EN ISO 80601-2-55:2011

SLOVENSKI STANDARD
01-november-2013
1DGRPHãþD
SIST EN ISO 21647:2009
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 80601-2-55:2011)
Medizinische elektrische Geräte - Teil 2-55: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Überwachungsgeräten für
Atemgase (ISO 80601-2-55:2011)
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-
55:2011)
Ta slovenski standard je istoveten z: EN ISO 80601-2-55:2011
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.

EUROPEAN STANDARD
EN ISO 80601-2-55
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2011
ICS 11.040.10 Supersedes EN ISO 21647:2009
English Version
Medical electrical equipment - Part 2-55: Particular requirements
for the basic safety and essential performance of respiratory gas
monitors (ISO 80601-2-55:2011)
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 80601-2-55:2011) Überwachungsgeräten für Atemgase (ISO 80601-2-
55:2011)
This European Standard was approved by CEN on 2 December 2011.

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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 80601-2-55:2011: E
worldwide for CEN national Members.

Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4

Foreword
This document (EN ISO 80601-2-55:2011) 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 June 2012, and conflicting national standards shall be withdrawn at
the latest by December 2014.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 21647:2009.
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.
For relationship with EU Directive, 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 80601-2-55:2011 has been approved by CEN as a EN ISO 80601-2-55:2011 without any
modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC
This International Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means to conforming to Essential Requirements of the
New Approach Directive 93/42/EEC, Council Directive of 14 June 1993 on the approximation of the laws of
the Member States concerning medical devices” (Medical Device Directive).
Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the 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.
Table ZA.1 — Correspondence between this European Standard
and Directive 93/42/EEC
Clause(s)/subclause(s) of this Essential requirements (ERs) Qualifying remarks/Notes
European Standard of EU Directive 93/42/EEC
201.11.6.4 to 201.11.6.6 7.2 Only the parts of ER 7.2 relating to
safety in use for the patient are
addressed
201.11.6.4, 201.11.6.8 7.3 Only the part of the first sentence
relating to design is addressed
201.11.6.4 7.5
201.11.6.5, 201.101 7.6
201.11.6.6, 201.11.6.7 , 201.105 8.1 The part of ER 8.1 relating to easy
handling is not addressed
201.11.6.7 8.4 Validated processes for
sterilization are required via the
normative references to
ISO 11134, ISO 11135, ISO 11137
201.7.2.17.101 8.7
201.7.2.101, 201.7.2.4.101, 201.7.2.13.101, 9.1
201.7.2.17.101, 201.12.1.102, 201.102,
201.103, 208
th
201.9, 201.101, 202, 206 9.2 The 4 indent of ER 9.2 is not
addressed
Table ZA.1 (continued)
Clause(s)/subclause(s) of this Essential requirements (ERs) Qualifying remarks/Notes
European Standard of EU Directive 93/42/EEC
201.11 9.3
201.12.1, 201.101 10.1
201.7, 201.12.1.103, 201.12.1.104, 206, 10.2
201.7.4.3 10.3
201.10 11.1.1
202 11.3.1
201.14 12.1
201.14 12.1 a)
201.11.8.101, 208 12.2
201.11.8.101, 208 12.3
208 12.4
202 12.5
201.8 12.6
201.9 12.7.1
201.9 12.7.2
201.9 12.7.3
201.8, 201.15, 201.103 12.7.4
201.11 12.7.5
201.104 12.8.2 Only the first sentence of ER
12.8.2 is covered
201.7, 201.12.1, 206 12.9
201.7, 201.7.2.4.101, 201.7.2.13.101, 13.1
201.7.2.17.101, 201.7.2.101
201.7, 201.7.2.3, 201.7.2.13.101, 13.2
201.7.2.17.101, 201.7.2.101
201.7.9.1 13.3 a)
201.7, 201.7.2.17.101, 201.7.2.101 13.3 b)
201.7, 201.7.2.17.101 13.3 c)
201.7.2.17.101, 201.7.2.101 13.3 d) Is only covered if the batch
number is preceded by the word
LOT
201.7.2.101 13.3 e)
201.7.2.4.101, 201.7.2.17.101 b) 13.3 f) Distinction between “single use“
and “single-patient use” taken into
account
201.7.2.101 a) 13.3 i)
201.7, 201.7.2 13.3 j)
Table ZA.1 (continued)
Clause(s)/subclause(s) of this Essential requirements (ERs) Qualifying remarks/Notes
European Standard of EU Directive 93/42/EEC
201.7, 201.7.9.2.2.101 13.3 k)
201.7, 201.7.2.17 a) 13.3 m) Presumption of conformity is only
provided if symbols 5.21 to 5.24
are utilized
201.7.9.2.1.101 a), 201.7.2.17.101, 13.4
201.7.2.101
201.7.2.17.101 a), 201.7.2.101 b) 13.5 Is only covered if the batch
number is preceded by the word
LOT
201.7, 201.7.9.1, 201.7.9.2.1.101, 13.6 a)
201.7.9.2.2.101
201.7, 201.7.9.2.1.101, 201.7.9.2.2.101, 13.6 b)
201.7.9.2.9.101 c), 201.7.9.2.9.101 d)
201.7, 201.7.9.2.2.101, 201.7.9.2.5.101, 13.6 c)
201.7.9.2.9.101 e)
201.7, 201.7.9.2.13.101 13.6 d)
201.7, 201.7.9.2.9.101 g), , 13.6 f)
201.7.9.2.9.101 k)
201.7.9.2.14.101 b) 13.6 g)
201.7, 201.7.9.2.9.101 l) , 13.6 h)
201.7.9.2.14.101 b)
201.7 13.6 i)
201.7.9.2.1.101 c) 13.6 j)
201.7 13.6 k)
201.7 13.6 l)
201.7, 201.7.9.2.14.101 c), 13.6 n)
201.7.9.2.15.101
201.12.1.101.1 13.6 p)
201.7.9.2.9.101 m) 13.6 q)
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
International Standard. 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)
Clause(s)/subclause(s) of this Essential health and safety Qualifying remarks/Notes
European Standard requirements (ERs)
of EU Directive 2006/42/EC
201.7, 201.12.1 1.1.4 Only the first sentence of EHSR
1.1.4 is addressed
201.12.1, 201.12.1.104, 206, 208.6.5.1, 1.2.2 Only the parts of EHST 1.2.2
208.6.6.2.101 relevant to the RGM are
addressed
201.7.2.101 d), 201.7.2.101 e), 1.5.4
201.7.2.101 f), 201.7.2.101 g)
201.7.2.101 h), 201.103, 201.105
201.7 1.6.2
201.8 1.6.3
201.7, 201.7.2.101 i) 3.6.2
WARNING: Other requirements and other EU Directives may be applicable to the products falling within the
scope of this standard.
INTERNATIONAL ISO
STANDARD 80601-2-55
First edition
2011-12-15
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 80601-2-55:2011(E)
©
ISO 2011
ISO 80601-2-55:2011(E)
©  ISO 2011
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
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ii © ISO 2011 – All rights reserved

ISO 80601-2-55:2011(E)
Contents Page
Foreword . vi
Introduction . vii
1  Scope . 1
201.1 Scope, object and related standards . 1
201.1. 1  * Scope . 1
201.1. 2  Object . 2
201.1. 3  Collateral standards . 2
201.1. 4  Particular standards . 2
201.2 Normative references . 3
201.3 Terms and definitions . 4
201.4 General requirements . 6
201.4. 3  ESSENTIAL PERFORMANCE . 6
201.4. 3.101  * Additional requirements for ESSENTIAL PERFORMANCE . 6
201.4. 3.102  Additional requirements for acceptance criteria . 6
201.4. 6  * ME EQUIPMENT or ME SYSTEM parts that contact the PATIENT . 6
201.4.10.2.101  * Additional requirements for SUPPLY MAINS for ME EQUIPMENT and ME SYSTEMS . 6
201.5 General requirements for testing ME EQUIPMENT . 7
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 7
201.7 ME EQUIPMENT identification, marking and documents . 7
201.7. 2.3  * Consult ACCOMPANYING DOCUMENTS . 7
201.7. 2.101  * Additional requirements for marking on the outside of ME EQUIPMENT or
ME EQUIPMENT parts . 7
201.7. 2.4.101  Additional requirements for ACCESSORIES . 8
201.7. 2.13.101  * Additional requirements for physiological effects (safety signs and warning
statements) . 8
201.7. 2.17.101  Additional requirements for protective packaging . 8
201.7. 4.3  Unit of measure . 8
201.7. 9.1  General requirements . 9
201.7. 9.2.1.101  * Additional general requirements . 9
201.7. 9.2.2.101  * Additional requirements for warnings and safety notices . 9
201.7. 9.2.5.101  Additional requirements for ME EQUIPMENT description . 10
201.7. 9.2.8.101  * Additional requirements for start-up procedure . 10
201.7. 9.2.9.101* Additional requirements for operating instructions . 10
201.7. 9.2.13.101  * Additional requirements for maintenance . 11
201.7. 9.2.14.101  * Additional requirements for ACCESSORIES, supplementary equipment, used
material 11
201.7. 9.2.15.101* Additional requirements for environmental protection . 11
201.7. 9.3.101  * Additional requirements for technical description. 12
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 12
201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS . 12
201.10 Protection against unwanted and excessive radiation HAZARDS . 12
201.11 Protection against excessive temperatures and other HAZARDS . 12
201.11. 6.4  Leakage . 12
201.11. 6.5  * Ingress of water or particulate matter into ME EQUIPMENT or ME SYSTEMS . 13
201.11. 6.6  * Cleaning and disinfection of ME EQUIPMENT or ME SYSTEMS . 13
201.11. 6.7  Sterilization of ME EQUIPMENT or ME SYSTEMS . 13
ISO 80601-2-55:2011(E)
201.11. 6.8  Compatibility with substances used with ME EQUIPMENT .13
201.11. 8.101  Additional requirements for interruption of the power supply/SUPPLY MAINS to
ME EQUIPMENT .14
201.11. 8.101.1  * Supply failure TECHNICAL ALARM CONDITION .14
201.11. 8.101.2  * Settings and data storage following short interruptions or automatic
switchover .14
201.11. 8.101.3  * Operation following long interruptions .14
201.11. 8.101.4  * RESERVE ELECTRICAL POWER SOURCE .14
201.11. 8.101.5  * RESERVE ELECTRICAL POWER SOURCE for transport outside a healthcare facility .15
201.12 Accuracy of controls and instruments and protection against hazardous outputs .15
201.12. 1  Accuracy of controls and instruments .15
201.12. 1.101  * Measurement accuracy .15
201.12. 1.101.1  General .15
201.12. 1.101.2  * DRIFT of MEASUREMENT ACCURACY .16
201.12. 1.101.3  * MEASUREMENT ACCURACY of GAS READINGS for gas mixtures .17
201.12. 1.102  * TOTAL SYSTEM RESPONSE TIME and rise time .17
201.12. 1.103  * Indication of units of measure for GAS READINGS .18
201.12. 1.104  * Indication of operating mode .19
201.13 HAZARDOUS SITUATIONS and fault conditions .19
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .19
201.15 Construction of ME EQUIPMENT.19
201.15. 3.5.101  * Additional requirements for rough handling .19
201.15. 3.5.101.1  * Shock and vibration .19
201.15. 3.5.101.2  * Shock and vibration for professional transportation .20
201.15. 101  * Mode of operation .21
201.16 ME SYSTEMS .21
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS .21
201.101 * Interfering gas and vapour effects .22
201.102 * Gas leakage.22
201.103 * Port connector for DIVERTING RGM .22
201.104 * Minimum sampling flowrate .23
201.105 * Contamination of breathing systems .23
201.105. 1  Sampling tube .23
201.105. 2  Exhaust tube .23
202  Electromagnetic compatibility — Requirements and tests .23
202.6.2.1.7  * PATIENT simulation .23
202.6.2.1.10  Compliance criteria .23
202.6.2.3.1  * Requirements.24
206  Usability .24
206.6.2.2.2  Primary operating functions .24
208  General requirements, tests and guidance for alarm systems in medical electrical
equipment and medical electrical systems .24
208.6.1.2  * ALARM CONDITION priority .24
208.6.5.1  * General requirements .26
208.6.6.2.101  * Additional requirements for adjustable ALARM LIMIT .26
208.6.8.5.101  * Additional requirements for ALARM SIGNAL deactivation states, indication and
access 26
209  Requirements for environmentally conscious design .26
iv © ISO 2011 – All rights reserved

ISO 80601-2-55:2011(E)
210  Requirements for the development of physiologic closed-loop controllers . 26
211  Requirements for MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS used in
the home healthcare environment . 27
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT and
ME SYSTEMS . 28
201.C.1 Marking on the outside of ME EQUIPMENT, ME SYSTEMS or their parts . 28
201.C.4 ACCOMPANYING DOCUMENTS, general . 28
201.C.5 ACCOMPANYING DOCUMENTS, instructions for use . 29
201.C.6 ACCOMPANYING DOCUMENTS, technical description . 30
Annex D (informative) Symbols on marking . 31
Annex AA (informative) Particular guidance and rationale . 33
Annex BB (informative) Environmental aspects . 43
Annex CC (informative) Test gas mixtures for calibration . 45
Annex DD (informative) Reference to the essential principles . 46
Bibliography . 48

ISO 80601-2-55:2011(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 80601-2-55 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 1, Breathing attachments and anaesthetic machines and IEC/TC 62, Electrical equipment
in medical practice, Subcommittee SC 62D, Electromedical equipment.
This first edition cancels and replaces ISO 21647:2004 and ISO 21647:2004/Cor.1:2005. This edition
constitutes a minor technical revision and alignment with the third edition of IEC 60601-1.
ISO 80601 consists of the following parts, under the general title Medical electrical equipment:
— Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
— Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic
workstation
— Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas
monitors
— Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for
body temperature measurement
— Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter
equipment
IEC 80601-2-30: Particular requirements for basic safety and essential performance of automated non-
invasive sphygmomanometers, IEC 80601-2-35: Particular requirements for basic safety and essential
performance of heating devices using blankets, pads or mattresses and intended for heating in medical use,
IEC 80601-2-58: Particular requirements for basic safety and essential performance of lens removal devices
and vitrectomy devices for ophthalmic surgery, IEC 80601-2-59: Particular requirements for basic safety and
essential performance of screening thermographs for human febrile temperature screening and
IEC 80601-2-60: Particular requirements for basic safety and essential performance of dental equipment are
published by IEC.
vi © ISO 2011 – All rights reserved

ISO 80601-2-55:2011(E)
Introduction
In this International Standard, the following print types are used:
 Requirements and definitions: roman type.
 Test specifications: italic type.
 Informative material appearing outside of tables, such as notes, examples and references: smaller type. Normative
text of tables is also in a smaller type.
 TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL
CAPITALS.
In referring to the structure of this International Standard, the term
 “clause” means one of the 17 numbered divisions within the table of contents, inclusive of all subdivisions
(e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
 “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 International Standard are preceded by the term “Clause” followed by the
clause number. References to subclauses within this particular standard are by number only.
In this International Standard, 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 International Standard conform to usage described in Annex H of the
ISO/IEC Directives, Part 2. For the purposes of this standard, the auxiliary verb:
 “shall” means that compliance with a requirement or a test is mandatory for compliance with this
standard;
 “should” means that compliance with a requirement or a test is recommended but is not mandatory for
compliance with this standard;
 “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 a rationale related to that item in Annex AA.
The attention of Member Bodies and National Committees is drawn to the fact that equipment
MANUFACTURERS and testing organizations may need a transitional period following publication of a new,
amended or revised ISO or IEC publication in which to make products in accordance with the new
requirements and to equip themselves for conducting new or revised tests. It is the recommendation of the
committee that the content of this publication be adopted for mandatory implementation nationally not earlier
than 3 years from the date of publication for equipment newly designed and not earlier than 5 years from the
date of publication for equipment already in production.

INTERNATIONAL STANDARD ISO 80601-2-55:2011(E)

Medical electrical equipment —
Part 2-55:
Particular requirements for the basic safety and essential
performance of respiratory gas monitors
1 Scope
201.1 Scope, object and related standards
IEC 60601-1:2005, Clause 1 applies, except as follows:
201.1.1 * Scope
Replacement:
This International Standard 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 International Standard specifies requirements for
 anaesthetic gas monitoring,
 carbon dioxide monitoring, and
 oxygen monitoring.
NOTE 1 An RGM can be either standalone ME EQUIPMENT or integrated into other equipment, e.g. an anaesthetic
workstation or a ventilator.
This International Standard is not applicable to an RGM intended for use with flammable anaesthetic agents.
Environmental aspects are addressed in Annex BB.
NOTE 2 Additional aspects of environmental impact are addressed in ISO 14971 and IEC 60601-1-9.
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 standard are not covered by specific requirements in this particular standard, except in 7.2.13 and 8.4.1 of
the general standard (IEC 60601-1).
NOTE 3 See also 4.2 of the general standard.
ISO 80601-2-55:2011(E)
201.1.2 Object
Replacement:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE
requirements for an RGM (as defined in 201.3.210) and its ACCESSORIES.
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
Addition:
This particular standard refers to those applicable collateral standards that are listed in Clause 2 of the
general standard and Clause 201.2 of this particular standard.
IEC 60601-1-3 does not apply.
201.1.4 Particular standards
Subclause 1.4 of the general standard is replaced by:
In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in the
general standard as appropriate for the particular ME EQUIPMENT under consideration, and may add other
BASIC SAFETY and ESSENTIAL PERFORMANCE requirements.
A requirement of a particular standard takes priority over the general standard.
For brevity, IEC 60601-1 is referred to in this particular standard as the general standard. Collateral standards
are referred to by their document number.
The numbering of clauses and subclauses of this particular standard corresponds to that of the general
standard with the prefix “201” (e.g. 201.1 in this particular standard addresses the content of Clause 1 of the
general standard) or applicable collateral standard with the prefix “20x” where x is the final digit(s) of the
collateral standard document number (e.g. 202.4 in this particular standard addresses the content of Clause 4
of the IEC 60601-1-2:2007 collateral standard, 206.4 in this particular standard addresses the content of
Clause 4 of the IEC 60601-1-6:2010 collateral standard, etc.).
The changes to the text of the general standard are specified by the use of the following words:
“Replacement” means that the clause or subclause of the general standard or applicable collateral standard is
replaced completely by the text of this particular standard.
“Addition” means that the text of this particular standard is additional to the requirements of the general
standard or applicable collateral standard.
“Amendment” means that the clause or subclause of the general standard or applicable collateral standard is
amended as indicated by the text of this particular standard.
Subclauses or figures which are additional to those of the general standard are numbered starting from
201.101. Additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.
Subclauses or figures which are additional to those of a collateral standard are numbered starting from 20x,
where “x” is the number of the collateral standard, e.g. 202 for IEC 60601-1-2:2007, 203 for
IEC 60601-1-3:2008, etc.
2 © ISO 2011 – All rights reserved

ISO 80601-2-55:2011(E)
The term “this standard” is used to make reference to the general standard, any applicable collateral
standards and this particular standard taken together.
Where there is no corresponding section, clause or subclause in this particular standard, the section, clause
or subclause of the general standard or applicable collateral standard, although possibly not relevant, applies
without modification; where it is intended that any part of the general standard or applicable collateral standard,
although possibly relevant, is not to be applied, a statement to that effect is given in this particular standard.
201.2 Normative references
The following referenced documents are indispensable for the application 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, Clause 2 applies, except as follows:
Replacement:
IEC 60601-1-2:2007, Medical electrical equipment — Part 1-2: General requirements for basic safety and
essential performance — Collateral Standard: Electromagnetic compatibility — Requirements and tests
IEC 60601-1-6:2010, Medical electrical equipment — Part 1-6: General requirements for basic safety and
essential performance — Collateral standard: Usability
IEC 60601-1-8:2006, 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 7000:2004, Graphical symbols for use on equipment — Index and synopsis
ISO 7010:2011, Graphical symbols — Safety colours and safety signs — Registered safety signs
ISO 14937, 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
1)
ISO 15223-1:— , Medical devices — Symbols to be used with medical device labels, labelling and information
to be supplied — Part 1: General requirements
Amendment 1:2008
ISO 17664, Sterilization of medical devices — Information to be provided by the manufacturer for the
processing of resterilizable medical devices
ISO 80369-1:2010, Small-bore connectors for liquids and gases in healthcare applications — Part 1: General
requirements
2 )
ISO/IEC 80601-2-13:2011 , 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

1) To be published.
2) Cancels and replaces ISO 8835-2:2007, ISO 8835-3:2007, ISO 8835-4:2004, ISO 8835-5:2004 and IEC 60601-2-13:2003.
ISO 80601-2-55:2011(E)
IEC 60068-2-31:2008, Environmental testing — Part 2-31: Tests — Test Ec: Rough handling shocks, primarily
for equipment type specimens
IEC 60068-2-64:2008, Environmental testing — Part 2-64: Test methods — Test Fh: Vibration, broad band
random and guidance
IEC 60529:2001, Degrees of protection provided by enclosures (IP code)
Corrigendum 1:2003
Corrigendum 2:2007
Corrigendum 3:2009
IEC 60601-1-9:2007, Medical electrical equipment — Part 1-9: General requirements for basic safety and
essential performance — Collateral Standard: Requirements for environmentally conscious design
IEC 60601-1-10:2007, Medical electrical equipment — Part 1-10: General requirements for basic safety and
essential performance — Collateral Standard: Requirements for the development of physiologic closed-loop
controllers
IEC 60601-1-11:2010, 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
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005, IEC 60601-1-2:2007,
IEC 60601-1-6:2010, IEC 60601-1-8:2006, IEC 60601-1-11:2010 and ISO/IEC 80601-2-13:2011 apply, except
as follows:
NOTE An alphabetized index of defined terms is found beginning on page 50.
Addition:
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
201.3.204
GAS READING
GAS LEVEL as displayed by the RGM
measured
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
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ISO 80601-2-55:2011(E)
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 For the purposes of this International Standard, 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
201.3.20
...