Biomaterial Database

Which requirements must be met by non-invasive blood pressure measuring devices bearing the CE-mark? 1996

S Mieke

Physikalisch-Technische Bundesanstalt, Institut Berlin, Dienststelle Charlottenburg.

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.

UI	MeSH Term	Description	Entries
D011786	Quality Control	A system for verifying and maintaining a desired level of quality in a product or process by careful planning, use of proper equipment, continued inspection, and corrective action as required. (Random House Unabridged Dictionary, 2d ed)	Control, Quality,Controls, Quality,Quality Controls
D012015	Reference Standards	A basis of value established for the measure of quantity, weight, extent or quality, e.g. weight standards, standard solutions, methods, techniques, and procedures used in diagnosis and therapy.	Standard Preparations,Standards, Reference,Preparations, Standard,Standardization,Standards,Preparation, Standard,Reference Standard,Standard Preparation,Standard, Reference
D001795	Blood Pressure Determination	Techniques used for measuring BLOOD PRESSURE.	Blood Pressure Determinations,Determination, Blood Pressure
D005060	Europe	The continent north of AFRICA, west of ASIA and east of the ATLANTIC OCEAN.	Northern Europe,Southern Europe,Western Europe
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D012815	Signal Processing, Computer-Assisted	Computer-assisted processing of electric, ultrasonic, or electronic signals to interpret function and activity.	Digital Signal Processing,Signal Interpretation, Computer-Assisted,Signal Processing, Digital,Computer-Assisted Signal Interpretation,Computer-Assisted Signal Interpretations,Computer-Assisted Signal Processing,Interpretation, Computer-Assisted Signal,Interpretations, Computer-Assisted Signal,Signal Interpretation, Computer Assisted,Signal Interpretations, Computer-Assisted,Signal Processing, Computer Assisted
D014481	United States	A country in NORTH AMERICA between CANADA and MEXICO.