Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement - Amendment 1 (ISO 80601-2-56:2017/Amd 1:2018)

DOW = DAV + 36 months

Medizinische elektrische Geräte - Teil 2-56: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von medizinischen Thermometern zum Messen der Körpertemperatur - Änderung 1 (ISO 80601-2-56:2017/Amd 1:2018)

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Appareils électromédicaux - Partie 2-56: Exigences particulières relatives à la sécurité fondamentale et aux performances essentielles des thermomètres médicaux pour mesurer la température de corps - Amendement 1 (ISO 80601-2-56:2017/Amd 1:2018)

Medicinska električna oprema - 2-56. del: Posebne zahteve za osnovno varnost in bistvene lastnosti kliničnih termometrov za merjenje telesne temperature - Dopolnilo A1 (ISO 80601-2-56:2017/Amd 1:2018)

General Information

Status
Published
Public Enquiry End Date
19-Apr-2018
Publication Date
16-Jun-2020
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
25-May-2020
Due Date
30-Jul-2020
Completion Date
17-Jun-2020

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SLOVENSKI STANDARD
SIST EN ISO 80601-2-56:2017/A1:2020
01-julij-2020
Medicinska električna oprema - 2-56. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti kliničnih termometrov za merjenje telesne temperature -
Dopolnilo A1 (ISO 80601-2-56:2017/Amd 1:2018)

Medical electrical equipment - Part 2-56: Particular requirements for basic safety and

essential performance of clinical thermometers for body temperature measurement -

Amendment 1 (ISO 80601-2-56:2017/Amd 1:2018)

Medizinische elektrische Geräte - Teil 2-56: Besondere Festlegungen für die Sicherheit

einschließlich der wesentlichen Leistungsmerkmale von medizinischen Thermometern
zum Messen der Körpertemperatur - Änderung 1 (ISO 80601-2-56:2017/Amd 1:2018)

Appareils électromédicaux - Partie 2-56: Exigences particulières relatives à la sécurité

fondamentale et aux performances essentielles des thermomètres médicaux pour
mesurer la température de corps - Amendement 1 (ISO 80601-2-56:2017/Amd 1:2018)
Ta slovenski standard je istoveten z: EN ISO 80601-2-56:2017/A1:2020
ICS:
11.040.55 Diagnostična oprema Diagnostic equipment
17.200.20 Instrumenti za merjenje Temperature-measuring
temperature instruments
SIST EN ISO 80601-2-56:2017/A1:2020 en

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

---------------------- Page: 1 ----------------------
SIST EN ISO 80601-2-56:2017/A1:2020
---------------------- Page: 2 ----------------------
SIST EN ISO 80601-2-56:2017/A1:2020
EN ISO 80601-2-
EUROPEAN STANDARD
56:2017/A1
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2020
ICS 11.040.55
English Version
Medical electrical equipment - Part 2-56: Particular
requirements for basic safety and essential performance of
clinical thermometers for body temperature measurement
- Amendment 1 (ISO 80601-2-56:2017/Amd 1:2018)

Appareils électromédicaux - Partie 2-56: Exigences Medizinische elektrische Geräte - Teil 2-56: Besondere

particulières relatives à la sécurité fondamentale et aux Festlegungen für die Sicherheit einschließlich der

performances essentielles des thermomètres médicaux wesentlichen Leistungsmerkmale von medizinischen

pour mesurer la température de corps - Amendement Thermometern zum Messen der Körpertemperatur -

1 (ISO 80601-2-56:2017/Amd 1:2018) Änderung 1 (ISO 80601-2-56:2017/Amd 1:2018)

This amendment A1 modifies the European Standard EN ISO 80601-2-56:2017; it was approved by CEN on 27 September 2018.

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 80601-2-56:2017/A1:2020 E

worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 80601-2-56:2017/A1:2020
EN ISO 80601-2-56:2017/A1:2020 (E)
Contents Page

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

---------------------- Page: 4 ----------------------
SIST EN ISO 80601-2-56:2017/A1:2020
EN ISO 80601-2-56:2017/A1:2020 (E)
European foreword

This document (EN ISO 80601-2-56:2017/A1:2020) 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 80601-2-56:2017 shall be given the status of a

national standard, either by publication of an identical text or by endorsement, at the latest by

November 2020, and conflicting national standards shall be withdrawn at the latest by May 2023.

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 80601-2-56:2017/Amd 1:2018 has been approved by CEN as EN ISO 80601-2-

56:2017/A1:2020 without any modification.
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SIST EN ISO 80601-2-56:2017/A1:2020
---------------------- Page: 6 ----------------------
SIST EN ISO 80601-2-56:2017/A1:2020
INTERNATIONAL ISO
STANDARD 80601-2-56
Second edition
2017-03-01
AMENDMENT 1
2018-11
Medical electrical equipment —
Part 2-56:
Particular requirements for basic
safety and essential performance
of clinical thermometers for body
temperature measurement
AMENDMENT 1
Appareils électromédicaux —
Partie 2-56: Exigences particulières relatives à la sécurité
fondamentale et aux performances essentielles des thermomètres
médicaux pour mesurer la température de corps
AMENDEMENT 1
Reference number
ISO 80601-2-
...

SLOVENSKI STANDARD
SIST EN ISO 80601-2-56:2017/oprA1:2018
01-april-2018
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Medical electrical equipment - Part 2-56: Particular requirements for basic safety and

essential performance of clinical thermometers for body temperature measurement -

Amendment 1 (ISO 80601-2-56:2017/DAM 1:2018)

Medizinische elektrische Geräte - Teil 2-56: Besondere Festlegungen für die Sicherheit

einschließlich der wesentlichen Leistungsmerkmale von medizinischen Thermometern
zum Messen der Körpertemperatur (ISO 80601-2-56:2017/DAM 1:2018)

Appareils électromédicaux - Partie 2-56: Exigences particulières relatives à la sécurité

fondamentale et aux performances essentielles des thermomètres médicaux pour
mesurer la température de corps - Amendement 1 (ISO 80601-2-56:2017/DAM 1:2018)
Ta slovenski standard je istoveten z: EN ISO 80601-2-56:2017/prA1
ICS:
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic equipment
17.200.20 Instrumenti za merjenje Temperature-measuring
temperature instruments
SIST EN ISO 80601-2- en
56:2017/oprA1:2018

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

---------------------- Page: 1 ----------------------
SIST EN ISO 80601-2-56:2017/oprA1:2018
---------------------- Page: 2 ----------------------
SIST EN ISO 80601-2-56:2017/oprA1:2018
DRAFT AMENDMENT
ISO 80601-2-56:2017 DAM 1
ISO/TC 121/SC 3 Secretariat: ANSI
Voting begins on: Voting terminates on:
2018-03-07 2018-05-30
Medical electrical equipment —
Part 2-56:
Particular requirements for basic safety and essential
performance of clinical thermometers for body
temperature measurement
AMENDMENT 1
Appareils électromédicaux —

Partie 2-56: Exigences particulières relatives à la sécurité fondamentale et aux performances essentielles

des thermomètres médicaux pour mesurer la température de corps
AMENDEMENT 1
ICS: 11.040.55
Member bodies are requested to consult relevant national interests in IEC/SC
62D before casting their ballot to the e-Balloting application.
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
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 80601-2-56:2017/DAM 1:2018(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 2018
---------------------- Page: 3 ----------------------
SIST EN ISO 80601-2-56:2017/oprA1:2018
ISO 80601-2-56:2017/DAM 1:2018(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2018

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
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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 2018 – All rights reserved
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SIST EN ISO 80601-2-56:2017/oprA1:2018
ISO 80601-2-56:2017/DAM 1:2018(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards

bodies (ISO member bodies). The work of preparing International Standards is normally carried out

through ISO technical committees. Each member body interested in a subject for which a technical

committee has been established has the right to be represented on that committee. International

organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.

ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of

electrotechnical standardization.

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

any patent rights identified during the development of t
...

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