specified date, only versions with a specified date are applicable to this document. In terms of references without a specified date, the latest version (including all the modifications) is applicable to this document.
GB/T 3768 Acoustics - Determination of Sound Power Levels and Sound Energy Levels of Noise Sources Using Sound Pressure - Survey Method Using an Enveloping Measurement Surface over a Reflecting Plane
GB/T 11463 Reliability Test for Electronic Measuring Instruments
GB/T 38517-2020 Particulate - Bioaerosols Sampling and Analysis - General Principles 3 Terms and Definitions
What is defined in GB/T 38517-2020, and the following terms and definitions are applicable to this document.
3.1 Sampling Airflow Ratio
Sampling airflow ratio refers to the volume of gas passing through the bioaerosol automatically controlling the start and stop of sampling; the time control is accurate to the second. It shall be possible to store the sampling time information in the sampling information record and storage unit.
4.2.5 Sampling information record and storage unit
4.2.5.1 The sampler shall be able to automatically measure and display the instantaneous airflow ratio and sampling time; the display update time shall not exceed 5 s. The cumulative working condition sampling volume and the standard condition sampling volume shall be calculated once in at least 1 min.
4.2.5.2 The sampling information record and storage unit shall at least be able to record and store information, such as: sampling date, sampling time, ambient temperature, ambient atmospheric pressure, sampling No., sampling airflow ratio, sampling volume and standard condition sampling volume, etc.
4.2.5.3 It shall be able to transmit the stored record information to a computer or other carriers for query or printing, and the data shall be stored for at least 3 months. 4.3 Working Conditions
4.3.1 Ambient temperature: -10 ??C ~ 50 ??C.
4.3.2 Ambient humidity: relative humidity is not greater than 85%.
4.3.3 Atmospheric pressure: 80 kPa ~ 106 kPa.
5 Technical Requirements
5.1 Sampling Efficiency
The sampling efficiency shall be not less than 70%. In addition, the corresponding particle size range shall be marked.
5.2 Survival Rate of Microbial
The survival rate of microbial shall be not less than 70%. In addition, the reference sampler type in the test shall be marked.
5.3 Sampling Airflow Ratio
5.3.1 The indication error of the sampling airflow ratio shall not exceed ?? 5%. 5.3.2 The repeatability of the sampling airflow ratio shall not be greater than 2%. 5.3.3 The stability of the sampling airflow ratio shall not exceed 5%.
6.2.6 Aerodynamic particle size spectrometer
The maximum allowable indication error is: ?? 30%FS.
6.2.7 Fluorescence spectrophotometer
The maximum allowable indication error of wavelength is: ?? 2 nm.
6.2.8 Aerosol generator
0.5 ??m ~ 15 ??m particles can be generated.
6.2.9 Constant-temperature biochemical incubator
The temperature deviation is: ?? 1.0 ??C.
6.2.10 Reference standard sampler
Andersen six-stage sampler air microbial sampler or AGI-30 air microbial sampler, with a sampling efficiency of not less than 70%.
6.3 Reagents or Materials
6.3.1 Monodisperse fluorescent polystyrene microspheres
The sizes of the microspheres are respectively: 1 ??m, 3 ??m, 5 ??m and 10 ??m; the coefficient of variation is 3% ~ 5%.
6.3.2 Indicator microorganisms for inspection
Certified standard substance of Serratia marcescens, certified standard substance of bacteriophage PHiX174 and certified standard substance of Bacillus atrophicus. 7 Test Methods
7.1 Sampling Efficiency
7.1.1 In the aerosol laboratory shelter, the sampling ports of the sampler to be tested and the filter membrane-type sampler have the same height, and the distance from the aerosol inlet is 0.5 m ~ 1 m. Use the aerosol generator to generate 1 ??m monodisperse fluorescent microsphere aerosol. 5 min after generation, use an aerodynamic particle counter to respectively measure the concentration of aerosol particles at the sampling ports where the sampler to be tested and the filter membrane-type sampler are located. 7.1.2 After the two measured concentrations reach the same level, simultaneously turn on the sampler to be tested and the filter membrane-type sampler for aerosol sampling for 5 min.
to culture and count the collected samples, so as to obtain the number of viable microorganisms collected by each sampler. The number of biological particles collected by the sampler to be tested is Ntest-vc; the sum of the number of biological particles collected by the sampler to be tested and the number of biological particles collected by the filter membrane-type sampler on the gas circuit is the total number of biological particles on the gas circuit Ntext-tot. The number of biological particles collected by the reference standard sampler is Nref-vc; the sum of the number of biological particles collected by the reference standard sampler and the number of biological particles collected by the filter membrane-type sampler on the gas circuit is the total number of biological particles on the gas circuit Nref-tot.
7.2.5 In accordance with Formula (2) and Formula (3), respectively calculate the survival rate of microbial Stest-eff of the sampler to be tested and the survival rate of microbial Sref-eff of the reference standard sampler:
Where,
Stest-eff---the survival rate of microbial of the sampler to be tested; Ntest-vc---the number of biological particles collected by the sampler to be tested; Ntext-tot---the total number of biological particles of the sampler to be tested on the gas circuit.
Where,
Sref-eff---the survival rate of microbial of the reference standard sampler; Nref-vc---the number of biological particles collected by the reference standard sampler; Nref-tot---the total number of biological particles of the reference standard sampler on the gas circuit.
7.2.6 In accordance with Formula (4), calculate the relative survival efficiency, Sre, namely, the survival rate of microbial:
Where,
Sre---the relative survival efficiency;
Qi---each measured value of the airflow ratio of the sampler to be tested, expressed in (L/min);
n---the number of measurements.
(see JJF 1826-2020, 7.2)
7.3.3 Stability of airflow ratio
After the sampler to be tested is installed with the sampling medium and runs stably, use the standard flowmeter to measure the airflow ratio (Q0) of the sampler to be tested and start timing. In every 1 min, record the airflow ratio once, for a total of 5 min. Take the maximum value and the minimum value of the 6 readings. In accordance with Formula (8), calculate the stability of airflow ratio (???):
Where,
???---the stability of the airflow ratio;
Qmax---the maximum measured value of the airflow ratio of the sampler to be tested, expressed in (L/min);
Qmin---the minimum measured value of the airflow ratio of the sampler to be tested, expressed in (L/min);
Q0---the initial measured value of the airflow ratio of the sampler to be tested, expressed in (L/min).
(see JJF 1826-2020, 7.3)
7.4 Air-tightness of Gas Circuit
7.4.1 Connect the vacuum manometer and a three-way valve to the air inlet of the sampler to be tested; turn on the sampler to be tested and slowly close the air inlet of the three-way valve. When the vacuum manometer indicates an increase of more than 5 kPa, turn off the power of the sampler; simultaneously, completely close the air inlet of the three-way valve and promptly clamp the inlet air pipe of the suction pump. At 1 min, record the reading (F) of the vacuum manometer; calculate the pressure variation , expressed in kPa.
7.4.2 If the sampler is a multi-channel sampling gas circuit, then, the air-tightness of each gas circuit shall be respectively inspected.
f) When a relevant national department puts forward a request for type
inspection.
8.3.2 In accordance with Table 1, conduct the type inspection. When one of the inspection items fails to comply with the requirements, then, the sampler shall be determined as disqualified in the type inspection.
8.4 Maintenance Inspection
In accordance with Table 1, conduct maintenance inspection at least once a year. When the sampler has its parts replaced or repaired, the maintenance inspection shall be conducted. When one of the inspection items fails to comply with the requirements, then, the sampler shall be determined as disqualified in the maintenance inspection. 9 Marking, Packaging, Transportation and Storage
9.1 Marking
9.1.1 The marking of the instrument shall include the following contents: a) Manufacturer?€?s name;
b) Instrument model;
c) Instrument name;
d) Trademark;
e) Date of manufacture;
f) Exit-factory No.
9.1.2 The nominal values shall include the following contents:
a) Sampling airflow ratio;
b) Sampling efficiency;
c) Survival rate of microbial;
d) Particle size range of sampled particles.
9.2 Packaging
9.2.1 The instrument packaging shall be moisture-proof and shock-proof. 9.2.2 The accompanying documents of the instrument shall include:
a) Packing list;

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