EN ISO 81060-2:2019

Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type (ISO 81060-2:2018)

Publication date:   Mar 16, 2020

General information

60.60 Standard published   Nov 27, 2019

CEN

CEN/TC 205 Non-active medical devices

European Norm

11.040.10   Anaesthetic, respiratory and reanimation equipment

Buying

Published

Language in which you want to receive the document.

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.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Harmonized/Supporting

Life cycle

PREVIOUSLY

Replaces
EN ISO 81060-2:2014

NOW

PUBLISHED
EN ISO 81060-2:2019
60.60 Standard published
Nov 27, 2019

CORRIGENDA / AMENDMENTS

Amended by
EN ISO 81060-2:2019/A1:2020

Amended by
EN ISO 81060-2:2019/prA2