YY/T 0657-2017 English PDF (YY/T0657-2017)

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YY/T 0657-2017: Medical centrifuge
YY/T 0657-2017
Medical centrifuge
ICS 11.100
C44
People's Republic of China pharmaceutical industry standards
Replacing YY/T 0657-2008
Medical centrifuge
2017-03-28 Posted
2018-04-01 implementation
State Food and Drug Administration released
Directory
Preface Ⅰ
1 range 1
2 Normative references 1
3 Terms and definitions 1
4 product categories 2
5 Requirements 2
6 test method 4
7 labels, marking and instructions for use 6
8 packaging, transportation and storage 6
Table 1 relative speed deviation 2
Table 2 test solution temperature rise 3
Table 3 Centrifuge lifting time 3
Table 4 background noise correction value 5
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard is the YY/T 0657-2008 revision, the main technical content changes as follows.
--- Increased on the electromagnetic compatibility requirements;
--- Added labeling, marking and providing information requirements;
--- Added terms and definitions;
--- Modify the centrifuge speed down time.
Please note that some of this document may be patentable. The issuing agencies of this document do not bear the responsibility of identifying these patents.
This standard proposed by the State Food and Drug Administration.
This standard by the National Medical Clinical Laboratory and in vitro diagnostic system standardization Technical Committee (SAC/TC136) centralized.
This standard was drafted. Beijing Medical Device Inspection Institute, Beijing Leibo Medical Devices Co., Ltd., Thermo Fisher Scientific (China)
Limited, Beckman Coulter Commerce (China) Co., Ltd., Beijing Bai Yang Medical Devices Co., Ltd.
The main drafters of this standard. Liao Xiaoman, Xu Zhiqiang, Cao Qing, Jiang Yun Dan, Liu Pei, Liu Chiu Yue, Liu Zhijie.
This standard replaces YY/T 0657-2008.
YY/T 0657 previous version of the release.
--- ZBC44002-84, YY 91100-1999;
--- GB 12258-90, YY 91046-1999;
--- YY/T 0657-2008.
Medical centrifuge
1 Scope
This standard specifies the terms and definitions of medical centrifuges (hereinafter referred to as centrifuges), product classification, requirements, test methods, signs and use
Instructions and packaging, transportation and storage.
This standard applies to centrifuge design, production and testing.
This standard does not apply to speeding centrifuge (speed greater than 30000r/min).
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version applies to this article
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 191 Packaging - Pictorial signs
GB 4793.1 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 1. General requirements
GB 4793.7 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 7. Particular requirements for centrifuges for laboratory use
GB/T 14710 medical appliances environmental requirements and test methods
GB/T 18268.1 Electromagnetic compatibility requirements for electrical equipment for measurement, control and laboratory use - Part 1. General requirements
YY/T 0466.1 Medical Devices Labeling, Marking and Notification of Use for Medical Devices Part 1. General Requirements
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Low speed centrifuge lowspeedcentrifuge
Rated maximum speed of less than 10000r/min centrifuge.
[GB/T 30099-2013 definition 3.4]
3.2
High speed centrifuge highspeedcentrifuge
Rated maximum speed at greater than or equal to 10000r/min less than or equal to 30000r/min centrifuge.
[GB/T 30099-2013 definition 3.5]
3.3
Ultracentrifuge superspeedcentrifuge
Rated maximum speed greater than 30000r/min centrifuge.
[GB/T 30099-2013 definition 3.6]
3.4
Large capacity centrifuge largecapacitycentrifuge
Centrifuge with a maximum rotor capacity of more than 3000 mL.
4 product categories
Centrifuge by type is divided into desktop and floor.
Centrifuge divided by speed into low speed, high speed and speeding.
Centrifuge functionally divided into frozen and non-frozen type.
Centrifuge by capacity is divided into ordinary and large capacity.
5 requirements
5.1 working conditions
Centrifuge working conditions.
a) Ambient temperature .10 ℃ ~ 30 ℃ (frozen type); 5 ℃ ~ 40 ℃ (non-frozen type);
Note. If the ambient temperature specified by the manufacturer is inconsistent with this standard, it may be implemented according to the manufacturer's instructions.
b) Relative humidity ≤ 80%
c) Atmospheric pressure .860hPa ~ 1060hPa;
d) no conductive dust in the surrounding environment, explosive gas and corrosive gases;
e) Power supply. Rated voltage AC 220V or 380V, the range of allowable deviation from the rated value is ± 10%; Rated frequency 50Hz, allowing
Deviation from the rated value is ± 2%.
5.2 relative speed deviation
Centrifuge rated voltage, maximum speed corresponding to the maximum load, the relative speed deviation should be consistent with the provisions of Table 1.
Table 1 Relative speed deviation
Name relative deviation /%
Low speed centrifuge ± 2.5
High Speed Centrifuge ± 1
Low-speed refrigerated centrifuge ± 2.5
High speed refrigerated centrifuge ± 1
Low speed high capacity centrifuge ± 2.5
Low-speed freezing high-capacity centrifuge ± 1
5.3 speed stability and accuracy
Rated voltage, maximum speed and the corresponding maximum load, the speed stability should be within ± 1% accuracy.
5.4 machine noise
Centrifuge at the maximum speed corresponding to the maximum load, the noise should not exceed 70dB (A).
5.5 Amplitude
Centrifuge at the maximum speed corresponding to the maximum load, the operation should be smooth, the amplitude should not exceed 0.1mm.
5.6 test solution temperature rise
Non-freezing centrifuge at the maximum speed corresponding to the maximum load, after a specified period of operation, the centrifuge tube (bottle) test solution temperature rise should comply with Table 2
Request.
Table 2 test solution temperature rise
Name Running time/min Test solution temperature rise/℃
High-speed centrifuge 15 ≤12
Low-speed centrifuge 20 ≤ 10
Low-speed high-capacity centrifuge 20 ≤ 10
5.7 Centrifuge timing relative deviation
5.7.1 The relative deviation of the digital timing device should not exceed ± 1%;
5.7.2 Mechanical timing device relative deviation should not exceed ± 5%.
5.8 Centrifuge lifting time
Centrifuge lifting time should meet the requirements of Table 3.
Table 3 Centrifuge lifting time
Name Speed up time/min Deceleration time/min
High speed refrigerated centrifuge ≤5 ≤7
High speed centrifuge ≤5 ≤7
Low-speed refrigerated centrifuge ≤3 ≤5
Low speed centrifuge ≤5 ≤7
Low-speed high-capacity centrifuge ≤ 6 ≤8
Low-speed freezing large-capacity centrifuge ≤ 6 ≤8
5.9 Freezing centrifuge refrigeration effect
5.9.1 Ambient temperature Under normal operating conditions, the centrifuge is not pre-cooling, the centrifuge at the highest speed and the corresponding maximum load, the most centrifugal chamber
Low temperature should be able to reach 4 ℃.
5.9.2 Ambient temperature Under normal operating conditions, the time for the temperature in the centrifuge chamber to drop from room temperature to 4 ° C should not exceed 20 min.
5.9.3 Ambient temperature at 20 ℃ ± 5 ℃, when the temperature control range of the centrifugal chamber at 4 ℃ ~ 15 ℃, temperature fluctuation deviation should not exceed
± 2 ℃.
5.10 safety
5.10.1 General requirements for electrical safety centrifuge should be consistent with the provisions of GB 4793.1.
5.10.2 centrifuge electrical safety special requirements shall comply with the provisions of GB 4793.7.
5.10.3 centrifuge electromagnetic compatibility requirements should be consistent with the provisions of GB/T 18268.1.
5.11 appearance
Centrifuge surface should be clean, smooth, no obvious scratches, burrs and uneven phenomenon, text and symbols clearly marked.
5.12 Environmental testing
Centrifuge environmental test according to GB/T 14710 regulations.
6 test methods
6.1 appearance
Eye observation, should be consistent with the provisions of 5.11.
6.2 Relative speed deviation
6.2.1 will be loaded to turn the centrifuge fully adjusted to the maximum speed, stable 5min.
6.2.2 Accuracy of one-thousandth of the speedometer measuring the actual speed centrifuge, according to equation (1) calculate the relative speed deviation should be consistent with 5.2
Provisions.
Relative deviation =
nA
A × 100%
(1)
In the formula.
n --- actual speed
A --- maximum speed.
6.3 Speed stability accuracy
Will be loaded to the turret full load transferred to the highest speed, smooth operation, the accuracy of one-thousandth of the speedometer measured every 5min 1
Speed, a total of 5 measurements, calculate the average, then press (2) calculate the speed stability accuracy, whichever is the maximum or minimum, should be consistent with 5.3
Provisions.
Speed stability accuracy =
nmax (or nmin) -n
n × 100%
(2)
In the formula.
n --- speed average;
nmax --- the actual maximum speed;
nmin --- the actual minimum speed.
6.4 machine noise
6.4.1 at a distance of centrifuges, left, right, front and rear 1m Department, with the sound pressure level A-weighted network to measure, take the maximum of 5 points
Value should be consistent with the provisions of 5.4.
6.4.2 Background noise The correction value of the sound level, the background A sound level and the sound pressure level of the letter band are 10dB lower than the noise value of the centrifuge under test (A)
Above, the measurement value is not modified. In 4dB (A) ~ 10dB (A), should be amended as specified in Table 4; below 4dB (A), its
The measurement is invalid.
Table 4 background noise correction in dB (A)
The difference between the measured noise level and the background sound pressure level when the centrifuge is running 4 5 6 7 8 9 10
Correction value K 2.2 1.7 1.3 1.0 0.8 0.6 0.4
Note 1. K indicates the value to be subtracted from the measured value.
Note 2. The quality of arbitration, the need to be amended background noise.
6.5 Amplitude
Vibration meter or dial indicator in the middle of the centrifuge to measure, whichever is the maximum value should be consistent with the provisions of 5.5.
6.6 test solution temperature rise
Take the same ambient temperature test solution into the centrifuge tube (bottle), with a precision of 1 ℃ point meter to measure, according to the provisions of 5.4.3
Time running, the temperature difference between the test solution and the ambient temperature should be consistent with the provisions of 5.6.
6.7 Relative timing deviation
With the division of the value of 1s stopwatch set at 5min and 60min or maximum time, the measured time between the measured value and the set value
Deviations should be consistent with the provisions of 5.7.
6.8 liters of deceleration time
6.8.1 Fitted with a fully loaded rotor capable of rising to the maximum speed of the centrifuge; measured with a stopwatch of 1s;
6.8.2 Starting the centrifuge to measure the time required for the rotor to rise from standstill to maximum speed shall comply with the provisions of 5.8;
6.8.3 When the centrifuge rotor at the maximum speed, press the stop key to measure the rotor from the maximum speed down to rest the time required should be consistent
5.8 provisions.
6.9 refrigeration centrifuge cooling effect
6.9.1 Cooling time
6.9.1.1 installed on the machine up to the maximum speed corresponding to the maximum rotor, set the maximum speed;
6.9.1.2 Start the centrifuge and refrigeration system, at the same time with the accuracy of 1s stopwatch time, measuring the centrifugal chamber or the sample temperature dropped to 4 ℃ time
Should comply with the provisions of 5.9.2.
6.9.2 Temperature fluctuation deviation
6.9.2.1 will be equipped with centrifuge maximum rotation corresponding to the maximum rotor centrifuge adjusted to the maximum speed;
6.9.2.2 Centrifugal chamber or sample temperature settings were 5 ℃, 10 ℃, 15 ℃, in each setting conditions, when the temperature display or indicator
The readings reach the set values respectively, and after the start of the reading, the readings are started. The reading temperature is read every 5 minutes, and the readings are taken five times for each file. Five temperatures per file
The average, minus the setting, shall meet the requirements of 5.9.3.
6.10 safety requirements
6.10.1 General requirements for electrical safety, according to the provisions of GB 4793.1 test method.
6.10.2 Electrical safety special requirements, according to the method of GB 4793.7 test.
6.10.3 Electromagnetic compatibility requirements, according to the provisions of GB/T 18268.1 test method.
6.11 Environmental testing
According to the provisions of GB/T 14710 for testing.
7 labels, marking and instructions for use
7.1 General
Instructions, labels and packaging logo text should be used in Chinese, you can add other languages. The use of Chinese should be consistent with the national common
Language specification. Instructions, labels and packaging logo text, symbols, graphics, tables, pictures, etc. should be accurate, clear and standardized. Standard
Symbols used in the instructions and instructions should be consistent with the requirements of YY/T 0466.1.
7.2 Instrument marking
Centrifuge should have the following mark.
a) product name, model;
b) manufacturer's name and address;
c) power connection conditions, input power;
d) date of production or batch (code).
7.3 Package marking
The box should have the following logo.
a) product name, model;
b) manufacturer's name and address;
c) the date of production or batch (ed.) number;
d) External dimensions. L × B × H (mm);
e) Gross or net weight (kg);
f) there are "up", "fragile items" "fear of rain" and other storage and transportation according to GB/T 191 requirements icon;
g...