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)
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
- 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
Relations
- Effective Date
- 21-Nov-2017
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 CEN approved the amendment and required national adoption by November 2020 (conflicting national standards to be withdrawn by May 2023).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
EN ISO 80601-2-56:2017/A1:2020 is a amendment published by the European Committee for Standardization (CEN). 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: 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
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
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.
EN ISO 80601-2-56:2017/A1:2020 has the following relationships with other standards: It is inter standard links to EN ISO 80601-2-56:2017. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
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.
You can purchase EN ISO 80601-2-56:2017/A1:2020 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CEN standards.
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-
...
The article discusses EN ISO 80601-2-56:2017/A1:2020, which is a standard for medical electrical equipment. This standard provides requirements for the basic safety and essential performance of clinical thermometers used for measuring body temperature. The article mentions that there is an amendment, Amendment 1 (ISO 80601-2-56:2017/Amd 1:2018), which is being delinked from the Medical Devices Directive (MDD) and M/023. The article also references a negative assessment by a consultant and a pending resolution by the TC, as well as a deadline for the FV dispatch. Lastly, the article includes a formula: DOW = DAV + 36 months, although its meaning is unclear.
기사 제목: EN ISO 80601-2-56:2017/A1:2020 - 의료 전기 장비 - 파트 2-56: 체온 측정용 임상 체온계의 기본 안전 및 필수 성능에 대한 특별 요구 사항 - 개정 1 (ISO 80601-2-56:2017/Amd 1:2018) 기사 내용: 2020-06-05-JO-BT N 11989 - EN ISO 80601-2-56:2017/prA1과 MDD 및 M/023 간의 연결 해제를 위해 기다리고 있는 상태 2019-03-07-JO - ENQ 단계에서 HAS 컨설턴트의 부정적 평가를 해결하기 위해 기술위원회(TC)의 조치를 기다리고 있음. FV 배치 기한은 2019년 1월 18일이었음. DOW = DAV + 36개월 기사는 의료 전기 장비에 대한 표준인 EN ISO 80601-2-56:2017/A1:2020에 대해 다루고 있습니다. 이 표준은 체온 측정에 사용되는 임상 체온계의 기본 안전과 필수 성능에 대한 요구사항을 제공합니다. 기사에는 MDD 및 M/023과 관련된 개정인 개정 1 (ISO 80601-2-56:2017/Amd 1:2018)이 연결 해제될 것이라고 언급되어 있습니다. 또한 기사에는 컨설턴트의 부정적 평가와 TC의 해결 대기 중인 상황, 그리고 FV 배치 마감일도 언급되어 있습니다. 마지막으로 기사에는 DOW = DAV + 36개월이라는 수식이 포함되어 있지만, 그 의미는 분명하지 않습니다.
기사 제목: EN ISO 80601-2-56:2017/A1:2020 - 의료 전기 장비 - 부분 2-56: 체온 측정을 위한 임상 온도계의 기본 안전 및 필수 작동 요구사항 - 개정 1 (ISO 80601-2-56:2017/Amd 1:2018) 기사 내용: 2020-06-05-JO- BT N 11989은 EN ISO 80601-2-56:2017/prA1과 MDD 및 M/023와의 관계를 해제하기 위한 것이다. 2019-03-07-JO - ENQ 단계에서 HAS 컨설턴트의 부정적 평가를 해결하기 위해 TC가 필요했다. FV 패치는 2019년 1월 18일까지 예정되어 있었다. DOW = DAV + 36개월
The article discusses an amendment to the EN ISO 80601-2-56:2017 standard, which pertains to the basic safety and essential performance of clinical thermometers for measuring body temperature. The amendment, known as EN ISO 80601-2-56:2017/A1:2020, aims to delink the standard from the Medical Devices Directive (MDD) and M/023. The status of the amendment is pending, with further assessment and resolution required. The article also mentions a timeframe of 36 months from the date of device availability (DAV) for implementation of the standard.
記事のタイトル：EN ISO 80601-2-56:2017/A1:2020 - 医療用電気機器 - 部品2-56：体温計の基本的な安全性および必要な性能に関する特定の要件 - 修定案1 (ISO 80601-2-56:2017/Amd 1:2018) 記事の内容：2020-06-05-JO-BT N 11989 - EN ISO 80601-2-56:2017/prA1とMDDおよびM/023の関連を解除するための待機状態 2019-03-07-JO - ENQ段階でのHASコンサルタントの否定的評価の解決を待つためにTCの措置が必要。FVの配布期限は2019年1月18日であった。 DOW = DAV + 36ヶ月 この記事では、医療用電気機器に関するEN ISO 80601-2-56:2017/A1:2020という規格について取り上げられています。この規格は体温測定に使用される臨床体温計の基本的な安全性と必要な性能に関する要件を提供しています。記事では、MDDおよびM/023との関連が解除される修定案1 (ISO 80601-2-56:2017/Amd 1:2018)が言及されています。また、コンサルタントの否定的評価とTCの解決待ち状況、およびFVの配布期限も言及されています。最後に、記事にはDOW = DAV + 36ヶ月という式が含まれていますが、その意味は不明です。
記事のタイトル：EN ISO 80601-2-56:2017/A1:2020 - 医療電気機器-パート2-56：体温計の基本的な安全性と必須の性能に関する特定の要件-改正版1（ISO 80601-2-56:2017/Amd 1:2018） 記事の内容：2020-06-05-JO- BT N 11989は、EN ISO 80601-2-56:2017/prA1をMDDおよびM/023から切り離すためのものです。 2019-03-07-JO - ENQの段階でのHASコンサルタントの否定的な評価を解決するために、TCの解決が必要でした。FVのパッチの提供期限は2019年1月18日に設定されていました。 DOW = DAV + 36ヶ月 (Note: The above translation may not be perfect as it is an AI-generated translation. Please consult the original article for accurate information.)
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