DR 03119 CP
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Implants for surgery - Active implantable medical devices Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
06-30-2017
02-28-2003
Proposes requirements that are generally applicable to active implantable medical devices. For particular types of active implantable medical devices, these general requirements are supplemented or modified by the requirements of particular standards which form additional parts of ISO 14708. Special care is required in applying ISO 14708-1 to active implantable medical devices where no particular standard exists. The tests that are specified in ISO 14708-1 are type tests intended to be crarried out on samples of a device to show compliance, and are not intended to be used for the routine testing of manufactured products. This draft Standard is applicable not only to active implantable medical devices that are electrically powered, but also to those powered by other energy sources (for example gas pressure or springs). It is also applicable to some non-implantable parts and accessories of the devices.
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