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1 Translated English of Chinese Standard: YY Pharmaceutical Industry Standard of the People s Republic of China YY C 31 File No.: Plasmapheresis centrifuge apparatus for single use - Part 2: Plasma tubing 一次性使用离心式血浆分离器第 2 部分 : 血浆管路 Issued on: January 07, 2002 Implemented on: April 01, 2002 Issued by: China Food and Drug Administration Page 1 of 18

2 Table of Contents Foreword Scope Normative references General requirements Materials Physical requirements Chemical requirements Biological requirements Inspection rules Mark Package Annex A (Normative) Sealing test Annex B (Normative) Ventilation test of pressure monitor connector Annex C (Normative) Bloody resistance test of pressure monitor connector Annex D (Normative) Pump tubing flexibility test Annex E (Informative) Bibliography Page 2 of 18

3 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. Page 3 of 18

4 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 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 Sampling procedures and tables for lot-by-lot inspection by attributes (Applicable to inspection of successive lots or batches) GB Medical infusion sets for single use (eqv ISO ) GB Medical transfusion sets for single use (eqv ISO ) GB/T Infusion, transfusion, injection equipment for medical use - Part 1: Chemical analysis methods GB/T Infusion, transfusion, injection equipment for medical use - Part 2: Biological test methods GB Plasticized polyvinyl chloride (PVC) compounds for transfusion (infusion) equipment GB/T Biological evaluation of medical devices - Part 1: Evaluation and testing (idt ISO :1997) YY General specification for single-use blood flow product YY/T Package, label, transport and storage for medical polymer products YY Plasmapheresis centrifuge apparatus for single use - Part 1: Page 4 of 18

5 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 Blood and blood components filter 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 The filter mesh shall be uniform; and the total area shall not be less than 10 cm 2. When testing according to Annex C of GB , the dried residue of filter shall not be less than 80% of the standard filter (m/m). 5.8 Pressure monitor connector Filtration rate The pressure monitor connector shall prevent the microorganism from entering the tubing. When testing according to Annex B of GB , the filtration rate of the pressure monitor connector; particles more than 0.5 µm in the air shall not be less than 90% 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 Page 7 of 18

6 The separation cup interface shall be matched with the inlet and outlet of plasma separation cup regulated in YY 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 The test liquid shall meet the requirements of Reducing substance When testing according to Article in GB/T , 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 When using the atomic absorption spectrophotometry method by GB/T 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 When testing according to 5.6 in GB/T , the tubing test liquid color shall not exceed the standard control solution with the mass concentration 2 ( Pb ) 1 g / ml. 6.3 PH When testing according to in GB/T , the ph difference between the tubing test liquid and blank liquid shall not exceed Evaporation residue When testing according to 5.5 in GB/T , the total mass of evaporation residue shall not exceed 2 mg. 6.5 UV absorbance When testing according to 5.7 in GB/T , the absorbance of tubing test liquid within the range of 250 nm 320 nm shall not be more than Page 9 of 18

7 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, starting with word Batch ; f) Expired year and month (must be clear); g) Name, address of manufacturer and/or distributor. 9.2 Outer package The information on the outer package shall meet the requirements of YY/T Package 10.1 After the single package is opened, there is opening-trace to indicate that the package has been opened before The tubing package and sterilization shall be free of flattening or kink phenomenon in the standby state There shall be free of visible foreign matters in the single package. Page 12 of 18

8 Annex E (Informative) Bibliography 1. GB Sterilization of health care products - Requirements for validation and routine control - Industrial moist heat sterilization 2. GB Medical devices - Validation and routine control of ethylene oxide sterilization 3. GB Sterilization of health care products - Requirement for validation and routine control - Radiation sterilization END Page 18 of 18