Reference number
ISO 81060-2:2018
International Standard
ISO 81060-2:2018
Non-invasive sphygmomanometers — Part 2: Clinical investigation of intermittent automated measurement type
Edition 3
2018-11
Preview
ISO 81060-2:2018
73339
No disponible en español
Publicado (Edición 3, 2018)
Esta publicación se revisó y confirmó por última vez en 2024. Por lo tanto, esta versión es la actual.
Esta norma tiene 2 modificación.

ISO 81060-2:2018

ISO 81060-2:2018
73339
Idioma
Formato
CHF 173
Convertir Franco suizo (CHF) a tu moneda

Resumen

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.

This document is not applicable to clinical investigations of a set of cuffs that are not of same materials and construction. Each type of cuff set is required to be evaluated separately according to this document.

 

Informaciones generales

  •  : Publicado
     : 2018-11
    : Norma Internacional para revisar [90.92]
  •  : 3
     : 36
  • ISO/TC 121/SC 3
    11.040.10 
  • RSS actualizaciones

 Modificaciones

Las enmiendas se emiten cuando se decide que puede ser necesario agregar nuevo material a un documento de normalización existente. También pueden incluir correcciones editoriales o técnicas que deban aplicarse al documento existente.

Amendment 1

Edición 2020

ISO 81060-2:2018/Amd 1:2020
75432
Idioma
Formato
CHF 18
Convertir Franco suizo (CHF) a tu moneda

Amendment 2

Edición 2024

ISO 81060-2:2018/Amd 2:2024
83598
Idioma
Formato
CHF 18
Convertir Franco suizo (CHF) a tu moneda

Ciclo de vida

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