YY 0326.1-2002_English: PDF (YY0326.1-2002)
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| YY 0326.1-2002 | English | 150 |
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Plasmapheresis centrifuge apparatus for single use - Part 1: Centrifuge bowl
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YY 0326.1-2002
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| YY/T 0326-2017 | English | 150 |
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Plasmapheresis centrifuge apparatus for single use
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YY/T 0326-2017
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Newer version: YY 0326.1-2017 Standards related to: YY 0326.1-2017
| Standard ID | YY 0326.1-2002 (YY0326.1-2002) | | Description (Translated English) | Plasmapheresis centrifuge apparatus for single use - Part 1: Centrifuge bowl | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C31 | | Word Count Estimation | 12,141 | | Date of Issue | 2002-01-07 | | Date of Implementation | 2002-04-01 | | Drafting Organization | Shanghai Blood Center | | Administrative Organization | National Technical Committee of Standardization for medical infusion | | Proposing organization | State Drug Administration | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the disposable centrifugal plasma separator component plasma separator cup (hereinafter referred to as separation cup) requirements in order to guarantee that by supporting the centrifugal automatic plasma collection machine to adapt, adapt and plasma tube. | YY 0326.1-2002
YY
Pharmaceutical Industry Standard
of the People’s Republic of China
C 31
File No.. 9936-2002
Plasmapheresis centrifuge apparatus for single
use - Part 1. Centrifuge bowl
Issued by. China Food and Drug Administration
ISSUED ON. JANUARY 07, 2002
IMPLEMENTED ON. APRIL 01, 2002
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 General requirements ... 4
4 Physical requirements ... 5
5 Chemical requirements ... 6
6 Biological requirements ... 7
7 Inspection rules ... 8
8 Mark ... 9
9 Package ... 10
Annex A (Normative) Measurement method of fine-particles limits ... 11
Annex B (Normative) Test method of sealing, friction heat, blood residues
... 12
Annex C (Normative) Measurement method of separating plasma
hemoglobin content (O-tolidine) ... 14
Annex D (Normative) Chemical analysis method of soluble substance ... 16
Annex E (Informative) Bibliography ... 18
Foreword
The single-use plasmapheresis centrifuge apparatus is composed of plasma centrifuge
bowl, plasma tubing, and blood collector as specified in YY 0328; it is used together with
the centrifugal automatic plasma collection machine to collect, separate the human
plasma and transfuse the blood.
The general title of YY 0326 is the single-use plasmapheresis centrifuge apparatus; it
includes the following parts.
Part 1. Plasma centrifuge bowl
Part 2. Plasma tubing
Annex A, Annex B, Annex C and Annex D in this Standard are the standard annexes.
This Standard was proposed by the State Drug Administration.
This Standard shall be under the jurisdiction of National Standardization Technical
Committee of Medical Infusion Apparatus.
The drafting organization of this Standard. Shanghai Blood Center, and Jinan Medical
Device Quality Supervision and Inspection Center of State Drug Administration.
Participating drafting organizations of this Standard. Shanghai Xili Medical Co., Ltd.,
Sichuang Nangeer Medical Appliances Co., Ltd., and Xi’an Zhengyuan Polymer Products
Co., Ltd.
Main drafters of this Standard. Pan Lihua, You Shaohua, Sun Jianfang, Shi Yanping,
Zhang Jiang, Jiang Yueqin, and Lu Ansong.
Plasmapheresis centrifuge apparatus for single use -
Part 1. Centrifuge bowl
1 Scope
This Standard specifies the requirements of the component of plasma tubing of the
single-use plasmapheresis centrifuge apparatus (hereinafter referred to as centrifuge
bowl), so as to ensure that the centrifugal automatic plasma collection machine is suitable
to the centrifuge bowl and blood collection apparatus.
2 Normative references
The articles contained in the following documents have become part of this Standard
when they are quoted herein. For the dated documents so quoted, all the modifications or
revisions made thereafter shall not be applicable to this Standard. For the undated
documents so quoted, the latest editions shall be applicable to this Standard.
GB/T 2828-1987 Sampling procedures and tables for lot-by-lot inspection by
attributes (Apply to inspection of successive lots or batches)
GB 8368-1998 Medical infusion sets for single use (eqv ISO 8536-4-1998)
GB/T 14233.1-1998 Infusion, transfusion, injection equipment for medical use - Part
1. Chemical analysis methods
GB/T 14233.2-1993 Infusion, transfusion, injection equipment for medical use - Part
2. Biological test methods
GB/T 16886.1-2001 Biological evaluation of medical devices - Part 1. Evaluation and
testing (idt ISO 10993-1.1997)
YY 0311-1998 General specification for single-use blood flow product
YY 0326.2-2002 Plasmapheresis centrifuge apparatus for single use - Part 2. Plasma
tubing
3 General requirements
3.1 Structure
The typical centrifuge bowl structure is shown in figure 1.
Each connection position (excluding protective case) of the centrifuge bowl shall be able
to withstand static tension of not less than 15N for 15s.
4.5 Friction heat
When the centrifuge bowl is tested based on Annex B B.2, the water temperature shall not
exceed 37°C centigrade.
4.6 Noise
When the centrifuge bowl is operated under 7 000 r/min, if sound level meter (A-weighting)
is used to measure four points when the distances of front, back, left and right position are
1m away the center of the centrifuge bowl, the average noise shall not exceed 70dB.
Note. when centrifugal machine is idling during test, the average noise shall not exceed
60dB.
4.7 Blood residues
When the centrifuge bowl is tested based on Annex B B.3, residues inside the bowl shall
not exceed 5.0 mL.
4.8 Separation plasma hemoglobin content
When test is conduced based on Annex C, the separation plasma hemoglobin content
shall not exceed 60mg /L.
4.9 Protective case
Protective sleeve which is firm and easy to be disassembled shall be equipped at the inlet
and outlet of the centrifuge bowl. The protective sleeve shall be able to keep cavity sterile
in the bowl.
4.10 Inlet and outlet of the centrifuge bowl
The inlet and outlet of the centrifuge bowl shall be matched with the centrifuge bowl
interface of plasma tubing as specified by YY 0326.2.
Note. The suitable inlet and outlet are external-cone joints with root diameter of 8mm and
conical degree of 1.40.
5 Chemical requirements
5.1 Reducing substances
When test is conducted based on Annex D D.2, the volume difference of potassium
permanganate solution [c(KMnO4)=0.02mol/L] that that is consumed by centrifuge bowl
There shall be at least the following information on the single package.
a) Product name, mark;
b) Sterilization, non-pyrogenic, single-use text instructions, or use of graphical symbols
given by YY/T 0313;
c) The text instructions of sterilization method or use of graphical symbols given by
YY/T 0313;
d) Use instructions and notes, including the cautionary note of “Prohibited to use if
package is damaged” and “Destroy after use”;
e) Batch number, starting with word “Batch”;
f) Expired year and month (must be clear);
g) Name, address of manufacturer and/or distributor.
8.2 Outer package
The information on the outer package shall meet the requirements of YY/T 0313.
9 Package
9.1 After the single package is opened, there is opening-trace to indicate that the package
has been opened before.
9.2 The centrifuge bowl package and sterilization shall be free of damage the standby
state.
9.3 There shall be free of visible foreign matters in the single package.
Annex A
(Normative)
Measurement method of fine-particles limits
A.1 Principle
The method is to simulate the use state of the centrifuge bowl; collect the particles in
eluent through internal cavity surface of centrifugal rinse bowl; count it to evaluate the
particle pollution.
A.2 Test instrument and solution
A.2.1 Special centrifugal machine. matched with the centrifuge bowl; centrifugal machine
can achieve centrifugal rotation speed of 7000 r/min.
A.2.2 Special particle counter. equipped with mixing system. Sampling amount for one
time is 100 mL; it can count 15 ~ 25 um particles and particle of more than 25 um at the
same time.
A.2.3 Rinse solution. 9g/L sodium chloride solution, filtered by microporous membrane of
0.45um (it’s applicable to resistance method particle counter) or distilled water (it’s
applicable to light resistance method particle counter.
A.3 Test steps
A.3.1 Eluent preparation
Inject 200mL of eluent from the inlet of the centrifuge bowl; place the inlet and outlet into
the special centrifugal machine with protective sleeves. The rotation speed of centrifugal
machine is adjusted to 7000r/min; turn up and down for 5 times after centrifuging for 5
minutes.
A.3.2 Particle inspection
Take 200mL of eluent out from the outlet of the centrifuge bowl; put into the sampling cup
of particle counter; count it with particle counter.
Note. Environmental pollution shall be avoided during test.
A.4 Results
The difference, between eluent and background liquid’s particle reading, divided by 100, is
the particle content in the eluent (piece/mL).
Annex B
(Normative)
Test method of sealing, friction heat, blood residues
B.1 Sealing test
Pump the air pressure, that is 8kPa higher than atmospheric pressure, into the inlet of the
centrifuge bowl for 10s; check whether the pointer of pressure gauge has air leakage.
Then, rotate the upper body of centrifuge bowl by 180 degree; repeat the
above-mentioned steps.
B.2 Test of friction heat
B.2.1 Principle
This method is to simulate operation state of the centrifuge bowl; evaluate friction heat
generated from high-speed centrifuge by measuring water temperature rising at the inlet
and outlet.
B.2.2 Ope...
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