SIST EN ISO 80601-2-55:2018

SLOVENSKI STANDARD
01-maj-2018
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SIST EN ISO 80601-2-55:2013
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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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

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

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.
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.
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.
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.
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
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
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
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.
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
ISO 80601-2-55:2018(E)
© ISO 2018
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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Published in Switzerland
ii © ISO 2018 – All rights reserved

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

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

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

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 beginning of a paragraph or table title indicates
that there is guidance or rationale related to that item in Annex AA.
© ISO 2018 – All rights reserved
vi
INTERNATIONAL STANDARD ISO 80601-2-55:2018(E)
Medical electrical equipment —
Part 2‐55:
Particular requirements for the basic safety and essential
performance of respiratory gas monitors
201.1 Scope, object and related standards
IEC 60601‐1:2005+Amd 1:2012, Clause 1 applies, except as follows:
201.1.1 *Scope
IEC 60601‐1:2005+Amd 1:2012, 1.1 is replaced by:
This document 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.
NOTE 1 An RGM can be either stand‐alone ME EQUIPMENT or integrated into other equipment, e.g. an anaesthetic
workstation or a ventilator.
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.
NOTE 2 Additional information can be found in IEC 60601‐1:2005+Amd 1:2012, 4.2.
201.1.2 Object
IEC 60601‐1:2005+Amd 1:2012, 1.2 is replaced by:
The object of this document is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE
requirements for an RGM (as defined in 201.3.210) and its ACCESSORIES.
© ISO 2018 – All rights reserved
ISO 80601-2-55:2018(E)
NOTE ACCESSORIES are included because the combination of the RGM and the ACCESSORIES needs to be safe.
ACCESSORIES can have a significant impact on the BASIC SAFETY and ESSENTIAL PERFORMANCE of an RGM.
201.1.3 Collateral standards
IEC 60601‐1:2005+Amd 1:2012, 1.3 applies with the following addition:
This document refers to those applicable collateral standards that are listed in IEC 60601‐1:2005+Amd
1:2012, Clause 2, as well as those listed in 201.2 of this document and to the following exceptions:
IEC 60601‐1‐3:2008 and IEC 60601‐1‐9:2007+Amd 1:2013 do not apply.
201.1.4 Particular standards
IEC 60601‐1:2005+Amd 1:2012, 1.4 is replaced by:
In the IEC 60601 series, particular standards can modify, replace or delete requirements contained in
the general standard, including the collateral standards, as appropriate for the particular ME EQUIPMENT
under consideration, and may add other BASIC SAFETY or ESSENTIAL PERFORMANCE requirements.
A requirement of a particular standard takes priority over IEC 60601‐1:2005+Amd 1:2012 or the
collateral standards.
For brevity, IEC 60601‐1:2005+Amd 1:2012 is referred to in this document as the general standard.
Collateral standards are referred to by their document number.
The numbering of clauses and subclauses of this document corresponds to those of the general
standard with the prefix “201” (e.g. 201.1 in this document addresses the content of Clause 1 of the
general standard) or applicable collateral standard with the prefix “2xx” where xx is the final digits of
the collateral standard document number (e.g. 202.4 addresses the content of IEC 60601‐1‐2, Clause 4
collateral standard, 208.4 addresses the content of IEC 60601‐1‐8, Clause 4 collateral standard, etc.).
The changes to the text of the general standard are specified by the use of the following words:
— “Replacement” means that the clause or subclause of IEC 60601‐1:2005+Amd 1:2012 or the
applicable collateral standard is replaced completely by the text of this document.
— “Addition” means that the text of this document is additional to the requirements of
IEC 60601‐1:2005+Amd 1:2012 or the applicable collateral standard.
— “Amendment” means that the clause or subclause of IEC 60601‐1:2005+Amd 1:2012 or the
applicable collateral standard is amended as indicated by the text of this document.
Subclauses or figures that are additional to those of the general standard are numbered starting from
201.101, additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.
Subclauses or figures that are additional to those of a collateral standard are numbered starting from
20x, where “x” is the number of the collateral standard, e.g. 202 for IEC 60601‐1‐2, 203 for IEC 60601‐1‐
3, etc.
The term “this standard” is used to make reference to IEC 60601‐1:2005+Amd 1:2012, any applicable
collateral standards, and this document taken together.
Where there is no corresponding clause or subclause in this document, the clause or subclause of
IEC 60601‐1:2005+Amd 1:2012 or the applicable collateral standard, although possibly not relevant,
applies without modification; where it is intended that any part of IEC 60601‐1:2005+Amd 1:2012 or
the applicable collateral standard, although possibly relevant, is not to be applied, a statement to that
effect is given in this document.
© ISO 2018 – All rights reserved
ISO 80601-2-55:2018(E)
201.2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
IEC 60601 1:2005+Amd 1:2012, Clause 2 applies, except as follows:
Replacement:
IEC 60601‐1‐2:2014, Medical electrical equipment — Part 1-2: General requirements for basic safety and
essential performance — Collateral standard: Electromagnetic disturbances — Requirements and tests
IEC 60601‐1‐6:2010+Amd 1:2013, Medical electrical equipment — Part 1-6: General requirements for
basic safety and essential performance — Collateral standard: Usability
IEC 60601‐1‐8:2006+Amd 1:2012, Medical electrical equipment — Part 1-8: General requirements for
basic safety and essential performance — Collateral standard: General requirements, tests and guidance
for alarm systems in medical electrical equipment and medical electrical systems
Addition:
ISO 7000:2014, Graphical symbols for use on equipment — Registered symbols
ISO 7010:2011, Graphical symbols — Safety colours and safety signs — Registered safety signs
ISO 14937:2009, Sterilization of health care products — General requirements for characterization of a
sterilizing agent and the development, validation and routine control of a sterilization process for medical
devices
ISO 15223‐1:2017, Medical devices — Symbols to be used with medical device labels, labelling and
information to be supplied — Part 1: General requirements
ISO 17664:2004, Sterilization of medical devices — Information to be provided by the manufacturer for
the processing of resterilizable medical devices
ISO 80369 (all parts), Small bore connectors for liquids and gases in healthcare applications
ISO 80601‐2‐13:2011+Amd 1:2015 and Amd 2:—, Medical electrical equipment — Part 2-13: Particular
requirements for basic safety and essential performance of an anaesthetic workstation
IEC 60068‐2‐27:2008, Environmental testing — Part 2-27: Tests — Test Ea and guidance: Shock
A consolidated edition, IEC 60601‐1:2012, which includes IEC 60601‐1:2005 and its amendment
(IEC 60601‐1:2005/Amd 1:2012) is available.
A consolidated edition, IEC 60601‐1‐6:2013, which includes IEC 60601‐1‐6:2010 and its amendment
(IEC 60601‐1‐6:2010/Amd 1:2013) is available.
A consolidated edition, IEC 60601‐1‐8:2012, which includes IEC 60601‐1‐8:2006 and its amendment
(IEC 60601‐1‐8:2006/Amd 1:2012) is available.
Under revision.
To be published. Stage at time of publication ISO 80601‐2‐13:2011+DAmd 2:2017.
© ISO 2018 – All rights reserved
ISO 80601-2-55:2018(E)
IEC 60068‐2‐64:2008, Environmental testing — Part 2-64: Test methods — Test Fh: Vibration, broad
band random and guidance
IEC 60529:1989+Amd 1:1999 and Amd 2:2013, Degrees of protection provided by enclosures (IP code)
IEC 60601‐1‐11:2015, Medical electrical equipment — Part 1-11: General requirements for basic safety
and essential performance — Collateral Standard: Requirements for medical electrical equipment and
medical electrical systems used in the home healthcare environment
IEC 60601‐1‐12:2014, Medical electrical equipment — Part 1-12: General requirements for basic safety
and essential performance — Collateral Standard: Requirements for medical electrical equipment and
medical electrical systems intended for use in the emergency medical services environment
IEC 62570:2014, Standard practice for marking medical devices and other items for safety in the magnetic
resonance environment
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601‐1:2005+Amd 1:2012,
IEC 60601‐1‐2, IEC 60601‐1‐6:2010+Amd 1:2013, IEC 60601‐1‐8:2006+Amd 1:2012, IEC 60601‐1‐11,
IEC 60601‐1‐12 and ISO 80601‐2‐13:2011+Amd 1:2015 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at https://www.electropedia.org/
— ISO Online browsing platform: available at https://www.iso.org/obp
Addition:
NOTE An alphabetical list of defined terms is given in Annex DD.
201.3.201
DIVERTING RGM
SIDESTREAM MONITOR
RGM that transports a portion of respiratory gases from the SAMPLING SITE through a SAMPLING TUBE to the
SENSOR, which is remote from the SAMPLING SITE
201.3.202
DRIFT
change in the GAS READING of an RGM, for a given GAS LEVEL over a stated period of time, under reference
conditions that remain constant
201.3.203
GAS LEVEL
content of a specific gas in a gaseous mixture

A consolidated edition, IEC 60529:2013, which includes IEC 60529:1989 and its amendments
(IEC 60529:1989/Amd 1:1999 and IEC 60529:1989/Amd 2:2013) is available.
© ISO 2018 – All rights reserved
ISO 80601-2-55:2018(E)
201.3.204
GAS READING
measured GAS LEVEL as displayed by the RGM
201.3.205
MEASUREMENT ACCURACY
quality which characterizes the ability of an RGM to give indications approximating to the true value of
the quantity measured
201.3.206
MINIMUM ALVEOLAR CONCENTRATION
MAC
alveolar concentration of an inhaled anaesthetic agent that, in the absence of other anaesthetic agents
and at equilibrium, prevents 50 % of subjects from moving in response to a standard surgical stimulus
Note 1 to entry: For the purposes of this document, MAC is calculated from the end‐tidal GAS LEVEL.
201.3.207
NON-DIVERTING RGM
MAINSTREAM MONITOR
RGM that uses a SENSOR at the SAMPLING SITE
201.3.208
PARTIAL PRESSURE
pressure that each gas in a gas mixture would exert if it alone occupied the volume of the mixture at the
same temperature
201.3.209
RESERVE ELECTRICAL POWER SOURCE
part of the ME EQUIPMENT that temporarily supplies power to the electrical system in the event of an
interruption of the primary electrical supply
201.3.210
RESPIRATORY GAS MONITOR
RGM
ME EQUIPMENT intended to measure the GAS LEVEL or PARTIAL PRESSURE of one or more gases in respiratory
gas
Note 1 to entry: The RGM consists of equipment, as specified in the ACCOMPANYING DOCUMENTS for the INTENDED USE of
the RGM, including a SENSOR, display, ALARM SYSTEM, ACCESSORIES and, for a DIVERTING RGM, the SAMPLING TUBE and
exhaust port.
201.3.211
RISE TIME
RT
time taken for a value to rise from 10 % to 90 % of the indicated reading
[SOURCE: ISO 23747:2015, 3.9, modified — replaced “achieved PEF (peak expiratory flowrate)” by
“indicated reading” and “flowrate” by “a value”.]
© ISO 2018 – All rights reserved
ISO 80601-2-55:2018(E)
201.3.212
SAMPLING SITE
location of the SENSOR for a NON‐DIVERTING RGM or location at which respiratory gases are diverted for
measurement to a remote SENSOR for a DIVERTING RGM
201.3.213
SAMPLING TUBE
conduit for the transfer of gas from the SAMPLING SITE to the SENSOR in a DIVERTING RGM
201.3.214
SENSOR
part of the RGM that is sensitive to the presence of the respiratory gas
201.3.215
TOTAL SYSTEM RESPONSE TIME
time from a step function change in GAS LEVEL at the SAMPLING SITE to the achievement of 90 % of the final
GAS READING of the RGM
201.3.216
VOLUME PERCENT
volume of a gas in a mixture, expressed as a percentage of the total volume
201.4 General requirements
IEC 60601‐1:2005+Amd 1:2012, Clause 4 applies, except as follows:
201.4.3 ESSENTIAL PERFORMANCE
IEC 60601‐1:2005+Amd 1:2012, 4.3 applies, except as follows:
Additional subclause:
201.4.3.101 *Additional requirements for ESSENTIAL PERFORMANCE
Additional ESSENTIAL PERFORMANCE requirements are found in the subclauses listed in Table 201.101.
Table 201.101 — Distributed ESSENTIAL PERFORMANCE requirements
Requirement Subclause
a
MEASUREMENT ACCURACY and ALARM CONDITION for the GAS READING 201.12.1.101
or generation of a TECHNICAL ALARM CONDITION 201.11.8.101.1,
208.6.1.2
a
Methods of evaluating MEASUREMENT ACCURACY as acceptance criteria following specific tests
required by this document are found in 202.8.1.
201.4.6 *ME EQUIPMENT or ME SYSTEM parts that contact the PATIENT
Amendment (add at end of 4.6 prior to the compliance check):
Parts and ACCESSORIES of an RGM intended to be connected with the breathing system shall be subject to
the requirements for APPLIED PARTS according to this subclause.
© ISO 2018 – All rights reserved
ISO 80601-2-55:2018(E)
201.5 General requirements for testing of ME EQUIPMENT
IEC 60601‐1:2005+Amd 1:2012, Clause 5 applies.
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
IEC 60601‐1:2005, Clause 6 applies.
201.7 ME EQUIPMENT identification, marking, and documents
IEC 60601‐1:2005+Amd 1:2012, Clause 7 applies, except as follows.
201.7.2.3 *Consult ACCOMPANY
...