Honsun Scian LD-586N
While the technology used in the Honsun Scian LD-586N, 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.
| Accuracy Assessment | Recommendation | Basis | ||
|---|---|---|---|---|
| Medaval | None | Although equivalence to another device is claimed, this has not been tested to MDR requirements. | ||
| BIHS (UK and IRL) | Self-measurement | Manufacturer declaration of equivalence | ||
| ESH (Europe) | Self-measurement | 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.
Honsun Scian LD-578
Zhang Y, Wang J, Huang QF, Sheng CS, Li Y, Wang JG. Validation of the HONSUN LD-578 blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol. Blood Press Monit. 2009 Jun;14(3):128-31. doi: 10.1097/MBP.0b013e32832ce149. PMID: 19454866.
ESH-IP:2002 - Pass General population
