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

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YY/T 0326-2017: Plasmapheresis centrifuge apparatus for single use
YY/T 0316-2017
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.20
C 31
Replacing YY 0326.1-2002, YY 0326.2-2002 and YY 0316.3-2005
Plasmapheresis centrifuge apparatus for single use
ISSUED ON. MAY 02, 2017
IMPLEMENTED ON. APRIL 01, 2018
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 4
Introduction ... 6
1 Scope ... 7
2 Normative references ... 7
3 Structure and type ... 8
4 A. V. fistula needle set (blood-taking set for machine)... 10
5 Physical requirements ... 11
5.1 Plasma centrifuge bowl ... 11
5.2 Plasma tubing ... 12
5.3 Plasma container ... 15
6 Chemical requirements ... 18
6.1 Centrifuge bowl ... 18
6.2 Plasma tubing ... 19
6.3 Plasma container ... 19
7 Biological requirements ... 20
7.1 Centrifuge bowl ... 20
7.2 Plasma tubing ... 20
7.3 Plasma container ... 20
7.4 Bacterial endotoxin ... 20
8 Type inspection ... 21
9 Marking ... 21
9.1 Single package ... 21
9.2 Plasma container label ... 21
9.3 Transport packaging ... 22
10 Packaging ... 23
Annex A (normative) Physical test method for centrifuge bowl ... 24
A.1 Particulate contamination test ... 24
A.2 Airtightness test ... 24
A.3 Frictional heat test ... 24
A.4 Blood residue test ... 25
A.5 Separated plasma’s hemoglobin content test ... 25
Annex B (normative) Physical test method for plasma tubing ... 28
B.1 Particulate contamination test ... 28
B.2 Airtightness test ... 28
B.3 Pressure monitor connector’s ventilation test ... 28
B.4 Pressure monitor connector’s blood blocking test ... 29
B.5 Flow test ... 30
B.6 Pump tubing elasticity test ... 31
Annex C (normative) Physical test method for plasma container ... 32
C.1 Transparency test ... 32
C.2 Particulate contamination test ... 32
Annex D (normative) Chemical test ... 33
D.1 Centrifuge bowl ... 33
D.2 Plasma tubing ... 34
Bibliography ... 36
Plasmapheresis centrifuge apparatus for single use
1 Scope
This Standard specifies the requirements for plasmapheresis centrifuge
apparatus for single use (hereinafter referred to as centrifuge apparatus) to
ensure that it is compatible with the matching centrifugal automatic plasma
collection machine.
The plasma collected and stored by the centrifuge apparatus 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 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/T 1962.1 Conical fittings with a 6 % (Luer) taper for syringes, needles
and certain other medical equipment - Part 1. General requirement
GB/T 1962.2 Conical fittings with a 6 % (Luer) taper for syringes, needles
and certain other medical equipment - Part 2. Lock fittings
GB/T 6682 Water for analytical laboratory use - Specification and test
methods
GB 8369 Medical transfusion sets for single use
GB 14232.1 Plastics collapsible containers for human blood and blood
components - Part 1. Conventional containers
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 within a risk management process
YY/T 0328 A.V. fistula needle sets for single use
YY 0321.3-2009 Single-use filter for anaesthesia
5 Physical requirements
5.1 Plasma centrifuge bowl
5.1.1 Appearance
5.1.1.1 The centrifuge bowl shall be transparent.
5.1.1.2 Observe the interior surface of the centrifuge bowl with normal vision or
corrected vision under natural light, it shall be clean and smooth, and there shall
be no obvious spots or impurities.
5.1.2 Particulate contamination
The centrifuge bowl shall be produced under the conditions of the minimum
particulate contamination. When tested according to A.1, the contamination
index shall not exceed 90.
5.1.3 Airtightness
When the centrifuge bowl is tested according to Annex A.2, it shall be able to
withstand the pressure of 8 kPa for 10 s without any signs of gas leakage.
5.1.4 Connection strength
The joints (excluding the protective sleeve) of the centrifuge bowl shall be able
to withstand the static tension of not less than 15 N for 15 s.
5.1.5 Frictional heat
When the centrifuge bowl is tested according to A.3, the water temperature
shall not exceed 37 °C.
5.1.6 Noise
The centrifuge bowl is operated at a speed of 7000 r/min, and when the average
noise of the test centrifuge is not more than 60 dB when idle, use a sound level
meter (A weighting) to measure 4 points in front, back, left, right at 1 m away
from the center of the centrifuge bowl, the average noise shall not exceed 70
dB.
5.1.7 Blood residual amount
When the centrifuge bowl is tested according to A.4, the residual amount in the
bowl shall not exceed 5.0 mL.
5.1.8 Separated plasma hemoglobin content
the tubing. When tested according to A.2 of YY 0321.3-2009, the pressure
monitor connector shall have a filtration rate of not less than 90 % for particles
larger than 0.5 μm in air.
5.2.8.2 Ventilation
The pressure monitor connector shall be sufficiently ventilated. When tested
according to B.3, the time required for the pressure monitor connector to
transfer 10 kPa air pressure shall not exceed 3 s.
5.2.8.3 Blood blocking
The filter material in the pressure monitor connector can effectively block the
blood. When tested according to B.4, at a hydraulic pressure of 40 kPa above
the atmospheric pressure for 40 s, there shall be no signs of liquid infiltration.
The mechanical end surface of the pressure monitor connector shall be
transparent, and it may visually inspect the blood for contamination during use.
5.2.8.4 Adaptability
The pressure monitor connector shall be tightly coupled with the pressure
monitor of the matching plasma collection machine. It shall not fall off naturally
and shall be easily disassembled. The conical fitting with taper in the joint shall
meet the requirements specified in GB/T 1962.1 or GB/T 1962.2.
5.2.9 Pump tubing2)
5.2.9.1 Flow
The anticoagulant flow and the blood flow shall be compatible with the state of
use of the matching centrifugal automatic plasma collection machine. When
tested according to B.5, the anticoagulant flow and the blood flow shall meet (1
± 0.1) mL/lap (peristaltic pump).
5.2.9.2 Elasticity
The pump tubing part of the tubing shall have good elasticity. When the water
temperature is 23 °C ± 2 °C, and tested according to B.6, the flow reduction
rate shall be less than 5 % after operating for 1 h.
5.2.10 Locating clip3)
2) The pump tubing refers to a hose installed in the peristaltic pump of the centrifugal plasma
collection machine.
3) The locating clip is a plastic piece that is mounted on the pump tubing to limit the displacement
of the pump tubing.
conjunction with the centrifuge bowl as specified in 5.1.
The plasma container shall be transparent or translucent, colorless, soft, sterile,
non-pyrogenic, non-toxic and not easily broken under the conditions of use. It
shall be compatible with the contents when stored under normal conditions. The
plasma container ...