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)

2020-06-05-JO- BT N 11989 to delink EN ISO 80601-2-56:2017/prA1 from MDD and M/023
2019-03-07-JO - Awaiting for TC to resolve the negative assessment of the HAS consultant at ENQ stages. FV dispactch was due  on the 18th of January 2019.
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
• Publication Date: 05-May-2020
• ICS: 11.040.55 - Diagnostic equipment
• ICS: 17.200.20 - Temperature-measuring instruments
• 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: 06-May-2020
• Completion Date: 06-May-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: 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)

Relations

• Amends: 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: 21-Nov-2017

Standards Content (Sample)

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

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.

Contents Page
European foreword . 3

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.

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-
...