Translation of "Dispositif pour voltages élevés " (French → English) :

high-voltage device

work positioning system

load elevating mechanism | load-lifting device

rescue lifting device

water-lifting device

The regulation tightens the rules concerning how the independent notified bodies — which assess the conformity of medium- and high-risk medical devices before they are placed on the market — are designated, organised and monitored.

The high duty cycle/continuous transmission device category covers radio devices that rely on low latency and high duty cycle transmissions.

Notified bodies should increase the frequency of unannounced audits if the devices bear a high risk, if the devices of the type in question are frequently non-compliant or if specific information provides reasons to suspect non-conformities of the devices or of their manufacturer.

In order to maintain a high level of safety and health protection against the risk of transmitting animal spongiform encephalopathies to patients or other persons via medical devices manufactured utilising non-viable animal tissues or derivatives rendered non-viable, including custom-made devices and devices intended for clinical investigation, it is necessary to update the rules laid down in Directive 2003/32/EC on the basis of the experience with the application of this Directive and to apply them also to active implantable medical devices manufactured utilising tissues of animal origin that fall within the scope of Directive 90/385/EE ...[+++]C.