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CEN

EN ISO 81060-2:2019/A1:2020

(Amendment)

Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type - Amendment 1 (ISO 81060-2:2018/Amd 1:2020)

Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type - Amendment 1 (ISO 81060-2:2018/Amd 1:2020)

Nichtinvasive Blutdruckmessgeräte - Teil 2: Klinische Prüfung der intermittierenden automatisierten Bauart - Änderung 1 (ISO 81060-2:2018/Amd 1:2020)

No scope available

Sphygmomanomètres non invasifs - Partie 2: Investigation clinique pour type ponctuel à mesurage automatique - Amendement 1 (ISO 81060-2:2018/Amd 1:2020)

Neinvazivni sfigmomanometri - 2. del: Klinične raziskave avtomatiziranih vrst merjenja s prekinitvami - Dopolnilo A1 (ISO 81060-2:2018/Amd 1:2020)

General Information

Status
Published
Publication Date
15-Sep-2020
Withdrawal Date
30-Mar-2021
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
6060 - Definitive text made available (DAV) - Publishing
Start Date
16-Sep-2020
Due Date
17-Jul-2022
Completion Date
16-Sep-2020
Ref Project
SIST EN ISO 81060-2:2020/A1:2020 - Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type - Amendment 1 (ISO 81060-2:2018/Amd 1:2020)

Relations

Amends
EN ISO 81060-2:2019 - Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type (ISO 81060-2:2018)
Effective Date
04-Feb-2020

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SLOVENSKI STANDARD
01-november-2020
Neinvazivni sfigmomanometri - 2. del: Klinične raziskave avtomatiziranih vrst
merjenja s prekinitvami - Dopolnilo A1 (ISO 81060-2:2018/Amd 1:2020)
Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent
automated measurement type - Amendment 1 (ISO 81060-2:2018/Amd 1:2020)
Nichtinvasive Blutdruckmessgeräte - Teil 2: Klinische Prüfung der intermittierenden
automatisierten Bauart - Änderung 1 (ISO 81060-2:2018/Amd 1:2020)
Sphygmomanomètres non invasifs - Partie 2: Investigation clinique pour type ponctuel à
mesurage automatique - Amendement 1 (ISO 81060-2:2018/Amd 1:2020)
Ta slovenski standard je istoveten z: EN ISO 81060-2:2019/A1:2020
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/A1
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2020
EUROPÄISCHE NORM
ICS 11.040.10
English Version
Non-invasive sphygmomanometers - Part 2: Clinical
investigation of intermittent automated measurement type
- Amendment 1 (ISO 81060-2:2018/Amd 1:2020)
Sphygmomanomètres non invasifs - Partie 2: Nichtinvasive Blutdruckmessgeräte - Teil 2: Klinische
Investigation clinique pour type ponctuel à mesurage Prüfung der intermittierenden automatisierten Bauart
automatique - Amendement 1 (ISO 81060- - Änderung 1 (ISO 81060-2:2018/Amd 1:2020)
2:2018/Amd 1:2020)
This amendment A1 modifies the European Standard EN ISO 81060-2:2019; it was approved by CEN on 17 August 2020.

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, Turkey 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
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 81060-2:2019/A1:2020 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
The text of ISO 81060-2:2018/Amd 1:2020 has been prepared by Technical Committee ISO/TC 121
"Anaesthetic and respiratory equipment” of the International Organization for Standardization (ISO)
and has been taken over as EN ISO 81060-2:2019/A1:2020 by 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 March 2021, and
conflicting national standards shall be withdrawn at the latest by March 2021.
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.
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, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 81060-2:2018/Amd 1:2020 has been approved by CEN as EN ISO 81060-
2:2019/A1:2020 without any modification.

INTERNATIONAL ISO
STANDARD 81060-2
Third edition
2018-11-29
AMENDMENT 1
2020-01
Non-invasive sphygmomanometers —
Part 2:
Clinical investigation of intermittent
automated measurement type
AMENDMENT 1
Sphygmomanomètres non invasifs —
Partie 2: Investigation clinique pour type ponctuel à mesurage
automatique
AMENDEMENT 1
Reference number
ISO 81060-2:2018/Amd.1:2020(E)
©
ISO 2020
ISO 81060-2:2018/Amd.1:2020(E)

© ISO 2020
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 2020 – All rights reserved

ISO 81060-2:2018/Amd.1:2020(E)

Foreword
ISO (the International Organization for Standardization) and IEC (the International Electrotechnical
Commission) form the specialized system for worldwide standardization. National bodies that
...

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NOTE 4       Additional information can be found in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 4.2.
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—    ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13;
—    ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601‑2‑84;
—    ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2‑72;
—    ventilatory support equipment or accessories intended for ventilatory insufficiency, which are given in ISO 80601‑2‑80;
—    sleep apnoea therapy ME equipment, which are given in ISO 80601‑2‑70;
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