BS EN ISO 81060-3:2022 PDF

Scope: 1 Scope This document specifies the requirements and methods for the clinical investigation of continuous automated non-invasive sphygmomanometers used for the measurement of the blood pressure of a patient. This document does not cover usability aspects such as the form and manner of the data display or output. This document does not specify a numerical threshold on the minimum output period . A continuous automated non-invasive sphygmomanometer providing blood pressure parameters (e.g., systolic blood pressure , diastolic blood pressure or mean arterial pressure ) with an output period considerably larger than 30 s is not typically considered a continuous automated non-invasive sphygmomanometer . This document covers both trending continuous automated non-invasive sphygmomanometers and absolute accuracy continuous automated non-invasive sphygmomanometers and focuses solely on requirements for the clinical investigation . Representation of output is not covered by this document. NOTE 1 IEC 62366‑1 provides requirements on the application of usability engineering to medical devices. The usability engineering process can be used to clarify for the intended user whether the displayed data concerns absolu...

BS EN ISO 81060-3:2022 Referenced Document

IEC 60601-2-34:2011 Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment
IEC 80601-2-30:2018 Medical electrical equipment - Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers
ISO 14155:2020 Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 14971:2019 Medical devices — Application of risk management to medical devices
ISO 81060-1:2007 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type

2023 BS EN ISO 81060-3:2022 Non-invasive sphygmomanometers - Clinical investigation of continuous automated measurement type