NF EN ISO 81060-2
Non-invasive sphygmomanometers - Part 2 : clinical investigation of automated measurement type
ISO 81060-2:2013 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. ISO 81060-2:2013 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. ISO 81060-2:2013 covers sphygmomanometers intended for use in all patient populations and all conditions of use. ISO 81060-2:2013 specifies additional disclosure requirements for the accompanying documents of sphygmomanometers that have undergone clinical investigation according to ISO 81060-2:2013.
ISO 81060-2:2013 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.
ISO 81060-2:2013 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.
ISO 81060-2:2013 covers sphygmomanometers intended for use in all patient populations and all conditions of use.
ISO 81060-2:2013 specifies additional disclosure requirements for the accompanying documents of sphygmomanometers that have undergone clinical investigation according to ISO 81060-2:2013.
<p>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.</p> <p>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.</p> <p>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).</p> <p>EXAMPLE Automated sphygmomanometer as given in IEC 80601-2-30 undergoing clinical investigation according to this document.</p> <p>This document specifies additional disclosure requirements for the accompanying documents of sphygmomanometers that have passed a clinical investigation according to this document.</p> <p>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.</p>
- Avant-proposiv
- Introductionvi
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1 Domaine d'application1
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2 Références normatives1
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3 Termes et définitions2
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4 Exigences générales relatives aux INVESTIGATIONS CLINIQUES2
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5 INVESTIGATION CLINIQUE avec un SPHYGMOMANOMETRE DE REFERENCE auscultatoire3
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6 INVESTIGATION CLINIQUE au moyen d'un APPAREIL DE SURVEILLANCE DE LA PRESSION SANGUINE PRELEVEE DIRECTEMENT18
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7 Populations de PATIENTES enceintes (y compris patientes pré-éclamptiques)23
- Annexe A (informative) Justification et lignes directrices25
- Annexe B (normative) Fréquences cardiaques cibles pour les épreuves d'effort38
- Annexe C (informative) Renvoi aux principes essentiels39
- Bibliographie40
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