YY/T 0946-2014 English PDF

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YY/T 0946-2014: Cardiac defibrillators. Connector assembly DF-1 for implantable defibrillators. Dimensions and test requirements
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 0946-2014	509	Add to Cart	4 days	Cardiac defibrillators. Connector assembly DF-1 for implantable defibrillators. Dimensions and test requirements	Valid

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Basic data

Standard ID: YY/T 0946-2014 (YY/T0946-2014)
Description (Translated English): Cardiac defibrillators. Connector assembly DF-1 for implantable defibrillators. Dimensions 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: 22,238
Date of Issue: 6/17/2014
Date of Implementation: 7/1/2015
Quoted Standard: GB/T 74-1985
Adopted Standard: ISO 11318-2002, MOD
Regulation (derived from): China Food and Drug Administration in 2014 Bulletin No. 30
Issuing agency(ies): State Food and Drug Administration
Summary: This Standard applies to the implantable cardioverter-defibrillator electrode lead with a maximum output does not exceed the DF-1 single-pole connector assembly at 1kV/50A of the implantable cardioverter defibrillator pulse generator connection. This Stan

YY/T 0946-2014: Cardiac defibrillators. Connector assembly DF-1 for implantable defibrillators. Dimensions 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.
Cardiac defibrillators. Connector assembly DF-1 for implantable defibrillators. Dimensions and test requirements ICS 11.040.40 C31 People's Republic of China pharmaceutical industry standards Defibrillator implantable cardioverter defibrillator Used DF-1 connector assembly dimensions and test requirements (ISO 11318.2002, MOD) Issued on. 2014-06-17 2015-07-01 implementation China Food and Drug Administration released

Table of Contents

Preface Ⅰ 1 Scope 1 2 Normative references 1 3 Definitions 1 4 requires 2 4.1 Overview 2 4.2 defibrillation electrode wire connector 2 4.3 defibrillator connector cavity 5 Appendix A (normative) Lead connections Electrical isolation Test 7 Appendix B (normative) connector cavity 11 test carriers Necessity (informative) electrode wire connector electrically isolated test Appendix C Notes 14 Annex D (informative) connector cavity carrier trials Rationale 16 Annex E (informative) introduced the basic reason of this standard 17 Figure 1 DF-1 connector electrode lead 3 Figure 2 DF-1 Lead connections through regulation 4 Mark 3 defibrillation lead connector and the pulse generator 5 Figure 4 DF-1 connector cavity 5 Figure 5 DF-1 connector cavity through regulation 6 Layout A.1 Electrical isolation Test 7 Figure A.2 Test signal 8 Figure A.3 test cavity 9 Figure A.4 impedance test pin 9 Figure A.5 leakage current waveform 10 Figure B.1 carrier test pin 11 Figure B.2 carrier test layout 12 Figure B.3 carrier test waveforms 13

Foreword

This standard was drafted in accordance with GB/T 1.1-2009 given rules. This standard uses the translation method, modify the use of ISO 11318.2002 "cardiac defibrillator implanted cardiac defibrillator Used DF-1 connector set Size pieces and testing requirements. " This standard and ISO 11318.2002 main technical differences are as follows. --- Remove the ISO 11318.2002 standard covers, foreword and introduction; --- For the international standard quoted in the standard ISO 7436. 1983, changed to refer to our standard GB/T 74-1985 "Slotted Screws "(eqvISO 7436. 1983). Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents. This standard was proposed by the China Food and Drug Administration. This standard by the National Standardization Medical Electrical Medical Electronic Instrument Standardization Technical Committee Technical Committee (SAC/TC10/SC5) Centralized. This standard was drafted. Shanghai Medical Device detection. The main drafters. Zhang Yi Dong, Yang Xin, Guo Yunqiu. Defibrillator implantable cardioverter defibrillator Used DF-1 connector assembly dimensions and test requirements

1 Scope

This standard applies to the implantable cardioverter defibrillator electrode lead with a maximum output of no more than 1kV/50A implantable cardiac defibrillation pulse Generator is used to connect the DF-1 single-pole connector assembly. This standard specifies the basic size between mating components, performance requirements and The appropriate test methods. Other features of the standard connector, such as fastening methods and materials not specified. This standard applies to the shape of the connector assembly and adaptation. This standard does not apply to different implantable defibrillation electrode lead and an implantable cardioverter defibrillator pulse generator used in conjunction with compatible features , System performance and reliability.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document. GB/T 74-1985 Slotted set screws (eqvISO 7436. 1983)

3 Definitions

The following terms and definitions apply to this document. 3.1 The connector assembly connectorassembly It comprises an electrode wire connector and a defibrillation pulse generator dovetail connector cavity, power poles and wires defibrillation pulse Generator electrical and mechanical connection means. 3.2 Lead connections leadconnector Portion of the connector lumen connector assembly is inserted. 3.3 Connector cavity connectorcavity Part defibrillation pulse generator on the connector assembly. 3.4 Sealing means sealingmechanism The connector assembly to maintain electrical isolation between the annular insulating member electrically insulating layer. 3.5 Sealing zone sealzone Between the connector and the electrode wire lumen connector carrying one or more sealed surface area. ......

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