Traduction de «dispositif de mesure » (Français → Anglais) :

The Agency has prepared a dossier proposing to restrict mercury in the following measuring devices used in industrial and professional (including healthcare) applications: mercury containing barometers, hygrometers, manometers, sphygmomanometers, strain gauges used with plethysmographs, tensiometers, thermometers and other non-electrical thermometric applications, mercury metering devices for the determination of softening point and mercury pycnometers.

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.

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.

On the basis of this review or as soon as new information on reliable safer alternatives for sphygmomanometers and other measuring devices containing mercury becomes available, the Commission shall, if appropriate, present a legislative proposal to extend the restrictions in paragraph 1 to sphygmomanometers and other measuring devices in healthcare and in other professional and industrial uses, so that mercury in measuring devices is phased out whenever technically and economically feasible.

The documentation provided by the manufacturer shows that certificate MED-B-4766 has been delivered in accordance with the applicable requirements concerning, inter alia: the testing of every valve model of the HPV series; the test plan and sequence; the additional testing concerning glass material; the identification of the devices under testing; the calibration of the measurement instrumentation; the measurement set-up; the monitoring of the valves behaviour during the testing; the report contents.

- if the device is custom-made, the words 'custom-made device',