Standards Development

Scope

NOTE There is guidance or rationale for this Clause in A.2.1.

This document specifies the requirements and methods for the clinical performance verification of cuffless automated non-invasive sphygmomanometers used for estimating systolic and diastolic arterial blood pressure providing a single set of blood pressure parameters from a number of heart beats without the need of arterial puncture and without the need of creating an arterial occlusion at each reading, and the requirements and methods for clinical performance verification of cuffless automated non-invasive sphygmomanometers used for estimating a magnitude of a systolic and diastolic arterial blood pressure change providing a single set of blood pressure change parameters from a number of heart beats without the need of arterial puncture and without the need of creating an arterial occlusion at each reading.

This document does not specify the requirements for the clinical performance verification of cuffless automated non-invasive sphygmomanometers used for estimating mean arterial blood pressure.

This document applies to a sphygmomanometer that requires initialization and those that do not require initialization . This document covers a sphygmomanometer intended for use in all patient populations (e.g. all age and weight ranges), and all use environments (e.g. ambulatory blood pressure monitoring, stress testing blood pressure monitoring and blood pressure monitoring in the home healthcare environment for self-measurement as well as use in a professional healthcare facility). This document specifies additional disclosure requirements for the accompanying documents of a sphygmomanometer that has conformed with a clinical performance verification according to this document.

This document is not applicable to clinical performance verification of:

— non-automated sphygmomanometers as given in ISO 81060-1:2007 [1];

— continuous automated sphygmomanometers as given in ISO 81060-3:2022 [2]; and

— invasive blood pressure monitoring equipment as given in IEC 60601-2-34:2011 [3].

Cuffless automated non-invasive sphygmomanometers may include device functions to automatically determine when a patient is in a condition/position to take a measurement within the device intended use and automatically initiate a blood pressure measurement. This document does not provide requirements or methods for clinical performance verification of such functions, and these functions are considered out of scope of this document.