BIHS statement on Derivative Devices 2023
Devices that are listed as being derivative of other models have been approved for addition to these lists on the basis of information supplied to the BIHS by the manufacturer. This comprises a checklist of the key components of each monitor (including algorithm, pressure sensors, cuff size and construction, inflation/deflation processes) which the manufacturer attests have not been materially changed from the originally validated device. This information has been carefully reviewed, with manufacturers’ attestations accepted in good faith. Derivative devices are indicated on the list and the original model name is given in brackets.
From 1st April 2023, the BIHS will only accept new derivative device applications where the original device validation was carried out under the European Society of Hypertension International Protocol revision 2010 or AAMI 2013 onwards or the Universal Standard (AAMI/ESH/ISO) validation protocol 2018[2,3,4]. This is because the 2002 ESH International Protocol and earlier protocols (including BIHS 1993) will be considered obsolete from then onwards.
From 1st April 2025, the BIHS will only accept new derivative device applications where the original device validation was carried out under the 2018 Universal Standard (AAMI/ESH/ISO) protocol or a subsequent modification of that protocol.
Validations carried out with other protocols subsequent to 2018 (including but not limited to subsequent AAMI protocols) may be accepted at the discretion of the BIHS but manufacturers should check in advance of any submission.
 Blood Pressure Monitoring 2010, 15:23–38
 Hypertension 2018; 71:368–374
 Journal of Hypertension 2019, 37:459–466