ISO 14708-2:2005
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
Implants for surgery Active implantable medical devices Part 2: Cardiac pacemakers
Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users
29-11-2018
English, Russian
11-10-2005
ISO 14708-2:2005 specifies requirements that are applicable to those active implantable medical devices intended to treat bradyarrhythmias (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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