This VDE application guide describes the technical requirements for the implantation, programming and monitoring of cardiac pacemakers, defibrillators and CRT (cardiac resynchronization therapy) devices. The requirements must be fulfilled for their safe, reliable and competent use. Taken as a whole, a therapy with implants is a medical treatment; i.e. the doctor is responsible for the treatment. The responsibility for all means, structures and processes in connection with the therapy lies with the organization that carries out the treatment. Such responsibilities are not described here.
Nowadays, the majority of devices/systems for the electrotherapy of the heart provide a high level of safety relieving the burden on the user and protecting the patient. Despite the high level of safety of medical products the user is responsible for the residual risk. This includes the safety gap between the product standards for implants on the one hand and the exposition protection standard for the limitation of electromagnetic fields on the other hand.
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