YY/T 0492-2026 Pending Industry standards-Medicine

YY/T 0492-2026 Implantable lead

YY/T 0492-2026 Implantable lead

Publish Date: 2026-03-09 Implement Date: 2027-03-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: YY/T 0492-2026

Standard Type: Industry standards

Standard Status: Pending

is_force_gb: no

CCS Name: Generally, it refers to microsurgical instruments

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2026-03-09

Implement Date: 2027-03-01

Pages: 20 pages

Scope

This document specifies the requirements for implantable cardiac pacemaker electrode leads, implantable neurostimulator electrode leads and extension leads, and implantable cardiac defibrillator electrode leads.
This document applies to implantable cardiac pacemaker electrode leads, implantable neurostimulator electrode leads and extension leads, and implantable cardiac defibrillator electrode leads.
Note 1: This document does not address the functional compatibility or reliability of different electrode leads, extension leads, and pulse generators in pacemaker systems, neurostimulator systems, or defibrillator systems.
Note 2: The connector characteristics of implantable cardiac pacemaker electrode leads are specified in YY/T 0491 (IS-1) and YY/T 0972 (IS4). The connector characteristics of implantable cardiac defibrillator electrode leads are specified in YY/T 0946 (DF-1) and YY/T 0972 (DF4).
Note 3: The tests specified in this document are type tests, which are used to evaluate the device through sample testing, and are not intended to be used as factory inspection items.

Development Information

Word Count: 25 Thousand words Pages: 20 pages

Replace the following standards

YY/T 0492-2017 Implantable cardiac pacing lead

Referenced Standards

GB/T 601-2002 Chemical reagent Preparations of standard volumetric solutions GB/T 601-2016 Chemical reagent—Preparations of reference titration solutions GB/T 14233.1-2022 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods 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 16886.18-2022 Biological evaluation of medical devices—Part 18:Chemical characterization of medical device materials within a risk management process YY/T 0491-2004 Cardiac pacemakers—Low-profile connectors(IS-1) for implantable pacemakers YY/T 0946-2014 Cardiac defibrillators—Connector assembly DF-1 for implantable defibrillators—Dimensions and test requirements YY/T 0972-2016 Active implantable medical devices—Four-pole connector system for implantable cardiac rhythm management devices—Dimensional and test requirements YY 0989.3-2023 Implants for surgery—Active implantable medical devices—Part 3:Implantable neurostimulators YY 0989.6-2025 Implants for surgery—Active implantable medical devices—Part 6:Particular requirements for active implantable medical devices intended to treat tachyarrhythmia(including implantable defibrillators)

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