Standards Development

Scope

This document specifies the requirements and methods for the clinical performance verification of me equipment used for estimating arterial blood pressure providing a single set of blood pressure parameters from a number of heart beats without the need of arterial puncture and without the need of creating an arterial occlusion at each reading.

This document covers sphygmomanometers that require calibration and those that do not require calibration. This document covers sphygmomanometers intended for use in all patient populations (e.g. all age and weight ranges), and all conditions of use (e.g. ambulatory blood pressure monitoring, stress testing blood pressure monitoring and blood pressure monitors for the home healthcare environment for self-measurement as well as use in a professional healthcare facility).

This document specifies additional disclosure requirements for the accompanying documents of sphygmomanometers that have passed a clinical performance verification according to this document.

This document is not applicable to clinical performance verification of:

- non-automated sphygmomanometers as given in ISO 81060-1;

- continuous automated sphygmomanometers as given in ISO 81060-3; or

- invasive blood pressure monitoring equipment as given in IEC 60601-2-34.

Purpose

The ISO 81060 family of standards covers the clinical performance verification of non-invasive sphygmomanometers. Part 1 covers non-automated measurement type, Part 2 covers intermittent automated measurement type and Part 3 covers continuous automated measurement type. Over the past decade a new class of sphygmomanometers has emerged that do not rely on an arterial occlusion to perform a measurement. These are referred to as “cuffless” sphygmomanometers and are being brought to market in many countries around the world by a wide variety of manufacturers. However, the measurement modalities behind cuffless devices raise a host of potential problems that are not adequately addressed by Part 2 intermittent measurement type, including calibration, drift, change tracking, use of demographic information, and new potential confounding factors such as skin tone and arterial compliance. A new standard document that addresses the specific requirements for clinical testing of cuffless sphygmomanometers is needed