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)

SIST EN- ISO 80601-2-56 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.

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
• 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: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 80601-2-56:2017
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
SIST EN ISO 80601-2-56:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 80601-2-56:2017

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SIST EN ISO 80601-2-56:2017


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.

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SIST EN ISO 80601-2-56:2017
EN ISO 80601-2-56:2017 (E)
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

2

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SIST EN ISO 80601-2-56:2017
EN ISO 80601-2-56:2017 (E)
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.
3

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SIST EN ISO 80601-2-56:2017
EN ISO 80601-2-56:2017 (E)
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.
4

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SIST EN ISO 80601-2-56:2017
EN ISO 80601-2-56:2017 (E)
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
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SIST EN ISO 80601-2-56:2017
EN ISO 80601-2-56:2017 (E)
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.
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SIST EN ISO 80601-2-56:2017
EN ISO 80601-2-56:2017 (E)
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,
206
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.
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SIST EN ISO 80601-2-56:2017
EN ISO 80601-2-56:2017 (E)
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,
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SIST EN ISO 80601-2-56:2017
EN ISO 80601-2-56:2017 (E)
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.
9

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SIST EN ISO 80601-2-56:2017

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SIST EN ISO 80601-2-56:2017
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

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SIST EN ISO 80601-2-56:2017
ISO 80601-2-56:2017(E)

COPYRIGHT PROTECTED DOCUMENT
© 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
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. [phone]
Fax [phone]
[e-mail]
www.iso.org
ii © ISO 2017 – All rights reserved

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SIST EN ISO 80601-2-56:2017
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

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SIST EN ISO 80601-2-56:2017
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
...

SLOVENSKI STANDARD
oSIST prEN ISO 80601-2-56:2015
01-september-2015
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLNOLQLþQLKWHUPRPHWURY]DPHUMHQMHWHOHVQHWHPSHUDWXUH,62',6

Medical electrical equipment - Part 2-56: Particular requirements for basic safety and
essential performance of clinical thermometers for body temperature measurement
(ISO/DIS 80601-2-56:2015)
Medizinische elektrische Geräte - Teil 2-56: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von medizinischen Thermometern
zum Messen der Körpertemperatur (ISO/DIS 80601-2-56:2015)
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 80601-2-56:2015)
Ta slovenski standard je istoveten z: prEN ISO 80601-2-56
ICS:
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic equipment
17.200.20 Instrumenti za merjenje Temperature-measuring
temperature instruments
oSIST prEN ISO 80601-2-56:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 80601-2-56:2015

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oSIST prEN ISO 80601-2-56:2015

DRAFT INTERNATIONAL STANDARD IEC/DIS 80601-2-56
ISO/TC 121/SC 3 Secretariat: ANSI

Voting begins on Voting terminates on
2015-06-25 2015-09-25
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION  МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ  ORGANISATION INTERNATIONALE DE NORMALISATION
INTERNATIONAL ELECTROTECHNICAL COMMISSION   МЕЖДУНАРОДНАЯ ЭЛЕКТРОТЕХНИЧЕСКАЯ КОММИСИЯ   COMMISSION ÉLECTROTECHNIQUE INTERNATIONALE



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


ICS 11.040.55















This draft is submitted to a parallel enquiry in ISO and a CDV vote in the IEC.

THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS THEREFORE SUBJECT TO CHANGE AND MAY NOT BE
REFERRED TO AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, TECHNOLOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON OCCASION HAVE TO 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.
©  International Electrotechnical Commission, 2015

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oSIST prEN ISO 80601-2-56:2015
IEC/DIS 80601-2-56

©  International Electrotechnical Commission, 2015
ii

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oSIST prEN ISO 80601-2-56:2015
ISO/TC 121/SC 3/ N1935
1 Contents
2 Foreword . 6
3 Introduction. 9
4 Scope, object and related standards . 11
5 201.1.1 Scope . 11
6 201.2 Object. 11
7 201.1.3 Collateral standards . 12
8 201.1.4 Particular standards . 12
9 Normative references . 13
10 Terminology and definitions . 14
11 General requirements . 17
12 201.4.2 RISK MANAGEMENT PROCESS for ME EQUIPMENT or ME SYSTEMS . 17
13 201.4.2.101 Additional requirements for RISK MANAGEMENT PROCESS for ME EQUIPMENT or
14 ME SYSTEMS . 17
15 201.4.3 ESSENTIAL PERFORMANCE . 17
16 201.4.3.101 Additional requirements for ESSENTIAL PERFORMANCE . 18
17 General requirements for testing of ME EQUIPMENT . 18
18 Classification of ME EQUIPMENT and ME SYSTEMS . 18
19 ME EQUIPMENT identification, marking and documents . 18
20 201.7.2.1 Minimum requirements for marking on ME EQUIPMENT and interchangeable parts . 18
21 201.7.2.1.101 Additional requirements for minimum requirements for marking on
22 ME EQUIPMENT and interchangeable parts, marking of the packaging . 18
23 201.7.2.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts . 18
24 201.7.2.101 Additional requirements for marking on the outside of ME EQUIPMENT or
25 ME EQUIPMENT parts . 19
26 201.7.4.3 Unit of measure . 19
27 201.7.4.3.101 Additional requirements for unit of measure . 19
28 201.7.9 ACCOMPANYING DOCUMENT . 19
29 201.7.9.1 Additional general requirements . 19
30 201.7.9.2 Additional requirements for instructions for use . 19
31 201.7.9.2.101 Instructions for use . 19
32 201.7.9.101 Additional requirements for ACCOMPANYING DOCUMENT . 20
33 Protection against electrical HAZARDS from ME EQUIPMENT . 20
34 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS . 20
35 Protection against unwanted and excessive radiation HAZARDs . 20
36 Protection against excessive temperatures and other HAZARDS. 20
© ISO/IEC 2014 – All rights reserved
iii

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oSIST prEN ISO 80601-2-56:2015
ISO 80601-2-56:—(E)
37 201.11.6.4 Leakage . 21
38 201.11.6.6 Cleaning and disinfection of ME EQUIPMENT or ME SYSTEM . 21
39 Accuracy of controls and instruments and protection against hazardous outputs . 21
40 201.12.1 Accuracy of controls and instruments . 22
41 201.12.1.101 Additional requirements for accuracy of controls and instruments . 22
42 201.12.2 USABILITY . 22
43 201.12.2.101 Additional requirements for USABILITY of ME EQUIPMENT . 22
44 HAZARDOUS SITUATIONS and fault conditions . 22
45 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 22
46 Construction of ME EQUIPMENT . 22
47 ME SYSTEMS . 22
48 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 23
49 201.101 Laboratory performance requirements . 23
50 201.101.1 General test requirements . 23
51 201.101.2 LABORATORY ACCURACY . 23
52 201.101.3 Time response for a CLINICAL THERMOMETER that is not an ADJUSTED MODE CLINICAL
53 THERMOMETER . 24
54 201.102 CLINICAL ACCURACY VALIDATION . 25
55 201.102.1 Method . 25
56 201.102.2 Human subject population requirements . 26
57 201.102.3 CLINICAL BIAS calculation . 26
58 201.102.4 LIMITS OF AGREEMENT calculation . 27
59 201.102.5 CLINICAL REPEATABILITY calculation . 27
60 201.103 PROBES, PROBE CABLE EXTENDERS and PROBE COVERS . 28
61 201.103.1 General . 28
62 201.103.2 Labeling . 28
63 202 Electromagnetic compatibility — Requirements and tests . 28
64 202.4.3.1 Configurations . 29
65 202.5.2.2.1 Requirements applicable to all ME EQUIPMENT and ME SYSTEMS . 29
66 202.8.1.101 . Additional general
67 requirements . 29
68 206 Usability . 29
69 208 General requirements, tests and guidance for alarm systems in medical electrical equipment
70 and medical electrical systems . 30
71 208.6.1.2 Determination of ALARM CONDITIONS and assignment of priority . 30
72 211 Requirements for medical electrical equipment and medical electrical systems used in the
73 home healthcare environment . 30
74 211.4.2.3.1 Continuous operating conditions . 30
75 211.10.1.1 General requirements for mechanical strength . 30
4 © ISO 2015 – All rights reserved

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oSIST prEN ISO 80601-2-56:2015
ISO 80601-2-56:—(E)
76 212 Requirements for medical electrical equipment and medical electrical systems intended for
77 use in the emergency medical services environment . 31
78 212.10.1.1 General requirements for mechanical strength . 31
79
80 Annexes . 31
81 Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT and
82 ME SYSTEMS . 32
83 Annex AA (informative) Particular Guidance and rationale . 37
84 Annex BB (informative) REFERENCE TEMPERATURE SOURCE . 53
85 Annex CC (informative) Reference to the essential principles of safety and performance of
86 medical devices in accordance with ISO/TR 16142 . 55
87 Annex DD (informative) Terminology — alphabetized index of defined terms . 57
88 Annex ZA (informative) Relationship between this International Standard and the Essential
89 Requirements of EU Directive 93/42/EEC . 60
90 Bibliography . 63
91
92
© ISO 2015 – All rights reserved 5

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oSIST prEN ISO 80601-2-56:2015
ISO 80601-2-56:—(E)
93 Foreword
94 ISO (the International Organization for Standardization) is a worldwide federation of national standards
95 bodies (ISO member bodies). The work of preparing International Standards is normally carried out
96 through ISO technical committees. Each member body interested in a subject for which a technical
97 committee has been established has the right to be represented on that committee. International
98 organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO
99 collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
100 electrotechnical standardization.
101 The procedures used to develop this document and those intended for its further maintenance are
102 described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
103 different types of ISO documents should be noted. This document was drafted in accordance with the
104 editorial rules of the ISO/IEC Directives, Part 2. www.iso.org/directives
105 Attention is drawn to the possibility that some of the elements of this document may be the subject of
106 patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any
107 patent rights identified during the development of the document will be in the Introduction and/or on
108 the ISO list of patent declarations received. www.iso.org/patents
109 Any trade name used in this document is information given for the convenience of users and does not
110 constitute an endorsement.
111 For an explanation on the meaning of ISO specific terms and expressions related to conformity
112 assessment, as well as information about ISO's adherence to the WTO principles in the Technical Barriers
113 to Trade (TBT) see the following URL: Foreword - Supplementary information
114 ISO 80601-2-56 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory
115 equipment, Subcommittee SC 3, Lung ventilators and related equipment, in cooperation with
116 Subcommittee 62D, Electrical equipment, of Technical Committee IEC/TC 62: Electrical equipment in
117 medical practice.
118 This second edition of ISO 80601-2-56 cancels and replaces the first edition of ISO 80601-2-56 (2009).
119 This edition of ISO 80601-2-56 constitutes a minor technical revision of ISO 80601-2-56:2009 and
120 includes an alignment with Amendment 1 of third edition of IEC 60601-1, Amendment 1 of third edition
121 of IEC 60601-1-6 and Amendment 1 of second edition of IEC 60601-1-8, as well as IEC 60601-1-12, the
122 second edition of IEC 60601-1-11 and the fourth edition of IEC 60601-1-2.
123 The most significant changes are the following modifications:
124  change in the clinical evaluation exclusion criteria related to antipyretics;
125  deletion of Annex CC as this material is covered by IEC 60601-1-9;
126 and the following additions:
127  disclosure requirement for a summary of the USE SPECIFICATION;
128  tests for mechanical strength (via IEC 60601-1-11 and IEC 60601-1-12);
129  tests for ENCLOSURE integrity (water ingress via IEC 60601-1-11 and IEC 60601-1-12);
6 © ISO 2015 – All rights reserved

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oSIST prEN ISO 80601-2-56:2015
ISO 80601-2-56:—(E)
130  tests for cleaning and disinfection PROCEDURES (via IEC 60601-1-11 and IEC 60601-1-12);
131 In this International Standard, the following print types are used.
132  Requirements and definitions: roman type.
133  Test specifications: italic type.
134  Informative material appearing outside of tables, such as notes, examples and references: in smaller type.
135 Normative text of tables is also in a smaller type.
136  TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL
137 CAPITALS.
138 In referring to the structure of this International Standard, the term
139  “clause” means one of the 20 numbered divisions within the table of contents, inclusive of all
140 subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
141  “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all subclauses of
142 Clause 7).
143 References to clauses within this International Standard are preceded by the term “Clause” followed by
144 the clause number. References to subclauses within this International Standard are by number only.
145 In this International Standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if
146 any combination of the conditions is true.
147 The verbal forms used in this International Standard conform to usage described in Annex H of the
148 ISO/IEC Directives, Part 2. For the purposes of this International Standard, the auxiliary verb:
149  “shall” means that compliance with a requirement or a test is mandatory for compliance with this
150 standard;
151  “should” means that compliance with a requirement or a test is recommended but is not mandatory
152 for compliance with this standard;
153  “may” is used to describe a permissible way to achieve compliance with a requirement or test.
154 An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates
155 that there is guidance or rationale related to that item in Annex AA.
156 ISO 80601 consists of the following parts, under the general title Medical electrical equipment:
157  Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
158  Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic
159 workstation
160  Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas
161 monitors
162  Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers
163 for body temperature measurement
© ISO 2015 – All rights reserved 7

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oSIST prEN ISO 80601-2-56:2015
ISO 80601-2-56:—(E)
164  Part 2-61: Particular requirements for the basic safety and essential performance of pulse oximeter
165 equipment for medical use
166  Part 2-67: Particular requirements for the basic safety and essential performance of oxygen conserving
167 equipment
168  Part 2-69: Particular requirements for the basic safety and essential performance of oxygen
169 concentrator equipment
170  Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea
171 breathing equipment
172 IEC 80601 consists of the following parts, under the general title Medical electrical equipment:
173  Part 2-30: Particular requirements for basic safety and essential performance of automated
174 non-invasive sphygmomanometers
175  Part 2-35: Particular requirements for basic safety and essential performance of blankets, pads and
176 mattresses intended for heating in medical use
177  Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices
178 and vitrectomy devices for ophthalmic surgery
179  Part 2-59: Particular requirements for basic safety and essential performance of screening
180 thermographs for human febrile temperature screening
181  Part 2-60: Particular requirements for basic safety and essential performance of dental equipment
182
8 © ISO 2015 – All rights reserved

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oSIST prEN ISO 80601-2-56:2015
ISO 80601-2-56:—(E)
183 European Foreword
184 The following referenced documents are indispensable for the application of this document. For undated
185 references, the latest edition of the referenced document (including any amendments) applies. For dated
186 references, only the edition cited applies. However, for any use of this standard “within the meaning of
187 Annex ZA", the user should always check that any referenced document has not been superseded and that
188 its relevant contents can still be considered the generally acknowledged state-of-art.
189 When the ISO or IEC standard is referred to in the ISO text standard, this must be understood as a
190 normative reference to the parallel EN standard or dated ISO standard, as outlined below, including the
191 foreword and the Annexes ZZ.
192 NOTE The way in which these references documents are cited in normative requirements determines the extent
193 (in whole or in part) to which they apply.
194 Table – Correlations between normative references and dated EN and ISO/IEC standards
Equivalent dated standard
Normative references as listed in
Clause 2
EN ISO/IEC
ISO 14155:2011 EN ISO 14155:2011 ISO 14155:2011
ISO 14937:2009 EN ISO 14937:2009 ISO 14937:2009
1 1 1
ISO 15223-1:2015 (Ed 3) EN ISO 15223-1:— ISO 15223-1:2015
ISO 17664:2004 EN ISO 17664:2004 ISO 17664:2004
IEC 60601-1:2005+A1:2012 EN 60601-1:2006+A1:2013 IEC 60601-1:2005+A1:2012
+AC:2014+A12:2014
1
IEC 60601-1-2:2014 IEC 60601-1-2:2014
EN 60601-1-2:—
IEC 60601-1-6:2010 EN 60601-1-6:2010 IEC 60601-1-6:2010
1 1 1 1
+A1:2013+A2:— +A1:— +A2:— +A1:2013+A2:—
IEC 60601-1-8:2006+A1:2012 EN 60601-1-8:2007 +A1:2013 IEC 60601-1-8:2006 +A1:2012
+AC:2014
IEC 60601-1-9:2007+A1:2013 EN 60601-1-9:2008 +A1:2013 IEC 60601-1-9:2007 +A1:2013
1
IEC 60601-1-10:2007+A1:2013 IEC 60601-1-10:2007 +A1:2013
EN 60601-1-10:2007 +A1:—
1
IEC 60601-1-11:2015 IEC 60601-1-11:2015
EN 60601-1-11:—
1
IEC 60601-1-12:2014 IEC 60601-1-12:2014
EN 60601-1-12:—
1
IEC 62366-1:2015 IEC 62366-1:2015
EN 62366-1:—
195
196

1
To be published.
© ISO 2015 – All rights reserved 9

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oSIST prEN ISO 80601-2-56:2015
ISO 80601-2-56:—(E)
197 Introduction
198 This international standard deals with electrical CLINICAL THERMOMETERS, either already available or that
199 will come available in the future.
200 The purpose of a CLINICAL THERMOMETER is to assess the true temperature of a REFERENCE BODY SITE. The
201 temperature of the PATIENT'S body is an important vital sign in assessing overall health, typically in
202 combination with blood pressure and pulse rate. Determining whether a PATIENT is afebrile, febrile or
203 hypothermic is an important purpose of a CLINICAL THERMOMETER, since being febrile suggests that the
204 PATIENT is ill.
205 There are different temperatures at each REFERENCE BODY SITE according to the balance between the
2
206 production, transfer, and loss of heat.[42] CLINICAL ACCURACY of a CLINICAL THERMOMETER is VERIFIED by
207 comparing its OUTPUT TEMPERATURE with that of a REFERENCE THERMOMETER, which has a specified
208 uncertainty for measuring true temperature. For an equilibrium CLINICAL THERMOMETER, the CLINICAL
209 ACCURACY can be sufficiently determined under laboratory conditions that create an equilibrium state
210 between the two thermometers.
211 For a CLINICAL THERMOMETER that operates in the ADJUSTED MODE, laboratory VERIFICATION alone is not
212 sufficient because the adjustment algorithm for deriving the OUTPUT TEMPERATURE includes the
213 characteristics of the PATIENT and the environment.[4] Therefore the CLINICAL ACCURACY of a CLINICAL
214 THERMOMETER that operates in the ADJUSTED MODE has to be VALIDATED clinically, using statistical methods
215 of comparing its OUTPUT TEMPERATURE with that of a REFERENCE CLINICAL THERMOMETER which has a
216 specified CLINICAL ACCURACY in representing a particular REFERENCE BODY SITE temperature.
217 For a CLINICAL THERMOMETER that operates in the ADJUSTED MODE, the LABORATORY ACCURACY is VERIFIED in a
218 DIRECT MODE and the CLINICAL ACCURACY is VALIDATED in the ADJUSTED MODE (OPERATING MODE) with a
219 sufficiently large group of human subjects.
220 The intention of this International Standard is to specify the requirements and the test PROCEDURES for
221 the VERIFICATION of the LABORATORY ACCURACY for all types of electrical CLINICAL THERMOMETERS as well as
222 for the VALIDATION of the CLINICAL ACCURACY of a CLINICAL THERMOMETER that operates in the ADJUSTED MODE.
223

2
Figures in square brackets refer to the Bibliography.
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oSIST prEN ISO 80601-2-56:2015
ISO 80601-2-56:—(E)
224 Small-bore connectors for liquids and gases in healthcare applications —
225 Part 6: Connectors for neuraxial applications
226 * Scope, object and related standards
227 IEC 60601-1:2005+A1:2012, Clause 1 applies, except as follows:
228 201.1.1 Scope
229 Replacement:
230 This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of a CLINICAL
231 THERMOMETER in combination with its ACCESSORIES, hereafter referred to as ME EQUIPMENT. This standard
232 specifies the general and technical requirements for electrical CLINICAL THERMOMETERS. This standard
233 applies to all electrical CLINICAL THERMOMETERS that are used for measuring the body temperature of
234 PATIENTS.
235 CLINICAL THERMOMETERS can be equipped with interfaces to accommodate secondary indicators, printing
236 equipment, and other auxiliary equipment to create ME SYSTEMS. This standard does not apply to auxiliary
237 equipment.
238 ME EQUIPMENT that measures a temperature not as a primary purpose, but as a secondary function, is
239 outside the scope of this standard.
240 EXAMPLE 1 Swan-Ganz thermodilution determination of cardiac output is
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