WHICH REQUIREMENTS MUST BE MET BY NONINVASIVE BLOOD-PRESSURE MEASURING DEVICES BEARING THE CE-MARK

Since 1995, non-invasive blood pressure measuring devices (sphygmomano meters) 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 Dir ective, 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 year s. It specifies performance as well as safety requirements, especially for accuracy, environmental performance and construction. Since the s tandard (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 mana gement system could be expected, but rather an improvement for all use rs in the whole EU.