EN ISO 81060-2:2019/A2:2024

SLOVENSKI STANDARD
01-junij-2024
Neinvazivni sfigmomanometri - 2. del: Klinične raziskave avtomatiziranih vrst
merjenja s prekinitvami - Dopolnilo A2 (ISO 81060-2:2018/Amd 2:2024)
Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent
automated measurement type - Amendment 2 (ISO 81060-2:2018/Amd 2:2024)
Nichtinvasive Blutdruckmessgeräte - Teil 2: Klinische Prüfung der intermittierenden
automatisierten Bauart - Änderung 2 (ISO 81060-2:2018/Amd 2:2024)
Sphygmomanomètres non invasifs - Partie 2: Investigation clinique pour type ponctuel à
mesurage automatique - Amendment 2 (ISO 81060-2:2018/Amd 2:2024)
Ta slovenski standard je istoveten z: EN ISO 81060-2:2019/A2:2024
ICS:
11.040.55 Diagnostična oprema Diagnostic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 81060-2:2019/A2
EUROPEAN STANDARD
NORME EUROPÉENNE
April 2024
EUROPÄISCHE NORM
ICS 11.040.10
English Version
Non-invasive sphygmomanometers - Part 2: Clinical
investigation of intermittent automated measurement type
- Amendment 2 (ISO 81060-2:2018/Amd 2:2024)
Sphygmomanomètres non invasifs - Partie 2: Nichtinvasive Blutdruckmessgeräte - Teil 2: Klinische
Investigation clinique pour type ponctuel à mesurage Prüfung der intermittierenden automatisierten Bauart
automatique - Amendment 2 (ISO 81060-2:2018/Amd - Änderung 2 (ISO 81060-2:2018/Amd 2:2024)
2:2024)
This amendment A2 modifies the European Standard EN ISO 81060-2:2019; it was approved by CEN on 26 February 2024.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This amendment exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 81060-2:2019/A2:2024 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 81060-2:2019/A2:2024) has been prepared by Technical Committee ISO/TC
121 "Anaesthetic and respiratory equipment" in collaboration with Technical Committee CEN/TC 205
“Non-active medical devices” the secretariat of which is held by DIN.
This Amendment to the European Standard EN ISO 81060-2:2019 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by October 2024,
and conflicting national standards shall be withdrawn at the latest by October 2024.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 81060-2:2018/Amd 2:2024 has been approved by CEN as EN ISO 81060-
2:2019/A2:2024 without any modification.

International
Standard
ISO 81060-2
Third edition
Non-invasive
2018-11
sphygmomanometers —
AMENDMENT 2
Part 2:
2024-03
Clinical investigation of intermittent
automated measurement type
AMENDMENT 2
Sphygmomanomètres non invasifs —
Partie 2: Investigation clinique pour type ponctuel à mesurage
automatique
AMENDEMENT 2
Reference number
ISO 81060-2:2018/Amd.2:2024(en) © ISO 2024

ISO 81060-2:2018/Amd.2:2024(en)
© ISO 2024
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
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 81060-2:2018/Amd.2:2024(en)
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, Part 1. In particular, the different approval criteria needed for the different types
of document should be noted. This document was drafted in accordance with the editorial rules of the ISO/
IEC Directives, Part 2 (see www.iso.org/directives or www.iec.ch/members_experts/refdocs).
ISO and IEC draw attention to the possibility that the implementation of this document may involve the
use of (a) patent(s). ISO and IEC take no position concerning the evidence, validity or applicability of any
claimed patent rights in respect thereof. As of the date of publication of this document, ISO and IEC had not
received notice of (a) patent(s) which may be required to implement this document. However, implementers
are cautioned that this may not represent the latest information, which may be obtained from the patent
database available at www.iso.org/patents and https://patents.iec.ch. ISO and IEC shall not be held
responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT) see www.iso.org/iso/foreword.html.
In the IEC, see www.iec.ch/understanding-standards.
This document was prepared jointly by Technical Committee ISO/TC 121, Anaesthetic and respiratory
equipment, Subcommittee SC 3, Respiratory devices and related equipment used for patient care, and Technical
Committee IEC/TC 62, Medical equipment, software, and systems, Subcommittee SC 62D, Particular medical
equipment, software, and systems, in collaboration with the European Committee for Standardization
(CEN) Technical Committee CEN/TC 205, Non-active medical devices, in accordance with the Agreement on
technical cooperation between ISO and CEN (Vienna Agreement).
A list of all parts in the ISO 81060 series can be found on the ISO and IEC websites.
Any feedback or questions on this document should be directed to the user’s national standards
body. A complete listing of these bodies can be found at www.iso.org/members.html and
www.iec.ch/national-committees.

iii
ISO 81060-2:2018/Amd.2:2024(en)
Non-invasive sphygmomanometers —
Part 2:
Clinical investigation of intermittent automated
measurement type
AMENDMENT 2
Scope
Add the following as the last paragraph in the scope:
This document is not applicable to clinical investigations of a set of cuffs that are no
...