AAMI/ISO 81060-1:2007 (R2013)

ISO/IEC 81060-1 specifies requirements for mechanical sphygmomanometers and their accessories that, by means of an inflatable cuff, are used for the non-invasive measurement of blood pressure. This standard also specifies requirements for the safety, essential performance, effectiveness, and labeling, for these instruments and their accessories, including test methods to determine the accuracy of their measurements. The standard covers non-invasive blood pressure measuring devices with a mechanical pressure sensing element and display used in conjunction with a stethoscope or other manual methods for detecting Korotkoff sounds.