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.
EN ISO 81060-2:2014 Referenced Document
EN 1060-4:2004 Non-invasive sphygmomanometers - Part 4: Test procedures to determine the overall system accuracy of automated noninvasive sphygmomanometers
IEC 60601-1-11:2010 Medical electrical equipmentPart 1-11:General requirements for basic safety and essential performance — Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
IEC 60601-1:2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
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 80601-2-30:2009 Medical electrical equipment - Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers
ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice
ISO 81060-1:2007 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type
ISO/TR 16142:2006 Medical devices - Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
EN ISO 81060-2:2014 history
2020EN ISO 81060-2:2019/A1:2020 Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type - Amendment 1 (ISO 81060-2:2018/Amd 1:2020)
2019EN ISO 81060-2:2019 Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type (ISO 81060-2:2018)
2014EN ISO 81060-2:2014 Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type
EN ISO 81060-2:2014 Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type has been changed from EN 1060-4:2004 Non-invasive sphygmomanometers - Part 4: Test procedures to determine the overall system accuracy of automated noninvasive sphygmomanometers.