Riester ri-medic Floor
While the technology used in the Riester ri-medic Floor, to measure blood pressure, has been declared as being equivalent to that used in a clinically validated device, no evidence has been published to show that the devices have been compared according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
|Medaval||None||Although equivalence to another device is claimed, this has not been tested to MDR requirements.|
|BIHS (UK and IRL)||Hospital use||Manufacturer declaration of equivalence|
|ESH (Europe)||Professional use||The BIHS recommendation, despite the absence of the scientific evidence required by the same authors' criteria.|
Note: This is a provisional list, as equivalence according to EU Regulation 2017/745 (e.g. MEDDEV 2.7/1 rev 4) is not proven. Accordingly, these publications are not used in the assessment of star-ratings.
Polo Friz H, Facchetti R, Primitz L, Beltrame L, Galbiati V, Ricioppo A, Bombelli M, Sega R. Simultaneous validation of the SunTech 247 diagnostic station blood pressure measurement device according to the British Hypertension Society protocol, the International Protocol and the Association for the Advancement of Medical Instrumentation standards. Blood Press Monit. 2009 Oct;14(5):222-7. doi: 10.1097/MBP.0b013e328330c873. PMID: 19741510.
ESH-IP:2002 - Pass General population
BHS:1993 - Pass (A/A) General population
SP10:2002 - Pass General population