YY/T 0916.6-2022 English PDFUS$804.00 · In stock
Delivery: <= 5 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 0916.6-2022: Small-bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications Status: Valid
Basic dataStandard ID: YY/T 0916.6-2022 (YY/T0916.6-2022)Description (Translated English): Small-bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C30 Word Count Estimation: 44,488 Issuing agency(ies): State Drug Administration YY/T 0916.6-2022: Small-bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial 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 6.Connectors for neuraxial applications ICS 11.040.25 C30 People's Republic of China Pharmaceutical Industry Standard Small Bore Connectors for Medical Liquids and Gases Part 6.Axle application connectors (ISO 80369-6.2016, 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 axonal applications 2 4.2 Materials for Small Bore Connectors 3 4.3 Type test 3 5 Dimensional Design Requirements for Small Aperture Connectors of Shaft Cables 3 6 Performance Requirements 3 6.1 Fluid leakage 3 6.1.1 Fluid leakage requirements 3 6.1.2 Pressure decay leakage 4 6.1.3 Positive pressure liquid leakage 4 6.2 Negative pressure air leakage 4 6.3 Stress cracking 4 6.4 Resistance to axial load separation 4 6.5 Anti-unscrew torque separation 4 6.6 Anti-overload (sliding wire) 4 Appendix A (informative) Appendix A of ISO 80369-6.2016 "Instructions and Guidelines" used in this part 5 Appendix B (Normative Appendix) Shaft Application Small Bore Connector 8 Appendix C (Normative Appendix) Standard Connectors for Small Bore Connectors for Shaft Application 15 Appendix D (informative) Evaluation of medical devices and their properties linked to this application 21 Appendix E (Informative) Summary of Availability Requirements for Small Bore Connectors for Axonal Applications 22 Appendix F (Informative) Summary of Design Requirements for Small Bore Connectors for Shaft Application 25 Appendix G (Informative Appendix) Summary of Design Evaluation of Axial Application Connectors 29 Annex H (normative) Mechanical tests to verify non-interconnection characteristics 32 Appendix I (Informative Appendix) Rationale 35 Appendix J (Informative Appendix) Terminology --- Index of defined terms in alphabetical order 37 Reference 38 Figure A.1 Length of connectors according to ISO 80369-6 (K >8.6mm) 6 Figure A.2 Length of connectors not conforming to ISO 80369-6 (K< 8.6mm) 6 Figure B.1 Non-locking (Sliding) Connector (N1) of Male Shaft Cable 8 Figure B.2 Male Shaft Locking Connector (N2) 9 Figure B.3 Male Axle Locking Connection with Rotatable Collar (N2) 10 Figure B.4 Female Shaft Cable Locking Connector (N2) 11 Figure B.5 Female Shaft Cable Locking Connection with Lug (N2) 13 Figure C.1 Female Standard Locking Connections for Leakage, Unscrew Torque Separation, Stress Cracking and Non-Interconnection Characteristics Tests for Male Axle Connections 16 Figure C.2 Male Standard (Non-Locking) for Testing Female Shaft Cable Connection Leakage, Axial Load Separation, Stress Cracking and Non-Interconnecting Characteristics Sliding connector 17 Figure C.3 Female Standard Connector for Axial Load Separation and Anti-Overload (Slide Wire) Tests for Male Shaft Connectors 18 Figure C.4 Male Standard Locking Connections for Testing Female Shaft Cable Connections for Leakage, Unscrew Torque Separation, Stress Cracking and Non-Interconnection Characteristics 19 Figure C.5 Male standard connector for axial load separation and anti-overload (sliding wire) test of female shaft cable locking connector 20 Figure G.1 wrong connection diagram of male N1 to male luer connector 30 Figure H.1 Connection incompatibility test device 34 Table A.1 Masses of Universal Shaft Assemblies7 Table B.1 Dimensions (N1) of non-locking (sliding) connectors of male shaft cables 8 Table B.2 Dimensions of Male Shaft Locking Connectors (N2) 10 Table B.3 Dimensions of Male Shaft Locking Connector with Rotatable Collar (N2) 11 Table B.4 Female Shaft Cable Locking Connector Dimensions (N2) 12 Table B.5 Dimensions of Female Shaft Cable Locking Connector with Lug (N2) 14 Table D.1 Examples of medical devices with axonal application connections and their properties 21 Table E.1 User characteristics 22 Table E.2 Usage scenarios 22 Table F.1 Special design requirements for shaft cable connections 25 Table G.1 Summary of possible incorrect connections by CAD analysis 29 Table I.1 Correspondence between this part and the Basic Principles35 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 6 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 80369-6.2016 "Small-bore connectors for medical liquids and gases - Part 6.Axons Application Connectors". 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, Zhejiang Volt Medical Device Co., Ltd., Henan Camel People Medical Equipment Group Co., Ltd., Beijing National Medical Equipment Huaguang Certification Co., Ltd. The main drafters of this section. Lu Wenbo, Su Weidong, Liu Yanhong, Milan Ying, Xu Hui, Lin Zechen, Zhang Jing, Sun Jianjun.IntroductionThis section was developed because of some catastrophic post-traumatic complications caused by inappropriate medication, liquid nutritional formula, or air infusion through the axon. The accident happened. The many accidents that have been reported have led to an international consensus on the importance of these issues and the need for medical devices Machinery and its accessories have been recognized for developing specialized connections for conveying fluids in other applications. The YY/T 0916 series of standards were developed to prevent wrong connections between small aperture connectors used in different applications. YY/T 0916.1-2014 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 0916.20-2019 includes general test methods to support performance requirements for small aperture connectors. This part of ISO 80369-6 specifies the design, dimensions and drawings of small bore connectors intended for use in axon applications. 2016 Appendix A "Instructions and Guidelines" see Appendix A, Appendix B and Appendix C give the shaft cable application small hole connector and shaft cable application respectively. Relevant dimensions of standard connectors for testing with small bore connectors, medical devices with connections for this application and evaluation of their properties see appendix D. See Appendix E for a summary of the availability requirements for small-bore connectors for shaft applications. See Appendix E for a summary of design requirements for small-bore connectors for shaft applications. See Appendix G for a summary of design evaluation of axon application connectors, and Appendix H for mechanical tests to verify non-interconnecting characteristics. See Appendix I for this principle, and Appendix J for the term index. This design has been evaluated by the methods described in Appendices D to G. Other parts of YY/T 0916 include requirements for small aperture connectors for different application categories. Internationally, there is evidence of death and serious injury caused by the "wrong way" medication of neuroaxon medical devices. Infusion of non-epidural drugs Reports of injection into the epidural space and local anesthetic fluid for epidural injection being injected into the intravenous route. There is also a report on intravenous anesthetics Reports of infusion into cerebrospinal fluid by extraventricular drainage and some early reports of antibiotics being inappropriately infused through this route. In July.2007, the World Health Organization's World Alliance for Patient Safety issued Alert No. 115, describing four incidents in different countries. accidental infusion into the intrathecal route of vincristine intended for the intravenous route. The alert states that since 1968, in various public There have been 55 reports of the same error across the agency. No matter how repeated risk warnings are issued, extensive requirements are introduced in labelling and recommendations for expected standardized operation and risk reduction are given. However, these accidents still occur from time to time. Other world health organisations have also issued detailed guidance to minimise the risk of 'wrong way' errors. However, deaths from vinca alkaloid infusions have been reported worldwide. In.2009, the U.S. Food and Drug Administration Published a medical device calendar that includes examples of case studies of misconnected axons. 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-bore connector series standard Connectors for any other application in ® are dimensionally incompatible. If these connectors are assembled to related medical devices and accessories, These connections should reduce the delivery of air, non-endovascular drugs, and liquid nutritional formulations through other routes (eg, nerve, intravenous, or airway devices) risks of. Small Bore Connectors for Medical Liquids and Gases Part 6.Axle application connectors1 ScopeThis part of YY/T 0916 specifies the requirements for small-bore connectors intended for connection in axonal applications. Axonal applications involve the following Use of several medical devices. anticipated drug delivery to axonal sites, wound infiltration anaesthetic delivery, and other local anaesthetic procedures, or for therapeutic or diagnostic purposes Monitoring or drainage of cerebrospinal fluid (CSF) for purposes. Note 1.The site of axonal application includes the spine, intrathecal or subarachnoid space, ventricle, subdural space, epidural space or dural space. Axonal application of anesthesia Agents can be infused locally to affect large parts of the body (eg, limbs) and include plexus block (eg, branchial nerve block or single nerve block). Axonal applications include continuous wound infusion of local anesthetics. Note 2.This section does not consider subcutaneous injection of local anesthesia as axonal application. Examples. Expected intrathecal chemotherapy, local anesthetics, contrast agents, antibiotics, analgesics. This section specifies the dimensions of these small-bore connectors intended for use in medical devices, as well as requirements for design and functional characteristics. This section does not specify requirements for medical devices or accessories using these connectors. These requirements are specified in the standard of the dedicated medical device or accessory. given in the standard. Note 3.Even if it is not required in the current special standards related to medical devices, manufacturers are encouraged to apply the small-bore connectors specified in this part to medical devices or accessories. on the piece. It is expected that the requirements for small bore connectors specified in this section will be included when revising the relevant dedicated medical device standards. In addition, many use Medical devices for axonal applications still need to develop standards. Note 4.5.8 of YY/T 0916.1-2014 specifies alternative methods for small aperture connectors that comply with YY/T 0916.1-2014 but do not comply with this part method, these small bore connectors are intended for medical devices or accessories for axonal applications.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 0916.3-2022 Small bore connectors for medical liquids and gases - Part 3.Connectors for gastrointestinal applications (ISO 80369-3.2016, 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 0916.6-2022_English be delivered?Answer: Upon your order, we will start to translate YY/T 0916.6-2022_English as soon as possible, and keep you informed of the progress. 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