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YY/T 0657-2017 English PDF (YYT0657-2017)

YY/T 0657-2017 English PDF (YYT0657-2017)

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YY/T 0657-2017: Medical centrifuge

This Standard specifies the terms and definitions, product classification, requirements, test methods, marking and instructions for use, packaging, transportation and storage of medical centrifuges.
YY/T 0657-2017
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE REPUBLIC OF CHINA
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
GB/T 18268.1 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1. General requirements
YY/T 0466.1 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1. General requirements 3 Terms and definitions
For the purpose of this document, the following terms and definitions apply. 3.1
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.
6.7 Relative timing deviation
USE a stopwatch with the division of 1 s to measure the relative deviation between the measured time and the set value at a set value of 5 min and 60 min or the maximum time, which shall comply with the provisions of 5.7.
6.8 Acceleration and deceleration time
6.8.1 INSTALL the fully loaded rotor to be tested capable of rising to the maximum speed of the centrifuge; MEASURE with a stopwatch with the division of 1 s; 6.8.2 TURN ON the centrifuge; MEASURE the time required for the rotor to rise from standstill to the maximum speed, which shall comply with the provisions of 5.8; 6.8.3 When the rotor of the centrifuge is at the maximum speed, press the stop key, and then measure the time required for the rotor to drop from the maximum speed to standstill, which shall comply with the provisions of 5.8.
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;
6.9.1.2 TURN ON the centrifuge and the refrigeration system, while timing with a stopwatch with the accuracy of 1 s, to measure the time taken for the temperature of the centrifugal chamber or the sample to fall to 4 ??C, which shall comply with the provisions of 5.9.2.
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
f) the pictorial marking for handling of goods such as ?€?This Way Up?€?, ?€?Fragile, Handle with Care?€? and ?€?Keep Dry?€? as specified in GB/T 191;
g) the storage and transportation conditions.
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.
a) the name, model, specification of the product;
b) the name, registered address, production address, contact information and after- sales service organization of the production enterprise;
c) the performance, main structure, scope of application of the product; d) the precautions and other contents need to be warned or prompted;
e) the explanations of the contents such as graphics, symbols and abbreviations used in medical device labels;
f) the instructions for installation and use or schematic diagrams;
g) the method for product maintenance and care, special storage conditions and methods;
h) any other contents which shall be indicated in the instructions as specified in the product standard.
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.
a) the inspection certificate;
b) the packing list;
c) the instructions for use of the product.
8.1.3 The inspection certificate shall include at least the following.
a) the name and model of the product;

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