EN ISO 81060-2:2019/A1:2020

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
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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
...