EN ISO 80601-2-55:2018

SLOVENSKI STANDARD
01-maj-2018
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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) 201.7.9.2.9.1
...