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Implants for surgery — Active implantable medical devices — Part 2: Cardiac pacemakers
The tests that are specified in ISO 14708-2:2005 are type tests, and are to be carried out on samples of a device to show compliance.
ISO 14708-2:2005 is also applicable to some non-implantable parts and accessories of the devices. The device that is commonly referred to as an active implantable medical device may 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.
The characteristics of the implantable pulse generator or lead are to be determined by either the appropriate method detailed in ISO 14708-2:2005 or by any other method demonstrated to have an accuracy equal to, or better than, the method specified. In the case of dispute, the method detailed in ISO 14708-2:2005 is applicable.
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