YY/T Translated English of Chinese Standard: YY/T PHARMACEUTICAL INDUSTRY STANDARD

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1 Translated English of Chinese Standard: YY/T Buy True-PDF Auto-delivery. PHARMACEUTICAL INDUSTRY STANDARD YY OF THE PEOPLE S REPUBLIC OF CHINA ICS C 31 YY/T Nylon blood filter nets for transfusion equipment for single use 一次性使用输血器具用尼龙血液过滤网 Issued on: March 2, 2015 Implemented on: January 1, 2016 Issued by: China Food and Drug Administration of China Buy True-PDF Auto-delivery. Page 1 of 14

2 Table of Contents Foreword Scope Normative references Classification and marking Materials Physical requirements Chemical requirements Biological requirements Type inspection Marks Packaging Annex A (Normative) Test method of filter net particle pollution Annex B (Normative) Test method of filtration performance of filter net Buy True-PDF Auto-delivery. Page 2 of 14

3 Foreword This Standard was drafted in accordance with the rules given in GB/T Attention is drawn to the possibility that some of the elements of this Standard may be the subject of patent rights. The issuing authority shall not be held responsible for identifying any or all such patent rights. This Standard shall be under the jurisdiction of National Technical Committee on Medical Infusion Apparatus of Standardization Administration of China (SAC/TC 106). Main drafting organizations of this Standard: Wuxi Bolcon Medical Machinery Plastic Co., Ltd. The drafting organizations of this Standard: Shandong Medical Device Quality Inspection Center, Shanghai Zhenpu Medical Equipment Co., Ltd., Jintan Kangda Medical Equipment Manufacturing Co., Ltd. Main drafters of this Standard: Zhang Xianshun, Guo Maochun, Jia Yufei, Zhang Songhe, Shi Lihu, Liu Lili, Wang Tongchao, Zhang Bo, Guo Xianhu. Buy True-PDF Auto-delivery. Page 3 of 14

4 Nylon blood filter nets for transfusion equipment for single use 1 Scope This Standard specifies the requirements for nylon blood filter nets for transfusion equipment for single use (hereinafter referred to as the filter net). The filter net can be installed in the dropping funnel or accessories of transfusion (blood collection) apparatus, used to filter blood clots, impurities and foreign bodies in blood or blood products. 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 8369, Medical transfusion sets for single use GB/T , Test methods for infusion transfusion injection equipment for medical use - Part 1: Chemical analysis methods GB/T , Biological evaluation of medical devices - Part 1: Evaluation and testing GB/T , Plastics - Differential scanning calorimetry (DSC) - Part 3: Determination of temperature and enthalpy of melting and crystallization Pharmacopoeia of the People's Republic of China (3 Volumes) Edition Classification and marking 3.1 Structure type of filter net See Figure 1 for the example of typical bracket filter net structure. See Figure 2 for the example of typical bag filter net (without fixed bracket) structure. 3.2 Marking The marking example of the filter net is as follow: Buy True-PDF Auto-delivery. Page 4 of 14

5 welding firmness according to the specific conditions. 5.4 Particulate pollution The filter net shall be made under conditions of minimum particulate contamination. When tested according to Annex A, the pollution index shall not exceed Filtration performance When tested according to Annex B, the rejection of the filter net to 240μm particles shall not be less than 95%, not less than 95% to 160μm particles. NOTE: If tested, the test filter net is organized as a single warp single weft. And when the wire diameter conforms to 100μm±10μm, and the aperture conforms to 200μm±20μm, it can be exempt from the filter performance test. 5.6 Melting peak temperature When tested according to the method specified in GB/T , the monofilament melting peak temperature (melting point) of the filter net made of nylon 66 monofilament shall be in the range of 246 C ~ 257 C (475 F ~ 495 F); the monofilament melting peak temperature (melting point) of the filter net made of nylon 1010 monofilament shall be in the range of 198 C ~ 210 C (388 F ~ 410 F). NOTE: It can also be measured using other validated equivalent test methods. 6 Chemical requirements 6.1 Preparation of chemical test liquid Take several samples and add them to a glass container. Add water in a ratio of 2:1 to the total surface area (cm 2 ) and water (ml) of the sample. After capping, place it at 37 C±1 C for 24h. Separate the sample from the liquid. Cool to room temperature. Use it as inspection liquid. Take the same volume of water in the glass container and prepare a blank control solution. 6.2 Reducing substance When tested according to the provisions of of GB/T , the difference between the volume of potassium permanganate solution c(kmno4)=0.002 mol/l consumed by the test solution and the blank solution shall not exceed 2.0 ml. 6.3 Metal ion Buy True-PDF Auto-delivery. Page 7 of 14

6 8 Type inspection 8.1 The type inspection is a full performance inspection. 8.2 In the type inspection, if there is no special requirement, the physical requirements shall be randomly sampled by 5, and other tests shall be carried out according to the standard regulations. If all inspection items are all qualified, it is determined as qualified, otherwise unqualified. 9 Marks 9.1 Initial packaging marks The product's initial packaging shall have the following marks: a) manufacturer's name and/or trademark, address, contact information; b) product name and specification model; c) material and organization of filter net; d) quantity; e) product effective date; f) batch number; g) reference to this Standard. 9.2 Outer packaging mark The outer packaging shall have the following marks: a) manufacturer's name and/or trademark, address, contact information; b) product name and specification model; c) material and organization of filter net; d) net weight, gross weight, quantity; e) volume (length x height x width); f) product effective date; g) batch number; h) reference to this Standard; Buy True-PDF Auto-delivery. Page 9 of 14