This standard specifies general, performance, efficiency and mechanical and electrical safety requirements, including test methods for type approval, for non-invasive mechanical sphygmomanometers and their accessories which, by means of an inflatable cuff, are used for the non-invasive measurement of arterial blood pressure. The application of the cuff is not limited to a particular extremity of the human body (e.g. the upper arm). Included within the scope of this standard are sphygmomanometers with mechanical pressure sensing element and display used in conjunction with a stethoscope or other manual methods for detecting Korotkoff sounds and for cuff inflation. Note: Luer locks shall not be used with these devices (See 7.5).