SIST EN ISO 80601-2-56:2017/A1:2020

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)

[Not available]

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
• ICS: 11.040.55 - Diagnostic equipment
• ICS: 17.200.20 - Temperature-measuring instruments
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 25-May-2020
• Due Date: 30-Jul-2020
• Completion Date: 17-Jun-2020
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN ISO 80601-2-56:2017/A1:2020 - 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)

Relations

• Amends: SIST EN ISO 80601-2-56:2017 - Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2017)
• Effective Date: 01-Jul-2020

Standards Content (Sample)

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.

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SIST EN ISO 80601-2-56:2017/A1:2020

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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.

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SIST EN ISO 80601-2-56:2017/A1:2020
EN ISO 80601-2-56:2017/A1:2020 (E)
Contents Page
European foreword . 3

2

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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.


3

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SIST EN ISO 80601-2-56:2017/A1:2020

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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
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLNOLQLþQLKWHUPRPHWURY]DPHUMHQMHWHOHVQHWHPSHUDWXUH
'RSROQLOR$,62'$0
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.

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SIST EN ISO 80601-2-56:2017/oprA1:2018

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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

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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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Phone: [phone]
Fax: [phone]
Email: [e-mail]
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
...