ISO 81060-2:2018 PDF

Scope: This document specifies the requirements and methods for the clinical investigation of me equipment used for the intermittent non-invasive automated estimation of the arterial blood pressure by utilizing a cuff. This document is applicable to all sphygmomanometers that sense or display pulsations, flow or sounds for the estimation, display or recording of blood pressure. These sphygmomanometers need not have automatic cuff inflation. This document covers sphygmomanometers intended for use in all patient populations (e.g. all age and weight ranges), and all conditions of use (e.g. ambulatory blood pressure monitoring, stress testing blood pressure monitoring and blood pressure monitors for the home healthcare environment for self-measurement as well as use in a professional healthcare facility). EXAMPLE Automated sphygmomanometer as given in IEC 80601-2-30 undergoing clinical investigation according to this document. This document specifies additional disclosure requirements for the accompanying documents of sphygmomanometers that have passed a clinical investigation according to this document. This document is not applicable to clinical investigations of non-automated sphygmomanometers as given in ISO 81060-1 or invasive blood pressure monitoring equipment as given in IEC 60601-2-34.

ISO 81060-2:2018 Referenced Document

IEC 60601-1-11:2015 Medical electrical equipment - Part 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 60601-2-34:2011 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 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice
ISO 14971:2007 Medical devices - Application of risk management to medical devices
ISO 16142-1:2016 Medical devices - Recognized essential principles of safety and performance of medical devices - Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
ISO 81060-1:2007 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type

2024 ISO 81060-2:2018/Amd 2:2024 Non-invasive sphygmomanometers
2020 ISO 81060-2:2018/Amd 1:2020 Non-invasive sphygmomanometers — Part 2: Clinical investigation of intermittent automated measurement type — Amendment 1
2018 ISO 81060-2:2018 Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type
2013 ISO 81060-2:2013 Non-invasive sphgmomanometers-Part 2:Clinical investigation of automated measurement type
2011 ISO 81060-2:2009/Cor 1:2011 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type; Technical Corrigendum 1
2009 ISO 81060-2:2009 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type