YY/T 0657-2017 (YY/T0657-2017, YYT 0657-2017, YYT0657-2017) & related versions
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YY/T 0657-2017
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S 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;
......
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;
......
| Standard ID | YY/T 0657-2017 (YY/T0657-2017) | | Description (Translated English) | Medical centrifuge | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100 | | Word Count Estimation | 10,154 | | Date of Issue | 2017-03-28 | | Date of Implementation | 2018-04-01 | | Older Standard (superseded by this standard) | YY/T 0657-2008 | | Drafting Organization | Beijing Medical Devices Testing Center, Beijing Leiboer Medical Devices Co., Ltd., Thermo Fisher Scientific (China) Co., Ltd., Beckman Coulter Business (China) Co., Ltd. and Beijing Baiyang Medical Devices Co., Ltd. | | Administrative Organization | National Medical Clinical Laboratory and in vitro diagnostic system standardization Technical Committee (SAC/TC 136) | | Proposing organization | China Food and Drug Administration | | Issuing agency(ies) | State Food and Drug Administration | | Standard ID | YY/T 0657-2008 (YY/T0657-2008) | | Description (Translated English) | Medical centrifuge | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100 | | Word Count Estimation | 8,866 | | Date of Issue | 2008-04-25 | | Date of Implementation | 2009-06-01 | | Older Standard (superseded by this standard) | YY 91046-1999; YY 91100-1999 | | Quoted Standard | GB/T 191; GB 4793.1; GB 4793.7; GB/T 14710 | | Drafting Organization | Beijing Medical Device Testing | | Administrative Organization | National Standardization Technical Committee of Medical clinical testing laboratories and in vitro diagnostic systems | | Regulation (derived from) | SFDA [2008] No. 192 | | Proposing organization | State Food and Drug Administration | | Issuing agency(ies) | China Food and Drug Administration | | Summary | This standard specifies the Medical Centrifuge (hereinafter referred to as centrifuges) product classification, requirements, test methods, marking, labeling, instructions, packaging, transportation and storage requirements. This standard applies to medical centrifuge design, production and testing. This standard does not apply to ultracentrifuge (speed above 30000r/min), | | Standard ID | () | | Description (Translated English) | (Technical specifications for ceramic capacitive sensor type partial discharge monitoring devices of 35kV and below) | | Sector / Industry | Chinese Industry Standard | | Date of Issue | 2023-10-11 | | Date of Implementation | 2024-04-11 | | Issuing agency(ies) | National Energy Board |
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