DIN EN ISO 81060-1:2012-08

This part of ISO 81060 specifies requirements for non-automated sphygmomanometers and their accessories, which, by means of an inflatable cuff, are used for the non-invasive blood pressure measurement by operator observation. This document specifies requirements for the safety, essential performance, effectiveness, and labelling for non-automated sphygmomanometers and their accessories, including test methods to determine the accuracy of their measurements. The document covers non-invasive blood pressure measurement devices with a pressure sensing element and display used in conjunction with means to determine blood flow (e. g., a stethoscope for detecting Korotkoff sounds, Doppler ultrasound, or other manual methods).