Over deze norm
Specifies 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 this 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 by gas pressure or by springs). Is also applicable to some non-implantable parts and accessories of the devices.
|Nederlandse titel||Chirurgische implantaten - Actieve implanteerbare medische hulpmiddelen - Deel 1: Algemene eisen voor veiligheid, merken en informatie te verstrekken door de fabrikant|
|Engelse titel||Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer|