ISO/AWI 80601-2-96

Medical electrical equipment — Part 2-96: Particular requirements for basic safety and essential performance of non-invasive arterial tonometer equipment

Scope

This document specifies particular requirements for the basic safety and essential performance of non-invasive arterial tonometer equipment and their parts or accessories. Devices that measure vessels other than vascular smooth muscle arteries are excluded.

The intended use of non-invasive arterial tonometer equipment includes, but is not limited to, the analysis of pulse waveform contours for estimating hemodynamic parameters (e.g.: blood pressure, blood vessel function, blood flow and circulation condition such as stroke volume, systemic vascular resistance, etc.) and pulse rate of patients in professional healthcare institutes.

This document is not applicable to non-invasive arterial tonometer equipment intended for use in laboratory research. Clinical performance verification of physiological parameters is not addressed.
This document is a particular standard in the IEC60601-1 and ISO and IEC80601 series of standards.