YY/T 0946-2014Cardiac defibrillators—Connector assembly DF-1 for implantable defibrillators—Dimensions and test requirements (English PDF)
心脏除颤器 植入式心脏除颤器用DF�1连接器组件 尺寸和试验要求
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
June 17, 2014
Implementation date
July 1, 2015
Scope
YY/T 0946-2014 is the English-translated version of 心脏除颤器 植入式心脏除颤器用DF�1连接器组件 尺寸和试验要求.
YY/T 0946-2014 is the Chinese pharmaceutical industry standard for the DF-1 connector assembly by which a defibrillation electrode lead is joined to an implantable cardioverter defibrillator pulse generator whose output does not exceed 1 kV and 50 A. It fixes the basic dimensions between the mating parts, the performance requirements and the tests for them, covering the electrical continuity and insulation of the connection, its mechanical retention and its behaviour under the defibrillation pulse. Issued on 17 June 2014, it has applied since 1 July 2015.
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Document preview — YY/T 0946-2014
National Standard of the People's Republic of China
- ICS
- 11.040.40
- Classification
- C 31
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Preface
- 1 Scope
- 2 Normative references
- 3 Definitions
- 4 requires
- 4.1 Overview
- 4.2 defibrillation electrode wire connector
- 4.3 defibrillator connector cavity
- Appendix A (normative) Lead connections Electrical isolation Test
- Appendix B (normative) connector cavity 11 test carriers Necessity (informative) electrode wire connector electrically isolated test Appendix C Notes
- Annex D (informative) connector cavity carrier trials Rationale
- Annex E (informative) introduced the basic reason of this standard
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).
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
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.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 17 pages — is available in the English PDF.
Referenced standards
Normative references
Cited by
- YY/T 0492-2026Implantable leads
- YY 0989.6-2025Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
- GB 16174.2-2024Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers
- YY/T 1935-2024Requirements and test methods for safety of implantable pacemakers and cardioverter defibrillators exposed to magnetic resonance imaging
- GB 16174.2-2015Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers
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