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YY 0326.2-2002Plasmapheresis centrifuge apparatus for single use - Part 2: Plasma tubing (English PDF)

一次性使用离心式血浆分离器第2部分：血浆管路

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Issued by

NMPA

Level / Type

Industry · Mandatory

Issue date

January 7, 2002

Implementation date

April 1, 2002

Scope

YY 0326.2-2002 is the English-translated version of 一次性使用离心式血浆分离器第2部分：血浆管路.

YY 0326.2-2002 is the Chinese pharmaceutical industry standard for the plasma tubing of single-use plasmapheresis centrifuge sets, the part that links the plasma separation cup and the blood collector to the automatic centrifugal plasma collection machine.

Part 2 of YY 0326, it sets general requirements, materials such as plasticized PVC to GB 15593, physical requirements including sealing, connection strength of at least 15 N for 15 s, appearance, Luer lock fittings and pump tubing flexibility, and chemical and biological requirements, together with inspection rules, marking and packaging.

Normative annexes describe the sealing test, the ventilation and blood resistance tests of the pressure monitor connector and the pump tubing flexibility test. Issued on 7 January 2002, it has applied since 1 April 2002.

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Document preview — YY 0326.2-2002

National Standard of the People's Republic of China

Issued by: National Medical Products Administration of the People's Republic of China

Foreword3
1 Scope4
2 Normative references4
3 General requirements5
4 Materials6
5 Physical requirements6
6 Chemical requirements9
7 Biological requirements10
8 Inspection rules10
9 Mark12
10 Package12
Annex A (Normative) Sealing test13
Annex B (Normative) Ventilation test of pressure monitor connector14
Annex C (Normative) Bloody resistance test of pressure monitor connector15
Annex D (Normative) Pump tubing flexibility test17
Annex E (Informative) Bibliography18

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.

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 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.

GB/T 14233.2-1993 Infusion, transfusion, injection equipment for medical use - Part 2. Biological test methods

5 Physical requirements

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.

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"; […]

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 18 pages — is available in the English PDF.

Referenced standards

Normative references

GB/T 2828-1987 · GB 8369-1998 · GB 15593-1995

Cited by

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