Active implantable medical devices (HS code(s): 902150); (ICS code(s): 11.040.40)
National Standard of the P.R.C., Implants for surgery — Active implantable medical devices — Part 2: Cardiac pacemakers; (55 page(s), in Chinese)
This document specifies requirements for cardiac pacemakers.
This document applies to those active implantable medical devices intended to treat bradyarrhythmias and devices that provide therapies for cardiac resynchronization.
This document also applies to some non-implantable parts and accessories of the devices.
The tests that are specified in this document are type tests, and are to be carried out on samples of a device to show compliance.
The electrical characteristics of the implantable pulse generator or lead are determined either by the appropriate method detailed in this particular document or by any other method demonstrated to have an accuracy equal to, or better than, the method specified. In case of dispute, the method detailed in this particular document applies.
NOTE The device that is commonly referred to as an active implantable medical device can in fact 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.