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CEN

EN ISO 81060-2:2019/FprA2

(Amendment)

Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type - Amendment 2 (ISO 81060 2:2018/FDAM 2:2023)

Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type - Amendment 2 (ISO 81060 2:2018/FDAM 2:2023)

Nichtinvasive Blutdruckmessgeräte - Teil 2: Klinische Prüfung der intermittierenden automatisierten Bauart - Änderung 2 (ISO 81060 2:2018/FDAM 2:2023)

No scope available

Sphygmomanomètres non invasifs - Partie 2: Investigation clinique pour type ponctuel à mesurage automatique - Amendment 2 (ISO 81060 2:2018/FDAM 2:2023)

Neinvazivni sfigmomanometri - 2. del: Klinične raziskave avtomatiziranih vrst merjenja s prekinitvami - Dopolnilo A2 (ISO 81060 2:2018/FDAM 2:2023)

General Information

Status
Not Published
Publication Date
25-Apr-2024
ICS
11.040.10 - Anaesthetic, respiratory and reanimation equipment
Technical Committee
CEN/TC 205 - Non-active medical devices
Drafting Committee
CEN/TC 205 - Non-active medical devices
Current Stage
6055 - CEN Ratification completed (DOR) - Publishing
Start Date
26-Feb-2024
Completion Date
26-Feb-2024
Ref Project
SIST EN ISO 81060-2:2020/kprA2:2024 - Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type - Amendment 2 (ISO 81060 2:2018/FDAM 2:2023)

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Amends
EN ISO 81060-2:2019 - Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type (ISO 81060-2:2018)
Effective Date
16-Feb-2022

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EN ISO 81060-2:2020/oprA2:2023EN ISO 81060-2:2020/oprA2:2023
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SLOVENSKI STANDARD
SIST EN ISO 81060-2:2020/oprA2:2023
01-junij-2023
Neinvazivni sfigmomanometri - 2. del: Klinične raziskave avtomatiziranih vrst
merjenja s prekinitvami - Dopolnilo A2 (ISO 81060 2:2018/DAM 2:2023)
Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent
automated measurement type - Amendment 2 (ISO 81060 2:2018/DAM 2:2023)
Nichtinvasive Blutdruckmessgeräte - Teil 2: Klinische Prüfung der intermittierenden
automatisierten Bauart - Änderung 2 (ISO 81060 2:2018/DAM 2:2023)
Sphygmomanomètres non invasifs - Partie 2: Investigation clinique pour type ponctuel à
mesurage automatique - Amendment 2 (ISO 81060 2:2018/DAM 2:2023)
Ta slovenski standard je istoveten z: EN ISO 81060-2:2019/prA2
ICS:
11.040.55 Diagnostična oprema Diagnostic equipment
SIST EN ISO 81060-2:2020/oprA2:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 81060-2:2020/oprA2:2023

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SIST EN ISO 81060-2:2020/oprA2:2023
DRAFT AMENDMENT
ISO 81060-2:2018/DAM 2
ISO/TC 121/SC 3 Secretariat: ANSI
Voting begins on: Voting terminates on:
2023-04-10 2023-07-03
Non-invasive sphygmomanometers —
Part 2:
Clinical investigation of intermittent automated
measurement type
AMENDMENT 2
ICS: 11.040.10
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO 81060-2:2018/DAM 2:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

---------------------- Page: 3 ----------------------
SIST EN ISO 81060-2:2020/oprA2:2023
ISO 81060-2:2018/DAM 2:2023(E)
DRAFT AMENDMENT
ISO 81060-2:2018/DAM 2
ISO/TC 121/SC 3 Secretariat: ANSI
Voting begins on: Voting terminates on:

Non-invasive sphygmomanometers —
Part 2:
Clinical investigation of intermittent automated
measurement type
AMENDMENT 2
ICS: 11.040.10
This document is circulated as received from the committee secretariat.
COPYRIGHT PROTECTED DOCUMENT
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2023
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
NOT BE REFERRED TO AS AN INTERNATIONAL
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on STANDARD UNTIL PUBLISHED AS SUCH.
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
IN ADDITION TO THEIR EVALUATION AS
or ISO’s member body in the country of the requester. BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
ISO copyright office
USER PURPOSES, DRAFT INTERNATIONAL
CP 401 • Ch. de Blandonnet 8
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
CH-1214 Vernier, Geneva
POTENTIAL TO BECOME STANDARDS TO
Phone: +41 22 749 01 11
WHICH REFERENCE MAY BE MADE IN
Reference number
Email: copyright@iso.org
NATIONAL REGULATIONS.
Website: www.iso.org ISO 81060-2:2018/DAM 2:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
Published in Switzerland
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
  © ISO 2023 – All rights reserved
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

---------------------- Page: 4 ----------------------
SIST EN ISO 81060-2:2020/oprA2:2023
ISO 81060-2:2018/DAM 2:2023(E)
Foreword
ISO (the International Organization for Standardization) and IEC (the International Electrotechnical
Commission) form the specialized system for worldwide standardization. National bodies that are
members of ISO or IEC participate in the development of International Standards through technical
committees established by the respective organization to deal with particular fields of technical
activity. ISO and IEC technical committees collaborate in fields of mutual interest. Other international
organizations, governmental and non-governmental, in liaison with ISO and IEC, also take part in the
work.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Pa
...

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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.
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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.
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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:
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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.
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