Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type

2Scope / Description

This part of ISO 81060 specifies CLINICAL TESTING requirements and procedures for ME DEVICES (MEDICAL ELECTRICAL DEVICE) used for non-continuous non-invasive automatic estimation of arterial BLOOD PRESSURE using a CUFF. This part of ISO 81060 applies to all NON-INVASIVE BLOOD PRESSURE METERS that detect or display pulsations, flow or noise to estimate, display or record BLOOD PRESSURE. These NON-INVASIVE BLOOD PRESSURE MONITORS do not necessarily need to be able to inflate the CUFF automatically. This part of ISO 81060 covers NON-INVASIVE BLOOD PRESSURE DEVICES that are suitable for all PATIENT groups (e.g. all age and weight ranges) and all use conditions (e.g. for long-term ambulatory BLOOD PRESSURE monitoring, exercise BLOOD PRESSURE monitoring and BLOOD PRESSURE monitoring). Self-measurement in MEDICAL CARE IN A HOME ENVIRONMENT and for use in a professional healthcare facility). Example automated non-invasive blood pressure measuring device as described in IEC 80601-2-30, clinically examined according to this part of the ISO 81060. This part of ISO 81060 places additional requirements for the description in the accompanying papers of non-invasive blood pressure measurement tea, clinical according to this part of ISO 81060, firmly. This part of ISO 81060 does not apply to CLINICAL TESTS OF NON-AUTOMATED NON-INVASIVE BLOOD PRESSURE DEVICES described in ISO 81060-1 or INVASIVE BLOOD PRESSURE DEVICES described in IEC 60601-2-34.