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

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Scope

This document specifies requirements that are generally applicable to active
implantable medical devices.
This document is applicable to active implantable medical devices that are electrically
powered and powered by other energy sources (for example by gas pressure or by
springs), as well as to some non-implantable parts and accessories of the active
implantable medical devices.
Note 1.For particular types of active implantable medical devices, these general
requirements are supplemented or modified by the requirements of particular
parts.
The tests that are specified in this document are type tests and are to be carried out on
samples of an active implantable medical device to show compliance.
Note 2.The device that is commonly referred to as an active implantable medical
device can be a single device, a combination of devices, or a combination of
a device or devices and one or more accessories. Not all of these parts are
required to be either partially or totally implantable, but there is a need to
specify some requirements of non-implantable parts and accessories if they
could affect the safety or performance of the implantable device.

Basic Data

Standard ID	GB 16174.1-2024 (GB16174.1-2024)
Description (Translated English)	Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
Sector / Industry	National Standard
Classification of Chinese Standard	C30
Word Count Estimation	44,413
Date of Issue	2024-08-23
Date of Implementation	2027-09-01
Older Standard (superseded by this standard)	GB 16174.1-2015
Issuing agency(ies)	State Administration for Market Regulation, China National Standardization Administration