SIST EN ISO 80601-2-56:2017/A1:2020
(Amendment)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)
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
Relations
Overview
EN ISO 80601-2-56:2017/A1:2020 is the CEN-adopted amendment to ISO 80601-2-56:2017 that specifies particular requirements for the basic safety and essential performance of clinical thermometers for body temperature measurement. This amendment (A1) updates definitions, scope clarifications and a number of technical and documentation requirements. CEN approved the amendment and required national adoption by November 2020 (conflicting national standards to be withdrawn by May 2023).
Key Topics and Requirements
- Scope clarification: Any medical equipment that measures and displays a body temperature falls within this standard (examples: pulmonary artery catheter systems that display temperature, Foley catheters with temperature probes).
- Rated output range: Clinical thermometers must at minimum cover an output range from 34.0 °C to 42.0 °C (wider or narrower ranges allowed for specific uses).
- Accuracy & alarms: If a thermometer cannot indicate temperature within the laboratory accuracy, it must provide a technical alarm condition or must not provide an output temperature (examples: low internal battery, output outside rated range).
- Verbal form definitions: The amendment clarifies normative language - “may” (permission), “can” (possibility), “must” (external constraint) - to reduce interpretation ambiguity.
- Compliance verification: Conformance is checked by inspection and functional testing.
- Editorial and formatting fixes: Corrections to definitions, examples (e.g., “Blackbody, fluid bath”), and annex titles to ensure consistency and clarity.
Applications and Who Uses This Standard
This standard is essential for:
- Manufacturers of clinical thermometers and medical devices that include temperature measurement and display.
- Design & R&D engineers developing temperature-sensing medical equipment.
- Test laboratories and conformity assessment bodies performing functional and safety testing.
- Regulatory and quality teams responsible for technical documentation, CE marking, and compliance with European requirements.
- Clinical engineers and procurement teams selecting thermometry devices for hospitals and clinics.
Practical applications include device design validation, safety risk assessment, production inspection, and clinical performance verification for devices used in patient core and peripheral temperature monitoring.
Related Standards
- ISO/IEC 80601 series (medical electrical equipment general and particular parts)
- IEC 60601-1 (general requirements for basic safety and essential performance of medical electrical equipment)
- National adoptions and EN versions (EN ISO 80601-2-56:2017/A1:2020)
Keywords: clinical thermometer standard, EN ISO 80601-2-56 amendment, body temperature measurement, medical electrical equipment, thermometer safety, rated output range, technical alarm, conformity testing.
Frequently Asked Questions
SIST EN ISO 80601-2-56:2017/A1:2020 is a amendment published by the Slovenian Institute for Standardization (SIST). Its full title is "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)". This standard covers: DOW = DAV + 36 months
DOW = DAV + 36 months
SIST EN ISO 80601-2-56:2017/A1:2020 is classified under the following ICS (International Classification for Standards) categories: 11.040.55 - Diagnostic equipment; 17.200.20 - Temperature-measuring instruments. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN ISO 80601-2-56:2017/A1:2020 has the following relationships with other standards: It is inter standard links to SIST EN ISO 80601-2-56:2017. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN ISO 80601-2-56:2017/A1:2020 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC; Standardization Mandates: M/023. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
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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-
...
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