Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators) (ISO 14708-6:2010, IDT)
This Malaysian Standard specifies requirements that are applicable to implantable cardioverter defibrillators and the functions of active implantable medical devices intended to treat tachyarrhythmia.
The tests that are specified in MS ISO 14708 are type tests and are to be carried out on samples of a device to show compliance.
This standard is also applicable to some non-implantable parts and accessories of the devices.
The characteristics of the implantable pulse generator or lead shall be determined by either the appropriate method detailed in this standard or by any other method demonstrated to have accuracy equal to, or better than, the method specified. In the case of dispute, the method detailed in this standard shall apply.
Published
• (none) / (none) / (none)
PDF
30/03/2019
122
NSC 18 - Medical Devices and Facilities for Healthcare
