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)

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.

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)

IEC 60601 1:2005+A1:2012, Abschnitt 1 gilt mit folgenden Abweichungen:
201.1.1 Anwendungsbereich
Ersatz:
Dieses Dokument gilt für die BASISSICHERHEIT und die WESENTLICHEN LEISTUNGSMERKMALE eines MEDIZINISCHEN THERMOMETERS in Kombination mit seinem ZUBEHÖR, nachstehend als ME GERÄTE bezeichnet. Dieses Dokument spezifiziert die allgemeinen und technischen Anforderungen für elektrische MEDIZINISCHE THERMOMETER. Dieses Dokument gilt für alle MEDIZINISCHEN THERMOMETER, die für die Messung der Körpertemperatur von PATIENTEN verwendet werden.
MEDIZINISCHE THERMOMETER können mit Schnittstellen zum Einbinden von Sekundäranzeigen, Druckgeräten und anderen Zusatzgeräten ausgestattet werden und somit ME SYSTEME bilden. Dieses Dokument gilt nicht für Zusatzgeräte.
ME GERÄTE, die eine KÖRPERTEMPERATUR messen, liegen innerhalb des Anwendungsbereiches dieses Dokuments.
Dieses Dokument spezifiziert nicht die Anforderungen an Wärmebildkameras, die für das individuelle nicht-invasive Fieber(temperatur)-Screening von Menschengruppen oder Einzelpersonen unter Innenraum-Umgebungsbedingungen eingesetzt werden; diese sind in IEC 80601 2 59[4] angegeben.
Ist ein Abschnitt oder Unterabschnitt nur speziell für die Anwendung auf ME GERÄTE oder ME SYSTEME vorgesehen, ist dies aus Überschrift und Inhalt des Abschnittes oder Unterabschnittes ersichtlich. Ist das nicht der Fall, trifft der Abschnitt oder Unterabschnitt, wo anwendbar, auf das ME GERÄT und das ME SYSTEM zu.
GEFÄHRDUNGEN, die sich aus der vorgesehenen physiologischen Wirkungsweise von ME GERÄTEN oder ME SYSTEMEN im Anwendungsbereich dieses Dokuments ergeben, sind nicht durch besondere Anforderungen in diesem Dokument erfasst, ausgenommen in IEC 60601 1:2005+A1:2012, 7.2.13 und 8.4.1.
ANMERKUNG   Zusätzliche Informationen können in IEC 60601 1:2005+A1:2012, 4.2, gefunden werden.

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 80601-2-56:2017)

ISO 80601-2-56:2017 s'applique à la sécurité de base et aux performances essentielles d'un thermomètre médical en combinaison avec ses accessoires, désigné ci-après appareil em. Le présent document spécifie les exigences générales et techniques relatives aux thermomètres médicaux électriques. Le présent document s'applique à tous les thermomètres médicaux électriques qui sont utilisés pour mesurer la température du corps des patients.
Les thermomètres médicaux peuvent être munis d'interfaces pour prendre en charge des indicateurs secondaires, un matériel d'impression et autres matériels auxiliaires pour créer des systèmes em. Le présent document ne s'applique pas au matériel auxiliaire.
Tout appareil em utilisé pour mesurer la température du corps entre dans le domaine d'application du présent document.
ISO 80601-2-56:2017 ne spécifie aucune exigence relative aux imageurs thermiques destinés à être utilisés pour le dépistage non invasif de la température de fébrilité humaine parmi des groupes d'individus dans des conditions ambiantes à l'intérieur de locaux données dans l'IEC 80601‑2‑59[4].
Si un article ou un paragraphe est destiné spécifiquement à être applicable à un appareil em seulement ou à des systèmes em seulement, le titre et le contenu de l'article ou du paragraphe en question en feront alors mention. Dans le cas contraire, l'article ou le paragraphe s'applique aussi bien aux appareils em qu'aux systèmes em, selon le cas.
Les dangers inhérents à la fonction physiologique prévue de l'appareil em ou des systèmes em relevant du domaine d'application du présent document ne sont pas couverts par les exigences spécifiques contenues dans le présent document, à l'exception de l'IEC 60601‑1:2005+A1:2012, 7.2.13 et 8.4.1.
NOTE          Des informations supplémentaires sont fournies dans l'IEC 60601?1:2005+A1:2012, 4.2.

Medicinska električna oprema - 2-56. del: Posebne zahteve za osnovno varnost in bistvene lastnosti kliničnih termometrov za merjenje telesne temperature (ISO 80601-2-56:2017)

Standard SIST EN- ISO 80601-2-56 se uporablja za OSNOVNO VARNOST in BISTVENE LASTNOSTI KLINIČNIH TERMOMETROV v kombinaciji s PRIPOMOČKI, v nadaljevanju: ELEKTROMEDICINSKA OPREMA. Ta dokument določa splošne in tehnične zahteve za električne KLINIČNE TERMOMETRE. Ta dokument se uporablja za vse električne KLINIČNE TERMOMETRE, ki se uporabljajo pri merjenju TELESNE TEMPERATURE BOLNIKOV. KLINIČNI TERMOMETRI so lahko opremljeni z vmesniki, ki lahko imajo sekundarne pokazatelje, opremo za tiskanje in drugo zunanjo opremo ter tako sestavljajo ELEKTROMEDICINSKO OPREMO. Ta dokument se ne uporablja za zunanjo opremo. ELEKTROMEDICINSKA OPREMA za merjenje TELESNE TEMPERATURE spada na področje uporabe tega dokumenta.

General Information

• Status: Published
• Public Enquiry End Date: 19-Sep-2015
• Publication Date: 17-Oct-2017
• 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: 02-Aug-2017
• Due Date: 07-Oct-2017
• Completion Date: 18-Oct-2017
• 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 - 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)

Relations

• Replaces: SIST EN ISO 80601-2-56:2013 - Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2009)
• Effective Date: 01-Nov-2017
• Amended By: 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)
• Effective Date: 01-Jul-2020

Standards Content (Sample)

SLOVENSKI STANDARD
01-november-2017
1DGRPHãþD
SIST EN ISO 80601-2-56:2013
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLNOLQLþQLKWHUPRPHWURY]DPHUMHQMHWHOHVQHWHPSHUDWXUH,62

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)
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)
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 80601-2-56:2017)
Ta slovenski standard je istoveten z: EN ISO 80601-2-56:2017
ICS:
11.040.55 'LDJQRVWLþQDRSUHPD 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 80601-2-56
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2017
EUROPÄISCHE NORM
ICS 11.040.55 Supersedes EN ISO 80601-2-56:2012
English Version
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)
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 (ISO 80601-2- Thermometern zum Messen der Körpertemperatur
56:2017) (ISO 80601-2-56:2017)
This European Standard was approved by CEN on 28 June 2017.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a 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 European Standard 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, 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: Avenue Marnix 17, B-1000 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 80601-2-56:2017 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered . 5

European foreword
This document (EN ISO 80601-2-56:2017) 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 European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by January 2018, and conflicting national standards shall
be withdrawn at the latest by July 2020.
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.
This document supersedes EN ISO 80601-2-56:2012.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this
document.
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, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
The following referenced documents are indispensable for the application of this document. For
undated references, the latest edition of the referenced document (including any amendments) applies.
For dated references, only the edition cited applies. However, for any use of this standard ‘within the
meaning of Annex ZA’, the user should always check that any referenced document has not been
superseded and that its relevant contents can still be considered the generally acknowledged state-of-
art.
When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a
normative reference to the corresponding EN standard, if available, and otherwise to the dated version
of the ISO or IEC standard, as listed below.
NOTE The way in which these referenced documents are cited in normative requirements determines the
extent (in whole or in part) to which they apply.
Table 1 — Correlations between undated normative references and dated EN and ISO standards
Normative references Equivalent dated standard
as listed in Clause
201.2 of the ISO
EN ISO or IEC
standard
IEC 60601-1 EN 60601-1:2006 + IEC 60601-1:2005 + Cor. :2006 + Cor.
Cor. :2010 + :2007 + A1:2012
A1:2013
IEC 60601-1-2 EN 60601-1-2:2015 IEC 60601-1-2:2014
IEC 60601-1-6 EN 60601-1-6:2010 IEC 60601-1-6:2010 + A1:2013
+ A1:2015
IEC 60601-1-8 EN 60601-1-8:2007 IEC 60601-1-8:2006 + A1:2012
+ Cor.:2010 +
A1:2013
IEC 60601-1-11 EN 60601-1- IEC 60601-1-11:2015
11:2015
IEC 60601-1-12 EN 60601-1- IEC 60601-1-12:2014
12:2015
IEC 62366-1 EN 62366-1:2015 IEC 62366-1:2015
ISO 14155:2011 EN ISO 14155:2011 ISO 14155:2011 + AC:2011
+ AC:2011
ISO 14937 EN ISO 14937:2009 ISO 14937:2009
ISO 15223-1 EN ISO 15223- ISO 15223-1:2016
1:2016
ISO 17664 EN ISO 17664:2004 ISO 17664:2004
Endorsement notice
The text of ISO 80601-2-56:2017 has been approved by CEN as EN ISO 80601-2-56:2017 without any
modification.
Annex ZA
(informative)
Relationship between this European Standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered
This European Standard has been prepared under a Commission’s standardization request M/023
concerning the development of European Standards related to medical devices to provide one voluntary
means of conforming to essential requirements of Council Directive 93/42/EEC of 14 June 1993
concerning medical devices [OJ L 169].
Once this standard is cited in the Official Journal of the European Union under that Directive,
compliance with the normative clauses of this standard given in Table ZA.1 confers, within the limits of
the scope of this standard, a presumption of conformity with the corresponding essential requirements
of that Directive and associated EFTA regulations.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Directive 93/42/EEC as amended by 2007/47/EC. This
means that risks have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’
or ‘removed’, according to the wording of the corresponding essential requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with Essential
Requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive.
NOTE 3 This Annex ZA is based on normative references according to the table of references in the European
foreword, replacing the references in the core text.
NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this
European Standard.
Table ZA.1 — Correspondence between this European Standard and Annex I of Directive
93/42/EEC [OJ L 169]
Essential Clause(s)/sub-clause(s) Remarks/Notes
Requirements of of this EN
Directive 93/42/EEC
7.2 201.11.6.6 ER 7.2 is covered only in respect to the
patient, operator and user.
8.7 201.7.2.1.101 c)
9.1 201.7.9.2.101 f), 201.16, ER 9.1 is covered by 201.103 in respect of
nd
201.101.1 2 para, probes, probe cable extenders and probe
rd
201.102.1 3 para, covers only.
201.103, 201.103.2
9.2 201.9, 201.12.1.101, ER 9.2 is covered by the listed standard
201.12.2, 201.15, 202 clauses as follows:
— 201.9 to the extent set out in the specified
EN version of IEC 60601-1:2005+A1, Clause
9,
— 201.12.1.101 for accuracy of controls and
Essential Clause(s)/sub-clause(s) Remarks/Notes
Requirements of of this EN
Directive 93/42/EEC
instruments only,
— 201.12.2 for display size and display
integrity only,
— 201.15 to the extent set out in the specified
EN version of IEC 60601-1:2005+A1, Clause
15,
— 202 Electromagnetic Compatibility.
The 4th indent of ER 9.2 is not covered.
9.3 201.13 ER 9.3 is covered by 201.13 to the extent set
out in the specified EN version of IEC 60601-
1:2005+A1:2012, Clause 13 only.
10.1 201.7.9.2.101 d),
201.7.9.2.101 e), 201.12,
201.101, 201.102, 201.103
10.2 201.12.2
10.3 201.7 ER 10.3 is covered by 201.7.4.3.101 and
201.7.9.2.101 i)
11.3.1 202
12.1 201.14 ER 12.1 is covered by 201.14 to the extent set
out in the specified EN version of IEC 60601-
1:2005 +A1:2012, Clause 14 only.
12.1 a) 201.14 ER 12.1 a) is covered by 201.14 to the extent
set out in the specified EN version of IEC
60601-1:2005+A1:2012, Clause 14 only.
12.4 201.12 ER 12.4 is covered by 201.12 to the extent set
out in the specified EN version of IEC 60601-
1:2005 +A1:2012, Clause 12 only.
Directive Annex 1 ER 12.4 is only covered if
the alarm alerts the user to situations which
could lead to death or severe deterioration of
the patient's state of health.
12.5 202
12.6 201.8 ER 12.6 is covered by 201.8 to the extent set
out in the specified EN version of IEC 60601-
1:2005 +A1:2012, Clause 8 only.
12.7.1 201.9 ER 12.7.1 is covered by 201.9 to the extent set
out in the specified EN version of IEC 60601-
1:2005 +A1:2012, Clause 9 only.
12.7.2 201.9 ER 12.7.2 is covered by 201.9 to the extent set
out in the specified EN version of IEC 60601-
1:2005 +A1:2012, Clause 9 only.
Essential Clause(s)/sub-clause(s) Remarks/Notes
Requirements of of this EN
Directive 93/42/EEC
12.7.3 201.9 ER 12.7.3 is covered by 201.9 to the extent set
out in the specified EN version of IEC 60601-
1:2005 +A1:2012, Clause 9 only.
12.7.4 201.8, 201.11, 201.15 ER 12.7.4 is covered
— by 201.8 as set out in the specified EN
version of IEC 60601-1:2005+A1:2012,
Clause 8 only,
— by 201.11 as set out in the specified EN
version of IEC 60601-1:2005+A1:2012,
Clause 11 only,
— by 201.15 as set out in the specified EN
version of IEC 60601-1:2005+A1:2012,
Clause 15 only.
12.7.5 201.11, 201.15 ER 12.7.4 is covered
— by 201.11 as set out in the specified EN
version of IEC 60601-1:2005+A1:2012,
Clause 11 only,
— by 201.15 as set out in the specified EN
version of IEC 60601-1:2005+A1:2012,
Clause 15 only.
12.9 201.7, 201.12.2, 201.15,
13.1 201.7, 201.7.2.1, The requirement for information on the sales
201.7.2.1.101, 201.7.2.2, packaging is not addressed. The last para of
201.7.9 ER 13.1 is not covered.
13.2 201.7, 201.7.2.1, 201.8, ER 13.2 is covered provided that any used
201.9 symbols conform to harmonized standards
and where no harmonized standards exist,
the symbols and colours are specified in the
instructions for use.
13.3 b) 201.7, 201.7.2.1.101 b) ER 13.3 b) is covered by 201.7 as set out in
the specified EN version of IEC 60601-
1:2005+A1:2012, Clause 7.2.2 only.
13.3 c) 201.7.2.1.101 c) ER 13.3 c) is covered by 201.7.2.1.101
provided that the information specified
appears on the device label.
13.3 e) 201.7.2.1.101 d) ER 13.3 e) is covered by 201.7.2.1.101
provided that the information appears on the
device label and that the 'Use by' date is
expressed as a year and month in that order.
13.3 i) 201.7, 201.7.2.1.101 e) ER 13.3 i) is covered by 201.7 as set out in the
specified EN version of IEC 60601-
1:2005+A1:2012, Clause 7 only.
Essential Clause(s)/sub-clause(s) Remarks/Notes
Requirements of of this EN
Directive 93/42/EEC
ER 13.3 i) is covered by 201.7.2.1.101 e)
provided that the information appears on the
device label.
13.3 j) 201.7 ER 13.3 j) is covered by 201.7 to the extent
set out in the specified EN version of IEC
60601-1:2005+A1:2012, Clause 7 only and
provided that the information is shown on the
device label.
13.3 k) 201.7 ER 13.3 k) is covered by 201.7 to the extent
set out in the specified EN version of IEC
60601-1:2005+A1:2012, Clause 7 only and
provided that the information is shown on the
device label.
13.3 m) 201.7.2.1.101 c) Presumption of conformity is only provided if
symbols 4 to 7 are utilized.
ER 13.3 m) is covered by 201.7.2.1.101 c)
provided that the information is shown on the
device label.
13.6 a) 201.7, 201.7.9.1, 201.16 ER 13.6 a) is covered by 201.7, 201.7.9.1, and
201.16 provided that all relevant information
in ER 13.3 a) to c) and f) to n) are covered in
the instructions for use.
13.6 b) 201.7.9.2.101 d), ER 13.6 b) is covered by 201.7.9.2.101 d) and
201.7.9.2.101 e) 201.7.9.2.101 e) for the parameters listed in
these clauses only.
13.6 c) 201.7, 201.7.9.2.101 f), ER 13.6 c) is covered by
201.16
— 201.7 as set out in the specified EN version
of IEC 60601-1:2005+A1:2012, Clause 7 only,
provided the information is included in the
instructions for use,
— 201.7.9.2.101 f) for the information set out
in this clause only,
— 201.16 as set out in the specified EN
version of IEC 60601-1:2005 +A1:2012,
Clause 16 only for the parameters listed in
that standard provided the information is
included in the instructions for use.
13.6 d) 201.7, 201.7.9.2.101 h), ER 13.6 d) is covered by
201.16
— 201.7 as set out in the specified EN version
of IEC 60601-1:2005+A1:2012, Clause 7 only,
provided the information is included in the
instructions for use,
— 201.7.9.2.101 h) for the information set
out in this clause only,
Essential Clause(s)/sub-clause(s) Remarks/Notes
Requirements of of this EN
Directive 93/42/EEC
— 201.16 as set out in the specified EN
version of IEC 60601-1:2005 +A1:2012,
Clause 16 only for the parameters listed in
that standard provided the information is
included in the instructions for use.
13.6 f) 201.7, 201.16 ER 13.6 f) is covered by
— 201.7 as set out in the specified EN version
of IEC 60601-1:2005+A1:2012, Clause 7 only,
provided the information is included in the
instructions for use,
— 201.16 as set out in the specified EN
version of IEC 60601-1:2005 +A1:2012,
Clause 16 only for the parameters listed in
that standard provided the information is
included in the instructions for use.
13.6 h) 201.7, 201.7.2.9.2.101 k), The requirement for information on the
201.11, 201.16 packaging is not addressed.
ER 13.6 h) is covered by
— 201.7 as set out in the specified EN version
of IEC 60601-1:2005+A1:2012, Clause 7 only,
provided the information is included in the
instructions for use,
— 201.7.9.2.101 k) for the information set out
in this clause only,
— 201.16 as set out in the specified EN
version of IEC 60601-1:2005 +A1:2012,
Clause 16 only for the parameters listed in
that standard provided the information is
included in the instructions for use.
13.6 i) 201.7 ER 13.6 i) is covered by 201.7 as set out in the
specified EN version of IEC 60601-
1:2005+A1:2012, Clause 7 only, provided the
information is included in the instructions for
use.
13.6 n) 201.7.9.2.101 j)
13.6 p) 201.7.9.2.101 e)
WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European
Standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2 — Other Union legislation may be applicable to the products falling within the scope of
this standard.
INTERNATIONAL ISO
STANDARD 80601-2-56
Second edition
2017-03
Medical electrical equipment —
Part 2-56:
Particular requirements for basic
safety and essential performance
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
Reference number
ISO 80601-2-56:2017(E)
©
ISO 2017
ISO 80601-2-56:2017(E)
© ISO 2017, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
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the requester.
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ii © ISO 2017 – All rights reserved

ISO 80601-2-56:2017(E)
Contents Page
Foreword . v
Introduction . vi
201.1  * Scope, object and related standards . 1
201.1.1  Scope . 1
201.1.2  Object . 1
201.1.3  Collateral standards . 2
201.1.4  Particular standards . 2
201.2  Normative references . 3
201.3  Terms and definitions . 4
201.4  General requirements . 7
201.4.2  RISK MANAGEMENT PROCESS for ME EQUIPMENT or ME SYSTEMS . 7
201.4.3  ESSENTIAL PERFORMANCE . 8
Table 201.101 — Distributed ESSENTIAL PERFORMANCE requirements . 8
201.5  General requirements for testing of ME EQUIPMENT . 8
201.6  Classification of ME EQUIPMENT and ME SYSTEMS . 8
201.7  ME EQUIPMENT identification, marking and documents . 8
201.7.9  ACCOMPANYING DOCUMENT . 9
201.8  Protection against electrical HAZARDS from ME EQUIPMENT . 10
201.9  Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS . 10
201.10 Protection against unwanted and excessive radiation HAZARDS . 10
201.11 Protection against excessive temperatures and other HAZARDS . 11
201.11.7  Biocompatibility of ME EQUIPMENT and ME SYSTEMS . 11
201.12 Accuracy of controls and instruments and protection against hazardous outputs . 12
201.12.1  Accuracy of controls and instruments . 12
201.12.2  Usability . 12
201.13 HAZARDOUS SITUATIONS and fault conditions. 12
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 12
201.15 Construction of ME EQUIPMENT . 12
201.16 ME SYSTEMS . 13
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 13
201.101  Laboratory performance requirements . 13
201.101.1  * General test requirements . 13
201.101.2  * LABORATORY ACCURACY . 13
© ISO 2017 – All rights reserved
iii
ISO 80601-2-56:2017(E)
201.101.3  * Time response for a DIRECT MODE CLINICAL THERMOMETER that is not an
ADJUSTED MODE CLINICAL THERMOMETER . 14
201.102  * CLINICAL ACCURACY VALIDATION . 15
201.102.1  Method . 15
201.102.2  * Human subject population requirements . 16
Table 201.102 — Subject age groups . 16
201.102.3  * CLINICAL BIAS calculation . 17
201.102.4  * LIMITS OF AGREEMENT calculation . 17
201.102.5  * CLINICAL REPEATABILITY calculation . 18
201.103  * PROBES, PROBE CABLE EXTENDERS and PROBE COVERS . 18
201.103.1  Gen era l . 18
201.103.2  Labelling . 19
202  Electromagnetic disturbances — Requirements and tests . 19
206  Usability . 20
208  General requirements, tests and guidance for alarm systems in medical electrical
equipment and medical electrical systems. 20
211  Requirements for medical electrical equipment and medical electrical systems used
in the home healthcare environment . 21
212  Requirements for medical electrical equipment and medical electrical systems
intended for use in the emergency medical services environment . 21
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT and
ME SYSTEMS . 22
Annex D (informative) Symbols on marking . 25
Annex AA (informative) Particular guidance and rationale . 27
Figure AA.101 — Example of temperature time adjustment for a predictive intermittent
CLINICAL THERMOMETER . 29
Figure AA.102 — General structure of a CLINICAL THERMOMETER . 30
Table AA.101 — Required tests for CLINICAL THERMOMETERS . 33
Table AA.102 — Example combinations of operating conditions and REFERENCE temperature
for testing the LABORATORY ACCURACY . 34
Figure AA.103 — Example of a comparison plot for DUT and RCT . 36
[18]
Figure AA.104 — Example of a Bland-Altman Plot of the temperature difference (DUT
minus RCT) versus the average OUTPUT TEMPERATURES of two thermometers . 37
Table AA.103 — Example of CLINICAL ACCURACY VALIDATION test results . 38
Annex BB (informative) Reference temperature source . 40
Annex CC (informative) Reference to the essential principles of safety and performance of
[24]
medical devices in accordance with ISO 16142-1 . 42
Table CC.1 — Correspondence between the essential principles and this document . 42
Annex DD (informative) Terminology — Alphabetized index of defined terms . 45
Bibliography . 48
© ISO 2017 – All rights reserved
iv
ISO 80601-2-56:2017(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 the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade
(TBT) see the following URL: www.iso.org/iso/foreword.html.
This document was prepared by ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee
SC 3, Lung ventilators and related equipment, and Technical Committee IEC/TC 62, Electrical
equipment in medical practice, Subcommittee SC D, Electrical equipment.
This second edition cancels and replaces the first edition (ISO 80601‐2‐56:2009), which has been
technically revised. It also incorporates the Amendments IEC 60601‐1:2005/AMD1:2012,
IEC 60601‐1‐6:2010/AMD1:2013 and IEC 60601‐1‐8:2006/AMD1:2012, as well as IEC 60601‐1‐12,
the second edition of IEC 60601‐1‐11 and the fourth edition of IEC 60601‐1‐2.
The most significant changes are the following modifications:
— change in the clinical evaluation exclusion criteria related to antipyretics;
[1]
— deletion of Annex CC as this material is covered by IEC 60601‐1‐9 ;
and the following additions:
— disclosure requirement for a summary of the USE SPECIFICATION;
— tests for mechanical strength (via IEC 60601‐1‐11 and IEC 60601‐1‐12);
— tests for ENCLOSURE integrity (water ingress via IEC 60601‐1‐11 and IEC 60601‐1‐12);
— tests for cleaning and disinfection PROCEDURES (via IEC 60601‐1‐11 and IEC 60601‐1‐12).
© ISO 2017 – All rights reserved
v
ISO 80601-2-56:2017(E)
Introduction
This document deals with electrical CLINICAL THERMOMETERS, either already available or that will come
available in the future.
The purpose of a CLINICAL THERMOMETER is to assess the true temperature of a REFERENCE BODY SITE. The
temperature of the PATIENT'S body is an important vital sign in assessing overall health, typically in
combination with blood pressure and pulse rate. Determining whether a PATIENT is afebrile, febrile or
hypothermic is an important purpose of a CLINICAL THERMOMETER, since being febrile suggests that the
PATIENT is ill.
There are different temperatures at each REFERENCE BODY SITE according to the balance between the
[2]
production, transfer, and loss of heat . CLINICAL ACCURACY of a CLINICAL THERMOMETER is VERIFIED by
comparing its OUTPUT TEMPERATURE with that of a REFERENCE THERMOMETER, which has a specified
uncertainty for measuring true temperature. For an equilibrium CLINICAL THERMOMETER, the CLINICAL
ACCURACY can be sufficiently determined under laboratory conditions that create an equilibrium state
between the two thermometers.
For a CLINICAL THERMOMETER that operates in the ADJUSTED MODE, laboratory VERIFICATION alone is not
sufficient because the adjustment algorithm for deriving the OUTPUT TEMPERATURE includes the
[3]
characteristics of the PATIENT and the environment . Therefore, the CLINICAL ACCURACY of a CLINICAL
THERMOMETER that operates in the ADJUSTED MODE has to be VALIDATED clinically, using statistical methods
of comparing its OUTPUT TEMPERATURE with that of a REFERENCE CLINICAL THERMOMETER which has a
specified CLINICAL ACCURACY in representing a particular REFERENCE BODY SITE temperature.
For a CLINICAL THERMOMETER that operates in the ADJUSTED MODE, the LABORATORY ACCURACY is VERIFIED in a
DIRECT MODE and the CLINICAL ACCURACY is VALIDATED in the ADJUSTED MODE (OPERATING MODE) with a
sufficiently large group of human subjects.
The intention of this document is to specify the requirements and the test PROCEDURES for the
VERIFICATION of the LABORATORY ACCURACY for all types of electrical CLINICAL THERMOMETERS as well as for
the VALIDATION of the CLINICAL ACCURACY of a CLINICAL THERMOMETER that operates in the ADJUSTED MODE.
This document has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this document, the following print types are used.
— Requirements and definitions: roman type.
— Test specifications: italic type.
— Informative material appearing outside of tables, such as notes, examples and references: in smaller
type. Normative text of tables is also in a smaller type.
— TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS DOCUMENT OR AS NOTED: SMALL CAPITALS.
In referring to the structure of this document, the term
— “clause” means one of the numbered divisions within the table of contents, inclusive of all
subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.), and
— “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all subclauses of
Clause 7).
© ISO 2017 – All rights reserved
vi
ISO 80601-2-56:2017(E)
References to clauses within this document are preceded by the term “Clause” followed by the clause
number. References to subclauses within this document are by number only.
In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
The verbal forms used in this document conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this document, the auxiliary verb:
— “shall” means that compliance with a requirement or a test is mandatory for compliance with this
document;
— “should” means that compliance with a requirement or a test is recommended but is not mandatory
for compliance with this document;
— “may” is used to describe a permissible way to achieve compliance with a requirement or test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates
that there is guidance or rationale related to that item in Annex AA.

© ISO 2017 – All rights reserved
vii
INTERNATIONAL STANDARD ISO 80601-2-56:2017(E)
Medical electrical equipment —
Part 2‐56:
Particular requirements for basic safety and essential
performance of clinical thermometers for body temperature
measurement
201.1 * Scope, object and related standards
IEC 60601‐1:2005+A1:2012, Clause 1 applies, except as follows:
201.1.1 Scope
Replacement:
This document 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.
LINICAL THERMOMETERS can be equipped with interfaces to accommodate secondary indicators, printing
C
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.
This document 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
[4]
indoor environmental conditions, which are given in IEC 80601‐2‐59 .
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.
201.1.2 Object
Replacement:
The object of this particular document is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE
requirements for a CLINICAL THERMOMETER, as defined in 201.3.206, and its ACCESSORIES.
NOTE ACCESSORIES are included because the combination of the CLINICAL THERMOMETER and the ACCESSORIES
needs to be safe and effective. ACCESSORIES can have a significant impact on the BASIC SAFETY and ESSENTIAL
PERFORMANCE of a CLINICAL THERMOMETER.
© ISO 2017 – All rights reserved
ISO 80601-2-56:2017(E)
201.1.3 Collateral standards
Addition:
This document refers to those applicable collateral standards that are listed in
IEC 60601‐1:2005+A1:2012, Clause 2, as well as 201.2 of this document.
IEC 60601‐1‐2, IEC 60601‐1‐6, IEC 60601‐1‐8, IEC 60601‐1‐11 and IEC 60601‐1‐12 apply as modified
[5]
in Clauses 202, 206, 208, 211 and 212, respectively. IEC 60601‐1‐3 does not apply. All other published
collateral standards in the IEC 60601‐1 series apply as published.
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in
the general standard as appropriate for the particular ME EQUIPMENT under consideration, and may add
other BASIC SAFETY and ESSENTIAL PERFORMANCE requirements.
A requirement of a document takes priority over IEC 60601‐1 and its collateral standards.
For brevity, IEC 60601‐1:2005+A1:2012 is referred to in this document as the general standard.
Collateral standards are referred to by their document number.
The numbering of sections, clauses and subclauses of this document corresponds to that of the general
standard with the prefix “201” (e.g. 201.1 in this document addresses the content of Clause 1 of the
general standard) or applicable collateral standard with the prefix “20x” where x is the final digit(s) of
the collateral standard document number (e.g. 202.4 in this document addresses the content of Clause 4
of the 60601‐1‐2 collateral standard, 203.4 in this document addresses the content of Clause 4 of the
60601‐1‐3 collateral standard, etc.). The changes to the text of the general standard are specified by the
use of the following words:
“Replacement” means that the clause or subclause of the IEC 60601‐1 or applicable collateral standard
is replaced completely by the text of this particular document.
“Addition” means that the text of this document is additional to the requirements of the IEC 60601‐1 or
applicable collateral standard.
“Amendment” means that the clause or subclause of the IEC 60601‐1 or applicable collateral standard is
amended as indicated by the text of this document.
Subclauses or figures which are additional to those of the general standard are numbered starting from
201.101, Additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.
Subclauses or figures which are additional to those of a collateral standard are numbered starting from
20x, where “x” is the number of the collateral standard, e.g. 202 for IEC 60601‐1‐2, 203 for
IEC 60601‐1‐3, etc.
The term “this document” is used to make reference to the IEC 60601‐1:2005+A1:2012, any applicable
collateral standards and this document taken together.
Where there is no corresponding section, clause or subclause in this document, the section, clause or
subclause of the IEC 60601‐1 or applicable collateral standard, although possibly not relevant, applies
without modification; where it is intended that any part of the IEC 60601‐1 or applicable collateral
standard, although possibly relevant, is not to be applied, a statement to that effect is given in this
document.
© ISO 2017 – All rights reserved
ISO 80601-2-56:2017(E)
201.2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
IEC 60601‐1:2005+A1:2012, Clause 2 applies, except as follows:
Replacement:
IEC 60601‐1‐2:2014, Medical electrical equipment — Part 1-2: General requirements for basic safety and
essential performance — Collateral Standard: Electromagnetic disturbances — Requirements and tests
IEC 60601‐1‐6:2010, Medical electrical equipment — Part 1-6: General requirements for basic safety and
essential performance — Collateral Standard: Usability
+Amendment 1:2013
IEC 60601‐1‐8:2006, Medical electrical equipment — Part 1-8: General requirements for basic safety and
essential perf
...