FprEN ISO 80601-2-56

• Abstract:

  ISO 80601-2-56:2017 applies to the basic safety and essential performance of a clinical thermometer in combination with its accessories, hereafter referred to as me equipment. This document specifies the general and technical requirements for electrical clinical thermometers. This document applies to all electrical clinical thermometers that are used for measuring the body temperature of patients.; Clinical thermometers can be equipped with interfaces to accommodate secondary indicators, printing equipment, and other auxiliary equipment to create me systems. This document does not apply to auxiliary equipment.; Me equipment that measures a body temperature is inside the scope of this document.; ISO 80601-2-56:2017 does not specify the requirements for screening thermographs intended to be used for the individual non-invasive human febrile temperature screening of groups of individual humans under indoor environmental conditions, which are given in IEC 80601‑2‑59[4].; If a clause or subclause is specifically intended to be applicable to me equipment only, or to me systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to me equipment and to me systems, as relevant.; Hazards inherent in the intended physiological function of me equipment or me systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601‑1:2005+A1:2012, 7.2.13 and 8.4.1.; NOTE Additional information can be found in IEC 60601?1:2005+A1:2012, 4.2.

• Status: Not Published
• Publication Date: 24-Mar-2027
• ICS: 11.040.55 - Diagnostic equipment
• ICS: 17.200.20 - Temperature-measuring instruments
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Current Stage: 4599 - Dispatch of FV draft to CMC - Finalization for Vote
• Start Date: 03-Nov-2026
• Completion Date: 03-Nov-2026
• Ref Project: oSIST prEN ISO 80601-2-56:2026 - Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO/DIS 80601-2-56:2025)

• Consolidated By: ISO/FDIS 80601-2-56 - Medical electrical equipment — Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
• Effective Date: 12-Feb-2026
• Revises: 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)
• Effective Date: 08-Apr-2024
• Revises: 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: 08-Apr-2024

FprEN ISO 80601-2-56 is a CEN draft standard for medical electrical (ME) equipment, focused on clinical thermometers for body temperature measurement. It specifies basic safety and essential performance requirements for the thermometer and any accessories that affect those functions, so manufacturers, test laboratories, and conformity assessors can judge whether a device is suitable for patient temperature measurement. It also covers the document structure, marking, usability, electromagnetic compatibility, cleaning and disinfection, and laboratory accuracy requirements for these devices.

What does FprEN ISO 80601-2-56 specify?

FprEN ISO 80601-2-56 applies to electrical clinical thermometers used to measure the temperature of patients, together with accessories that can affect basic safety or essential performance. The document follows the IEC 60601-1 structure, with 201-prefixed clauses for the particular requirements and 20x-prefixed clauses where collateral standards are adapted.

The document does not apply to auxiliary equipment by itself, and it points screening thermographs for febrile screening to IEC 80601-2-59. It also leaves hazards inherent in the intended physiological function to the general standard, except where IEC 60601-1 addresses them.

Annex	What it covers
Annex C	Marking and labelling guidance for ME equipment and ME systems
Annex D	Symbols used for marking
Annex AA	Particular guidance and rationale
Annex BB	Reference temperature source
Annex CC	Mapping to IMDRF essential principles and labelling guidances
Annex DD	Alphabetized index of defined terms

The main body covers scope, terminology, testing, classification, identification, electrical and mechanical hazards, temperature and radiation hazards, accuracy, fault conditions, programmable electrical medical systems (PEMS), construction, ME systems, electromagnetic disturbances, and the extra requirements that apply to probes, accessories, usability, alarms, home healthcare use, and emergency medical services (EMS) use.

What are the key requirements of FprEN ISO 80601-2-56?

FprEN ISO 80601-2-56 is built around one central idea: a clinical thermometer must either show a valid temperature with the declared accuracy or clearly indicate that the reading is not reliable. Several clauses and annexes turn that idea into concrete design, labelling, processing, and test requirements.

Essential performance and output behavior

Clause 201.4.3.101 and Table 201.101 make accuracy the main essential performance target. If the clinical thermometer cannot indicate a temperature within its laboratory accuracy, it must either generate a technical alarm condition or not provide an output temperature. In practice, this means the device should not present a misleading value as if it were valid.

Clause 201.12.1.101 also requires the output range to cover a minimum body-temperature span, and the document allows an extended output range when the manufacturer defines one. That matters because a thermometer has to remain useful across the intended clinical range, not only at one ideal point.

Marking, packaging, and instructions for use

Clause 201.7.1.101 requires manufacturer information to comply with ISO 20417. Clause 201.7.2.1.101 requires the packaging to identify the measuring site and the reference site, and Clause 201.7.2.101 adds the key markings on the device itself.

Those markings include the temperature unit, the intended measuring site, when a new probe cover is needed, and the required measurement distance for non-contact devices unless the device can confirm the distance itself. Where the thermometer is intended for the magnetic resonance (MR) environment, the device and accessories must carry the relevant MR marking from IEC 62570. In practice, this helps users match the device to the body site and use it correctly before the first measurement.

Clause 201.7.9.2.101 requires the instructions for use (IFU) to state the measuring site, reference site, rated output range, laboratory accuracy, probe cover instructions, measurement mode, power-source replacement information, and the conditions for non-contact use. Clause 201.7.9.2.2.101 adds a warning that patient/environment equilibration can affect accuracy. For the user, this is the practical guide to obtaining a trustworthy reading.

Cleaning, disinfection, and reuse

Clause 201.11.6.6 requires enclosures intended for single-patient multiple use or multiple-patient multiple use, where they can contact mucous membranes or be contaminated by body fluids, to be designed for cleaning and disinfection or cleaning and sterilization. The processing instructions must follow ISO 17664-1 or ISO 17664-2, and ISO 14937 applies when sterilization is relevant.

The clause also requires the manufacturer to disclose those processing instructions in the IFU and to show that repeated processing does not compromise safety or essential performance. In practice, the design has to survive the declared cleaning and disinfection method over the expected service life, not just pass a single clean-looking sample.

Laboratory accuracy, test mode, and time response

Clause 201.12.1.102 requires laboratory accuracy to be assessed in direct measurement mode or test mode, and it requires the probe cover to be used exactly as declared. The test uses a reference temperature source, either a fluid bath or a blackbody radiator, and the method includes repeated independent measurements across the rated output range and any extended output range.

This matters because the device is verified under controlled but realistic environmental conditions, not only under one convenient setup. Annex BB supports this by describing the reference temperature source, the fluid bath and blackbody options, and the uncertainty considerations for the reference setup.

Clause 201.12.1.102.3 requires a direct measurement mode clinical thermometer to have its transient response characterized and disclosed in the IFU. The test moves the probe between two reference temperature sources and checks that the heating and cooling response stays within the declared measurement-time limits. That is especially important for fast-reading thermometers and predictive devices.

Clinical verification, accessories, EMC, usability, and alarms

Clause 201.12.1.103 requires indirect measurement mode clinical thermometers intended for human patients to undergo clinical performance verification in accordance with ISO 12487. The accompanying information must also state that the thermometer was clinically investigated according to that standard. This means indirect devices need clinical evidence as well as bench verification.

Clause 201.101 requires probes, probe cable extenders, and probe covers to be tested with every clinical thermometer model or type reference they are intended to work with, and their processing methods must be validated. Their accompanying documents must list the compatible thermometers. For buyers and service teams, this is the compatibility control point for accessories.

Clause 202 tightens the electromagnetic disturbance requirements so that relevant failures, parameter changes, resets, operating mode changes, and excessive accuracy changes are not allowed without a technical alarm condition or an indication of abnormal operation. Temporary degradation is allowed only if it does not need operator intervention and does not affect safety or essential performance. Clause 206 identifies the primary operating functions that usability engineering has to protect, including observing the output, positioning the probe, starting, stopping, and performing a basic pre-use check. Clause 208 states that a clinical thermometer need not have a physiological alarm condition.

What terms does FprEN ISO 80601-2-56 define?

FprEN ISO 80601-2-56 defines the terms that matter most for understanding how the thermometer measures, converts, displays, and verifies temperature.

• Clinical thermometer - ME equipment used to measure temperature at the measuring site and indicate the temperature at the reference site.
• Measuring site - The body location of the patient where the probe directly interacts.
• Reference site - The body part whose temperature the output is intended to represent.
• Direct measurement mode - An operating mode where the output temperature represents the measuring site temperature while the probe is in thermal equilibrium with that site.
• Indirect measurement mode - An operating mode where the output temperature is adjusted or converted and may represent a different site from the measuring site.
• Laboratory accuracy - The closeness of agreement between the output temperature of the clinical thermometer and a reference thermometer.
• Test mode - A state used for laboratory accuracy determination where the output reflects the sensor measurement without site conversion or time prediction.
• Instructions for use (IFU) - The part of the accompanying information directed to the user and essential for safe and effective use.

Who uses FprEN ISO 80601-2-56?

FprEN ISO 80601-2-56 is used by manufacturers of clinical thermometers, probes, probe cable extenders, and probe covers to design, label, validate, and test products. It is also used by test laboratories and conformity assessment bodies that verify laboratory accuracy, transient response, EMC behavior, cleaning and disinfection performance, and clinical performance.

Quality, regulatory, and clinical teams use the document to check risk controls, IFU content, accessory compatibility, and MR marking. Buyers, biomedical engineers, and reprocessing teams use it when choosing, using, maintaining, or reprocessing thermometers in hospitals, home healthcare, and EMS settings.

What changed in FprEN ISO 80601-2-56 from the previous edition?

FprEN ISO 80601-2-56 replaces ISO 80601-2-56:2017. The foreword states that this third edition was technically revised.

The stated changes are:

• harmonization with Edition 3.2 of the general standard
• harmonization with ISO 20417
• deletion of the clinical performance verification requirements and replacement by the requirement to conform with ISO 12487

Which standards are used with FprEN ISO 80601-2-56?

FprEN ISO 80601-2-56 relies on the general standard and on several named references for safety, processing, usability, and clinical evaluation.

• IEC 60601-1:2005+AMD1:2012+AMD2:2020 - baseline requirements for basic safety and essential performance
• IEC 60601-1-2:2014+AMD1:2020 - electromagnetic disturbances and immunity testing
• IEC 60601-1-6:2010+AMD1:2013+AMD2:2020 - usability engineering requirements
• IEC 60601-1-8:2006+AMD1:2012+AMD2:2020 - alarm systems
• IEC 60601-1-11:2015+AMD1:2020 - home healthcare environment requirements
• IEC 60601-1-12:2014+AMD1:2020 - emergency medical services environment requirements
• ISO 14937:2009 - sterilization process characterization and validation
• ISO 17664-1:2021 and ISO 17664-2:2021 - processing information for medical devices
• ISO 20417:- - manufacturer information and accompanying information
• ISO 12487:- - clinical performance evaluation of clinical thermometers
• IEC 62366-1:2015+AMD2:2020 - usability engineering for medical devices
• IEC 62570:2025 - MR safety marking for medical devices and other items

What does the FprEN ISO 80601-2-56 document contain?

FprEN ISO 80601-2-56 contains the particular requirements, the modified collateral-standard clauses, the annexes, and the supporting rationale needed to evaluate clinical thermometers as ME equipment. Clause 201.4 includes Table 201.101 on distributed essential performance requirements, and Clause 201.7 is backed by tables for markings and accompanying information.

Clause 201.12 contains the laboratory accuracy method, the transient-response method, and the clinical-performance link to ISO 12487. Annex BB gives the reference temperature source arrangements and uncertainty approach, while Annex AA explains the rationale behind the main technical choices with Figure AA.2, Figure AA.1, and Table AA.1. Annex CC maps the document to IMDRF essential principles and labelling guidances, and Annex DD provides an alphabetized index of defined terms.

SLOVENSKI STANDARD
01-februar-2026
Medicinska električna oprema - 2-56. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti kliničnih termometrov za merjenje telesne temperature (ISO/DIS
80601-2-56:2025)
Medical electrical equipment - Part 2-56: Particular requirements for basic safety and
essential performance of clinical thermometers for body temperature measurement
(ISO/DIS 80601-2-56:2025)
Medizinische elektrische Geräte - Teil 2 56: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von medizinischen Thermometern
zum Messen der Körpertemperatur (ISO/DIS 80601-2-56:2025)
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 (ISO/DIS 80601-2-56:2025)
Ta slovenski standard je istoveten z: prEN ISO 80601-2-56
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.

DRAFT
International
Standard
ISO/DIS 80601-2-56
ISO/TC 121/SC 3
Medical electrical equipment —
Secretariat: ANSI
Part 2-56:
Voting begins on:
Particular requirements for basic 2025-12-17
safety and essential performance
Voting terminates on:
2026-03-11
of clinical thermometers for body
temperature measurement
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
ICS: 11.040.55
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
This document is circulated as received from the committee secretariat. IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This draft is submitted to a parallel vote in ISO and in IEC.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
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.
Reference number
ISO/DIS 80601-2-56:2025(en)
DRAFT
ISO/DIS 80601-2-56:2025(en)
International
Standard
ISO/DIS 80601-2-56
ISO/TC 121/SC 3
Medical electrical equipment —
Secretariat: ANSI
Part 2-56:
Voting begins on:
Particular requirements for basic
safety and essential performance
Voting terminates on:
of clinical thermometers for body
temperature measurement
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
ICS: 11.040.55
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
This document is circulated as received from the committee secretariat.
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This draft is submitted to a parallel vote in ISO and in IEC.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2025
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
ISO copyright office
RECIPIENTS OF THIS DRAFT ARE INVITED
CP 401 • Ch. de Blandonnet 8
TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
Phone: [phone]
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Published in Switzerland Reference number
ISO/DIS 80601-2-56:2025(en)
ii
ISO/DIS 80601-2-56:2025(en)
ISO 80601-2-56:2025(E)
1 Contents Page
2 Foreword . 3
3 Introduction . 4
4 201.1 Scope, object and related standards . 6
5 201.2 Normative references . 8
6 201.3 Terms and definitions . 9
7 201.4 General requirements . 16
8 Table 201.101 — Distributed essential performance requirements . 16
9 201.5 General requirements for testing of ME equipment . 16
10 201.6 Classification of ME equipment and ME systems . 16
11 201.7 ME equipment identification, marking and documents . 16
12 201.8 Protection against electrical hazards from ME equipment . 18
13 201.9 Protection against mechanical hazards of ME equipment and ME systems . 19
14 201.10 Protection against unwanted and excessive radiation hazards . 19
15 201.11 Protection against excessive temperatures and other hazards . 19
16 201.12 Accuracy of controls and instruments and protection against hazardous outputs . 20
17 201.13 Hazardous situations and fault conditions . 25
18 201.14 Programmable electrical medical systems (PEMS) . 25
19 201.15 Construction of ME equipment . 25
20 201.16 Me systems . 25
21 201.17 Electromagnetic disturbances . 25
22 201.101.1 General . 25
23 201.101.2 Labelling . 26
24 202 Electromagnetic disturbances — Requirements and tests . 26
25 206 Usability . 27
26 208 General requirements, tests and guidance for alarm systems in medical electrical
27 equipment and medical electrical systems . 27
28 211 Requirements for medical electrical equipment and medical electrical systems used
29 in the home healthcare environment . 28
30 212 Requirements for medical electrical equipment and medical electrical systems
31 intended for use in the emergency medical services environment . 28
32 Annex C (informative) Guide to marking and labelling requirements for ME equipment and
33 ME systems . 29
34 Table 201.C.101 — Marking on the outside of a clinical thermometer or its parts . 29
35 Table 201.C.102 — Accompanying documents, general, of a clinical thermometer . 30
ISO/DIS 80601-2-56:2025(en)
ISO 80601-2-56:2025(E)
36 Table 201.C.103 — Accompanying documents, instructions for use of a clinical thermometer

37 .30
38 Annex D (informative) Symbols on marking .32
39 Table 201.D.2.101 — Additional symbols on marking .32
40 Annex AA (informative) Particular guidance and rationale .33
41 Figure AA.2 — General structure of a clinical thermometer .34
42 Figure AA.1 — Example of temperature time adjustment for a predictive intermittent
43 clinical thermometer .36
44 Table AA.1 — Example combinations of operating conditions and reference temperature for
45 testing the laboratory accuracy .38
46 Annex BB (informative) Reference temperature source .39
47 Annex CC (informative)  Reference to the IMDRF essential principles and labelling
48 guidances .41
49 Table CC.1 — Correspondence between this document and the essential principles .41
50 Table CC.2 — Correspondence between this document and the labelling principles .42
51 Annex DD (informative) Terminology — Alphabetized index of defined terms .43
52 Bibliography .46
ISO/DIS 80601-2-56:2025(en)
ISO 80601-2-56:2025(E)
54 Foreword
55 ISO (the International Organization for Standardization) is a worldwide federation of national standards
56 bodies (ISO member bodies). The work of preparing International Standards is normally carried out
57 through ISO technical committees. Each member body interested in a subject for which a technical
58 committee has been established has the right to be represented on that committee. International
59 organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO
60 collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
61 electrotechnical standardization.
62 The procedures used to develop this document and those intended for its further maintenance are
63 described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
64 different types of ISO documents should be noted. This document was drafted in accordance with the
65 editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
66 Attention is drawn to the possibility that some of the elements of this document may be the subject of
67 patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any
68 patent rights identified during the development of the document will be in the Introduction and/or on
69 the ISO list of patent declarations received (see www.iso.org/patents).
70 Any trade name used in this document is information given for the convenience of users and does not
71 constitute an endorsement.
72 For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and
73 expressions related to conformity assessment, as well as information about ISO's adherence to the World
74 Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL:
75 www.iso.org/iso/foreword.html.
76 This document was prepared by ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 3,
77 Lung ventilators and related equipment, and Technical Committee IEC/TC 62, Electrical equipment in
78 medical practice, Subcommittee SC D, Electrical equipment.
79 This third edition cancels and replaces the second edition (ISO 80601-2-56:2017), which has been
80 technically revised.
81 The most significant changes are the following modifications:
82 — harmonization with the Edition 3.2 of the general standard;
83 — harmonization with ISO 20417;
84 — deletion of the clinical performance verification requirements and replacement by the requirement to
85 conform with ISO 12487
ISO/DIS 80601-2-56:2025(en)
ISO 80601-2-56:2025(E)
86 Introduction
87 This document deals with electrical clinical thermometers, either already available or that will come
88 available in the future.
89 The purpose of a clinical thermometer is to assess the true temperature of a reference site. The
90 temperature of the patient's body is an important vital sign in assessing overall health, typically in
91 combination with blood pressure and pulse rate. Determining whether a patient is afebrile, febrile or
92 hypothermic is an important purpose of a clinical thermometer.
93 There are different temperatures at each reference site according to the balance between the production,
[22]
94 transfer, and loss of heat .
95 The intention of this document is to specify the requirements and the test procedures for the verification
96 of the laboratory accuracy for all types of electrical clinical thermometers.
97 This document has been drafted in accordance with the ISO/IEC Directives, Part 2.
98 In this document, the following print types are used.
99 — Requirements and definitions: roman type.
100 — Test specifications: italic type.
101 — Informative material appearing outside of tables, such as notes, examples and references: in smaller type.
102 Normative text of tables is also in a smaller type.
103 — Terms defined in Clause 3 of the general standard, in this document or as noted: small capitals.
104 In referring to the structure of this document, the term
105 — “clause” means one of the numbered divisions within the table of contents, inclusive of all
106 subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.), and
107 — “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all subclauses of
108 Clause 7).
109 References to clauses within this document are preceded by the term “Clause” followed by the clause
110 number. References to subclauses within this document are by number only.
111 In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination
112 of the conditions is true.
113 The verbal forms used in this document conform to usage described in Annex H of the ISO/IEC Directives,
114 Part 2. For the purposes of this document, the auxiliary verb:
115 — “shall” means that conformance with a requirement or a test is mandatory for conformance with this
116 document;
Figures in square brackets refer to the Bibliography.
ISO/DIS 80601-2-56:2025(en)
ISO 80601-2-56:2025(E)
117 — “should” means that conformance with a requirement or a test is recommended but is not mandatory

118 for conformance with this document;
119 — “may” is used to describe a permissible way to achieve conformance with a requirement or test.
ISO/DIS 80601-2-56:2025(en)
ISO 80601-2-56:2025(E)
120 Medical electrical equipment —

122 Part 2-56:
123 Particular requirements for basic safety and essential
124 performance of clinical thermometers for human temperature
125 measurement
126 201.1 Scope, object and related standards
127 NOTE 1 There is guidance or rationale for this Clause contained in Clause AA.2.1.
128 IEC 60601-1:2005+AMD1:2012+AMD2:2020, Clause 1 applies, except as follows:
129 NOTE 2 The general standard is IEC 60601-1:2005+AMD1:2012+AMD2:2020.
130 201.1.1 Scope
131 IEC 60601-1:2005+AMD1:2012, 1.1 is replaced by:
132 This document applies to the basic safety and essential performance of a clinical thermometer in
133 combination with its accessories, hereafter referred to as ME equipment. This document specifies the
134 general and technical requirements for electrical clinical thermometers. This document only applies to all
135 electrical clinical thermometers that are used for measuring the temperature of patients.
136 This document is also applicable to those accessories intended by their manufacturer to be connected to
137 the clinical thermometer, where the characteristics of those accessories can affect the basic safety or
138 essential performance of the clinical thermometer.
139 EXAMPLE 1     Probes, probe cable extenders and probe covers.
140 Clinical thermometers can be equipped with interfaces to accommodate secondary indicators, printing
141 equipment, and other auxiliary equipment to create ME systems. This document does not apply to
142 auxiliary equipment.
143 ME equipment that measures the temperature of a patient is within the scope of this document.
144 EXAMPLE 2 ME equipment using accessories such as a pulmonary artery catheter for the determination of
145 cardiac output by thermodilution is in the scope of this document if it displays a temperature.
146 EXAMPLE 3 ME equipment using accessories such as a Foley catheter that includes a temperature probe is in the
147 scope of this document.
148 This document does not specify requirements for screening thermographs intended to be used for the
149 individual non-invasive human febrile temperature screening of humans under indoor environmental
[4]
150 conditions, whose laboratory accuracy requirements are described in IEC 80601-2-59 .
151 If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems
152 only, the title and content of that clause or subclause will say so. If that is not the case, the clause or
153 subclause applies both to ME equipment and to ME systems, as relevant.
ISO/DIS 80601-2-56:2025(en)
ISO 80601-2-56:2025(E)
154 Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope

155 of this document are not covered by specific requirements in this document except in
156 IEC 60601-1:2005+AMD1:2012, 7.2.13 and 8.4.1.
157 NOTE Additional information can be found in IEC 60601–1:2005+AMD1:2012, 4.2.
158 201.1.2 Object
159 Replacement:
160 The object of this particular document is to establish particular basic safety and essential performance
161 requirements for a clinical thermometer, as defined in 201.3.205, and its accessories.
162 NOTE Accessories are included because the combination of the clinical thermometer and the accessories needs
163 to be safe and effective. Accessories can have a significant impact on the basic safety and essential performance of a
164 clinical thermometer.
165 201.1.3 Collateral standards
166 IEC 60601-1:2005+AMD1:2012+AMD2:2020, 1.3 applies with the following addition:
167 Addition (add after existing text):
168 This document refers to those applicable collateral standards that are listed in general standard, as well
169 as 201.2 of this document.
170 IEC 60601-1-2:2014+AMD1:2020, IEC 60601-1-6:2010+AMD1:2013+AMD2:2020,
171 IEC 60601-1-8:2006+AMD1:2012, IEC 60601-1-11:2015+AMD1:2020 and
172 IEC 60601-1-12::2014+AMD1:2020 apply as modified in Clauses 202, 206, 208, 211 and 212,
[5]
173 respectively. IEC 60601-1-3 does not apply. All other published collateral standards in the IEC 60601-1
174 series apply as published.
175 201.1.4 Particular standards
176 Replacement:
177 In the IEC 60601 series, particular standards define basic safety and essential performance requirements,
178 and may modify, replace or delete requirements contained in the general standard as appropriate for the
179 particular ME equipment under consideration.
180 A requirement of a document takes priority over the general standard and its collateral standards.
181 For brevity, IEC 60601-1:2005+AMD1:2012+AMD2:2020 is referred to in this document as the general
182 standard. Collateral standards are referred to by their document number.
183 The numbering of sections, clauses and subclauses of this document corresponds to that of the general
184 standard with the prefix “201” (e.g. 201.1 in this document addresses the content of Clause 1 of the
185 general standard) or applicable collateral standard with the prefix “20x” where x is the final digit(s) of
186 the collateral standard document number (e.g. 202.4 in this document addresses the content of Clause 4
187 of the 60601-1-2 collateral standard, 206.4 in this document addresses the content of Clause 4 of the
188 60601-1-6 collateral standard, etc.). The changes to the text of the general standard are specified by the
189 use of the following words:
190 “Replacement” means that the clause or subclause of the general standard or applicable collateral
191 standard is replaced completely by the text of this particular document.
ISO/DIS 80601-2-56:2025(en)
ISO 80601-2-56:2025(E)
192 “Addition” means that the text of this document is additional to the requirements of the general standard

193 or applicable collateral standard.
194 “Amendment” means that the clause or subclause of the general standard or applicable collateral
195 standard is amended as indicated by the text of this document.
196 Clauses, subclauses or figures which are additional to those of the general standard are numbered
197 starting from 201.101, Additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.
198 Clauses, subclauses or figures which are additional to those of a collateral standard are numbered starting
199 from 20x, where “x” is the number of the collateral standard, e.g. 202 for IEC 60601-1-2, 206 for
200 IEC 60601-1-6, etc.
201 The term “this document” is used to make reference to the general standard, any applicable collateral
202 standards and this document taken together.
203 Where there is no corresponding section, clause or subclause in this document, the section, clause or
204 subclause of the general standard or applicable collateral standard, although possibly not relevant,
205 applies without modification; where it is intended that any part of the general standard or applicable
206 collateral standard, although possibly relevant, is not to be applied, a statement to that effect is given in
207 this document.
208 201.2 Normative references
209 The following documents are referred to in the text in such a way that some or all of their content
210 constitutes requirements of this document. For dated references, only the edition cited applies. For
211 undated references, the latest edition of the referenced document (including any amendments) applies.
212 NOTE 1 The way in which these referenced documents are cited in normative requirements determines the
213 extent (in whole or in part) to which they apply.
214 NOTE 2 Informative references are listed in the Bibliography.
215 IEC 60601-1:2005+AMD1:2012+AMD2:2020, Clause 2 applies, except as follows:
216 Addition:
217 ISO 14937:2009, Sterilization of health care products — General requirements for characterization of a
218 sterilizing agent and the development, validation and routine control of a sterilization process for medical
219 devices
220 ISO 17664-1:2021, Processing of health care products — Information to be provided by the medical device
221 manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices
222 ISO 17664-2:2021, Processing of health care products — Information to be provided by the medical device
223 manufacturer for the processing of medical devices — Part 2: Non-critical medical devices
224 ISO 12487:— , Medical electrical equipment — Clinical performance evaluation of clinical thermometers

Under preparation. Stage at the time of publication: ISO/FDIS 12487:2025.
ISO/DIS 80601-2-56:2025(en)
ISO 80601-2-56:2025(E)
225 IEC 60601-1:2005+AMD1:2012+AMD2:2020, Medical electrical equipment — Part 1: General

226 requirements for basic safety and essential performance
227 ISO 20417:— , Medical devices — Information to be supplied by the manufacturer
228 IEC 62366-1:2015+AMD2:2020, Medical devices — Part 1: Application of usability engineering to medical
229 devices
230 IEC 62570:2025, Standard practice for marking medical devices and other items for safety in the magnetic
231 resonance environment
232 201.3 Terms and definitions
233 For the purposes of this document, the terms and definitions given in
234 IEC 60601-1:2005+AMD1:2012+AMD2:2020 and the following apply.
235 ISO and IEC maintain terminological databases for use in standardization at the following addresses:
236 — IEC Electropedia: available at http://www.electropedia.org/
237 — ISO Online browsing platform: available at http://www.iso.org/obp
238 NOTE An alphabetized index of defined terms is found beginning in Annex DD.
239 201.3.201
240 accompanying information
241 information supplied by the manufacturer with or marked on a medical device or accessory for the user or
242 responsible organization, particularly regarding safe use
243 Note 1 to entry: The accompanying information is regarded as part of the medical device or accessory.
244 Note 2 to entry: The accompanying information can consist of the label, marking, instructions for use, technical
245 description, information shown on the packaging or graphical user interface (GUI), installation manual, quick
246 reference guide, etc and can address the installation, use, processing, maintenance and disposal of the medical device
247 or accessory.
248 Note 3 to entry: Accompanying information is not necessarily a written or printed document but can involve
249 auditory, visual, or tactile materials and multiple media types (e.g. CD-ROM, DVD-ROM, USB stick, website).
250 [SOURCE: ISO 20417:—, 3.2, modified — deleted note 4.]
251 201.3.202
252 alarm limit
253 threshold used by an alarm system to determine an alarm condition
254 [SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.3]

Under preparation. Stage at the time of publication: ISO/FDIS 20417:2025.
ISO/DIS 80601-2-56:2025(en)
ISO 80601-2-56:2025(E)
255 201.3.203
256 blackbody
257 reference temperature source of infrared radiation characterized by precisely known temperature and
258 having an effective emissivity close to one
259 201.3.204
260 cleaning
261 removal of contaminants to the extent necessary for further processing or for intended use
262 Note 1 to entry: Cleaning consists of the removal of adherent soil (e.g. blood, protein substances, and other debris)
263 from the surfaces, crevices, serrations, joints, and lumens of a medical device by a manual or automated process that
264 prepares the items for safe handling or further processing.
265 [SOURCE: ISO 17664-2:2021, 3.1, modified — replaced “and/or” with “or”.]
266 201.3.205
267 clinical accuracy
268 closeness of agreement between the output temperature of a clinical thermometer and the reference value
269 of the temperature of the reference site that the clinical thermometer purports to represent
270 201.3.206
271 clinical thermometer
272 ME equipment used for measuring at the measuring site and indicating the temperature at the reference
273 site
274 Note 1 to entry: The measuring site can be the same as the reference site.
275 Note 2 to entry: There is guidance or rationale for this definition contained in AA.2.2.
276 201.3.207
277 direct measurement mode
278 operating mode of a clinical thermometer where the output temperature represents the temperature of
279 the measuring site with which the probe is in thermal equilibrium
280 Note 1 to entry: There is guidance or rationale for this definition contained in AA.2.3.
281 201.3.208
282 disinfection
283 process to reduce the number of viable microorganisms to a level previously specified as being
284 appropriate for a defined purpose
285 [SOURCE: ISO 17664-1:2021, 3.3]
286 201.3.209
287 essential principles
288 essential principles of safety and performance
289 fundamental high-level requirements that when complied with ensure a medical device is safe and
290 performs as intended
291 [SOURCE: ISO 16142-1:2016, 3.3]
292 201.3.210
293 extended output range
294 output temperature range having one or both limits that are outside of the rated output range
ISO/DIS 80601-2-56:2025(en)
ISO 80601-2-56:2025(E)
295 201.3.211
296 fluid bath
297 reference temperature source containing fluid at a uniform temperature
298 EXAMPLE Water, oil and air.
299 201.3.212
300 home healthcare environment
301 dwelling place in which a patient lives or other places where patients are present, excluding the
302 professional healthcare environment and the EMS environment
303 EXAMPLE Other places include in a car, bus, train, boat or plane, in a wheelchair or walking outdoors.
304 Note 1 to entry: Nursing homes are considered home healthcare environments.
305 Note 2 to entry: In some countries, nursing homes are considered professional healthcare facilities.
306 [SOURCE: IEC 60601-1-11:2015+AMD1:2020, 3.1, modified —replaced “professional healthcare facility
307 environments where operators with medical training are continually available when patients are
308 present” with ”the professional healthcare environment and the EMS environment”, deleted notes 1 and
309 3, modified note 2 as new note 1, added note 2 and added to the example “Other places include”.]
310 201.3.213
311 immunity
312 ability of ME equipment or an ME system to perform without degradation in the presence of an
313 electromagnetic disturbance
314 [SOURCE: IEC 60601-1-2:2014+AMD1:2020, 3.8]
315 201.3.214
316 indirect measurement mode
317 operating mode of a clinical thermometer where the output temperature represents the temperature of a
318 measuring site with which the probe is not in thermal equilibrium
319 Note 1 to entry: Infrared clinical thermometers are not typically in thermal equilibrium with the measuring site and
320 are therefore typically in indirect measurement mode.
321 Note 2 to entry: There is guidance or rationale for this definition contained in AA.2.4.
322 201.3.215
323 information supplied by the manufacturer
324 information related to the identification and use of a medical device or accessory, in whatever form
325 provided, intended to ensure the safe and effective use of the medical device or accessory
326 Note 1 to entry: e-documentation is included in the information supplied by the manufacturer.
327 Note 2 to entry: Shipping documents (e.g. packing list and customs documents) and promotional material are
328 excluded from information supplied by the manufacturer. However, some authorities having jurisdiction can consider
329 such supplemental information as information supplied by the manufacturer.
330 Note 3 to entry: The primary purpose of information supplied by the manufacturer is to identify the medical device
331 or accessory and its manufacturer, and provide essential information about its safety, performance, and appropriate
332 use.
333 [SOURCE: ISO 20417:—, 3.15, modified — deleted note 4.]
ISO/DIS 80601-2-56:2025(en)
ISO 80601-2-56:2025(E)
334 201.3.216
335 instructions for use
336 IFU
337 package insert
338 portion of the accompanying information that is
339 - directed to the user;
340 - essential for the safe and effective use of a medical device or accessory
341 Note 1 to entry: A user can be either a lay user or professional user with relevant specialized training.
342 Note 2 to entry: Instructions for the professional processing between uses of a medical device or accessory can be
343 included in the instructions for use.
344 Note 3 to entry: The instructions for use, or portions thereof, can be located on the display of a medical device or
345 accessory.
346 Note 4 to entry: Medical devices or accessories that can be used safely and effectively without instructions for use
347 are exempted from having instructions for use by some authorities having jurisdiction.
348 [SOURCE: ISO 20417:—, 3.16, modified — deleted note 5.]
349 201.3.217
350 laboratory accuracy
351 closeness of agreement between the output temperature of a clinical thermometer and a reference
352 thermometer
353 Note 1 to entry: Laboratory accuracy is sometimes referred to as maximum permissible error.
354 201.3.218
355 lay, adj
356 lay person, adj
357 not having formal education in a relevant field of healthcare or medical discipline and, if appropriate, not
358 having relevant specialized training on the use of the specific medical device
359 EXAMPLE Lay operator, lay responsible organization.
360 [SOURCE: ISO 20417:, 3.19]
361 201.3.219
362 marking
363 information, in text or graphical format, durably affixed, printed, etched or by equivalent means to a
364 product
365 Note 1 to entry: The word marked is used to designate the corresponding act.
366 Note 2 to entry: Marking is different from ‘direct marking’ as commonly described in unique device identification
367 (UDI) standards and regulations. A UDI ‘direct marking’ is a type of marking.
368 [SOURCE: ISO 20417:—, 3.22, modified — deleted note 3.]
369 201.3.220
370 measuring site
371 body location of a patient that the probe directly interacts with
372 EXAMPLE Pulmonary artery, distal oesophagus, sublingual space in the mouth, rectum, ear canal, axilla
373 (armpit), forehead skin.
ISO/DIS 80601-2-56:2025(en)
ISO 80601-2-56:2025(E)
374 201.3.221
375 operating mode
376 state of a clinical thermometer that gives an output temperature of an intended reference site
377 201.3.222
378 output range
379 span between the lowest and highest limits of output temperature where a clinical thermometer indicates
380 output temperature within the specified characteristics of laboratory accuracy
381 201.3.223
382 output temperature
383 temperature indicated by a thermometer
384 Note 1 to entry: Methods of indication can include printed, spoken, displayed and remotely displayed.
385 201.3.224
386 physiological alarm condition
387 alarm condition arising from a monitored patient-related variable
388 EXAMPLE 1 High exhaled anaesthetic agent concentration.
389 EXAMPLE 2 Low exhaled tidal volume.
390 EXAMPLE 3 Low oxygen saturation measured by pulse oximetry.
391 EXAMPLE 4 High arterial pressure.
392 EXAMPLE 5 High heart rate.
393 [SOURCE: IEC 60601-1-8:2006, 3.31]
394 201.3.225
395 probe
396 part of a clinical thermometer that provides a thermal coupling between the sensor and the patient
397 Note 1 to entry: Thermal coupling can be contact or non-contact.
398 201.3.226
399 probe cable extender
400 cable that connects a clinical thermometer to a probe
401 Note 1 to entry: Not every clinical thermometer utilizes a probe cable extender.
402 Note 2 to entry: A probe cable extender can be an applied part.
403 201.3.227
404 probe cover
405 disposable or reusable accessory of a clinical thermometer that provides a sanitary barrier between the
406 probe and the patient
407 201.3.228
408 processing
409 processes to prepare a new or used healthcare product for its
410 intended use
ISO/DIS 80601-2-56:2025(en)
ISO 80601-2-56:2025(E)
411 Note 1 to entry: Processing includes cleaning, disinfection and sterilization, as appropriate.

412 [SOURCE: ISO 20417:—, 3.31]
413 201.3.229
414 reference site
415 part of a patient to which the output temperature refers
416 EXAMPLE Pulmonary artery, distal oesophagus, sublingual space in the mouth, rectum, ear canal, axilla
417 (armpit), forehead skin.
418 Note 1 to entry: There is guidance or rationale for this definition contained in AA.2.5.
419 201.3.230
420 reference thermometer
421 equilibrium thermometer of a contact type for laboratory application whose calibration is traceable to a
422 national standard of temperature, with a specified accuracy and associated uncertainty
423 EXAMPLE Platinum resistance thermometer with calibration traceable to a national standard of temperature.
424 201.3.231
425 sensor
426 part of the clinical thermometer that converts thermal energy into an electrical signal
427 201.3.232
428 site conversion
429 process of measuring temperature at a measurement site and converting the value to another site
430 201.3.233
431 skin temperature
432 temperature of the skin of the patient at the point on which the sensing device is intended to measure the
433 temperature
[7]
434 [SOURCE: IEC 60601-2-19:2009 , 3.8.5, modified — replaced “infant” with “patient”, "at a point" with "at
435 the point", and “infant skin temperature” with “the sensing device is intended to measure the
436 temperature”]
437 201.3.234
438 single use
439 do not reuse
440 use only once
441 intended by the manufacturer to be used on an individual patient or an individual specimen during a
442 single procedure and then disposed of
443 Note 1 to entry: A single use medical device or accessory is not intended by its manufacturer to be further processed
444 and used again.
445 [SOURCE: ISO 20417:—, 3.39, modified — deleted note 2.]
446 201.3.235
447 sterilization
448 process used to render product free from viable microorganisms
ISO/DIS 80601-2-56:2025(en)
ISO 80601-2-56:2025(E)
449 Note 1 to entry: In a sterilization process, the nature of microbial inactivation is exponential and thus the survival

450 of a microorganism on an individual item can be expressed in terms of probability. While this probability can be
451 reduced to a very low number, it can never be reduced to zero.
452 [SOURCE: ISO 17664-1:2021, 3.17]
453 201.3.236
454 symbol
455 graphical representation appearing on the label or in accompanying information of a product that
456 communicates characteristic information without the need for the supplier or receiver of the information
457 to have knowledge of the language of a particular nation or people
458 Note 1 to entry: The symbol can be an abstract representation or a graphical representation, or one that uses
459 familiar objects, including alphanumeric characters (with sufficient justification).
460 [SOURCE: ISO 20417:—, 3.42]
461 201.3.237
462 technical alarm condition
463 alarm condition arising from a monitored equipment-related or alarm system-related variable
464 EXAMPLE 1 An electrical, mechanical or other failure.
465 EXAMPLE 2 A failure of a sensor or component (unsafe voltage, high impedance, signal impedance, artefact,
466 noisy signal, disconnection, calibration error, tubing obstruction, etc.).
467 EXAMPLE 3 An algorithm that cannot classify or resolve the available data.
468 [SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.36]
469 201.3.238
470 technical description
471 portion of the accompanying information that is:
472 directed to the responsible organization and service personnel; and
473 essential for preparation for the first use and safe use, maintenance or repair as well as processing
474 transport or storage for the expected lifetime including decommissioning or disposal of a medical device
475 or accessory
476 Note 1 to entry: The technical description can be included in the instructions for use.
477 [SOURCE: ISO 20417:—, 3.43, modified — deleted note 2.]
478 201.3.239
479 test mode
480 state of a clinical thermometer where the output temperature represents the temperature measured by
481 the sensor and does not include site conversion or time prediction
482 Note 1 to entry: The test mode is used for the determination of the laboratory accuracy of the clinical thermometer.
483 Note 2 to entry: The test mode does not necessarily need to be an additional mode and may be the direct
484 measurement mode of the clinical thermometer.
485 201.3.240
486 time prediction
487 process of predicting the temperature of a measurement site before thermal equilibrium has been
488 reached
ISO/DIS 80601-2-56:2025(en)
ISO 80601-2-56:2025(E)
489 201.3.241
490 transit-operable
491 term referring to transportable equipment whose intended use includes operation while it is being moved
492 EXAMPLE Transportable ME equipment that is body-worn, hand-held, attached to a wheelchair, or used in a
493 car, bus, train, boat or plane.
494 Note 1 to entry: Transit-operable use in the home healthcare envir
...