Active implantable medical devices (HS code(s): 902150; 902190); (ICS code(s): 11.040.40)

National Standard of the P.R.C., Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer; (42 page(s), in Chinese)

This document specifies the requirements that are generally applicable to active implantable medical devices.

This document applies not only to electrically powered active implantable medical devices, but also to active implantable medical devices powered by other energy sources(e.g., gas pressure or springs).

This document also applies to certain non-implantable parts and accessories of 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 of the document.

The tests that are specified in this documents 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.