YY 0326.2-2002 (YY0326.2-2002) & related versions
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Plasmapheresis centrifuge apparatus for single use - Part 2: Plasma tubing
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YY 0326.2-2002
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YY 0326.2-2002
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YY 0326.2-2002: PDF in English
YY 0326.2-2002
YY
Pharmaceutical Industry Standard
of the People’s Republic of China
C 31
File No.. 9937-2002
Plasmapheresis centrifuge apparatus for single
use - Part 2. Plasma tubing
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 ... 5
4 Materials ... 6
5 Physical requirements ... 6
6 Chemical requirements ... 9
7 Biological requirements ... 10
8 Inspection rules ... 10
9 Mark ... 12
10 Package ... 12
Annex A (Normative) Sealing test ... 13
Annex B (Normative) Ventilation test of pressure monitor connector ... 14
Annex C (Normative) Bloody resistance test of pressure monitor
connector ... 15
Annex D (Normative) Pump tubing flexibility test ... 17
Annex E (Informative) Bibliography ... 18
Foreword
The single-use plasmapheresis centrifuge apparatus is composed of plasma separation
cup, 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 separation cup
Part 2. Plasma tubing
Annex A, Annex B, Annex C and Annex D in this Standard are the standard annexes.
Annex E is informative.
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. Sichuang Nangeer Medical
Appliances Co., Ltd., Xi’an Zhengyuan Polymer Products Co., Ltd., and Shanghai Xili
Medical Co., Ltd.
Main drafters of this Standard. Jiang Yueqin, Shi Yanping, Yao Lan, You Shaohua, Zhang
Qiang, Pan Lihua, and Lu Ansong.
Plasmapheresis centrifuge apparatus for single use -
Part 2. Plasma tubing
1 Scope
This Standard specifies the requirements of the component of plasma tubing of the
single-use plasmapheresis centrifuge apparatus (hereinafter referred to as tubing), so as
to ensure that the centrifugal automatic plasma collection machine is suitable to the
plasma separation cup 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 1962.2-2001 Conical fittings with a 6% (Luer) taper for syringes, needles and
certain other medical equipment - Part 2. Lock fittings (idt ISO 594-2. 1998)
GB/T 2828-1987 Sampling procedures and tables for lot-by-lot inspection by
attributes (Applicable to inspection of successive lots or batches)
GB 8368-1998 Medical infusion sets for single use (eqv ISO 8536-4-1998)
GB 8369-1998 Medical transfusion sets for single use (eqv ISO 1135-4-1998)
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 15593-1995 Plasticized polyvinyl chloride (PVC) compounds for transfusion
(infusion) equipment
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/T 0313-1998 Package, label, transport and storage for medical polymer products
YY 0326.1-2002 Plasmapheresis centrifuge apparatus for single use - Part 1.
5.3 Connection strength
The connection position of components of tubing (excluding the protective cover) shall be
able to withstand the static axial tension not less than 15 N; it shall not break and fall off
within continuous 15s.
5.4 Appearance
The tubing hose shall be plasticizing uniformly, be free of kink and flat, and be transparent
or transparent enough; when there is the bubble to pass through, using normal or
corrected sight shall be able to find out the interface between the water and air.
5.5 Flow
The anticoagulant fluid flow and flood flow shall be adapted to the use state of the
supported centrifugal automatic plasma collection machine.
Note. The conventional plasma collection machine is controlled at 1 mL/circle (peristaltic pump)
generally. The tubing flow is an important indicator of supporting with the plasma collection
machine; at present, there is no confirmed test method.
5.6 Puncture outfit
The dimensions of puncture outfit shall meet the regulations of GB 8369-1998.
5.7 Blood and blood components filter
5.7.1 The tubing shall be equipped with a blood and blood components filter; the filter
screen shall be in scaffolding form or other three-dimensional forms; its structure shall
make that the blood and blood components through the blood filter must pass through the
blood filter screen.
5.7.2 The filter mesh shall be uniform; and the total area shall not be less than 10 cm2.
When testing according to Annex C of GB 8369-1998, the dried residue of filter shall not
be less than 80% of the standard filter (m/m).
5.8 Pressure monitor connector
5.8.1 Filtration rate
The pressure monitor connector shall prevent the microorganism from entering the tubing.
When testing according to Annex B of GB 8369-1998, the filtration rate of the pressure
monitor connector; particles more than 0.5 µm in the air shall not be less than 90%.
5.8.2 Ventilation
The pressure monitor connector shall have enough ventilation. When testing according to
Annex B, the time that pressure monitor connector transfers 10 kPa pressure shall not be
The separation cup interface shall be matched with the inlet and outlet of plasma
separation cup regulated in YY 0326.1.
5.14 Protective sleeve
The outlet and inlet of tubing shall be equipped with the suitable protective sleeve to
maintain the outer conical connector, puncture outfit, separation cup interface and inner
surface of tubing from bacteria. The protective sleeve shall be firm, not be easily fallen off,
and shall be easily disassembled.
6 Chemical requirements
Take a set of tubing and glass flask to connect a circulating system; add 250 mL of water;
for the rest, prepare the tubing test liquid according to Method I in Table 1 of GB/T
14233.1-1998. The test liquid shall meet the requirements of 6.1 – 6.5.
6.1 Reducing substance
When testing according to Article 5.2.2 in GB/T 14233.1-1998, the volume difference
between the tubing test liquid and blank consumption potassium permanganate
[c(KMnO4)= 0.002mol/L] shall not exceed 2.0 mL.
6.2 Metal ion
6.2.1 When using the atomic absorption spectrophotometry method by GB/T
14233.1-1998 to test, the total content of barium, chromium, copper, lead and tin in the
tubing test liquid shall not be more than 1 µg/mL. The content of cadmium shall not be
more than 0.1 µg/mL.
6.2.2 When testing according to 5.6 in GB/T 14233.1-1998, the tubing test liquid color
shall not exceed the standard control solution with the mass concentration
mLgPb /12 )( .
6.3 PH
When testing according to 5.4.1 in GB/T 14233.1–1998, the pH difference between the
tubing test liquid and blank liquid shall not exceed 1.5.
6.4 Evaporation residue
When testing according to 5.5 in GB/T 14233.1–1998, the total mass of evaporation
residue shall not exceed 2 mg.
6.5 UV absorbance
When testing according to 5.7 in GB/T 14233.1–1998, the absorbance of tubing test liquid
within the range of 250 nm – 320 nm shall not be more than 0.1.
ethylene oxide after sterilization shall be less than the regulated value (6.6) before
delivery.
9 Mark
9.1 Single package
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, st...
......
| Standard ID | YY 0326.2-2002 (YY0326.2-2002) | | Description (Translated English) | Plasmapheresis centrifuge apparatus for single use - Part 2: Plasma tubing | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C31 | | Word Count Estimation | 12,129 | | 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 assembly plasma line (hereinafter referred to as pipeline) requirements in order to guarantee that by supporting the centrifugal automatic plasma collection machine to adapt, and plasma separation cup, lancing devices to adapt. |
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