YY/T 0326-2017 English PDF (YYT0326-2017)

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YY/T 0326-2017: Plasmapheresis centrifuge apparatus for single use
YY/T 0326-2017
Plasmapheresis centrifuge apparatus for single use
ICS 11.040.20
C31
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0326.1-2002, YY 0326.2-2002 and YY 0326.3-2005
Disposable Centrifugal Plasma Separator
Published on.2017-05-02
2018-04-01 Implementation
The State Food and Drug Administration issued
Directory
Preface III
Introduction IV
1 Range 1
2 Normative references 1
3 Structure and Type 1
4 Venipuncture device (mechanical blood collector) 4
5 Physical Requirements 4
5.1 Plasma Cup 4
5.2 Plasma line 5
5.3 Blood Bag 7
6 Chemical Requirements 8
6.1 Separation Cup 8
6.2 Plasma Line 9
6.3 Blood Bag 9
7 Biological Requirements 10
7.1 Separation Cup 10
7.2 Plasma Tubing 10
7.3 Blood Bag 10
7.4 Bacterial endotoxin 10
8 type inspection 10
9 Signs 10
9.1 Single Pack 10
9.2 Blood Bag Label 11
9.3 Transport Packaging 11
10 Packing 11
Appendix A (Normative) Physical Test Method for Separation Cups 12
A.1 Particle Pollution Test 12
A.2 Sealing test 12
A.3 Frictional heat test 12
A.4 Blood Residual Test 12
A.5 Separation of Plasma Hemoglobin Content 13
Appendix B (Normative Appendix) Physical Test Method for Plasma Tubing 15
B.1 Particle Pollution Test 15
B.2 Sealing test 15
B.3 pressure monitor joint ventilation test 15
B.4 pressure monitor joint blood block test 16
B.5 flow test 16
B.6 Pump tube elasticity test 17
Appendix C (Normative) Physical Methods for Blood Bag Physical Testing 18
C.1 Transparency test 18
C.2 Particle Pollution Test 18
Appendix D (Normative) Chemical Test 19
D.1 Separation cup 19
D.2 Plasma lines 19
Reference 21
Figure 1 Example of a single-use, disposable centrifugal plasma separator
Figure 2 Example 2 of plasma separation cup
Figure 3 Example of plasma line 3
Figure 4 Sample of Blood Bag 3
Figure B.1 Ventilation Test Schematic 15
Figure B.2 Blocking blood test diagram 16
Table 1 Sizes of hoses for plasma tubes 5
Table A.1 Preparation Method 14
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY 0326.1-2002 "Disposable Centrifugal Plasma Separator Part 1. Plasma Separation Cup",
YY 0326.2-2002 "Disposable Centrifugal Plasma Separator Part 2. Plasma Pipelines" and YY 0326.3-2005 "Disposable
Centrifugal Plasma Separator Part 3. Blood Bag. This standard and YY 0326.1-2002, YY 0326.2-2002 and
Compared with YY 0326.3-2005, the main technical changes are as follows.
--- Modify the structure of the type, delete the product's naming mark;
--- Updated requirements for venipuncture device (mechanical blood collection device) and blood and blood component filters.;
--- Modified particle contamination requirements and test methods for separation cups and plasma tubes;
---Complete the test requirements for the sealability of the separation cup;
--- Modify the pressure monitoring connector requirements;
--- Increased pump tube flow requirements and test methods;
--- Modify the requirements of the three links in the plasma line;
--- Increased the preparation method of hemoglobin (Hb) standard solution;
--- Uniformly modified the requirements for the "input line" of "separation cup inlet, outlet", "separation cup interface" and blood bag;
--- Modified biological requirements.
Please note that some of the contents of this document may involve patents. The issuing agency of this document does not assume responsibility for identifying these patents.
This standard is under the jurisdiction of the National Standardization Technical Committee for Medical Infusion Devices (SAC/TC106).
Drafters of this standard. Sichuan Nangeer Biomedical Co., Ltd., Shandong Medical Device Product Quality Inspection Center, Shaanxi
Xizhengyuan Technology Development Co., Ltd., Chongqing Sanwei Weiye Pharmaceutical Co., Ltd., Shandong Zhongbaokang Medical Appliance Co., Ltd., Chengdu City
Ying Medical Products Co., Ltd., Shandong Weigao Group Medical Polymer Products Co., Ltd.
The main drafters of this standard are. Yang Yong, Zhang Qing, Nie Jiayi, Liu Zhongrang, Lu Ansong, Zhang Min, Zhao Qingbin, and Wang Jianwei.
This standard replaces YY 0326.1-2002, YY 0326.2-2002 and YY 0326.3-2005.
The previous version of YY 0326 was published as.
---YY 0326.1-2002;
---YY 0326.2-2002;
---YY 0326.3-2005.
introduction
The single-use centrifugal plasma separator consists of a plasma separation cup, a plasma tube (including a vein trocar) and a plasma bag, and a centrifugal self
The use of a dynamic plasma collection machine is used to collect and separate human plasma and return blood cells.
Disposable Centrifugal Plasma Separator
1 Scope
This standard stipulates the requirements for a disposable centrifugal plasma separator (hereinafter referred to as separator) to ensure that it is compatible with the centrifugal type
Automatic plasma collection machine adapts.
The plasma collected and stored by the separator specified in this standard is used for the preparation of blood products and cannot be used for clinical blood transfusion.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article
Pieces. For undated references, the latest version (including all amendments) applies to this document.
GB/T 1962.1 Syringes, injection needles and other medical devices 6% (Luer) conical connectors Part 1. General requirements
GB/T 1962.2 Syringes, injection needles and other medical devices 6% (Luer) conical joints Part 2. Locking joints
GB/T 6682 Analysis Laboratory Water Specifications and Test Methods
GB 8369 One-time use of blood transfusion device
GB 14232.1 Human blood and blood components Bag-type plastic containers Part 1. Traditional blood bags
GB/T 14233.1-2008 Medical infusion, blood transfusion, injection equipment inspection methods Part 1. Chemical analysis methods
GB/T 16886.1 Biological evaluation of medical devices Part 1. Assessment and testing in risk management process
YY/T 0328 One-time use of arteriovenous trocar
YY 0321.3-2009 Disposable Anesthesia Filter
YY/T 0615.1 Requirements for Labeling “Aseptic” Medical Devices Part 1. Requirements for Final Sterilization Medical Devices
YY/T 1288-2015 Nylon blood filter for single use blood transfusion apparatus
Pharmacopoeia of the People's Republic of China (2010 edition) 3
ISO 11607-1.2006 Packagingforterminalysterilizedmedicaldevices Part 1.Requirementsfor
Materials,sterilebarriersystemsandpackagingsystems Packaging for terminally sterilized medical devices. Part 1.Materials,
Sterile barrier system and packaging system requirements 1).
1) GB/T 19633.1 equivalent to ISO 11607-1.2006 is currently in the approval stage.
3 Structure and Type
A typical set of supplied separators (Figure 1) consists of a venipuncture device (YY 0328), a plasma separation cup (Figure 2), a plasma tube (Figure 3) and blood
Pulp bags (Figure 4) consist of four components.
Only one or more components can be supplied on request.
Explanation.
1 --- venipuncture device (mechanical blood collection device);
2 --- plasma lines (see Figure 3 for specific structural components);
3 --- plasma separation cup (see Figure 2 for specific structural components);
4 --- plasma bag (see Figure 4 for specific structural components).
Figure 1 Example of a single-use, disposable centrifugal plasma separator
Explanation.
1---Import;
2---Export;
3---cup body.
Note 1. When the plasma separation cup is supplied separately, protective sleeves should be provided at the inlet.
Note 2. When the plasma separation cup is supplied separately, there should be a protective cover at the outlet.
Figure 2 Example of a plasma separation cup
Explanation.
1 --- three protective cover;
2 --- Three links;
3 --- anti-condensation fluid tube;
4 --- Blood collection tube 1;
5 --- limit card (between limit cards for the pump tube);
6 ---Thrors;
7 --- puncture protector;
8 --- blood and blood components filter;
9 --- pressure monitoring tube;
10---fixtures;
11---Pressure monitor connector;
12 --- blood collection tube 2;
13 --- separation cup interface;
14 --- separation cup interface protection sleeve.
Note. When the plasma tube is supplied with the blood collection kit or the plasma tube and plasma separation cup is supplied as a kit, there can be no protective sleeve.
Figure 3 Example of plasma line
Explanation.
1---hanging hole (specific position is not limited);
2 --- plasma bag body;
3 --- input pipeline;
4 --- separation cup interface;
5 --- separation cup interface protection sleeve.
Note. When the plasma bag is supplied separately, there should be a protective sleeve at the interface of the separation cup.
Figure 4 Example of a blood bag
4 Venipuncture device (machine blood collection device)
If venipuncture device, it should comply with the provisions of YY/T 0328.
5 Physical requirements
5.1 Plasma separation cup
5.1.1 Appearance
5.1.1.1 The separation cup shall be transparent.
5.1.1.2 Observe that the surface of the inner surface of the separation cup should be bright and clean with normal vision or corrected vision under natural light, and there should be no obvious spots and impurities.
5.1.2 Particle Pollution
The separation cup should be made under the conditions of the smallest particulate contamination. When tested in accordance with A.1, the pollution index should not exceed 90.
5.1.3 Sealing
When the separation cup is tested according to Appendix A.2, it should be able to withstand the pressure of 8kPa for 10s without any signs of gas leakage.
5.1.4 Connection strength
The joints (excluding the protective sleeve) of the separation cup should be able to withstand the static tensile force of not less than 15N for 15 seconds.
5.1.5 Frictional heat
When the separation cup is tested according to A.3, its water temperature should not exceed 37°C.
5.1.6 Noise
The separation cup is operated at a speed of 7000 r/min, and the average noise when the test centrifuge is idle does not exceed 60 dB.
The average noise should not exceed 70dB when measuring four points with a sound level meter (A weighting) at a distance of 1m from the center of the separation cup between the rear, left and right sides.
5.1.7 Blood residue
When the separation cup is tested according to A.4, the residual amount in the cup should not exceed 5.0 mL.
5.1.8 Separation of plasma hemoglobin
When tested according to A.5, the separated plasma hemoglobin content should not exceed 60 mg/L.
5.1.9 Protective Cover
Separately packaged separation cups should have a strong but easy-to-remove protective sleeve at the entrance and exit of the cup. The protection sleeve should be able to keep the interior of the cup sterile.
5.1.10 Separation cup inlet and outlet
The inlet and outlet of the separation cup should match the separation cup interface of the plasma tube specified in 5.2. Assemble the separation cup according to the manufacturer's instructions
Port, joints should be able to withstand 8kPa pressure 10s no signs of leakage.
NOTE 1 The appropriate inlet and outlet are conical joints with a root diameter of 8 mm and a taper of 1.40.
Note 2. If the separator is a complete set (four sets), the test does not require an assembly operation and is tested directly on the manufacturer's assembled product.
5.2 Plasma lines
5.2.1 Appearance
The hoses of the pipeline should be plasticized uniformly, without kinks, transparent and transparent enough. When bubbles pass through, normal or corrected vision can be used.
To discover the interface between water and air.
5.2.2 Particle Pollution
Plasma lines should be manufactured under conditions of minimal particulate contamination. When tested according to B.1, the pollution index should not exceed 90.
5.2.3 Sealing
When the pipeline is tested according to B.2, there should be no signs of gas leakage.
5.2.4 Connection strength
The joints of the pipeline components (excluding the protective sleeve) should be able to withstand the static axial tensile force of 15N, and should not break or fall off for 15s.
5.2.5 pipe size
The size of the hoses of the pipeline should meet the requirements of Table 1.
Table 1 Sizes of hoses in plasma line
Name length/mm inner diameter/mm wall thickness/mm
Pipeline ≥2600a
Anti-condensation tube ≥ 1800
Blood collection tube 1 ≥ 1800
Blood collection tube 2 ≥ 690
Pressure monitoring tube ≥190
Pump tube 160±5
3.0~3.3
≥0.6
0.60~0.70
Length ≥8 - -
Spacing 160±5 - -
With a puncture pitch ≥ 240 - -
With separation cup spacing ≥150 - -
Blood filter (shell) ≥100 ≥15 ≥0.75
Special specifications according to the order contract.
a Line length refers to the distance from the tee to the separation cup interface.
5.2.6 Piercing device
Puncture size should be consistent with the provisions of GB 8369.
5.2.7 Blood and Blood Components Filter
5.2.7.1 The pipeline shall have a blood and blood component filter. The filter mesh shall be a bracket or other three-dimensional form. Its construction shall be such that it passes through the blood.
The blood and blood components of the filter must pass through the blood filter.
5.2.7.2 The mesh of the filter should be uniform with a total area of not less than 10cm2. The filter should also comply with the YY/T 1288-2015 "one-time use
The filter performance requirements specified in the nylon blood filters for blood transfusion apparatus.
5.2.8 Pressure Monitor Connector
5.2.8.1 Filtering rate
Pressure monitor fittings should prevent microorganisms from entering the tubing. Pressure monitor when tested according to YY 0321.3-2009A.2
The filtration rate of the joints to particles in the air above 0.5 μm should not be less than 90%.
5.2.8.2 Ventilation
Pressure monitor fittings should be sufficiently ventilated. When testing according to B.3, the time required for the pressure monitor connector to pass 10kPa air pressure should be
Not more than 3s.
5.2.8.3 B...