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GB 16174.2-2024Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers (English PDF)

手术植入物有源植入式医疗器械第2部分：心脏起搏器

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Issued by

SAMR; SAC

Level / Type

National · Mandatory

Issue date

August 23, 2024

Implementation date

September 1, 2027

Scope

GB 16174.2-2024 is the English-translated version of 手术植入物有源植入式医疗器械第2部分：心脏起搏器.

GB 16174.2-2024 is the Chinese standard "Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers". Its scope clause reads: This document specifies requirements specific to cardiac pacemakers.

This document applies to active implantable medical devices for the treatment of bradyarrhythmias and devices that provide cardiac resynchronization therapy, as well as Certain non-implantable parts and accessories of implantable medical devices.

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

If other methods can be demonstrated to be equal to or superior in accuracy to the method specified, in case of dispute, the method specified in this document shall prevail.

ISO 14708-6 covers all aspects of active implantable medical devices intended for the treatment of tachyarrhythmias. NOTE. What is often referred to as an “active implantable medical device” may in fact be a single device, a combination of multiple devices, or one or more devices in combination with one or more A combination of multiple accessories.

Not all of these components are partially or fully implantable, but if non-implanted components or accessories may affect the implanted device To ensure the safety and performance of a device, requirements for non-implanted parts and accessories should be specified. Its clauses include terms and definitions.

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Document preview — GB 16174.2-2024

National Standard of the People's Republic of China

ICS: 11.040.40
Classification: C35

Issued by: State Administration for Market Regulation; Standardization Administration of the PRC

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 of active implantable medical devices
9 Marking 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 emitted by active implantable medical devices
19 Protection against unintended effects caused by active implantable medical devices
20 Protection of external defibrillators from damage by active implantable medical devices
22 Protection of active implantable medical devices against changes caused by hybrid medicine
23 Protection of active implantable medical devices against mechanical forces
24 Protection of active implantable medical devices from 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 from non-ionizing electromagnetic radiation
28 Attached Documents
Appendix A (Informative) Basic Principles
Appendix B (Informative) Code describing the working mode of implantable pulse generator
Appendix C (Normative) Pulse Waveform

1 Scope

This document specifies requirements specific to cardiac pacemakers.

This document applies to active implantable medical devices for the treatment of bradyarrhythmias and devices that provide cardiac resynchronization therapy, as well as

Certain non-implantable parts and accessories of implantable medical devices.

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

The electrical characteristics of the implantable pulse generator or electrode lead are verified by appropriate methods listed in this document or other methods.

If other methods can be demonstrated to be equal to or superior in accuracy to the method specified, in case of dispute, the method specified in this document shall prevail.

ISO 14708-6 covers all aspects of active implantable medical devices intended for the treatment of tachyarrhythmias.

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

A combination of multiple accessories. Not all of these components are partially or fully implantable, but if non-implanted components or accessories may affect the implanted device

To ensure the safety and performance of a device, requirements for non-implanted parts and accessories should be specified.

2 Normative references

The contents of the following documents constitute 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)

YY/T 0946-2014 Cardiac Defibrillator DF-1 connector assembly dimensions and test requirements for implantable cardioverter defibrillators

Request (ISO 11318.2002, MOD)

Note. There is no technical difference between the referenced content of YY/T 0946-2014 and the referenced content of ISO 11318.2002.

YY/T 1874-2023 Electromagnetic compatibility of active implantable medical devices - implantable cardiac pacemakers, implantable cardioverter-defibrillators

Electromagnetic compatibility test details for cardiac resynchronization devices and cardiac resynchronization devices (ISO 14117.2019, IDT)

ISO 5841-3.2013 Surgical implants - Cardiac pacemakers - Part 3.Small cross-section connectors for implantable cardiac pacemakers pacemakers]

ISO 27186.2020 Active implantable medical devices - Implantable cardiac rhythm management devices - Four-pole connector system - Dimensions and tests

3 Terms and definitions

The terms and definitions defined in GB 16174.1-2024 and the following apply to this document.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 45 pages — is available in the English PDF.

Referenced standards

Normative references

ISO 14708 · ISO 11318.2002 · ISO 14117.2019 · ISO 5841

Cited by

Similar standards

GB 38031-2025|GB 16174.2|GB 16174.2-2015|GB16174.2-2024|GB/T 1.1-2020|GB 16174|GB 16174.1-2024|YY/T 1874-2023

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