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ISO 81060-2:2018

(Main)

Non-invasive sphygmomanometers — Part 2: Clinical investigation of intermittent automated measurement type

Non-invasive sphygmomanometers — Part 2: Clinical investigation of intermittent automated measurement type

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.

Sphygmomanomètres non invasifs — Partie 2: Investigation clinique pour type ponctuel à mesurage automatique

Le présent document précise les exigences et les méthodes d'investigation clinique des appareils électromédicaux utilisés pour estimer ponctuellement, de manière non invasive et automatique, la pression artérielle au moyen d'un brassard. Le présent document est applicable à tous les sphygmomanomètres qui captent ou affichent des pulsations, des flux ou des sons pour l'estimation, l'affichage ou l'enregistrement de la pression artérielle. Il n'est pas nécessaire que ces sphygmomanomètres aient un dispositif de gonflage automatique du brassard. Le présent document couvre les sphygmomanomètres utilisables pour toutes les populations de patients (par exemple: toutes les tranches d'âge et gammes de poids) et dans toutes les conditions d'emploi (par exemple: contrôle ambulatoire de la pression artérielle, contrôle de la pression artérielle lors d'épreuves d'effort, auto-contrôle de la pression artérielle en environnement de soins à domicile et contrôle de la pression artérielle dans un établissement de soins de santé). EXEMPLE Sphygmomanomètre automatique tel que défini dans l'IEC 80601‑2‑30 faisant l'objet d'une investigation clinique conformément au présent document. Le présent document spécifie des exigences supplémentaires de divulgation d'informations pour les documents d'accompagnement des sphygmomanomètres ayant subi avec succès une investigation clinique conformément au présent document. Le présent document n'est pas applicable à l'investigation clinique des sphygmomanomètres non automatiques tels que définis dans l'ISO 81060‑1 ou des appareils de surveillance de la pression sanguine prélevée directement tels que définis dans l'IEC 60601‑2‑34. Le présent document n’est pas applicable à l’INVESTIGATION CLINIQUE d’un ensemble de BRASSARDS dont les matériaux et la construction ne sont pas identiques. Il est nécessaire d’évaluer séparément chaque type d’ensemble de BRASSARDS conformément au présent document.

General Information

Status
Published
Publication Date
20-Nov-2018
ICS
11.040.10 - Anaesthetic, respiratory and reanimation equipment
Technical Committee
ISO/TC 121/SC 3 - Respiratory devices and related equipment used for patient care
Drafting Committee
ISO/TC 121/SC 3/JWG 7 - Joint ISO/TC 121/SC 3-IEC/SC 62D WG : Non-invasive blood pressure monitoring equipment
Current Stage
Ref Project

Relations

Consolidates
ISO 11114-4:2017 - Transportable gas cylinders — Compatibility of cylinder and valve materials with gas contents — Part 4: Test methods for selecting steels resistant to hydrogen embrittlement
Effective Date
06-Jun-2022
Amended By
ISO 81060-2:2018/Amd 2:2024 - Non-invasive sphygmomanometers — Part 2: Clinical investigation of intermittent automated measurement type — Amendment 2
Effective Date
06-Jun-2022
Amended By
ISO 81060-2:2018/Amd 1:2020 - Non-invasive sphygmomanometers — Part 2: Clinical investigation of intermittent automated measurement type — Amendment 1
Effective Date
14-Jul-2018
Revises
ISO 81060-2:2013 - Non-invasive sphygmomanometers — Part 2: Clinical investigation of automated measurement type
Effective Date
25-Feb-2017

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Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 81060-2
Third edition
2018-11
Non-invasive sphygmomanometers —
Part 2:
Clinical investigation of intermittent
automated measurement type
Sphygmomanomètres non invasifs —
Partie 2: Investigation clinique pour type ponctuel à mesurage
automatique
Reference number
ISO 81060-2:2018(E)
©
ISO 2018

---------------------- Page: 1 ----------------------
ISO 81060-2:2018(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2018
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved

---------------------- Page: 2 ----------------------
ISO 81060-2:2018(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General requirements for clinical investigations . 2
4.1 Clinical investigation methods . 2
4.2 Good clinical practice . 3
4.3 Status of previous clinical investigations . 3
4.4 Disclosure of summary of clinical investigation . 3
5 Clinical investigation with an auscultatory reference sphygmomanometer .3
5.1 Subject requirements . 3
5.1.1 * Number . 3
5.1.2 * Gender distribution . 3
5.1.3 * Age distribution . 4
5.1.4 * Limb size distribution . 4
5.1.5 Blood pressure distribution . 4
5.1.6 * Special patient populations . 5
5.2 Clinical investigation method with a reference sphygmomanometer . 5
5.2.1 * Subject preparation . 5
5.2.2 * Observer preparation .
...

NORME ISO
INTERNATIONALE 81060-2
Troisième édition
2018-11
Sphygmomanomètres non invasifs —
Partie 2:
Investigation clinique pour type
ponctuel à mesurage automatique
Non-invasive sphygmomanometers —
Part 2: Clinical investigation of intermittent automated
measurement type
Numéro de référence
ISO 81060-2:2018(F)
©
ISO 2018

---------------------- Page: 1 ----------------------
ISO 81060-2:2018(F)

DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2018
Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette
publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,
y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut
être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
ISO copyright office
Case postale 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Genève
Tél.: +41 22 749 01 11
Fax: +41 22 749 09 47
E-mail: copyright@iso.org
Web: www.iso.org
Publié en Suisse
ii © ISO 2018 – Tous droits réservés

---------------------- Page: 2 ----------------------
ISO 81060-2:2018(F)

Sommaire Page
Avant-propos .v
Introduction .vi
1 Domaine d’application . 1
2 Références normatives . 1
3 Termes et définitions . 2
4 Exigences générales relatives aux investigations cliniques . 3
4.1 Méthodes d’investigation clinique . 3
4.2 Bonnes pratiques cliniques . 3
4.3 Statut des investigations cliniques précédentes . 3
4.4 Divulgation des informations de synthèse d’une investigation clinique . 3
5 Investigation clinique avec un sphygmomanomètre de référence auscultatoire .4
5.1 Exigences relatives aux sujets . 4
5.1.1 * Nombre de sujets . 4
5.1.2 * Distribution par sexe . 4
5.1.3 * Distribution par âge . 4
5.1.4 * Distribution des tailles de bras . 4
5.1.5 Distribution de la pression artérielle . 5
5.1.6 * Populations spéciales de patients . 5
5.2 Méthode d’investigation clinique avec un sphygmomanomètre de référence . 6
5.2.1 * Préparation des sujets . 6
5.2.2 * Préparation des observateurs . 6
5.2.3 * Lectures de référence.
...

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ISO 81060-3:2022(Main)
Non-invasive sphygmomanometers — Part 3: Clinical investigation of continuous automated measurement type

This document specifies the requirements and methods for the clinical investigation of continuous automated non-invasive sphygmomanometers used for the measurement of the blood pressure of a patient. This document does not cover usability aspects such as the form and manner of the data display or output. This document does not specify a numerical threshold on the minimum output period. A continuous automated non-invasive sphygmomanometer providing blood pressure parameters (e.g., systolic blood pressure, diastolic blood pressure or mean arterial pressure) with an output period considerably larger than 30 s is not typically considered a continuous automated non-invasive sphygmomanometer. This document covers both trending continuous automated non-invasive sphygmomanometers and absolute accuracy continuous automated non-invasive sphygmomanometers and focuses solely on requirements for the clinical investigation. Representation of output is not covered by this document. NOTE 1 IEC 62366-1 provides requirements on the application of usability engineering to medical devices. The usability engineering process can be used to clarify for the intended user whether the displayed data concerns absolute accurate values or trending values. The requirements and methods for the clinical investigation of continuous automated non-invasive sphygmomanometers provided in this document are applicable to any subject population, and any condition of use of the continuous automated non-invasive sphygmomanometers. NOTE 2 Subject populations can, for example, be represented by age or weight ranges. NOTE 3 This document does not provide a method to assess the effect of artefacts during the clinical investigation (e.g. motion artefacts induced by the movement of the subject or the movement of the platform supporting the subject). This document specifies additional disclosure requirements for the accompanying documents of continuous automated non-invasive sphygmomanometers that have undergone clinical investigation according to this document. This document is not applicable to: — the clinical investigation of a non-automated sphygmomanometer as given in ISO 81060-1, — the clinical investigation of an intermittent automated non-invasive sphygmomanometer as given in ISO 81060-2, — an automated non-invasive sphygmomanometer as given in IEC 80601-2-30, or — invasive blood pressure monitoring equipment as given in IEC 60601‑2‑34.

  • Standard
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    English language
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    French language
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