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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) (English PDF)

手术植入物有源植入式医疗器械第6部分：治疗快速性心律失常的有源植入式医疗器械（包括植入式除颤器）

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Issued by

NMPA

Level / Type

Industry · Mandatory

Issue date

June 18, 2025

Implementation date

July 1, 2028

Scope

YY 0989.6-2025 is the English-translated version of 手术植入物有源植入式医疗器械第6部分：治疗快速性心律失常的有源植入式医疗器械（包括植入式除颤器）.

YY 0989.6-2025 is the Chinese standard "Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)".

Its scope clause reads: This document specifies requirements for active implantable medical devices, including implantable defibrillators, intended for the treatment of tachyarrhythmias.

This document applies to implantable cardioverter-defibrillators, implantable cardiac resynchronization therapy/defibrillators, and devices with Active implantable medical devices with a functional function and certain non-implantable components and accessories of active implantable medical devices (see Note).

This document does not apply to active implantable medical devices for the treatment of bradyarrhythmias or cardiac resynchronization. GB 16174.2-2024 Such requirements are set out.

NOTE 1 The tests specified in this document are type tests and compliance is confirmed by testing of samples. NOTE 2 The characteristics of the implantable pulse generator or lead are verified by the appropriate methods listed in this document or other methods.

The accuracy of other methods is not guaranteed. In case of dispute, the method specified in this document shall apply.

Note 3.What is often referred to as an “active implantable medical device” may actually be a single device, a combination of multiple devices, or one or more devices in combination with a Not all of these components are partially or fully implantable, but if non-implanted components or accessories may affect the implant The safety and performance of the device shall specify requirements for non-implantable components and accessories. Its clauses include terms and definitions.

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Document preview — YY 0989.6-2025

National Standard of the People's Republic of China

ICS: 11.040.40
Classification: C35
Replacing: YY 0989.6-2016

Issued by: National Medical Products Administration

Preface
Introduction
1 Scope
2 Normative references
3 Terms and Definitions
4 Symbols and abbreviations
5 General requirements for active implantable medical devices
6 Measurement of implantable pulse generator and electrode lead characteristics
7 General requirements for packaging
8 Common marking for active implantable medical devices
9 Markings on sales packaging
10.Structure of sales packaging
11 Marking on sterile packaging
12 Construction of non-reusable packaging
13 Marking on active implantable medical devices
14 Protection against unintended biological effects caused by active implantable medical devices
16 Protection of patients from injury caused by electric current
17 Protection of patients from thermal injury
18 Protection against ionizing radiation emitted or released by active implantable medical devices
19 Protection against unintended effects caused by active implantable medical devices
20 Protection of external defibrillators from damage caused by active implantable medical devices
22 Protection of active implantable medical devices against changes caused by hybrid medical treatment
23 Protection of active implantable medical devices against mechanical forces
24 Protection of active implantable medical devices against damage caused by electrostatic discharge
25 Protection of active implantable medical devices against damage caused by changes in atmospheric pressure
26 Protection of active implantable medical devices against damage caused by temperature changes
27 Protection of active implantable medical devices against non-ionizing electromagnetic radiation
28 Attached Document
Appendix A (Informative) Note 26 on YY 0989.
Appendix B (Informative) Code describing the working mode of implantable pulse generator

1 Scope

This document specifies requirements for active implantable medical devices, including implantable defibrillators, intended for the treatment of tachyarrhythmias.

This document applies to implantable cardioverter-defibrillators, implantable cardiac resynchronization therapy/defibrillators, and devices with

Active implantable medical devices with a functional function and certain non-implantable components and accessories of active implantable medical devices (see Note).

This document does not apply to active implantable medical devices for the treatment of bradyarrhythmias or cardiac resynchronization. GB 16174.2-2024

Such requirements are set out.

NOTE 1 The tests specified in this document are type tests and compliance is confirmed by testing of samples.

NOTE 2 The characteristics of the implantable pulse generator or lead are verified by the appropriate methods listed in this document or other methods. The accuracy of other methods is not guaranteed.

In case of dispute, the method specified in this document shall apply.

Note 3.What is often referred to as an “active implantable medical device” may actually be a single device, a combination of multiple devices, or one or more devices in combination with a

Not all of these components are partially or fully implantable, but if non-implanted components or accessories may affect the implant

The safety and performance of the device shall specify requirements for non-implantable components and accessories.

2 Normative references

The contents of the following documents constitute the essential clauses of this document through normative references in this document.

For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to

This document.

GB 16174.1-2024 Surgical implants - Active implantable medical devices - Part 1.Safety, marking and information provided by the manufacturer

General requirements for information (ISO 14708-1.2014, MOD)

GB 16174.2-2024 Surgical implants Active implantable medical devices Part 2.Cardiac pacemakers (ISO 14708-2.

2019, MOD)

YY/T 0491-2004 Cardiac pacemakers - Small cross-section connectors for implantable cardiac pacemakers (ISO 5841-3.2000, IDT)

YY/T 0946-2014 Cardiac Defibrillators - Dimensions and test requirements for DF-1 connector assemblies for implantable cardioverter defibrillators (ISO 11318.2002, MOD)

YY/T 0972-2016 Active Implantable Medical Devices - Dimensions and Test Requirements for Four-Pole Connector Systems for Implantable Cardiac Rhythm Regulators (ISO 27186.2010, MOD)

YY/T 1874 Electromagnetic compatibility of active implantable medical devices Implantable cardiac pacemakers, implantable cardioverter-defibrillators and

Electromagnetic compatibility testing specifications for cardiac resynchronization devices (YY/T 1874-2023, ISO 14117.2019, IDT)

3 Terms and Definitions

The terms and definitions defined in GB 16174.1 and the following apply to this document.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 42 pages — is available in the English PDF.

Referenced standards

Normative references

ISO 14708 · ISO 5841 · ISO 11318.2002 · ISO 27186.2010 · ISO 14117.2019

Editions of YY 0989.6

Edition	Title	Revision	Status
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)	current edition	Current
YY 0989.6-2016	Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)	previous edition	In force until 2028-07-01

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