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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)
Status: Valid YY 0989.6: Evolution and historical versions
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| YY 0989.6-2025 | English | 919 |
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Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia(including implantable defibrillators)
| Valid |
YY 0989.6-2025
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| YY 0989.6-2016 | English | 1999 |
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Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia(including implantable defibrillators)
| Valid |
YY 0989.6-2016
|
Basic data | Standard ID | YY 0989.6-2025 (YY0989.6-2025) | | Description (Translated English) | Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia(including implantable defibrillators) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C35 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 46,493 | | Date of Issue | 2025-06-18 | | Date of Implementation | 2028-07-01 | | Older Standard (superseded by this standard) | YY 0989.6-2016 | | Issuing agency(ies) | National Medical Products Administration | YY 0989.6-2025: Implants for surgery - Active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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ICS 11.040.40
CCSC35
Pharmaceutical Industry Standards of the People's Republic of China
Replaces YY 0989.6-2016
Surgical Implants Active Implantable Medical Devices
Part 6.Active implantable devices for the treatment of tachyarrhythmias
Particular requirements for medical devices (including implantable defibrillators)
(ISO 14708-6.2019,MOD)
Released on June 18, 2025, implemented on July 1, 2028
The State Food and Drug Administration issued
Table of Contents
Preface III
Introduction V
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Symbols and abbreviations 5
5 General requirements for active implantable medical devices 5
6 Measurement of implantable pulse generator and electrode lead characteristics 6
7 General requirements for packaging 8
8 Common marking for active implantable medical devices 8
9 Markings on sales packaging 8
10.Structure of sales packaging 9
11 Marking on sterile packaging 9
12 Construction of non-reusable packaging10
13 Marking on active implantable medical devices11
14 Protection against unintended biological effects caused by active implantable medical devices11
15 Protection against harm to patients or users caused by the external physical properties of active implantable medical devices11
16 Protection of patients from injury caused by electric current 11
17 Protection of patients from thermal injury 15
18 Protection against ionizing radiation emitted or released by active implantable medical devices15
19 Protection against unintended effects caused by active implantable medical devices15
20 Protection of external defibrillators from damage caused by active implantable medical devices17
21 Protection of active implantable medical devices against changes caused by electric fields acting directly on the patient 17
22 Protection of active implantable medical devices against changes caused by hybrid medical treatment 17
23 Protection of active implantable medical devices against mechanical forces 17
24 Protection of active implantable medical devices against damage caused by electrostatic discharge 22
25 Protection of active implantable medical devices against damage caused by changes in atmospheric pressure 22
26 Protection of active implantable medical devices against damage caused by temperature changes 22
27 Protection of active implantable medical devices against non-ionizing electromagnetic radiation 22
28 Attached Document 22
Appendix A (Informative) Note 26 on YY 0989.6
Appendix B (Informative) Code describing the working mode of implantable pulse generator 36
Reference 38
Preface
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents"
Drafting.
This document is part 6 of the Active Implantable Medical Devices for Surgical Implants.
The following parts have been published.
--- Part 1.General requirements for safety, marking and information to be provided by the manufacturer;
--- Part 2.Cardiac pacemakers;
--- Part 3.Implantable neurostimulators;
--- Part 5.Circulatory support devices;
--- Part 6.Particular requirements for active implantable medical devices (including implantable defibrillators) for the treatment of tachyarrhythmias;
--- Part 7.Particular requirements for cochlear implants and auditory brainstem implant systems.
This document replaces YY 0989.6-2016 "Surgical Implants - Active Implantable Medical Devices - Part 6.Treatment of Tachyarrhythmias"
Particular requirements for active implantable medical devices (including implantable defibrillators)”, compared with YY 0989.6-2016, in addition to structural adjustments and
In addition to the logical changes, the main technical changes are as follows.
a) The titles of Chapters 5, 20, and 28 have been changed (see Chapters 5, 20, and 28; for the.2016 edition, see Chapters 5, 20, and 28);
b) Added overall considerations (see 6.1.1);
c) The requirements for electrical neutrality have been changed (see 16.2, 16.2 of the.2016 edition);
d) The requirements for protection against thermal injury to patients have been modified (see 17.1, 17.1 of the.2016 edition);
e) The protection of active implantable medical devices against damage caused by changes in atmospheric pressure has been changed (see 25.1, 25.1 of the.2016 edition);
f) The protection of active implantable medical devices against non-ionizing electromagnetic radiation has been changed (see Chapter 27, Chapter 27 of the.2016 edition).
This document is modified to adopt ISO 14708-6.2019 “Surgical implants - Active implantable medical devices - Part 6.Treatment of tachyarrhythmias”
Particular requirements for active implantable medical devices (including implantable defibrillators) that are susceptible to malfunction.
The technical differences between this document and ISO 14708-6.2019 and their reasons are as follows.
--- Replaced ISO 11318.2002 (see 23.5) with the normative reference YY/T 0946-2014.The consistency between the two documents
The degree of modification is to adapt to my country's national conditions;
--- Replaced ISO 14708-1.2014 with the normative reference GB 16174.1-2024 (see 3, 4, 5, 7, 8, 9, 10, 11, 12,
13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28), the consistency between the two documents is the revision
to adapt to my country's national conditions;
--- Replaced ISO 14708-2.2019 with the normative reference GB 16174.2-2024 (see 6.1, 6.2, 9.4, 11.12, 28.8,
28.19), the consistency between the two documents is modified to adapt to my country's national conditions;
--- Replaced ISO 5841-3.2013 (see 23.5) with the normative reference YY/T 0491-2004.The consistency between the two documents
The degree of modification is to adapt to my country's national conditions;
--- Replaced ISO 27186.2010 (see 23.5) with the normative reference YY/T 0972-2016.The consistency between the two documents
The degree of modification is to adapt to my country's national conditions.
--- Replaced ISO 14117.2019 (see Chapters 20, 21, and 27) with the normative reference YY/T 1874 to adapt to my country's national conditions
The following editorial changes have been made to this document.
--- Change the title of Chapter 5 to “General requirements for active implantable medical devices”.
--- Deleted Annex A of ISO 14708-6.2019.
Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents.
This document is proposed by the State Food and Drug Administration.
This document is prepared by the National Technical Committee for Standardization of Surgical Implants and Orthopedic Devices, Active Implants Subcommittee (SAC/TC110/SC4)
Centralized.
The previous versions of the standards replaced by this document are as follows.
---First released in.2016 as YY 0989.6-2016;
---This is the first revision.
introduction
Active Implantable Medical Devices for Surgical Implants aims to provide basic safety assurance for patients and users.
"Surgical Implants and Active Implantable Medical Devices" is planned to contain 7 parts.
--- Part 1.General requirements for safety, marking and information to be provided by the manufacturer. The purpose is to specify the requirements for active implantable medical devices.
General requirements for safety, marking and information to be provided by the manufacturer.
--- Part 2.Cardiac pacemakers. The purpose is to specify the special requirements for cardiac pacemakers.
--- Part 3.Implantable neurostimulators. The purpose is to specify the specific requirements for implantable neurostimulators.
--- Part 4.Implantable infusion pumps. The purpose is to specify the special requirements for implantable infusion pumps.
--- Part 5.Circulatory support devices. The purpose is to specify special requirements for circulatory support devices.
--- Part 6.Particular requirements for active implantable medical devices (including implantable defibrillators) for the treatment of tachyarrhythmias.
The purpose of this standard is to specify special requirements for active implantable medical devices (including implantable defibrillators) for the treatment of tachyarrhythmias.
--- Part 7.Particular requirements for cochlear implants and auditory brainstem implant systems.
Specific requirements for the system.
An external defibrillator is a medical device used in emergency situations to defibrillate ventricular fibrillation (rapid, chaotic)
External defibrillators can also deliver high-energy electrical shocks to patients with heart rhythm disorders (which can be fatal) to restore normal heartbeat.
The device delivers a high-energy electrical shock in sync with the intrinsic heart rhythm (a procedure called cardioversion) to terminate other ventricular or atrial tachycardia.
In patients known to be at risk for such arrhythmias, due to previous arrhythmic events or predisposition to specific cardiac conditions,
For heart disease, an implantable cardioverter-defibrillator (ICD) may be implanted to perform similar treatment functions. This implant is much smaller than an external defibrillator.
The implantable device is enclosed in a sealed enclosure and can generate high voltage pulses through an enclosed pocket battery.
The electrodes (electrode leads) deliver the impulses to the heart. Implantable cardioverter defibrillators may also incorporate other sensing and pacing functions, such as
Chronic arrhythmias and antitachycardia pacing (ATP) rate support to terminate certain tachyarrhythmias without high-energy shocks.
Defibrillators can be adjusted non-invasively using electronic devices such as programmers.
In recent years, other active implantable cardiovascular devices have emerged. The most noteworthy is that this device not only has the functions of ICD, but also
Can improve cardiac output by optimizing ventricular synchronization.
Although these devices may provide additional therapy compared to ICD devices, most requirements are similar and therefore, in most cases,
In this case, the concepts that apply to ICDs also apply to CRT-D devices, and the testing methods for CRT-D devices are similar to those for ICDs.
Method of testing.
This document covers pacing for the treatment of tachyarrhythmias other than those used to control bradyarrhythmias or provide cardiac resynchronization.
All components of active implantable medical devices. Typical examples include implantable pulse generators, electrode leads, adapters, accessories, programmers,
and related software (bradyarrhythmia and cardiac resynchronization pacing functions are introduced in GB 16174.2).
The requirements of this document supplement or modify GB 16174.1-2024 "Surgical implants - Active implantable medical devices - Part 1.
The requirements listed in this document take precedence over those listed in GB 16174.1-2024.
Require.
Surgical Implants Active Implantable Medical Devices
Part 6.Active implantable devices for the treatment of tachyarrhythmias
Particular requirements for medical devices (including implantable defibrillators)
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.
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