YY/T 0657-2017 PDF English
US$150.00 · In stock · Download in 9 secondsYY/T 0657-2017: Medical centrifuge Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedureStatus: Valid YY/T 0657: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| YY/T 0657-2017 | English | 150 |
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Medical centrifuge
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| YY/T 0657-2008 | English | 170 |
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Medical centrifuge
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YY/T 0657-2017: Medical centrifuge---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT0657-2017
YY
PHARMACEUTICAL INDUSTRY STANDARD
ICS 11.100
C 44
Replacing YY/T 0657-2008
Medical centrifuge
Issued on. MARCH 28, 2017
Implemented on. APRIL 01, 2018
Issued by. China Food and Drug Administration
Table of Contents
Foreword... 3
1 Scope... 4
2 Normative references... 4
3 Terms and definitions... 4
4 Product classifications... 5
5 Requirements... 5
6 Test methods... 8
7 Labels, markings and instructions for use... 11
8 Packaging, transportation and storage... 12
Foreword
This Standard is drafted in accordance with the rules given GB/T 1.1-2009.
This Standard is the revision of YY/T 0657-2008; the main technical content changes
are as follows.
- ADD the requirements for electromagnetic compatibility;
- ADD the requirements for labels, labelling and information to be supplied;
- ADD the terms and definitions;
- MODIFY the acceleration and deceleration time of centrifuge.
Attention is drawn to the possibility that some of the elements of this document may
be the subject of patent rights. The issuing agency of this document shall not be held
responsible for identifying any or all of such patent rights.
This Standard was proposed by China Food and Drug Administration.
This Standard shall be under the jurisdiction of National Technical Committee on
Medical Clinical Laboratory and in vitro Diagnostic Systems of Standardization
Administration of China (SAC/TC 136).
Drafting organizations of this Standard. Beijing Institute of Medical Device Testing,
Beijing Lab Medical Devices Co., Ltd., Thermo Fisher Scientific (China) Co., Ltd.,
Beckman Coulter Business (China) Co., Ltd., Beijing Baiyang Medical Devices Co.,
Ltd.
Main drafters of this Standard. Liao Xiaoman, Xu Zhiqiang, Cao Qing, Jiang Yundan,
Liu Pei, Liu Qiuyue, Liu Zhijie.
This Standard replaces YY/T 0657-2008.
The historical versions of YY/T 0657 are as follows.
- ZBC 44002-84, YY 91100-1999;
- GB 12258-90, YY 91046-1999;
- YY/T 0657-2008.
Medical centrifuge
1 Scope
This Standard specifies the terms and definitions, product classification, requirements,
test methods, marking and instructions for use, packaging, transportation and storage
of medical centrifuges (hereinafter referred to as centrifuges).
This Standard applies to the design, production and testing of centrifuges.
This Standard does not apply to super speed centrifuges (with the speed greater than
30 000 r/min).
2 Normative references
The following referenced documents are indispensable for the application of this
document. For dated references, only the dated edition cited applies. For undated
references, the latest edition of the referenced document (including all amendments)
applies.
GB/T 191 Packaging - Pictorial marking for handling of goods
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 laboratory centrifuges
GB/T 14710 The environmental requirement and test methods for medical electrical
equipment
3 Terms and definitions
For the purpose of this document, the following terms and definitions apply.
3.1
low speed centrifuge
Centrifuge with the rated maximum speed less than 10 000 r/min.
[GB/T 30099-2013, definition 3.4]
3.2
high speed centrifuge
Centrifuge with the rated maximum speed between ≥ 10 000 r/min and ≤ 30 000 r/min.
[GB/T 30099-2013, definition 3.5]
3.4
large capacity centrifuge
Centrifuge with the maximum rotor capacity greater than 3 000 mL.
4 Product classifications
According to the type, centrifuges are divided into desktop type and floor type.
According to the speed, centrifuges are divided into low speed, high speed and super
speed.
5 Requirements
5.1 Working conditions
Working conditions of centrifuges.
5.2 Relative speed deviation
At the rated voltage, the maximum load and the corresponding maximum speed, the
relative speed deviation of centrifuges shall comply with the provisions of Table 1.
5.3 Speed stability accuracy
At the rated voltage, the maximum speed and the corresponding maximum load, the
speed stability accuracy shall be within ± 1 %.
5.4 Complete machine noise
At the maximum speed and the corresponding maximum load, the noise of centrifuges
shall not exceed 70 dB (A).
5.6 Temperature rise of sample solution
For non-refrigerated centrifuges at the maximum speed and the corresponding
maximum load, after operating for a specified period of time, the temperature rise of
the sample solution in the centrifuge tube (bottle) shall meet the requirements of Table
2.
5.7 Relative timing deviation of centrifuges
5.8 Acceleration and deceleration time of centrifuges
The acceleration and deceleration time of centrifuges shall meet the requirements of
Table 3.
5.9 Refrigeration effect of refrigerated centrifuges
5.12 Environmental test
The environmental test of centrifuges shall be carried out according to the provisions
of GB/T 14710.
6 Test methods
6.1 Appearance
Visual observation, which shall comply with the provisions of 5.11.
6.2 Relative speed deviation
6.3 Speed stability accuracy
ADJUST the centrifuge installed with a fully loaded rotor TO the maximum speed. After
the operation is smooth, USE a speedometer of one-thousandth accuracy to measure
the speed of the centrifuge every 5 min; MEASURE five times; CALCULATE the
average value; CALCULATE the speed stability accuracy according to equation (2),
take whichever is the maximum value or the minimum value, which shall comply with
the provisions of 5.3.
6.5 Amplitude
USE a vibration meter or dial indicator to measure in the middle of the centrifuge
enclosure, take whichever is the maximum value, which shall comply with the
provisions of 5.5.
6.6 Temperature rise of sample solution
TAKE the sample solution with the same temperature as ambient temperature into a
centrifuge tube (bottle); MEASURE with a point thermometer with the accuracy of 1 °C.
After operating for the operating time as specified in 5.4.3, the difference between the
measured sample solution temperature and the ambient temperature shall comply with
the provisions of 5.6.
6.9 Refrigeration effect of refrigerated centrifuge
6.9.1 Refrigeration time
6.9.1.1 INSTALL the centrifuge with the maximum rotor corresponding to the maximum
speed; SET the maximum speed;
6.9.2 Temperature fluctuation deviation
6.9.2.1 ADJUST the centrifuge installed with the maximum rotor corresponding to the
maximum speed TO the maximum speed;
6.9.2.2 SET the temperature of the centrifuge chamber or the sample TO 5 °C, 10 °C,
15 °C respectively. Under each setting condition, when the temperature display or the
indicator reading reaches the set value, start reading after it is stable. READ the display
temperature every 5 min; READ five times per gear; CALCULATE the average value
of 5 temperatures of each gear; MINUS the set value. It shall meet the requirements
of 5.9.3.
6.10 Safety requirements
6.11 Environmental test
Test according to the provisions of GB/T 14710.
7 Labels, markings and instructions for use
7.1 General
Characters of instructions, labels and packaging markings shall be in Chinese, other
languages may be attached. The use of Chinese shall comply with the national
language specification. Characters, symbols, graphics, tables, pictures, etc. of
instructions, labels and packaging markings shall be accurate, clear and standardized.
Symbols used in instructions and markings shall meet the requirements of YY/T 0466.1.
7.2 Instrument markings
The centrifuge shall have the following markings.
7.3 Packaging box markings
The packaging box shall have the following markings.
7.4 Instructions for use
The instructions for use shall meet the relevant requirements of national standards or
industry standards. Generally, it shall include the following.
8 Packaging, transportation and storage
8.1 Packaging
8.1.1 Each centrifuge shall have outer packaging, which shall be moisture-proof and
shock-proof.
8.1.2 The attached documents shall include at least.
8.2 Transportation
Centrifuges, at the packaging state, shall be transported according to the requirements
of the order contract. During the transportation, they shall be protected against severe
shocks, rain and exposure.
8.3 Storage
Fully packaged centrifuges shall be stored in well-ventilated rooms with relative
humidity less than 80 %, and without corrosive gases.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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