Technical specifications for pre-market assessment of blood pressure measuring device with cuff, automated and semi-automated

Overview

The purpose of this document is to provide technical specifications for manufacturers of blood pressure measuring devices (BPMD). This document is intended mainly for manufacturers and as a reference by regulators for pre-market assessment. Manufacturers should consider the technical specifications outlined here as minimum requirements to ensure that a BPMD has been designed, evaluated and validated in compliance with these requirements and is therefore safe and effective.