YY/T 0657-2008 English PDF (YYT0657-2008)

This Standard specifies the classification, requirements, test methods, marking, labeling, use instructions, as well as packaging, transportation and storage requirements for medical centrifuges. This Standard is applicable to the design, production and inspection of medical centrifuges.

YY/T 0657-2008
YY
ICS 11.100
C 44
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE'S REPUBLIC OF CHINA
Replacing YY 91046-1999 and YY 91100-1999
Medical centrifuge
ISSUED ON. APRIL 25, 2008
IMPLEMENTED ON. JUNE 01, 2009
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Product classification ... 4
4 Requirements ... 5
5 Test methods ... 7
6 Marking and use instructions ... 10
7 Packaging, transportation and storage ... 12
Foreword
This Standard is the revision of YY 91046-1999 “Medical low-speed centrifuge” and YY 91100-1999 “High-speed refrigerated centrifuge”; this revision was prepared by merging the content of the two standards.
Compared with the original standards, the main changes of this Standard are as follows.
- ADD the content of low-speed large-capacity refrigerated centrifuge;
- For general requirements for electrical safety, the original standard implement GB 9706.1, which is now changed to GB 4793.1;
- ADD special safety requirements, implementing GB 4793.7.
This Standard has replaced YY 91046-1999 and YY 91100-1999 from the date of implementation.
This Standard is proposed by China Food and Drug Administration.
This Standard shall be under the jurisdiction of by National Standardization Technical Committee on Medical Clinical Laboratory and In Vitro Diagnostic System. Drafting organizations of this Standard. Beijing Medical Devices Laboratory, Shanghai Anting Scientific Instrument Factory.
Main drafters of this Standard. Liao Xiaoman, Shen Yaming, Zhang Zhaoyuan. The previous version of the standards replaced by this Standard are as follows. - GB 12258-90, YY 91046-1999;
- ZBC 44002-84, YY 91100-1999.
Medical centrifuge
1 Scope
This Standard specifies the classification, requirements, test methods, marking, labeling, use instructions, as well as packaging, transportation and storage requirements for medical centrifuges (hereinafter referred to as centrifuges). This Standard is applicable to the design, production and inspection of medical centrifuges.
This Standard does not apply to ultracentrifuges (rotational speed higher than 30000 r/min).
2 Normative references
The provisions in following documents become the provisions of this Standard through reference in this Standard. For dated references, the subsequent amendments (excluding corrections) or revisions do not apply to this Standard, however, parties who reach an agreement based on this Standard are encouraged to study if the latest versions of these documents are applicable. For undated references, the latest edition of the referenced document 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 Environmental requirement and test methods for medical electrical equipment
3 Product classification
3.1 Centrifuge type is divided into bench and ground type.
3.2 The basic parameters of centrifuges shall comply with the specifications of Table 1.
Low-speed large-capacity centrifuge ≤ 6 ≤ 10
Low-speed refrigerated large-capacity
centrifuge
≤ 6 ≤ 10
4.7 Refrigerated centrifuge’s cooling effect
4.7.1 At ambient temperature and normal operating conditions, when the centrifuge is not pre-cooled, and at the maximum rotational speed and the corresponding load, the minimum temperature of the centrifugal chamber shall be able to reach 4 °C. 4.7.2 At ambient temperature and normal operating conditions, the time the centrifugal chamber takes to lower down its temperature from room temperature to 4 °C shall be less than 20 min.
4.7.3 Temperature fluctuation deviation of centrifuge. when the ambient temperature is 20 °C ± 5 °C, and the temperature of centrifugal chamber is 4 °C ~ 15 °C, the temperature fluctuation deviation shall not be more than ± 2 °C.
4.8 Safety
4.8.1 General requirements for electrical safety of centrifuges shall comply with the specifications of GB 4793.1.
4.8.2 The special safety requirements for centrifuges shall comply with the specifications of GB 4793.7.
4.9 Appearance
Centrifuge surface shall be neat, smooth, no obvious scratches, glitches and rugged phenomenon, text and symbol marks shall be clear.
4.10 Environmental test
Environmental test of centrifuge shall be conducted according to the specifications of GB/T 14710.
5 Test methods
5.1 Appearance
Visual observation, which shall comply with the specifications of 4.9.
5.2 Relative deviation of rotational speed
5.2.1 SET the centrifuge with a full-load rotor TO the maximum rotational speed; SET the maximum rotational speed.
5.9.1.2 START the centrifuge and refrigeration system, meanwhile, USE the stopwatch with a precision of 1 s to time; MEASURE the time the centrifugal chamber takes to lower down its temperature to 4 °C, which shall comply with the specifications of 4.7.2. 5.9.2 Temperature fluctuation deviation
5.9.2.1 SET the centrifuge with a full-load rotor TO the maximum rotational speed. 5.9.2.2 SET the temperature of centrifugal chamber TO 5 °C, 10 °C and 15 °C respectively. Under each setting condition, when the temperature display or indication meter reading reaches the set value respectively, start reading after stabilization. Read the display temperature every 5 min, and 5 times for each speed level; CALCULATE the average value of 5 temperature values of each speed level; MINUS the set value, which shall comply with the specifications of 4.7.3.
5.10 Safety requirements
5.10.1 General safety requirements, inspect according to the method specified in GB 4793.1.
5.10.2 Special safety requirements, inspect according to the method specified in GB 4793.7.
5.11 Environmental test
INSPECT according to the specifications of GB/T 14710.
6 Marking and instructions for use
6.1 General
Words of instructions, labels and packaging marks shall be written in Chinese characters, and can be attached to other languages. The use of Chinese language shall comply with the national language norms. The words, symbols, graphics, tables, pictures, etc. of the instructions, labels and packaging marks shall be accurate, clear and standardized.
6.2 Instrument marking
Centrifuges shall have the following marks.
a) product name and model;
b) name and address of the manufacturer;