YY/T 0972-2016 English PDFUS$1479.00 · In stock
Delivery: <= 10 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 0972-2016: Active implantable medical devices--Four-pole connector system for implantable cardiac rhythm management devices--Dimensional and test requirements Status: Valid
Basic dataStandard ID: YY/T 0972-2016 (YY/T0972-2016)Description (Translated English): Active implantable medical devices--Four-pole connector system for implantable cardiac rhythm management devices--Dimensional and test requirements Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C31 Classification of International Standard: 11.040.40 Word Count Estimation: 74,775 Date of Issue: 2016-03-23 Date of Implementation: 2017-01-01 Quoted Standard: GB/T 74-1985; ASTM A276; ASTM B348; ASTM F562; ASTM F746-04; ASTM B896 Adopted Standard: ISO 27186-2010, MOD Regulation (derived from): Notice of the General Administration of Food and Drug Administration (No. 74 of 2016) Issuing agency(ies): State Food and Drug Administration Summary: This standard applies to quadrupole connector systems for implantable pacemaker devices with pacing, ECG perception and/or defibrillation. This standard specifies the requirements for the part of the implantable electrode lead connector and the requirements for the basic dimensions and performance requirements of the submerged pulse generator attached to the connector, and the test method for its adaptation. This standard is not intended to replace existing unipolar or bipolar connector standards (eg ISO 11318 and YY/T O491). This standard does not apply to systems that can output voltages higher than 1 000 V and/or 50 A. This standard does not apply to systems with sensors or special electrodes that do not support traditional pacing, ECG perception and/or defibrillation functions. This standard does not specify all connector characteristics. Standard is not clear functional compatibility, YY/T 0972-2016: Active implantable medical devices--Four-pole connector system for implantable cardiac rhythm management devices--Dimensional and test requirements---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. Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements ICS 11.040.40 C31 People's Republic of China Pharmaceutical Industry Standard Active implantation of medical devices for implantable pacemaker equipment Quadrupole connector system dimensions and test requirements Activeimplantablemedicaldevices-Four-poleconnectorsystem forimplantable (ISO 27186..2010, MOD) 2016-03-23 release 2017-01-01 Implementation State Food and Drug Administration issued Directory Preface III 1 Scope 1 2 normative reference document 1 3 Terms and definitions 1 4 requirements 4 Appendix A (Normative Appendix) Electrical Isolation Test 20 Appendix B (informative) Basic principles of Appendix A 25 Appendix C (Normative Appendix) Dielectric Strength Test 27 Appendix D (informative) Basic principles of Appendix C 32 Appendix E (normative) High pressure current carrying test Appendix F (informative) Basic principles of Appendix E 39 Appendix G (informative) Test for fatigue strength of electrode lead connectors Appendix H (informative) Material of the electrode lead connector sealing area Appendix I (informative) Seal zone creep 44 Appendix J (informative) Contact resistance stability 48 Appendix K (informative) Basic principles of Appendix J 51 Appendix L (informative) Selection of contact materials 53 Appendix M (normative) Requirements for contact material for electrode lead connectors Appendix N (informative) Basic principles of Appendix M 58 Appendix O (informative) Basic principles required by this standard 63 Appendix P (informative) Connector product (eg adapter, expander, patient wire, etc.) 69 Figure 1 quadrupole electrode lead connector body 7 Figure 2 Quadrupole Electrode Wire Connector High Pressure Pin and Low Pressure Special Needle Details 7 Figure 3 Contact portion of the electrode lead connector Figure 4 electrode lead connector gauge Figure 5 ring contact force test tooling 12 Figure 6 quadrupole connector cavity 13 Figure 7 Four-pole connector cavity tip detail 14 Figure 8 The contact portion 15 in the connector cavity Figure 9 connector lumen maximum needle 17 Figure 10 Minimum fixed needle 18 Figure A.1 Connector Insulation Test Pin 22 Figure A.2 Maximum offset pin 23 Figure C.1 Electrolyte Strength Test Device Figure C.2 Test signal 28 Figure C.3 Leakage Current Waveform 30 Figure E.1 Current carrying test pin Figure E.2 Current carrying test device for electrode lead connector Figure E.3 Current carrying test device for connector cavity 37 Figure E.4 Pulse by measuring the voltage under resistor 1Ω Figure G.1 Fixing device 41 Figure I.1 Creep test needle 45 Figure I.2 Sample Ozone ringing depth after soaking for 30 days to 32 days at 37 ° C ± 5 ° C salt solution 46 Figure J.1 360 ° rotation of the contact resistance fixture Figure M.1 Cross resistance requirements - Force and resistance Figure N.1 The average resistance of the alloy as specified in ASTM F562 Figure N.2 Power and 316L stainless steel average resistance 60 Table 1 Electrode connection marks and electrical connections inside the wire --- Permitted structure 9 Table 2 Marker symbols for the pulse generator and electrical connection to the device output --- Permitted structure Table A.1 Test combinations for electrode lead connectors 21 Table A.2 Test combinations for synthetic bipolar electrode lead connectors 21 Table A.3 Test combinations for connector lumens 24 Table B.1 Recommended test combinations for connector lumens 26 Table C.1 Test combinations for non-synthetic bipolar high voltage (DF4) electrode lead connectors Table C.2 Test combinations for synthetic bipolar high voltage (DF4) electrode lead connectors Table C.3 Acceptance criteria 30 Table C.4 Test combinations for high pressure (DF4) connector lumens 31 Table C.5 Acceptance criteria 31 Table D.1 Electrode Conductor for High and Low Voltage and Connector Induction Voltage Recommended Test Set 34 Table N.1 Contact Resistance 61 Table O.1 Configuration of the connector system Table P.1 Configuration of the connector system 69 ForewordThis standard is drafted in accordance with the rules given in GB/T 1.1-2009. This standard uses the re-drafting method to modify the use of ISO 27186..2010 (first edition) "active implantation of medical devices implantable cardiac rhythm Device quadrupole connector system size and test requirements ". The main differences between this standard and ISO 27186..2010 (first edition) are as follows. --- For the standard cited in the standard, if China has been converted into domestic standards, then refer to our standards; --- According to the Chinese version of the requirements, page number, font and font size, etc. have been modified, does not affect the degree of consistency; Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents. This standard is proposed by the State Food and Drug Administration. This standard by the National Medical Electrical Standardization Technical Committee of medical electronic equipment standardization sub-technical committee (SAC/TC10/SC5) Go back. The drafting of this standard. Shanghai Medical Devices Testing Institute. The main drafters of this standard. Yang Xin, Xie Qiong. Active implantation of medical devices for implantable pacemaker equipment Quadrupole connector system dimensions and test requirements1 ScopeThis standard applies to quadrupole connector systems for implantable pacemaker devices with pacing, ECG perception and/or defibrillation. This standard Specifies the requirements for the part of the implantable electrode lead connector and the requirements for the inner cavity of the connector attached to the enclosed implanted pulse generator. Set the basic dimensions and performance requirements and their adaptation test methods. This standard is not intended to replace existing unipolar or bipolar connector standards (eg ISO 11318 and YY/T 0491). This standard does not Suitable for systems that can output high voltages above 1000V and/or 50A. This standard does not apply to those who do not support traditional pacing, ECG Knowledge and/or defibrillation function of the sensor or special electrode system. This standard does not specify all connector characteristics. The standard is not clear functional compatibility, electrode wire safety and reliability and pulse generator with System adaptation requirements. WARNING - If the implantable pulse generator is able to conduct a dangerous non-pacing stimulus signal through the contact portion of the lumen (eg, Defibrillation), it is not possible to use the connector cavity for low voltage only specified in this standard. Likewise, this standard provides for High voltage electrode connectors can not be used in electrode lines for low voltage therapy. Note. Electrode conductors and pulse generator connectors that do not meet this standard may be safe, reliable, and may have clinical advantages.2 normative reference documentsThe following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article Pieces. For undated references, the latest edition (including all modifications) applies to this document. GB/T 74. 1985 Slotted terminal set screws (ISO 7436. 1983, MOD) ASTMA276 stainless steel bar and profile standard (StandardSpecification forStainlessSteelBarsand Shapes Standard Specification for Titanium and Titanium Alloy Rods and Billets (StandardSpecification for Titaniumand TitaniumAloyUGISanobilets) ASTMF562 Standard Specification for Forged Cobalt-Chromium-Molybdenum Alloy for Surgical Implantation (StandardSpecification forWught) 35Cobalt-35Nickel-20Chromium-10MolybdenumAloyforSurgicalImplantApplications ASTM F746-04 Standard Test Method for Dent or Fissure Corrosion of Metallic Surgical Implants (StandardTestMethod forPittingorCreviceCorrosionofMetalicSurgicalImplantMaterials) Standard Test Method for Evaluation of Connection Properties of Electrical Conductor Materials by ASTMB896 (StandardTestMethods forEvaluating ConnectabilityCharacteristicsofElectricalConductorMaterials)3 terms and definitionsThe following terms and definitions apply to this document. 3.1 Needle axial movement axialpinmovement In some designs, particularly in the design with a rotatable connector pin, the electrode lead connector pin is connected to the electrode lead connector body ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 0972-2016_English be delivered?Answer: Upon your order, we will start to translate YY/T 0972-2016_English as soon as possible, and keep you informed of the progress. 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