AS 80601.2.30:2018 PDF
The objective of this Standard is to specify basic safety and essential performance requirements for automated sphygmomanometers, including requirements for the accuracy of a determination. This document covers automatic electrically-powered equipment used for the intermittent and indirect estimation, by means of an inflatable cuff, of the blood pressure. It is also applicable to blood pressure monitors for the home healthcare environment.
The objective of this Standard is to specify basic safety and essential performance requirements for automated sphygmomanometers, including requirements for the accuracy of a determination. This document covers automatic electrically-powered equipment used for the intermittent and indirect estimation, by means of an inflatable cuff, of the blood pressure. It is also applicable to blood pressure monitors for the home healthcare environment.
This particular standard amends and supplements the general standard IEC 60601.1, Medical electrical equipment — Part 1: General requirements for basic safety and essential performance.
This Standard is an adoption with national modifications, and has been reproduced from, IEC 80601‑2‑30:2018 (ED. 2.0), Medical electrical equipment — Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers. The modifications are additional requirements, which have been added at the end of the source text.
