SIST EN ISO 80601-2-55:2018

Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 80601-2-55:2018)

ISO 80601-2-55 specifies particular requirements for the BASIC SAFETY and ESSENTIAL PERFORMANCE of a RESPIRATORY GAS MONITOR (RGM), hereafter referred to as ME EQUIPMENT, intended for CONTINUOUS OPERATION for use with a PATIENT. This document specifies requirements for - anaesthetic gas monitoring, - carbon dioxide monitoring, and - oxygen monitoring. This document is not applicable to an RGM intended for use with flammable anaesthetic agents. 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+Amd 1:2012, 7.2.13 and 8.4.1.

Medizinische elektrische Geräte - Teil 2-55: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Überwachungsgeräten für Atemgase (ISO 80601-2-55:2018)

IEC 60601-1:2005+AMD1:2012, 1.1 wird durch Folgendes ersetzt:
Dieses Dokument gilt für die BASISSICHERHEIT einschließlich der WESENTLICHEN LEISTUNGSMERKMALE von ÜBERWACHUNGSGERÄTEN FÜR ATEMGASE, RGM (en: respiratory gas monitor), nachfolgend als ME GERÄTE bezeichnet, die für die ununterbrochene Anwendung am Menschen bestimmt sind.
Dieses Dokument legt Anforderungen fest für:
—   Überwachungsgeräte für Anästhesiegase;
—   Überwachungsgeräte für Kohlendioxid;
—   Überwachungsgeräte für Sauerstoff.
ANMERKUNG 1   Ein RGM kann entweder ein einzelnes ME-GERÄT sein oder in andere Geräte, wie z. B. Anästhesie-Arbeitsplätze oder Beatmungsgeräte, integriert sein.
RGM, die für die Verwendung mit brennbaren Anästhesiemitteln bestimmt sind, liegen außerhalb des Anwendungsbereichs dieses Dokuments.
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 physio¬logischen 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+AMD1:2012, 7.2.13 und 8.4.1.
ANMERKUNG 2   Zusätzliche Informationen sind in IEC 60601-1:2005+AMD1:2012, 4.2 enthalten.

Appareils électromédicaux - Partie 2-55: Exigences particulières relatives à la sécurité de base et aux performances essentielles des moniteurs de gaz respiratoires (ISO 80601-2-55:2018)

ISO 80601-2-55:2018 spécifie les exigences particulières relatives à la sécurité de base et aux performances essentielles des moniteurs de gaz respiratoire (mgr), désignés ci-après par appareils em, destinés à être utilisés en service continu sur un patient.
ISO 80601-2-55:2018 spécifie les exigences relatives au:
-      monitorage des gaz anesthésiques;
-      monitorage du dioxyde de carbone; et
-      monitorage de l'oxygène.
NOTE 1    Un mgr peut être soit un appareil em autonome, soit un appareil em intégré à un autre appareil, par exemple un poste de travail d'anesthésie ou un ventilateur.
Les mgr destinés à être utilisés avec des agents anesthésiques inflammables ne font pas partie du domaine d'application du présent document.
Si un article ou paragraphe est spécifiquement destiné à ne s'appliquer qu'aux appareils em ou aux systèmes em, le titre et le contenu de cet article ou de ce paragraphe l'indiquent. Si cela n'est pas le cas, l'article ou le paragraphe s'applique aux appareils em et aux systèmes em, selon le cas.
Les dangers inhérents à la fonction physiologique prévue des appareils em ou des systèmes em dans le cadre du domaine d'application du présent document ne sont pas couverts par des exigences spécifiques dans le présent document, à l'exception des paragraphes 7.2.13 et 8.4.1 de l'IEC 60601‑1:2005+Amd 1:2012.
NOTE 2    Des informations supplémentaires peuvent être consultées dans l'IEC 60601‑1:2005+Amd 1:2012, 4.2.

Medicinska električna oprema - 2-55. del: Posebne zahteve za osnovno varnost in bistvene lastnosti monitorjev dihalnih plinov (ISO 80601-2-55:2018)

ISO 80601-2-55 določa posebne zahteve za OSNOVNO VARNOST in BISTVENE LASTNOSTI MONITORJEV DIHALNIH PLINOV (RGM), v nadaljnjem besedilu imenovanih ELEKTROMEDICINSKA OPREMA, namenjenih za NEPREKINJENO DELOVANJE za uporabo pri BOLNIKU. Ta dokument določa zahteve za – spremljanje anestezijskih plinov, – spremljanje ogljikovega dioksida in – spremljanje kisika. Ta dokument se ne uporablja za monitorje RGM, ki se uporabljajo z vnetljivimi anestetičnimi snovmi. Če je točka ali podtočka namenjena samo obravnavi ELEKTROMEDICINSKE OPREME ali ELEKTROMEDICINSKIH SISTEMOV, bo to zapisano v naslovu in vsebini dane točke ali podtočke. Če ni zapisano, točka ali podtočka obravnava ELEKTROMEDICINSKO OPREMO in ELEKTROMEDICINSKE SISTEME. Posebne zahteve tega dokumenta ne vključujejo inherentnih TVEGANJ pri predvideni fiziološki funkciji ELEKTROMEDICINSKE OPREME ali ELEKTROMEDICINSKIH SISTEMOV, ki sodijo v obseg tega dokumenta, razen v točkah 7.2.13 in 8.4.1 standarda IEC 60601‐1:2005+Amd 1:2012.

General Information

• Status: Published
• Public Enquiry End Date: 19-Dec-2016
• Publication Date: 16-Apr-2018
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 09-Mar-2018
• Due Date: 14-May-2018
• Completion Date: 17-Apr-2018
• 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 80601-2-55:2018 - Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 80601-2-55:2018)

Relations

• Amended By: SIST EN ISO 80601-2-55:2018/oprA1:2023 - Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors - Amendment 1 (ISO 80601-2-55:2018/DAM 1:2023)
• Effective Date: 28-Jul-2021
• Replaces: SIST EN ISO 80601-2-55:2013 - Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 80601-2-55:2011)
• Effective Date: 01-May-2018

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 80601-2-55:2018
01-maj-2018
1DGRPHãþD
SIST EN ISO 80601-2-55:2013
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLPRQLWRUMHYGLKDOQLKSOLQRY,62
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and
essential performance of respiratory gas monitors (ISO 80601-2-55:2018)
Medizinische elektrische Geräte - Teil 2-55: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Überwachungsgeräten für
Atemgase (ISO 80601-2-55:2018)
Appareils électromédicaux - Partie 2-55: Exigences particulières relatives à la sécurité de
base et aux performances essentielles des moniteurs de gaz respiratoires (ISO 80601-2-
55:2018)
Ta slovenski standard je istoveten z: EN ISO 80601-2-55:2018
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 80601-2-55:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 80601-2-55:2018

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SIST EN ISO 80601-2-55:2018


EN ISO 80601-2-55
EUROPEAN STANDARD

NORME EUROPÉENNE

February 2018
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 80601-2-55:2011
English Version

Medical electrical equipment - Part 2-55: Particular
requirements for the basic safety and essential
performance of respiratory gas monitors (ISO 80601-2-
55:2018)
Appareils électromédicaux - Partie 2-55: Exigences Medizinische elektrische Geräte - Teil 2-55: Besondere
particulières relatives à la sécurité de base et aux Festlegungen für die Sicherheit einschließlich der
performances essentielles des moniteurs de gaz wesentlichen Leistungsmerkmale von
respiratoires (ISO 80601-2-55:2018) Überwachungsgeräten für Atemgase (ISO 80601-2-
55:2018)
This European Standard was approved by CEN on 18 January 2018.

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: Rue de la Science 23, B-1040 Brussels
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 80601-2-55:2018 E
worldwide for CEN national Members.

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SIST EN ISO 80601-2-55:2018
EN ISO 80601-2-55:2018 (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 . 6

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SIST EN ISO 80601-2-55:2018
EN ISO 80601-2-55:2018 (E)
European foreword
This document (EN ISO 80601-2-55:2018) has been prepared by Technical Committee ISO/TC 121
“Anaesthetic and respiratory equipment” in collaboration with Technical Committee CEN/TC 215
“Respiratory and anaesthetic equipment” the secretariat of which is held by BSI.
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 August 2018, and conflicting national standards shall
be withdrawn at the latest by August 2021.
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 80601-2-55:2011.
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.
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SIST EN ISO 80601-2-55:2018
EN ISO 80601-2-55:2018 (E)
Table 1 — Correlation between normative references and dated EN and ISO standards
Normative references Equivalent dated International Standard
as listed in 201.2
EN ISO
ISO 7000:2014 - ISO 7000:2014
ISO 7010:2011 EN ISO 7010:2012 ISO 7010:2011
ISO 14937:2009 EN ISO 14937:2009 ISO 14937:2009
ISO 15223-1:2016, corrected EN ISO 15223-1:2016 ISO 15223-1:2016, corrected
version 2017 version 2017
ISO 17664:2004 EN ISO 17664:2004 ISO 17664:2004
ISO 80601-2-13:2011 a ISO 80601-2-13:2011
EN ISO 80601-2-13:2012
a a
+ Amd 1:2015 and Amd 2:— a + Amd 1:2015 and Amd 2:—
+ Amd 1: — and Amd 2:—
b b b
ISO 80369-1: 2010 EN ISO 80369-1:2010 ISO 80369-1:2010
a a a
ISO 80369-2 EN ISO 80369-2:- ISO 80369-2
ISO 80369-3 EN ISO 80369-3:2016 ISO 80369-3:2016
IEC 80369-5 EN ISO 80369-5:2016 IEC 80369-5:2016
ISO 80369-6 EN ISO 80369-6:2016 ISO 80369-6:2016
ISO 80369-7 EN ISO 80369-7:2017 ISO 80369-7:2017
ISO 80369-20 EN ISO 80369-20:2015 ISO 80369-20:2015
IEC 60601-1:2005 EN 60601-1:2006 IEC 60601-1:2005
+ Amd 1:2012 + Cor:2010 and + Amd 1:2013 + Amd 1:2012
IEC 60601-1-2:2014 EN 60601-1-2:2015 IEC 60601-1-2:2014
IEC 60601-1-6:2010 EN 60601-1-6:2010 IEC 60601-1-6:2010
+ Amd 1:2013 + Amd 1:2015 + Amd 1:2013
IEC 60601-1-8:2006 EN 60601-1-8:2007 IEC 60601-1-8:2006
+ Amd 1:2012 + Cor:2010 and Amd 1:2013 + Amd 1:2012
IEC 60601-1-11:2015 EN 60601-1-11:2015 IEC 60601-1-11:2015
IEC 60601-1-12:2014 EN 60601-1-12:2015 IEC 60601-1-12:2014
IEC 60068-2-27:2008 EN 60068-2-27:2009 IEC 60068-2-27:2008
IEC 60068-2-64:2008 EN 60068-2-64:2008 IEC 60068-2-64:2008
IEC 60529:1989 EN 60529:1991 IEC 60529:2001
+ Amd 1:1999 and Amd 2:2013 + Amd 1:2000 and
Amd 2:2013
a
To be published.
b
Under revision.
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SIST EN ISO 80601-2-55:2018
EN ISO 80601-2-55:2018 (E)
Endorsement notice
The text of ISO 80601-2-55:2018 has been approved by CEN as EN ISO 80601-2-55:2018 without any
modification.

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SIST EN ISO 80601-2-55:2018
EN ISO 80601-2-55:2018 (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 requirements Clause(s)/subclause(s) of this Remarks/Notes
of Directive 93/42/EEC European Standard
7.3 201.11.6.4 Only the first sentence
relating to design is
partially addressed as
follows:
- only normal use is
addressed;
- only leaking or leaching
of substances is
addressed.
7.6 201.11.6.5 only addressed with
regard to
- ingress of water
or particulate matter
and only addressed for
normal use.
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Essential requirements Clause(s)/subclause(s) of this Remarks/Notes
of Directive 93/42/EEC European Standard
8.1 201.11.6.6, 201.105 Only addressed as far as
contamination resulting
from reverse flow
through the sampling
tube and return flow. Easy
handling and
manufacturing are not
addressed.
8.7 201.7.2.17.101
9.1 201.7.2.101 d), e), f), g), h), Only addressed by
201.103 marking
− of the gas sampling
gas inlet and outlet
including the related
tubes
− of flow-direction-
sensitive components that
are operator-
interchangeable
9.2 201.101, 202, 206 Covered for the effects of
interfering gases and
vapours, electromagnetic
disturbances and
usability.
10.1 201.12.1, 201.101
10.2 201.12.1.103, 201.12.1.104, 206 Covered for the indication
of units of measures for
gas readings, for
indication of the
operating mode and for
usability.
10.3 201.7.4.3
12.2 201.11.8.101
12.3 201.11.8.101
12.4 208
12.5 202 Covered with respect to
electromagnetic
disturbances
12.7.4 201.103 Covered for the risk of
misconnecting the
exhaust port of a
diverting RGM
12.8.2 201.104 Only the first sentence of
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SIST EN ISO 80601-2-55:2018
EN ISO 80601-2-55:2018 (E)
Essential requirements Clause(s)/subclause(s) of this Remarks/Notes
of Directive 93/42/EEC European Standard
ER 12.8.2 is covered
12.9 201.7, 201.12.1, 206
13.2 201.7.2.3, 201.7.2.13.101, Covered with regard to
201.7.2.17.101, 201.7.2.101
− marking of the
equipment with the safety
sign “Follow instructions
for use”
− marking of the
equipment, parts or
accessories with the
symbol for presence of
latex, if applicable, and
with the symbol for serial
or lot number, for gas
inlet or outlet, with the
appropriate symbol
indicating the possible
use in the magnetic
resonance environment,
and with the symbol for
the use-by-date
− marking of the
protective packaging of
equipment, parts or
accessories with the
symbol for serial, type or
batch number, and if
applicable, for presence of
latex, for sterile
conditions, and for single
use
Except for the
requirement on marking
with the safety sign
“Follow instructions for
use” all other
requirements on marking
with symbols are included
as alternatives to
corresponding
requirements on marking
using text elements
13.3 b) 201.7.2.17.101 a) first dash Covered for marking of
the packages of the
equipment, parts or
accessories with a
description of the content
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SIST EN ISO 80601-2-55:2018
EN ISO 80601-2-55:2018 (E)
Essential requirements Clause(s)/subclause(s) of this Remarks/Notes
of Directive 93/42/EEC European Standard
13.3 c) 201.7.2.17.101, a) 4th dash Covered for marking of
the packages of the
equipment, parts or
accessories with text or
symbol indicating sterile
conditions, if applicable
13.3 d) 201.7.2.17.101, 201.7.2.101 Is only covered if the
batch number is preceded
by the word LOT
13.3 e) 201.7.2.101, last paragraph
13.3 f) 201.7.2.4.101, 201.7.2.17.101 b) Distinction between
“single use“ and “single-
patient use” taken into
account
13.3 i) 201.7.2.101 a)
13.4 201.7.9.2.1.101 a),
201.7.2.17.101, 201.7.2.101
13.5 201.7.2.17.101 a), 201.7.2.101 b) Is only covered if the
batch number is preceded
by the word LOT
13.6 d) 201.7.9.2.8.101 a), Covered for instructions
201.7.9.2.13.101 for procedures for
calibration before and
during use including
methods and frequency of
routine inspection and
testing.
Covered for verifying
alarms.
13.6 f) 201.7.9.2.9.101 g) Covered for indication if
the equipment is suitable
for use in a magnetic
resonance imaging
environment
13.6 h) 201.7.9.2.9.101 l) Covered with regard to
information on
characteristics and
technical factors known
to the manufacturer that
could pose a risk if
equipment, parts or
accessories, that intended
for single use, were re-
used
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Essential requirements Clause(s)/subclause(s) of this Remarks/Notes
of Directive 93/42/EEC European Standard
13.6 n) 201.7.9.2.15.101 covered for the disposal
of calibration gas and
sampled gas
13.6 p) 201.12.1.101.1
For devices which are also machinery within the meaning of Article 2(a) of Directive 2006/42/EC on
Machinery, in accordance with Article 3 of Directive 93/42/EEC, the following Table ZA.2 details the
relevant essential health and safety requirements of Directive 2006/42/EC on Machinery to the extent
to which they are more specific than essential requirements of Directive 93/42/EEC along with the
corresponding clauses of this document. Table ZA.2, however, does not imply any citation in the OJEU
under the machinery directive and thus does not provide presumption of conformity for the machinery
directive.
Table ZA.2 — Relevant Essential Requirements from Directive 2006/42/EC on machinery that
are addressed by this European Standard
(according to article 3 of amended Directive 93/42/EEC)
Essential health and safety Clause(s)/subclause(s) of this Remarks/Notes
requirements European Standard
of Directive 2006/42/EC
1.2.2 201.12.1, 201.12.1.104, 206 Only the parts of
EHSR 1.2.2 relevant to the
RGM are addressed
1.5.4 201.7.2.101 d), 201.7.2.101 e),
201.7.2.101 f), 201.7.2.101 g)
201.7.2.101 h), i), 201.103,
201.105
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.
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SIST EN ISO 80601-2-55:2018
INTERNATIONAL ISO
STANDARD 80601-2-55
Second edition
2018-02
Medical electrical equipment —
Part 2-55:
Particular requirements for the basic
safety and essential performance of
respiratory gas monitors
Appareils électromédicaux —
Partie 2-55: Exigences particulières relatives à la sécurité de base et
aux performances essentielles des moniteurs de gaz respiratoires
Reference number
ISO 80601-2-55:2018(E)
©
ISO 2018

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SIST EN ISO 80601-2-55:2018
ISO 80601-2-55:2018(E)

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Published in Switzerland
ii © ISO 2018 – All rights reserved

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SIST EN ISO 80601-2-55:2018
ISO 80601-2-55:2018(E)
Contents Page
Foreword .iv
Introduction .vi
201.1  Scope, object, and related standards . 1
201.2  Normative references . 3
201.3  Terms and definitions . 4
201.4  General requirements . 6
201.5  General requirements for testing of ME EQUIPMENT . 7
201.6  Classification of ME EQUIPMENT and ME SYSTEMS . 7
E EQUIPMENT identification, marking, and documents . 7
201.7  M
201.8  Protection against electrical HAZARDS from ME EQUIPMENT . 13
201.9  Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 14
201.10Protection against unwanted and excessive radiation HAZARDS . 14
201.11Protection against excessive temperatures and other HAZARDS . 14
201.12Accuracy of controls and instruments and protection against hazardous outputs . 16
201.13HAZARDOUS SITUATIONS and fault conditions . 22
201.14PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 22
201.15Construction of ME EQUIPMENT . 22
201.16ME SYSTEMS . 24
201.17Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 24
201.101  *Interfering gas and vapour effects . 24
201.102  *Gas leakage . 25
201.103  *Port connectors for DIVERTING RGMs . 25
201.104  *Sampling flowrate . 25
201.105  *Contamination of breathing systems . 25
201.106  FUNCTIONAL CONNECTION . 25
202  Electromagnetic disturbances — Requirements and tests . 27
206  USABILITY . 27
208  General requirements, tests and guidance for ALARM SYSTEMS in MEDICAL ELECTRICAL
EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS . 28
211  General requirements, tests and guidance for medical electrical equipment and
medical electrical systems used in the home healthcare environment . 30
212  General requirements, tests and guidance for MEDICAL ELECTRICAL EQUIPMENT and
MEDICAL ELECTRICAL SYSTEMS intended for use in the EMERGENCY MEDICAL SERVICES
ENVIRONMENT . 30
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT and
ME SYSTEMS . 31
Annex D (informative) Symbols on marking . 35
Annex AA (informative) Particular guidance and rationale . 38
Annex BB (informative) Test gas mixtures for calibration. 48
Annex CC (informative) Data interface requirements. 49
Annex DD (informative) Alphabetized index of defined terms used in this document. 54
Bibliography . 61
© ISO 2018 – All rights reserved iii

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SIST EN ISO 80601-2-55:2018
ISO 80601-2-55:2018(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 Technical Committee ISO/TC 121, Anaesthetic and respiratory
equipment, Subcommittee SC 1, Breathing attachments and anaesthetic machines, 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 80601‐2‐55:2011), which has been
technically revised.
The main changes compared to the previous edition are as follows:
— additional requirements on respiratory gas monitors for use during professional transport of a
patient outside a healthcare facility have been deleted because these are now covered by
IEC 60601‐1‐12;
— requirements on marking, warning and safety notices, as well as accompanying documents have
been updated;
— 201.11.6.5 and 201.15.3.5 have been revised to distinguish between requirements for stand‐alone
respiratory gas monitors and requirements for respiratory gas monitors that are incorporated into
another medical electrical equipment;
— requirements on port connectors for diverting respiratory gas monitors have been revised;
— a new subclause on functional connection has been added (see 201.106) accompanied by the
related rationale and informative annex on data interface requirements;
iv © ISO 2018 – All rights reserved

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SIST EN ISO 80601-2-55:2018
ISO 80601-2-55:2018(E)
— Clause 202 has been updated to align with IEC 60601‐1‐2:2014;
— Clause 208 has been updated to align with IEC 60601‐1‐8:2006/Amd 1:2012;
— IEC 60601‐1‐9 has been excluded;
— Annex BB has been deleted;
— requirements on calibration/zeroing have been added.
A list of all the parts of ISO 80601 can be found on the ISO website.
© ISO 2018 – All rights reserved v

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SIST EN ISO 80601-2-55:2018
ISO 80601-2-55:2018(E)
Introduction
In this document, the following print types are used:
— requirements and definitions: roman type.
— compliance checks: italic type.
— informative material appearing outside of tables such as notes, examples and references: 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,
— “clause” means one of the 17 numbered divisions within the table of contents, inclusive of all
subdivisions (e.g. Clause 7 includes 7.1, 7.2, etc.), and
— “subclause” means a numbered subdivision of a clause (e.g. 201.7.1, 201.7.2 and 201.7.2.1 are all
subclauses of Clause 201.7).
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 ISO/IEC Directives, Part 2,
Clause 7. For the purposes of this document, the auxiliary verb
— “shall” means that compliance with a requirement or a test is mandatory for compliance with
document,
— “should” means that compliance with a requirement or a test is recommended but is not mandatory
for compliance with this document, and
— “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
...

SLOVENSKI STANDARD
oSIST prEN ISO 80601-2-55:2016
01-december-2016
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLPRQLWRUMHYGLKDOQLKSOLQRY,62',6
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and
essential performance of respiratory gas monitors (ISO/DIS 80601-2-55:2016)
Medizinische elektrische Geräte - Teil 2-55: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Überwachungsgeräten für
Atemgase (ISO/DIS 80601-2-55:2016)
Appareils électromédicaux -- Partie 2-55: Exigences particulières relatives à la sécurité
de base et aux performances essentielles des moniteurs de gaz respiratoires (ISO/DIS
80601-2-55:2016)
Ta slovenski standard je istoveten z: prEN ISO 80601-2-55
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
oSIST prEN ISO 80601-2-55:2016 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 80601-2-55:2016

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oSIST prEN ISO 80601-2-55:2016
DRAFT INTERNATIONAL STANDARD
ISO/DIS 80601-2-55
ISO/TC 121/SC 1 Secretariat: DIN
Voting begins on: Voting terminates on:
2016-09-30 2016-12-22
Medical electrical equipment —
Part 2-55:
Particular requirements for the basic safety and essential
performance of respiratory gas monitors
Appareils électromédicaux —
Partie 2-55: Exigences particulières relatives à la sécurité de base et aux performances essentielles des
moniteurs de gaz respiratoires
ICS: 11.040.10
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
This draft is submitted to a parallel vote in ISO and in IEC.
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
ISO/CEN PARALLEL PROCESSING
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
Reference number
NATIONAL REGULATIONS.
ISO/DIS 80601-2-55:2016(E)
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. ISO 2016

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oSIST prEN ISO 80601-2-55:2016
ISO/DIS 80601-2-55:2016(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2016, 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 2016 – All rights reserved

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oSIST prEN ISO 80601-2-55:2016
ISO/DIS 80601-2-55:2016(E)
1 COPYRIGHT PROTECTED DOCUMENT
2 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or
3 utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or
4 posting on the internet or an intranet, without prior written permission. Permission can be
5 requested from either ISO at the address below or ISO’s member body in the country of the requester.
6 ISO copyright office
7 Ch. de Blandonnet 8 • CP 401
8 CH-1214 Vernier, Geneva, Switzerland
9 Tel. + 41 22 749 01 11
10 Fax + 41 22 749 09 47
11 [e-mail]
12 www.iso.org
© ISO 2016 – All rights reserved i

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oSIST prEN ISO 80601-2-55:2016
ISO/DIS 80601-2-55:2016(E)
13 Contents Page
14 Foreword . 5
15 Introduction . 8
16 201.1 Scope, object, and related standards . 1
17 201.1.1 * Scope . 1
18 201.1.2 Object . 1
19 201.1.3 Collateral standards . 2
20 201.1.4 Particular standards . 2
21 201.2 Normative references . 3
22 201.3 Terms and definitions . 4
23 201.4 General requirements . 6
24 201.4.3 ESSENTIAL PERFORMANCE . 6
25 201.4.3.101 * Additional requirements for ESSENTIAL PERFORMANCE . 6
26 201.4.6 * ME EQUIPMENT or ME SYSTEM parts that contact the PATIENT . 6
27 201.5 General requirements for testing of ME EQUIPMENT . 6
28 201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 6
29 201.7 ME EQUIPMENT identification, marking, and documents . 6
30 201.7.2.3 * Consult ACCOMPANYING DOCUMENTS . 6
31 201.7.2.4.101 Additional requirements for ACCESSORIES . 7
32 201.7.2.13.101 * Additional requirements for physiological effects (safety signs and warning
33 statements) . 7
34 201.7.2.17.101 Additional requirements for protective packaging . 7
35 201.7.2.101 * Additional requirements for marking on the outside of ME EQUIPMENT or
36 ME EQUIPMENT parts . 7
37 201.7.4.3 Units of measurement . 8
38 201.7.9.1 Additional general requirements . 9
39 201.7.9.2.1.101 * Additional general requirements . 9
40 201.7.9.2.2 Warnings and safety notices . 10
41 201.7.9.2.2.101 * Additional requirements for warnings and safety notices . 10
42 201.7.9.2.5 ME EQUIPMENT description . . 10
43 201.7.9.2.5.101 Additional requirements for ME EQUIPMENT description . 10
44 201.7.9.2.8 Start-up PROCEDURE . 10
45 201.7.9.2.8.101 * Additional requirements for start-up PROCEDURE . 11
46 201.7.9.2.9 Operating instructions . . 11
47 201.7.9.2.9.101 * Additional requirements for operating instructions . 11
48 201.7.9.2.13 Maintenance . . 12
49 201.7.9.2.13.101 * Additional requirements for maintenance . 12
50 201.7.9.2.14 ACCESSORIES, supplementary equipment, used material . 12
51 201.7.9.2.14.101 * Additional requirements for ACCESSORIES, supplementary equipment and
52 used material . . 12
53 201.7.9.2.15 Environmental protection . . 13
54 201.7.9.2.15.101 * Additional requirements for environmental protection . 13
55 201.7.9.3 Technical description . 13
56 201.7.9.3.101 * Additional requirements for technical description . 13
57 201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 13
58 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS. 13
59 201.10 Protection against unwanted and excessive radiation HAZARDS . 13
60 201.11 Protection against excessive temperatures and other HAZARDS . 13
61 201.11.6.4 Leakage . . 14
62 201.11.6.5 * Ingress of water or particulate matter into ME EQUIPMENT or ME SYSTEMS . 14
63 201.11.6.6 * Cleaning and disinfection of ME EQUIPMENT or ME SYSTEMS . 14
ii © ISO 2016 – All rights reserved

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oSIST prEN ISO 80601-2-55:2016
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64 201.11.6.7 Sterilization of ME EQUIPMENT or ME SYSTEM .15
65 201.11.8 Interruption of the power supply/SUPPLY MAINS to ME EQUIPMENT .15
66 201.11.8.101 Additional requirements for interruption of the power supply/SUPPLY MAINS to
67 ME EQUIPMENT .15
68 201.11.8.101.1 * Supply failure TECHNICAL ALARM CONDITION .15
69 201.11.8.101.2 * Settings and data storage following short interruptions or automatic
70 switchover .15
71 201.11.8.101.3 * Operation following long interruptions .16
72 201.11.8.101.4 * RESERVE ELECTRICAL POWER SOURCE (except for transport outside a healthcare
73 facility) .16
74 201.11.8.101.5 * RESERVE ELECTRICAL POWER SOURCE for transport outside a healthcare facility .16
75 201.12 Accuracy of controls and instruments and protection against hazardous outputs .16
76 201.12.1 Accuracy of controls and instruments .16
77 201.12.1.101 * MEASUREMENT ACCURACY .16
78 201.12.1.101.2 * DRIFT of MEASUREMENT ACCURACY .17
79 201.12.1.101.3 * MEASUREMENT ACCURACY of GAS READINGS for gas mixtures .18
80 201.12.1.101.4 Calibration/Zeroing .19
81 201.12.1.101.4.2 Suppression of device-initiated calibration/zeroing .20
82 201.12.1.102 * TOTAL SYSTEM RESPONSE TIME and rise time .20
83 201.12.1.103 * Indication of units of measure for GAS READINGS .21
84 201.12.1.104 * Indication of operating mode .21
85 201.13 HAZARDOUS SITUATIONS and fault conditions .22
86 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .22
87 201.15 Construction of ME EQUIPMENT .22
88 201.15.3.5 Rough handling test .22
89 201.15.3.5.101 Additional requirements for shock and vibration .22
90 201.15.101 * Mode of operation .23
91 201.16 ME SYSTEMS .23
92 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS .23
93 201.101 * Interfering gas and vapour effects.23
94 201.102 * Gas leakage .24
95 201.103 * Port connectors for DIVERTING RGMs .24
96 201.104 * Sampling flowrate .25
97 201.105 * Contamination of breathing systems .25
98 201.105.1 SAMPLING TUBE .25
99 201.105.2 Exhaust tube .25
100 201.106 FUNCTIONAL CONNECTION .25
101 201.106.1 General .25
102 201.106.2* Connection to an electronic health record .25
103 201.106.3 * Connection to a DISTRIBUTED ALARM SYSTEM .25
104 201.106.4 Connection for remote control .25
105 201.106.5 *Connection to external medical device data interface .25
106 201.106.5.1 General .25
107 201.106.5.2 *Data transmitted or received .26
108 202 Electromagnetic disturbances — Requirements and tests .26
109 202.8.1 General .26
110 206 USABILITY .27
111 208 General requirements, tests and guidance for ALARM SYSTEMS in MEDICAL ELECTRICAL
112 EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS .27
113 208.6.1.2 * Determination of ALARM CONDITIONS and assignment of priority .27
114 208.6.5.1 * General requirements .29
115 208.6.6.2 Adjustable ALARM LIMIT .29
116 208.6.6.2.101 * Additional requirements for adjustable ALARM LIMIT .29
117 208.6.8.5 Indication and access .29
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ISO/DIS 80601-2-55:2016(E)
118 208.6.8.5.101 * Additional requirements for ALARM SIGNAL deactivation states, indication and
119 access . . 30
120 212 General requirements, tests and guidance for ALARM SYSTEMS in MEDICAL ELECTRICAL
121 EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS . 30
122 Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT and
123 ME SYSTEMS. 31
124 Annex D (informative) Symbols on marking . 34
125 Annex AA (informative) Particular guidance and rationale . 36
126 Annex BB (informative) Test gas mixtures for calibration . . 45
127 Annex CC (informative) Data interface requirements . 46
128 Annex DD (informative) Reference to the essential principles . 51
129 Annex EE (informative) Alphabetized index of defined terms used in this document . 53
130 Annex ZA (informative) Relationship between this European Standard and the the essential
131 requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered . 56
132 Bibliography . . 60
133
iv © ISO 2016 – All rights reserved

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oSIST prEN ISO 80601-2-55:2016
ISO/DIS 80601-2-55:2016(E)
134 Foreword
135 ISO (the International Organization for Standardization) is a worldwide federation of national standards
136 bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
137 ISO technical committees. Each member body interested in a subject for which a technical committee has
138 been established has the right to be represented on that committee. International organizations,
139 governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely
140 with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
141 The procedures used to develop this document and those intended for its further maintenance are described
142 in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of
143 ISO documents should be noted. This document was drafted in accordance with the editorial rules of the
144 ISO/IEC Directives, Part 2 (see www.iso.org/directives).
145 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
146 rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent
147 rights identified during the development of the document will be in the Introduction and/or on the ISO list of
148 patent declarations received (see www.iso.org/patents).
149 Any trade name used in this document is information given for the convenience of users and does not
150 constitute an endorsement.
151 For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment,
152 as well as information about ISO's adherence to the World Trade Organization (WTO) principles in the
153 Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.
154 The committee responsible for this document is ISO/TC 121, Anaesthetic and respiratory equipment,
155 Subcommittee SC 1, Breathing attachments and anaesthetic machines, and Technical Committee IEC/TC 62,
156 Electrical equipment in medical practice, Subcommittee SC D, Electrical equipment.
157 This second edition of ISO 80601-2-55 cancels and replaces the first edition of ISO 80601-2-55:2011. This
158 edition of ISO 80601-2-55 constitutes a technical revision of ISO 80601-2-55:2011 and includes the
159 following technical modifications:
160 — amendments following the publication of IEC 60601-1-12 (Collateral Standard: Requirements for
161 medical electrical equipment and medical electrical systems used in the emergency medical services
162 environment) that resulted in the deletion of additional requirements on respiratory gas monitors for
163 use during professional transport of a patient outside a healthcare facility because these are now
164 covered by IEC 60601-1-12;
165 — amendment of requirements on marking, warning and safety notices as well as accompanying
166 documents, in part due to the publication of the amendment 1:2012 to IEC 60601-1:2005;
167 — revision of 201.11.6.5 – ingress of water or particulate matter into equipment – and 201.15.3.5 - shock
168 and vibration – in order to distinguish between requirements on stand-alone respiratory gas monitors
169 and requirements on respiratory gas monitors that are incorporated into another medical electrical
170 equipment;
171 — inclusion of ISO 80369-2 - Connectors for breathing systems and driving gases applications – as the
172 normative reference for the port connector for diverting respiratory gas monitors;
© ISO 2016 – All rights reserved v

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oSIST prEN ISO 80601-2-55:2016
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173 — addition of a new subclause 201.106 on functional connection accompanied by the related rationale and
174 informative annex on data interface requirements;
175 — revision of Clause 202 on electromagnetic disturbances based on the new edition of
176 IEC 60601-1-2:2014;
177 — revision of Clause 208 on alarms by taking into consideration the amendment 1:2012 to IEC
178 60601-1-8:2006;
179 — exclusion of IEC 60601-1-9 - Collateral Standard: Requirements for environmentally conscious design;
180 — deletion of the informative Annex BB on environmental aspects
181 — addition of requirements on calibration/zeoring.
182 ISO 80601 consists of the following parts, under the general title Medical electrical equipment:
183 — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
184 — Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic
185 workstation
186 — Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas
187 monitors
188 — Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for
189 body temperature measurement
190 — Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
191 for medical use
192 — Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving
193 equipment
194 — Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator
195 equipment
196 — Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing
197 therapy equipment
198 — Part 2-72: Particular requirements for basic safety and essential performance of home healthcare
199 environment ventilators for ventilator-dependent patients
200 IEC 80601 consists of the following parts, under the general title Medical electrical equipment:
201 — Part 2-30: Particular requirements for the basic safety and essential performance of automated non-
202 invasive sphygmomanometers
203 — Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using
204 blankets, pads and mattresses and intended for heating in medical use
205 — Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices
206 and vitrectomy devices for ophthalmic surgery
207 — Part 2-59: Particular requirements for the basic safety and essential performance of screening
208 thermographs for human febrile temperature screening
vi © ISO 2016 – All rights reserved

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oSIST prEN ISO 80601-2-55:2016
ISO/DIS 80601-2-55:2016(E)
209 — Part 2-60: Particular requirements for basic safety and essential performance of dental equipment
210 — Part 2-71: Particular requirements for the basic safety and essential performance of functional Near-
211 Infrared Spectroscopy (NIRS) equipment
212 The ISO and IEC 80601 family of standards are also parts of the IEC 60601 family of standards.
213 European foreword
214 The following referenced documents are indispensable for the application of this document. For undated
215 references, the latest edition of the referenced document (including any amendments) applies. For dated
216 references, only the edition cited applies. However, for any use of this standard within the meaning of
217 Annex ZA, the user should always check that any referenced document has not been superseded and that its
218 relevant contents can still be considered the generally acknowledged state-of-art.
219 When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as
...