SIST EN ISO 81060-2:2020/A2:2024
(Amendment)Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type - Amendment 2 (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)
No scope available
Sphygmomanomètres non invasifs - Partie 2: Investigation clinique pour type ponctuel à mesurage automatique - Amendment 2 (ISO 81060-2:2018/Amd 2:2024)
Neinvazivni sfigmomanometri - 2. del: Klinične raziskave avtomatiziranih vrst merjenja s prekinitvami - Dopolnilo A2 (ISO 81060-2:2018/Amd 2:2024)
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Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 81060-2:2020/A2:2024
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
SIST EN ISO 81060-2:2020/A2:2024 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/A2:2024
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SIST EN ISO 81060-2:2020/A2:2024
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.
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SIST EN ISO 81060-2:2020/A2:2024
EN ISO 81060-2:2019/A2:2024 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 81060-2:2020/A2:2024
EN ISO 81060-2:2019/A2:2024 (E)
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, Luxemb
...
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,
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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
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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
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NATIONAL REGULATIONS.
Website: www.iso.org ISO 81060-2:2018/DAM 2:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
Published in Switzerland
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NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
© ISO 2023 – All rights reserved
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023
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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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