YY/T 0916.3-2022 English PDFUS$714.00 · In stock
Delivery: <= 5 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 0916.3-2022: Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications Status: Valid
Basic dataStandard ID: YY/T 0916.3-2022 (YY/T0916.3-2022)Description (Translated English): Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C30 Word Count Estimation: 39,325 Issuing agency(ies): State Drug Administration YY/T 0916.3-2022: Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order. Small-bore connectors for liquids and gases in healthcare applications - Part 3.Connectors for enteral applications ICS 11.040.25 C30 People's Republic of China Pharmaceutical Industry Standard Small Bore Connectors for Medical Liquids and Gases Part 3.Connectors for gastrointestinal applications (ISO 80369-3.2016, IDT) Published on 2022-05-18 2023-06-01 Implementation Released by the State Drug Administration directory Preface III Introduction IV 1 Scope 1 2 Normative references 1 3 Terms and Definitions 2 4 General Requirements 2 4.1 General Requirements for Small Bore Connectors for Gastrointestinal Applications 2 4.2 Materials used in gastrointestinal small-bore connectors3 4.3 Type test 3 5 Dimensional design requirements for gastrointestinal small-bore connectors 3 6 Performance Requirements 3 6.1 Fluid leakage 3 6.1.1 Fluid leakage requirements 3 6.1.2 Pressure decay leakage 3 6.1.3 Positive pressure liquid leakage 3 6.2 Stress cracking 4 6.3 Resistance to axial load separation 4 6.4 Anti-unscrew torque separation 4 6.5 Anti-overload (sliding wire) 4 6.6 Unscrew separation 4 Appendix A (informative) Appendix A of ISO 80369-3.2016 "Instructions and Guidelines" used in this part 5 Appendix B (Normative Appendix) Gastrointestinal Small Bore Connectors 8 Appendix C (Normative Appendix) Standard Connectors 12 Appendix D (informative) Evaluation of medical devices and their properties linked to this application16 Appendix E (Informative) Summary of Requirements for Usability of Small Bore Connectors for Gastrointestinal Applications 17 Appendix F (Informative) Summary of Guidelines and Requirements for Small Bore Connectors for Gastrointestinal Applications 22 Appendix G (Informative Appendix) Summary of Design Evaluation of Connectors for Gastrointestinal Applications 26 Appendix H (Informative) References to the Basic Principles 31 Appendix I (Informative Appendix) Terms - Alphabetical Search Terms and Definitions 33 Reference 34 Figure B.1 Male E1 Small Aperture Connector 8 Figure B.2 Female E1 Small Aperture Connector 10 Figure B.3 E1 connector assembly 11 Figure C.1 Male Gastrointestinal Connector Leakage, Anti-screw Torque Separation, Unscrew Separation, Stress Cracking and Non-Interconnection Characteristics Test Female Standard connector 12 Figure C.2 Female standard connectors for tests of resistance to axial load separation, overload resistance and non-interconnection characteristics of male gastrointestinal connectors 13 Figure C.3 Male Gastrointestinal Connector Leakage, Anti-screw Torque Separation, Unscrew Separation, Stress Cracking and Non-Interconnection Characteristics Tests Standard Connector 14 Figure C.4 Male standard connectors for tests of resistance to axial load separation, overload resistance and non-interconnection characteristics of female gastrointestinal connectors 15 Table B.1 Male E1 Small Bore Connector Dimensions 9 Table B.2 Female E1 Small Bore Connector Dimensions 10 Table D.1 Examples of medical devices and their attributes to which the connection specified in this part is applied 16 Table E.1 User characteristics 17 Table E.2 Use scenarios for gastrointestinal feeding18 Table E.3 Use Scenarios for Gastrointestinal Administration 18 Table E.4 Use scenarios for decompression and aspiration of gastrointestinal contents19 Table E.5 Use scenarios for delivering radiocontrast material19 Table F.1 Summary of Specific Design Criteria and Requirements for Small Bore Fittings in the Gastrointestinal Tract 22 Table G.1 Summary of possible incorrect connections for CAD analysis 26 Table G.2 Survey Results for the Failed Participant 29 Table H.1 Correspondence of this part to the basic principles 31 forewordYY/T 0916 "Small Aperture Connectors for Medical Liquids and Gases" consists of the following parts. --- Part 1.General requirements; --- Part 3.Connectors for gastrointestinal applications; --- Part 5.Limb airbag inflation application connectors; --- Part 6.Shaft application connectors; --- Part 7.Connectors for intravascular or subcutaneous application; --- Part 20.General test methods. This part is part 3 of YY/T 0916. This section is drafted in accordance with the rules given in GB/T 1.1-2009. This part uses the translation method equivalent to ISO 80369-3.2016 "Medical liquids and gases with small aperture connectors - Part 3.Gastrointestinal Road Application Connectors. This part incorporates the amendments to ISO 80369-3.2016/Amd.1.2019, the clauses involved in these amendments have been adopted in its A vertical double line (‖) in the margin of the outer page is indicated. Please note that some content of this document may be patented. The issuing authority of this document assumes no responsibility for identifying these patents. This part is proposed by the State Drug Administration. This part is under the jurisdiction of the National Technical Committee for Standardization of Medical Infusion Devices (SAC/TC106). This section is drafted by. Shandong Medical Device Product Quality Inspection Center, Anhui Tiankang Medical Technology Co., Ltd., Nutricia Pharmaceutical (Wuxi) Co., Ltd., Shandong Xinhua Ande Medical Products Co., Ltd., Beijing National Medical Equipment Huaguang Certification Co., Ltd. The main drafters of this section. Zhang Bo, Chong Xiuming, Zhu Yanqin, Gong Bingxian, Wang Meiying, Wu Ping, Wang Changbin, Bai Baodong, Shi Kai.IntroductionThis section was developed because of a number of accidents with catastrophic consequences due to. First, the infusion of inappropriate drugs Nutrient channels; the second is that the gastrointestinal nutrient solution is injected into the wrong channels, such as venous and gas channels. The many accidents that have been reported make these There is an international consensus on the magnitude of the issue and the need to develop dedicated connections for medical devices and their accessories to deliver fluids in other applications. The connection has been approved. The YY/T 0916 series of standards were developed to prevent wrong connections between small aperture connectors used in different applications. YY/T 0916.1 specifies the necessary requirements for verifying the design and dimensions of small aperture connectors to ensure. a) they will not be misconnected with other small aperture connectors; b) They form a secure and reliable connection with their counterpart to another connector. YY/T 0916.20 includes general test methods to support performance requirements for small aperture connectors. This section specifies the design, dimensions and drawings of small bore connectors intended for use in gastrointestinal applications. used in this section Annex A of ISO 80369-3.2016 "Instructions and guidelines" refer to Annex A, Annex B and Annex C respectively give the connection for gastrointestinal applications For dimensions related to standard connectors, see Appendix D for the evaluation of medical devices with connectors for this application and their properties, Small Bore Size for Gastrointestinal Applications See Appendix E for a summary of connector availability requirements, and Appendix F for a summary of guidelines and requirements for small-bore connectors for gastrointestinal applications. Refer to Appendix G for a summary of the design evaluation using connectors, refer to Appendix H for references to basic principles, and refer to Appendix I for a term index. through the appendix The methods described in D to Appendix G have been evaluated for this design. Other parts of YY/T 0916 include categories for different applications requirements for small-bore connectors. Except as pointed out in G.2, the connectors manufactured according to the dimensions stated in this section are in accordance with the YY/T 0916 small hole connector series standard. Connectors for any other application are not dimensionally compatible. If these connectors are assembled to related medical devices and accessories, this These connections reduce the risk of delivering air, non-endovascular drugs, and liquid nutritional formulations through other routes, such as intravenous or airway devices. During the development of ISO 80369-3, the ISO /TC210 committee decided to cover the entire gastrointestinal system, but for the connection of the reservoir It remains an independent international standard. ISO 18250-3 specifies connections for accumulators. This section includes small Dimensions of the mating surface of aperture connectors, and mating surfaces of small aperture connectors for gastrointestinal infusion devices and gastrointestinal syringes. Small Bore Connectors for Medical Liquids and Gases Part 3.Connectors for gastrointestinal applications1 ScopeThis part of YY/T 0916 specifies the dimensions, design and functional characteristics requirements. Note 1 to entry. Gastrointestinal medical devices include gastrointestinal feeder systems, gastrointestinal drain systems, gastrointestinal syringes, and patient-entry devices with input ports. instrument. This section does not specify the dimensions and requirements of medical devices or accessories using these connectors. These requirements are specified in dedicated medical devices or attached given in the standard for the piece. This standard does not specify requirements for small bore connectors for. --- Medical devices for gastric suction only; --- Medical devices for oral use only; Example. Oral terminal syringes that are not intended to be connected to other medical devices and are intended to be used directly for patient oral administration. --- Pressurized or pressure-relieved fixation mechanisms (such as balloons) used to fix medical devices inserted into the gastrointestinal tract in the correct position; --- Gastrointestinal endoscopy equipment; --- Medical devices for performing gastrostomy on the skin. Note 2.Even if the current special standards related to medical devices do not require it, manufacturers are encouraged to apply small-bore connectors that meet the requirements of this part to gastrointestinal medical devices. on the device or accessory. When it is expected to revise the relevant special medical device standards, the requirements for small aperture connectors specified in YY/T 0916 will be included in the in.2 Normative referencesThe following documents are essential for the application of this document. For dated references, only the dated version applies to this article pieces. For undated references, the latest edition (including all amendments) applies to this document. YY/T 0316-2016 Application of Medical Device Risk Management to Medical Devices (ISO 14971.2007 Corrected Edition, IDT) YY/T 0916.1-2014 Small bore connectors for medical liquids and gases - Part 1.General requirements (ISO 80369-1. 2010, IDT) YY/T 0916.6-2022 Small bore connectors for medical liquids and gases - Part 6.Connectors for shaft applications (ISO 80369- 6.2016, IDT) YY/T 0916.20-2019 Small aperture connectors for medical liquids and gases-Part 20.General test methods (ISO 80369- 20.2015, IDT) ISO 80369-7.2016 Small bore connectors for medical liquids and gases - Part 7.Connectors for intravascular or subcutaneous applications tics) ASTM D790 Standard Test Method for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials (Standardtestmeth- ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 0916.3-2022_English be delivered?Answer: Upon your order, we will start to translate YY/T 0916.3-2022_English as soon as possible, and keep you informed of the progress. 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