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 Single use subcutaneous infusion sets for use with insulin pump 一次性使用胰岛素泵用皮下输液器 Issued on: March 23, 2016 Implemented on: January 1, 2017 Issued by: China Food and Drug Administration of China Buy True-PDF Auto-delivery. Page 1 of 23

2 Table of Contents Foreword... 3 Introduction Scope Normative references Terms and definitions Structure and composition Materials Physical requirements Chemical properties Biological requirements Type inspection Marks Packaging Annex A (Normative) Physical test Annex B (Informative) Design guide for subcutaneous infusion set Bibliography Buy True-PDF Auto-delivery. Page 2 of 23

3 Single use subcutaneous infusion sets for use with insulin pump 1 Scope This Standard specifies the requirements for the subcutaneous infusion set for use with insulin pump that consists of interface, piping, piercing assembly (hereinafter referred to as "the subcutaneous infusion set"). This product is a single use sterile product. This Standard does not include the requirements for insulin-filled devices (e.g., drug reservoirs, pre-filled cassette bottles) in insulin pumps. This Standard does not address the accuracy requirements for flow control when the subcutaneous infusion set are fitted with an insulin pump. 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/T , Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings (GB/T , ISO 594-2:1998, IDT) GB , Infusion sets for single use, gravity feed (ISO :2004, MOD) GB , Medical electrical equipment - Part 2: Particular requirements for the safety of infusion pumps and controllers (GB , IEC :1998, IDT) GB/T , Test methods for infusion transfusion injection equipment for medical use - Part 1: Chemical analysis methods GB/T , Test methods for infusion, transfusion, injection equipment for medical use - Part 2: Biological test methods GB/T , Biological evaluation of medical devices - Part 1: Evaluation Buy True-PDF Auto-delivery. Page 5 of 23

4 and testing (GB/T , ISO :2009, IDT) GB 18457, Stainless steel needle tubing for the manufacture of medical devices (GB , ISO 9626:1991, IDT) YY/T , Medical adhesive bandages - General requirements YY , Sterile, single-use intravascular catheters - Part 1: General requirements (ISO :1995, IDT) YY , Sterile, single-use intravascular catheters - Part 5: Overneedle peripheral catheters (ISO :1996, IDT) YY/T , Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (YY/T , ISO :2007, IDT) YY/T , Requirements for medical devices to be designated STERILE - Part 1: Requirements for terminally sterilized medical devices ISO :2006, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems 1 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 introducer needle unit a unit on the subcutaneous infusion set for subcutaneous puncture, usually consisting of hypodermic needle (or hypodermic needle and catheter assembly), needle handle (or catheter base), adhesive tape for fixing use. 3.2 hypodermic needle a rigid tube with cutting edge on one end for subcutaneous administration; it generally has oblique insertion type and in-line type 3.3 hypodermic needle and catheter assembly an assembly that consists of a metal piercing needle and a catheter over it; the hypodermic needle and catheter assembly punctures the skin, the metal puncture needle is pulled out, catheter is indwelled subcutaneously for subcutaneous administration 1 The Chinese standard GB/T that is equivalent to ISO :2006 is currently in the approval stage. Buy True-PDF Auto-delivery. Page 6 of 23

5 It shall be transparent or sufficiently transparent. When tested according to A.1, it shall be able to detect the gas-liquid interface Length The pipeline length shall not be less than 90% of the nominal value. 6.2 Hypodermic needle (if any) Needle tube The needle section and wall thickness shall be uniform. The liquid passage of the needle shall be unimpeded Needle tube length The effective length of the needle tube shall meet the requirements of the nominal value, the tolerance is ±1mm. NOTE: The effective length of the needle is the length of the first bend from the needle tip to the needle tube. For in-line hypodermic needle, the first bend is the junction of the needle tube and the introducer needle unit adhesive tape, i.e. the bending angle is close to 90. For oblique insertion type hypodermic needle, the first bend is exposed at the outside bend Bending direction and angle of needle tube When the direction is parallel to the fixed surface of the needle handle and the direction of the pipeline (in the direction shown in Figure 1), it is visually observing the bending angle of the needle tube, the included angle between the needle tube and the tube side on the needle stem shall be equal to or greater than Needle tip With normal vision or corrected vision, the needle tip shall be sharp, free from kinks, nicks, and hooks when examined under magnification 2.5 times Connection firmness of needle handle At the connection between hypodermic needle and needle handle, apply 10N of axial static tensile force for 15s. It shall not be disconnected or loosened. 6.3 Hypodermic needle and catheter assembly (if any) Catheter length The effective length of the catheter (the length from the tip of the catheter to the end of the catheter) shall be expressed in millimeters. The effective length of the catheter shall meet the requirements of the nominal value, the tolerance is Buy True-PDF Auto-delivery. Page 9 of 23

6 When tested according to in GB/T , the difference between the volume of potassium permanganate solution c(kmno4)=0.002mol/l consumed by test solution and blank solution shall not exceed 2.0 ml. 7.3 Metal ion When tested in atomic absorption spectrophotometry (AAS) or the equivalent method in GB/T , the total content of antimony, chromium, copper, lead, and tin in the test liquid shall not exceed 1 μg/ml, and the content of cadmium not exceed 0.1 μg/ml. When tested according to the colorimetric method in of GB/T , the color of the test liquid shall not exceed the standard control solution with a mass concentration ρ(pb 2+ )=1 μg/ml. 7.4 Acidity titration When tested according to the method of of GB/T , any standard solution required to gray the color of the indicator shall not exceed 1 ml. 7.5 Evaporation residue When tested according to the method of 5.5 in GB/T , the total amount of evaporation residue shall not exceed 2 mg. 7.6 UV absorbance When tested according to the method of 5.7 in GB/T , the absorbance of the test liquid for the wavelength range of 250nm ~ 320nm shall not be greater than Biological requirements 8.1 Biocompatibility The biological evaluation of the subcutaneous infusion set shall be carried out according to GB/T Evaluation results shall indicate no biological hazards. 8.2 Sterility The sterility of the subcutaneous infusion set shall meet the requirements of YY/T Bacterial endotoxin When tested according to GB/T , take the endotoxin-removal syringe Buy True-PDF Auto-delivery. Page 13 of 23

7 requirements. NOTE 2: It can use the symbol 2725 of ISO 7000 to indicate the existence of a substance of concern. The method is to use the abbreviations of the substance instead of "XXX". When it does not contain the substance of concern, draw a X on its symbol Accompanying documents The following information shall be available on the accompanying documents: a) (maximum) blocking alarm threshold value (pressure), in kpa; b) maximum pellet volume at which the device is operating at medium speed and (maximum) blocking alarm threshold (pressure), to the nearest of 0.01 ml; c) instructions for use, including at least the following warnings and instructions: - contraindications include use only for subcutaneous infusions, not for intravenous (IV) infusion or infusion of blood or blood products; - give time interval when the subcutaneous infusion set needs to be replaced; - check packaging integrity and product integrity before use, including instructions for needle damage not to use this subcutaneous infusion set; - if applicable, the instructions that do not reinsert puncture needle into indwelling hose; - if applicable, the instructions that use aseptic technique when temporarily disconnecting the subcutaneous infusion set, and ask medical staff how to compensate for drugs that have not been transfused when disconnected; - warning that do not replace the subcutaneous infusion set before going to sleep unless it can test blood glucose levels 1h ~ 3h after replacement. NOTE 1: The graphic symbols given in YY/T can be used to satisfy the above requirements. NOTE 2: It can use the symbol 2725 of ISO 7000 to indicate the existence of a substance of concern. The method is to use the abbreviations of the substance instead of "XXX". When it does not contain the substance of concern, draw a X on its symbol. Buy True-PDF Auto-delivery. Page 15 of 23

8 Annex A (Normative) Physical test A.1 Transparency test Fill the pipeline with distilled water. Use normal or corrected vision to check if the gas-liquid interface is visible. A.2 Performance test of segregator A.2.1 Pre-test According to the instructions for use, repeatedly connect and disconnect the plug and socket of the separation device five times (or the maximum number of disconnections specified in the instructions for use, whichever is greater), so that the last is disconnected. Install a special socket protector (if equipped), immerse the entire fixed section in water (40±2) C for 30 min. A.2.2 Self tightness According to A.2.1, remove the special socket protector (if equipped). From the puncture end to the pretested fixed segment, fill an air pressure 50kPa higher than the atmospheric pressure for 15s. Check the socket for water leakage in (40 ± 2) C water. From the puncture end, suck 10kPa of negative pressure 15s. Verify that there is liquid entering the system at each socket. A.2.3 Locking performance According to A.2.1, remove the special socket protector (if equipped). Connect the socket of the pre-tested fixed segment segregator to the plug of the moving segregator and keep it locked. Allow the disconnection assembly to withstand 10N of axial static pull force for 15s. Check whether the two are disconnected. A.3 Performance test of adhesive tape A.3.1 Pretest Respectively adhere the adhesive tape of the piercing assembly of which the puncture needle or trocar has been removed AND the adhesive tape of segregator on the clean stainless-steel plate that complies with YY/T Roll four times for each adhesive tape with a roller complying with B.1.2 in YY/T And let it park for 10min under standard atmospheric pressure. Cover with waterproof protective layer (if equipped). Immerse the steel plate Buy True-PDF Auto-delivery. Page 18 of 23