Chinese Standards Shop Partner of Google-Books Database: 169759 (Nov 10, 2019)
 HOME   Quotation   Tax   Examples Standard-List   Contact-Us   View-Cart
  

YY/T 0657-2008

Chinese Standard: 'YY/T 0657-2008'
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusRelated Standard
YY/T 0657-2008English170 Add to Cart 0--15 minutes. Auto immediate delivery. Medical centrifuge Obsolete YY/T 0657-2008
YY/T 0657-2008Chinese14 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]

 YY/T 0657-2008 -- Click to view a PDF In 0~10 minutes time, full copy of this English-PDF will be auto-immediately delivered to your email by our cloud-server.  
Detail Information of 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: 8,899
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Older Standard (superseded by this standard): YY 91046-1999; YY 91100-1999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),

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
医用离心机
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 ......
Related standard:   YY/T 0657-2017  YY/T 0653-2017
   
 
Privacy   ···   Product Quality   ···   About Us   ···   Refund Policy   ···   Fair Trading   ···   Quick Response
Field Test Asia Limited | Taxed in Singapore: 201302277C | Copyright 2012-2019