YY/T 1288-2015 PDF in English
YY/T 1288-2015 (YY/T1288-2015, YYT 1288-2015, YYT1288-2015)
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| YY/T 1288-2015 | English | 150 |
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Nylon blood filter nets for transfusion equipments for single use
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Standards related to (historical): YY/T 1288-2015
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YY/T 1288-2015: PDF in English (YYT 1288-2015) YY/T 1288-2015
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.20
C 31
Nylon blood filter nets for
transfusion equipment for single use
ISSUED ON. MARCH 2, 2015
IMPLEMENTED ON. JANUARY 1, 2016
Issued by. China Food and Drug Administration of China
Table of Contents
Foreword . 3
1 Scope .. 4
2 Normative references . 4
3 Classification and marking .. 4
4 Materials . 5
5 Physical requirements . 6
6 Chemical requirements . 7
7 Biological requirements . 8
8 Type inspection . 9
9 Marks .. 9
10 Packaging . 10
Annex A (Normative) Test method of filter net particle pollution . 11
Annex B (Normative) Test method of filtration performance of filter net . 12
Foreword
This Standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Attention is drawn to the possibility that some of the elements of this Standard
may be the subject of patent rights. The issuing authority shall not be held
responsible for identifying any or all such patent rights.
This Standard shall be under the jurisdiction of National Technical Committee
on Medical Infusion Apparatus of Standardization Administration of China
(SAC/TC 106).
Main drafting organizations of this Standard. Wuxi Bolcon Medical Machinery
Plastic Co., Ltd.
The drafting organizations of this Standard. Shandong Medical Device Quality
Inspection Center, Shanghai Zhenpu Medical Equipment Co., Ltd., Jintan
Kangda Medical Equipment Manufacturing Co., Ltd.
Main drafters of this Standard. Zhang Xianshun, Guo Maochun, Jia Yufei,
Zhang Songhe, Shi Lihu, Liu Lili, Wang Tongchao, Zhang Bo, Guo Xianhu.
Nylon blood filter nets for
transfusion equipment for single use
1 Scope
This Standard specifies the requirements for nylon blood filter nets for
transfusion equipment for single use (hereinafter referred to as the filter net).
The filter net can be installed in the dropping funnel or accessories of
transfusion (blood collection) apparatus, used to filter blood clots, impurities and
foreign bodies in blood or blood products.
2 Normative references
The following referenced documents are indispensable for the application of
this document. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any
amendments) applies.
GB 8369, Medical transfusion sets for single use
GB/T 14233.1-2008, Test methods for infusion transfusion injection
equipment for medical use - Part 1. Chemical analysis methods
GB/T 16886.1, Biological evaluation of medical devices - Part 1. Evaluation
and testing
GB/T 19466.3-2004, Plastics - Differential scanning calorimetry (DSC) - Part
3. Determination of temperature and enthalpy of melting and crystallization
Pharmacopoeia of the People's Republic of China (3 Volumes) Edition 2010
3 Classification and marking
3.1 Structure type of filter net
See Figure 1 for the example of typical bracket filter net structure. See Figure
2 for the example of typical bag filter net (without fixed bracket) structure.
3.2 Marking
The marking example of the filter net is as follow.
welding firmness according to the specific conditions.
5.4 Particulate pollution
The filter net shall be made under conditions of minimum particulate
contamination. When tested according to Annex A, the pollution index shall not
exceed 90.
5.5 Filtration performance
When tested according to Annex B, the rejection of the filter net to 240μm
particles shall not be less than 95%, not less than 95% to 160μm particles.
NOTE. If tested, the test filter net is organized as a single warp single weft. And when the wire
diameter conforms to 100μm±10μm, and the aperture conforms to 200μm±20μm, it can be
exempt from the filter performance test.
5.6 Melting peak temperature
When tested according to the method specified in GB/T 19466.3, the
monofilament melting peak temperature (melting point) of the filter net made of
nylon 66 monofilament shall be in the range of 246°C ~ 257°C (475°F ~ 495°F);
the monofilament melting peak temperature (melting point) of the filter net made
of nylon 1010 monofilament shall be in the range of 198°C ~ 210°C (388°F ~
410°F).
NOTE. It can also be measured using other validated equivalent test methods.
6 Chemical requirements
6.1 Preparation of chemical test liquid
Take several samples and add them to a glass container. Add water in a ratio
of 2.1 to the total surface area (cm2) and water (mL) of the sample. After capping,
place it at 37°C±1°C for 24h. Separate the sample from the liquid. Cool to room
temperature. Use it as inspection liquid. Take the same volume of water in the
glass container and prepare a blank control solution.
6.2 Reducing substance
When tested according to the provisions of 5.2.2 of GB/T 14233.1-2008, the
difference between the volume of potassium permanganate solution
c(KMnO4)=0.002 mol/L consumed by the test solution and the blank solution
shall not exceed 2.0 mL.
6.3 Metal ion
8 Type inspection
8.1 The type inspection is a full performance inspection.
8.2 In the type inspection, if there is no special requirement, the physical
requirements shall be randomly sampled by 5, and other tests shall be carried
out according to the standard regulations. If all inspection items are all qualified,
it is determined as qualified, otherwise unqualified.
9 Marks
9.1 Initial packaging marks
The product's initial packaging shall have the following marks.
a) manufacturer's name and/or trademark, address, contact information;
b) product name and specification model;
c) material and organization of filter net;
d) quantity;
e) product effective date;
f) batch number;
g) reference to this Standard.
9.2 Outer packaging mark
The outer packaging shall have the following marks.
a) manufacturer's name and/or trademark, address, contact information;
b) product name and specification model;
c) material and organization of filter net;
d) net weight, gross weight, quantity;
e) volume (length x height x width);
f) product effective date;
g) batch number;
h) reference to this Standard;
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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