Which requirements must be met by non-invasive blood pressure measuring devices bearing the CE-mark?
Since 1995. non-invasive blood pressure measuring devices (sphygmomanometers) may bear the CE-mark. This indicates conformity of the device with the provisions of the relevant EC directives. The most important directive for non-invasive sphygmomanometers is the Medical Device Directive, which includes only essential requirements, not specific ones for special devices. The detailed requirements for special devices are laid down in harmonized standards. For non-invasive sphygmomanometers a harmonized European standard (EN 1060) was developed in recent years. It specifies performance as well as safety requirements, especially for accuracy. environmental performance and construction. Since the standard (EN 1060) defines the state of the art on a quite high level, no change to the worse in Member States which had a legal quality management system could be expected, but rather an improvement for all users in the whole EU.
Mieke
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Physikalisch-Technische Bundesanstalt, Institut Berlin, Dienststelle Charlottenburg.
D001795:Blood Pressure Determination / Q000295:instrumentation*; D005060:Europe; D006801:Humans; D011786:Quality Control; D012015:Reference Standards; D012815:Signal Processing, Computer-Assisted / Q000295:instrumentation*; D014481:United States