International Organization for Standardization

Implants for Surgery - Active Implantable Medical Devices - Part 1: General Requirements for Safety, Marking and for Information to be Provided by the Manufacturer - First Edition
 N 14708-1

Annotation

This part of ISO 14708 specifies requirements that are generally applicable to active implantable medical devices.

NOTE 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 this part of ISO 14708 to active implantable medical devices where no particular standard exists.

The tests that are specified in this part of ISO 14708 are type tests intended to be carried out on samples of a device to show compliance, and are not intended to be used for the routine testing of manufactured products.

This part of ISO 14708 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).

This part of ISO 14708 is also applicable to some non-implantable parts and accessories of the devices (see 3.3).

Автоматический перевод:

Внедрения для Хирургии - Активные Вживляемые Медицинские устройства - Часть 1: Общие Требования для Безопасности, отмечая и для получения информации, которая будет Обеспечена Изготовителем - Первый Выпуск