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

Since 1995 non-invasive blood pressure measuring devices (sphygmomanom eters) must bear the CE-mark if they should be sold in all Member Stat es of the European Union. The CE-mark indicates the conformity of the device with the provisions of the relevant EC-directives. The most imp ortant directive for non-invasive sphygmomanometers is the Medical Dev ice Directive, which includes only essential requirements, not specifi c one's for special kinds of devices. The detailed requirements are la id down in harmonized European standards, such as EN 1060 ''Non-invasi ve sphygmomanometers''. It specifies performance as well as safety req uirements, especially for accuracy, environmental performance, and con struction.