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)

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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
Public Enquiry End Date
09-Jul-2020
Publication Date
08-Oct-2020
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
24-Sep-2020
Due Date
29-Nov-2020
Completion Date
09-Oct-2020

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Standards Content (sample)

SLOVENSKI STANDARD
SIST EN ISO 81060-2:2020/A1:2020
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
SIST EN ISO 81060-2:2020/A1:2020 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 81060-2:2020/A1:2020
---------------------- Page: 2 ----------------------
SIST EN ISO 81060-2:2020/A1:2020
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.
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SIST EN ISO 81060-2:2020/A1:2020
EN ISO 81060-2:2019/A1:2020 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

---------------------- Page: 4 ----------------------
SIST EN ISO 81060-2:2020/A1:2020
EN ISO 81060-2:2019/A1:2020 (E)
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.
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SIST EN ISO 81060-2:2020/A1:2020
---------------------- Page: 6 ----------------------
SIST EN ISO 81060-2:2020/A1:2020
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
---------------------- Page: 7 ----------------------
SIST EN ISO 81060-2:2020/A1:2020
ISO 81060-2:2018/Amd.1:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© 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
---------------------- Page: 8 ----------------------
SIST EN ISO 81060-2:2020/A1:2020
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

...

SLOVENSKI STANDARD
SIST EN ISO 81060-2:2020/oprA1:2020
01-julij-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/prA1
ICS:
11.040.55 Diagnostična oprema Diagnostic equipment
SIST EN ISO 81060-2:2020/oprA1:2020 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 81060-2:2020/oprA1:2020
---------------------- Page: 2 ----------------------
SIST EN ISO 81060-2:2020/oprA1:2020
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
---------------------- Page: 3 ----------------------
SIST EN ISO 81060-2:2020/oprA1:2020
ISO 81060-2:2018/Amd.1:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© 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
---------------------- Page: 4 ----------------------
SIST EN ISO 81060-2:2020/oprA1:2020
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

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).

Attention is drawn to the possibility that some of the elements of this document may be the subject

of patent rights. ISO and IEC shall not be held responsible for identifying any or all such patent

rights. Details of any patent rights identified during the development of the document will be in the

Introduction and/or on the ISO list of patent declarations received (see www .iso .org/ patents) or the IEC

list of patent declarations received (see http:// patents .iec .ch).

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.

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, Electrical equipment in medical practice, Subcommittee SC D,

Electromedical equipment.

A list of all parts in the ISO 81060 series and in the IEC 81060 series can be found on

...

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