Accuracy Assessment | Recommendation | Basis | |
BP | Medaval | None | When an evaluation is carried out using a non-standard protocol, no inference can be made on accuracy based on a standard protocol. |
BP | Japanese Society of Hypertension | Self-measurement (Previous: 2016-2019) | Possibly the intended device, listed as with an incomplete internal report |
血圧計に関するワーキンググループ, 日本高血圧学会学術委員会 [Working Group on Sphygmomanometers, Academic Committee on Hypertension in Japan] [Test reports on the Terumo R800 and P2000] [Internet] Tokyo: JSH; 2010. Available from: www.jpnsh.jp.
JIS T 1115:2005 General population
JIS T 1115:2005 General population
There is insufficient information provided in either of two reports to enable scientific assessment. Furthermore, apart from the report and the JSH recommendation, there is no evidence of an R800 device per se but Terumo do make an ES-R800ST and an ES-R800SZ. The report is listed here, as the ES-R800ST may be the device intended but caution is advised.
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.
Terumo ES-R800SZ
血圧計に関するワーキンググループ, 日本高血圧学会学術委員会 [Working Group on Sphygmomanometers, Academic Committee on Hypertension in Japan] [Test reports on the Terumo R800 and P2000] [Internet] Tokyo: JSH; 2010. Available from: www.jpnsh.jp.
JIS T 1115:2005 General population
JIS T 1115:2005 General population
There is insufficient information provided in either of two reports to enable scientific assessment. Furthermore, apart from the report and the JSH recommendation, there is no evidence of an R800 device per se but Terumo do make an ES-R800ST and an ES-R800SZ. The report is listed here, as the ES-R800SZ may be the device intended but caution is advised.