YY/T 0492-2026Implantable leads (English PDF)
植入式电极导线
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
March 9, 2026
Implementation date
March 1, 2027
Scope
YY/T 0492-2026 is the English-translated version of 植入式电极导线.
YY/T 0492-2026 is the Chinese standard "Implantable leads". Its scope clause reads: This document specifies implantable cardiac pacing electrode leads, implantable neurostimulator electrode leads and extension leads, and implantable cardiac defibrillators.
Requirements for electrode wires. This document applies to implantable cardiac pacing electrode leads, implantable neurostimulator electrode leads and extension leads, and implantable cardiac defibrillators.
Electrode wires. Note 1.This document describes the functions of different pacemaker systems, neurostimulator systems, or defibrillator systems composed of different electrode leads, extension leads, and pulse generators.
No requirements were made regarding compatibility or reliability. Note 2.The connector characteristics of implantable cardiac pacing electrode leads are specified in YY/T 0491 (IS-1) and YY/T 0972 (IS4).
Implantable cardiac defibrillation electrodes. The connector characteristics of the wires are specified by YY/T 0946 (DF-1) and YY/T 0972 (DF4). Note 3.The tests specified in this document are type tests, which are conducted on samples to evaluate the device and are not intended to be used as items for factory inspection. Its clauses include terms and definitions.
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Document preview — YY/T 0492-2026
National Standard of the People's Republic of China
- ICS
- 11.040.40
- Classification
- C31
- Replacing
- YY/T 0492-2017
Issued by: National Medical Products Administration
Contents
- Preface
- 1.Scope
- 2 Normative References
- 3.Terms and Definitions
- 4 Requirements and Test Methods
- 4.1 Physical Dimensions
- 4.2 Appearance
- 4.3 Electrical Characteristics of Electrode Conductors
- 4.4 Protection against mechanical damage
- 4.5 Protection against damage caused by temperature changes
- 4.6 X-ray detectability
- 4.7 Chemical Properties
- 4.8 Sterilization
- 4.9 Protection against biological effects
- 4.10 Packaging and labeling
- 4.11 Accompanying Documents
- Appendix A (Informative) Measurement of Electrical Properties of Electrode Leads for Implantable Neurostimulators
- Appendix B (Normative) Chemical Performance Test
- References
1 Scope
This document specifies implantable cardiac pacing electrode leads, implantable neurostimulator electrode leads and extension leads, and implantable cardiac defibrillators.
Requirements for electrode wires.
This document applies to implantable cardiac pacing electrode leads, implantable neurostimulator electrode leads and extension leads, and implantable cardiac defibrillators.
Electrode wires.
Note 1.This document describes the functions of different pacemaker systems, neurostimulator systems, or defibrillator systems composed of different electrode leads, extension leads, and pulse generators.
No requirements were made regarding compatibility or reliability.
Note 2.The connector characteristics of implantable cardiac pacing electrode leads are specified in YY/T 0491 (IS-1) and YY/T 0972 (IS4). Implantable cardiac defibrillation electrodes.
The connector characteristics of the wires are specified by YY/T 0946 (DF-1) and YY/T 0972 (DF4).
Note 3.The tests specified in this document are type tests, which are conducted on samples to evaluate the device and are not intended to be used as items for factory inspection.
2 Normative references
The contents of the following documents, through normative references within the text, constitute essential provisions of this document. Dated citations are listed below.
For references to documents, only the version corresponding to that date applies to this document; for undated references, the latest version (including all amendments) applies.
document.
GB/T 601 Preparation of Standard Titration Solutions for Chemical Reagents
GB/T 14233.1-2022 Medical infusion, transfusion and injection equipment test methods - Part 1.Chemical analysis methods
GB 16174.1-2024 Surgical Implants - Active Implantable Medical Devices - Part 1.Safety, Marking and Manufacturer's Information
General requirements for information
GB 16174.2-2024 Surgical Implants - Active Implantable Medical Devices - Part 2.Cardiac Pacemakers
GB/T 16886.18-2022 Biological evaluation of medical devices – Part 18.Chemical analysis of medical device materials during risk management
Characterization
YY/T 0491 Small cross-section connectors for implantable cardiac pacemakers
YY/T 0946 Dimensions and Test Requirements for DF-1 Connector Assemblies for Implantable Cardiac Defibrillators
YY/T 0972 Dimensions and Test Requirements for Four-Pole Connector Systems for Implantable Cardiac Rhythm Regulators in Active Implantable Medical Devices
YY 0989.3-2023 Surgical Implants - Active Implantable Medical Devices - Part 3.Implantable Neurostimulators
YY 0989.6-2025 Surgical Implants - Active Implantable Medical Devices - Part 6.Active Implantable Devices for the Treatment of Tachyarrhythmias
Specific requirements for medical devices (including implantable defibrillators).
3 Terms and Definitions
The terms defined in GB 16174.1-2024, GB 16174.2-2024, YY 0989.3-2023 and YY 0989.6-2025, and the following technical terms
The terms and definitions apply to this document.
3.1 Electrode lead
An electrical connection device connecting the pulse generator and the target point.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 16 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 601Chemical Reagent - Preparations of Standard Volumetric Solutions
- GB/T 14233.1-2022Test methods for infusion, transfusion, injection equipments for medical use - Part 1: Chemical analysis methods
- GB 16174.1-2024Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
- GB 16174.2-2024Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers
- GB/T 16886.18-2022Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process
- YY/T 0491Cardiac pacemakers—Low-profile connectors(IS-1) for implantable pacemakers
Similar standards
Editions of YY/T 0492
| Edition | Title | Revision | Status |
|---|---|---|---|
| YY/T 0492-2026 | Implantable leads | current edition | Current |
| YY/T 0492-2017 | Implantable leads | previous edition | In force until 2027-03-01 |
This page sells the current edition, YY/T 0492-2026. Earlier editions are listed for reference only.
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Related Standards
GB 16174.1-2024 — Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
GB 16174.2-2024 — Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers
GB/T 14233.1-2022 — Test methods for infusion, transfusion, injection equipments for medical use - Part 1: Chemical analysis methods
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