EN ISO 80601-2-69:2014

SLOVENSKI STANDARD
01-oktober-2014
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SIST EN ISO 8359:2009
SIST EN ISO 8359:2009/A1:2012
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Medical electrical equipment - Part 2-69: Particular requirements for basic safety and
essential performance of oxygen concentrator equipment (ISO 80601-2-69:2014)
Medizinische elektrische Geräte - Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale für Sauerstoff-Konzentratoren (ISO
80601-2-69:2014)
Appareils électromédicaux - Partie 2-63 : exigences particulières pour la sécurité de
base et les performances essentielles des dispositifs concentrateurs d'oxygène (ISO
80601-2-69:2014)
Ta slovenski standard je istoveten z: EN ISO 80601-2-69:2014
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 80601-2-69
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2014
ICS 11.040.10 Supersedes EN ISO 8359:2009
English Version
Medical electrical equipment - Part 2-69: Particular requirements
for basic safety and essential performance of oxygen
concentrator equipment (ISO 80601-2-69:2014)
Appareils électromédicaux - Partie 2-69: Exigences Medizinische elektrische Geräte - Teil 2-69: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des dispositifs concentrateurs d'oxygène (ISO wesentlichen Leistungsmerkmale für Sauerstoff-
80601-2-69:2014) Konzentratoren (ISO 80601-2-69:2014)
This European Standard was approved by CEN on 28 May 2014.

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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 80601-2-69:2014 E
worldwide for CEN national Members.

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

Foreword
This document (EN ISO 80601-2-69:2014) 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 January 2015, and conflicting national standards shall be withdrawn at
the latest by July 2017.
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 8359:2009.
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(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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 80601-2-69:2014 has been approved by CEN as EN ISO 80601-2-69:2014 without any
modification.
Annex ZA
(informative)
Relationship between this Document and
the Essential Requirements of EU Directive 93/42/EEC
This Document 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 document 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
document given in Table ZA.1, within the limits of the scope of this document, a presumption of conformity
with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA.1 — Correspondence between this Document and Directive 93/42/EEC
Clause/subclause Corresponding essential Qualifying remarks/notes
of this Document requirement of
Directive 93/42/EEC
201.11.6.4, 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, 201.11.6.6 7.3 Only the part of the first sentence
of ER 7.3 relating to design is
addressed.
201.11.6.4 7.5
201.11 7.6
201.11.6.6, 201.11.6.7 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 11135-1, ISO 11137-1 and
ISO 17665-1.
201.4.6, 201.7.2.4.101, 9.1
201.7.2.13.101, 201.7.2.17.101,
201.7.2.101, 201.7.9.2.2.101,
201.7.9.2.5.101, 201.7.9.2.14.101,
201.12.1.101, 201.12.1.102,
201.12.1.103, 201.16, 201.101,
201.102
201.9, 202, 206, 211 9.2 The 4th indent of ER 9.2 is not
addressed.
201.11 9.3
201.12.1, 201.102 10.1 The part of ER 10.1 relating to
stability is not addressed.
Clause/subclause Corresponding essential Qualifying remarks/notes
of this Document requirement of
Directive 93/42/EEC
201.7, 201.12.1, 206, 208 10.2
201.7.4.3 10.3
201.14 12.1
201.14 12.1 a)
202 12.5
201.8 12.6
201.9, 211 12.7.1
201.9 12.7.2
201.9 12.7.3
201.8, 201.101, 201.15, 201.103 12.7.4
201.11 12.7.5
201.12.1 12.8.1 Only the protection of the PATIENT
is covered.
201.12.4 12.8.2 Only the first sentence of ER

12.8.2 is covered.
201.7, 206 12.9
201.7, 201.11.6.4 13.1
201.7.2.1, 201.7.2.13.101, 13.2
201.7.2.17.101, 201.7.2.101,
201.8, 201.9, 201.11.6.4
201.7.9.1 13.3 a)
201.7.2.17.101 13.3 b)
201.7, 201.7.2.17.101 a) 13.3 c)
201.7.2.17.101 13.3 d) Is only covered if the batch number
is preceded by the word LOT.
201.7.2.17.101 13.3 f)
201.7.2.101 a), 211 13.3 i)
201.7.2.101 b), 201.7.2.101 d), 211 13.3 j)
201.7.2.101 b) 13.3 k)
201.7, 201.7.2.17.101 a) 13.3 m) Presumption of conformity is only
provided if one of the symbols 5.21
to 5.24 from ISO 15223-1:2012 are

utilized, as applicable.
201.7.9.1, 201.7.9.2, 201.16 13.6 a)
201.7.9.2.5.101 13.6 b)
201.7.9.2.14.101, 201.16, 201.102 13.6 c)
201.7, 201.7.9.2.8.101, 13.6 d)
201.7.9.2.13.101, 201.16
Clause/subclause Corresponding essential Qualifying remarks/notes
of this Document requirement of
Directive 93/42/EEC
201.16 13.6 f)
201.7.9.2.1.101, 201.7.9.2.12, 13.6 h)
201.16, 211
201.7 13.6 i)
211 13.6 k)
211 13.6 k)
211 13.6 l)
211 13.6 n)
201.12.1.103, 211 13.6 p)
WARNING: Other requirements and other EU Directives may be applicable to the products falling within the
scope of this European Standard.
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
European 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)/sub-clause(s) EHSR of 2006/42/EC Qualifying remarks/Notes
of this EN
— 1.1.4 This relevant EHSR is not
covered by this European
Standard.
201.12.1, 201.12.101 1.2.2
201.7.2.101 c), 201.7.2.101 d), 1.5.4
201.101
— 1.6.2 This relevant EHSR is not
covered by this European
Standard.
201.8 1.6.3
INTERNATIONAL ISO
STANDARD 80601-2-69
First edition
2014-07-15
Medical electrical equipment —
Part 2-69:
Particular requirements for basic safety
and essential performance of oxygen
concentrator equipment
Appareils électromédicaux —
Partie 2-69: Exigences particulières pour la sécurité de base et
les performances essentielles des dispositifs concentrateurs
d'oxygène
Reference number
ISO 80601-2-69:2014(E)
©
ISO 2014
ISO 80601-2-69:2014(E)
©  ISO 2014
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
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56  CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
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Published in Switzerland
ii
ISO 80601-2-69:2014(E)
Contents Page
Foreword . 5
Introduction . 7
201.1 Scope, object and related standards . 1
201.2 Normative references . 3
201.3 Terms and definitions . 4
201.4 General requirements . 5
201.5 General requirements for testing of ME EQUIPMENT . 6
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 6
201.7 ME EQUIPMENT identification, marking and documents . 6
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 . 13
201.11 Protection against excessive temperatures and other HAZARDS . 13
201.12 Accuracy of controls and instruments and protection against hazardous outputs . 16
201.13 HAZARDOUS SITUATIONS and fault conditions . 20
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 20
201.15 Construction of ME EQUIPMENT . 20
201.16 ME SYSTEMS . 20
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 21
201.101 Outlet connector . 21
201.102 Requirements for parts and ACCESSORIES . 21
201.102.1  * General . 21
201.102.2  Labelling . 21
201.102.3  * Fire RISK reduction in ACCESSORIES . 22
201.103 SIGNAL INPUT/OUTPUT PART . 22
201.103.1  General . 22
201.103.2  * Connection to a DISTRIBUTED ALARM SYSTEM . 22
201.103.3  * Connection for remote control . 23
201.104 * Indication of duration of operation . 23
201.105 Integrated CONSERVING EQUIPMENT . 23
202  Medical electrical equipment – Part 1-2: General requirements for basic safety and
essential performance – Collateral standard: Electromagnetic compatibility –
Requirements and tests . 23
202.6.2.1.10  Compliance criteria . 23
206  Medical electrical equipment – Part 1-6: General requirements for basic safety and
essential performance – Collateral Standard: Usability . 23
208  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 . 24
iii
ISO 80601-2-69:2014(E)
211  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
............................................................................................................................. 24
211.4.2.2  Environmental operating conditions . 24
ANNEX C (informative) Guide to marking and labelling requirements for ME EQUIPMENT and
ME SYSTEMS . 25
Annex D (informative) Symbols on marking . 29
Annex AA (informative) Particular guidance and rationale . 30
Annex BB (informative) Reference to the Essential Principles . 37

Figures
Figure 201.101 – Standard resistance . 13

iv
ISO 80601-2-69:2014(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/IEC 80601-2-69 was prepared by a joint working group of Technical Committee ISO/TC 121,
Anaesthetic and respiratory equipment, Subcommittee SC 3, Lung ventilators and related
equipment and Technical Committee IEC/TC 62, Electrical equipment in medical practice,
Subcommittee SC D, Electrical equipment.
This first edition of ISO 80601-2-69 cancels and replaces the first edition of ISO 8359:1996. This
edition of ISO 80601-2-69 constitutes a major technical revision of ISO 8359:1996 and includes an
alignment with the third edition of IEC 60601-1 and IEC 60601-1-11.
The most significant changes are the following modifications:
– extending the scope to include not only the OXYGEN CONCENTRATOR but also its ACCESSORIES,
where the characteristics of those ACCESSORIES can affect the BASIC SAFETY and ESSENTIAL
PERFORMANCE of the OXYGEN CONCENTRATOR;
– identification of ESSENTIAL PERFORMANCE for an OXYGEN CONCENTRATOR and its ACCESSORIES;
– and the following additions:
 tests for oxygen delivery performance;
 new symbols;
 new requirement for a means to prevent the propagation of fire into the OXYGEN CONCENTRATOR
and its ACCESSORIES;
 tests for cleaning and disinfection PROCEDURES; and
 consideration of contamination of the breathing gas delivered to the PATIENT from the gas
pathways.
In this standard, the following print types are used:
– Requirements and definitions: roman type.
– Test specifications: italic type.
v
ISO 80601-2-69:2014(E)
– Informative material appearing outside of tables, such as notes, examples and references: in 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 TYPE.
In referring to the structure of this standard, the term
– "clause” means one of the seventeen 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 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 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 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 rationale related to that item in Annex A.
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 not be adopted for mandatory
implementation nationally 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.
vi
ISO 80601-2-69:2014(E)
Introduction
Oxygen supplementation can be part of management of PATIENTS with chronic, acute–on-chronic
and acute respiratory disorders. The amount of supplemental oxygen depends on the individual
PATIENT’S needs under various conditions. The managing healthcare team typically prescribes the
endpoint of treatment, for example a target value for oxygen saturation. The amount of
supplemental oxygen can be controlled by the flowrate.
The goal of long term oxygen therapy is to keep the oxygen saturation above 90 % in PATIENTS that
require supplemental oxygen. The flowrate should be adjusted for rest, exertion, and sleep to meet
the individual PATIENT’S needs under these various conditions. Ideally, the resting flowrate is
adjusted to maintain SpO > 90 % as indicated by pulse oximetry.
Supplemental oxygen is supplied by various sources: MEDICAL GAS PIPELINE SYSTEMS, OXYGEN
CONCENTRATORS, compressed gas cylinders, and liquid oxygen reservoirs. This standard covers the
particular requirements for BASIC SAFETY and ESSENTIAL PERFORMANCE of OXYGEN CONCENTRATORS.
OXYGEN CONCENTRATORS produce oxygen enriched air from room air for delivery to a PATIENT
requiring oxygen therapy. The most common OXYGEN CONCENTRATOR uses molecular sieve beds to
filter and concentrate oxygen molecules from the ambient air, generating oxygen concentrations of
typically 82 % to 96 %. The main component of this type of OXYGEN CONCENTRATOR is the molecular
sieve, which adsorbs nitrogen from air to produce a product gas which is a mixture of typically up to
95 % oxygen and 5 % of other gases. The periodic adsorbing and purging of nitrogen is referred to
as the pressure swing adsorption process.

vii
INTERNATIONAL STANDARD ISO 80601-2-69:2014(E)

Medical electrical equipment —
Part 2-69:
Particular requirements for basic safety and essential
performance of oxygen concentrator equipment
201.1 Scope, object and related standards
IEC 60601-1:2005+Amendment 1:2012, Clause 1 applies, except as follows:
201.1.1 Scope
IEC 60601-1:2005+Amendment 1:2012, 1.1 is replaced by:
This particular standard specifies requirements for the BASIC SAFETY and ESSENTIAL PERFORMANCE of an
OXYGEN CONCENTRATOR in combination with its ACCESSORIES, hereafter referred to as ME EQUIPMENT,
intended to increase the oxygen concentration of gas intended to be delivered to a single PATIENT. Such
OXYGEN CONCENTRATORS are typically intended for use in the HOME HEALTHCARE ENVIRONMENT, including
TRANSIT‐OPERABLE use by a single PATIENT in various environments including any private and public
transportation as well as in commercial aircraft.
NOTE 1 Such an OXYGEN CONCENTRATOR can also be used in professional healthcare facilities.
This particular standard is applicable to a TRANSIT‐OPERABLE and non‐TRANSIT‐OPERABLE OXYGEN
CONCENTRATOR. This particular standard is applicable to an OXYGEN CONCENTRATOR integrated into or used
with other medical devices, ME EQUIPMENT or ME SYSTEMS.
EXAMPLE 1 An OXYGEN CONCENTRATOR with integrated oxygen CONSERVING EQUIPMENT [10] or humidifier [4].
EXAMPLE 2 An OXYGEN CONCENTRATOR used with a flowmeter stand.
EXAMPLE 3 An OXYGEN CONCENTRATOR as part of an anaesthetic system for use in areas with limited logistical
supplies of electricity and anaesthetic gases. [3]
EXAMPLE 4 An OXYGEN CONCENTRATOR with an integrated liquid reservoir or gas cylinder filling system.
This particular standard is also applicable to those ACCESSORIES intended by their MANUFACTURER to be
connected to an OXYGEN CONCENTRATOR, where the characteristics of those ACCESSORIES can affect the
BASIC SAFETY or ESSENTIAL PERFORMANCE of the OXYGEN CONCENTRATOR.
This particular standard does not specify the requirements for OXYGEN CONCENTRATORS for use with a
MEDICAL GAS PIPELINE SYSTEM which are given in ISO 10083.
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.
ISO 80601-2-69:2014(E)
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 standard except in 7.2.13 and 8.4.1 of
the general standard.
NOTE 2 See also 4.2 of the General Standard.
This International Standard is a particular standard in the IEC 60601‐1 series of standards.
201.1.2 Object
IEC 60601-1:2005, 1.2 is replaced by:
The object of this International Standard is to establish particular BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements for an OXYGEN CONCENTRATOR [as defined in 201.3.203] and its ACCESSORIES.
NOTE ACCESSORIES are included because the combination of the OXYGEN CONCENTRATOR and the ACCESSORIES
needs to be adequately safe. ACCESSORIES can have a significant impact on the BASIC SAFETY or ESSENTIAL PERFORMANCE
of an OXYGEN CONCENTRATOR.
201.1.3 Collateral standards
IEC 60601-1:2005+Amendment 1:2012, 1.3 applies with the following addition:
This particular standard refers to those applicable collateral standards that are listed in IEC 60601‐
1:2005+Amendment 1:2012, Clause 2 of the general standard and 201.2 of this particular standard.
IEC 60601‐1‐3:2008+Amendment 1:2013 does not apply.
201.1.4 Particular standards
IEC 60601-1:2005+Amendment 1:2012, 1.4 is replaced by:
In the IEC 60601 series, particular standards may 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 the general standard or the collateral
standards.
For brevity, IEC 60601‐1:2005+Amendment 1:2012 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 those of the general
standard with the prefix “201” (e.g. 201.1 in this standard 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 in this particular standard addresses the content
of Clause 4 of the IEC 60601‐1‐2 collateral standard, 208.4 in this particular standard addresses the
content of Clause 4 of the IEC 60601‐1‐8 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.
ISO 80601-2-69:2014(E)
"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 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
2xx, 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 the general standard, any applicable collateral
standards and this particular standard taken together.
Where there is no corresponding 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. The way in
which these referenced documents are cited in normative requirements determines the extent (in
whole or in part) to which they apply. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
NOTE Informative references are listed in the Bibliography beginning on page 37.
IEC 60601-1:2005+Amendment 1:2012, 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
+Amendment 1:2013
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
+Amendment 1:2012
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
Addition:
ISO 3744:2010, Acoustics -- Determination of sound power levels and sound energy levels of noise sources
using sound pressure -- Engineering methods for an essentially free field over a reflecting plane
ISO 7000:2012, Graphical symbols for use on equipment -- Registered symbols
ISO 80601-2-69:2014(E)
ISO 7010:2011, Graphical symbols -- Safety colours and safety signs -- Registered safety signs
+Amendment 1:2012
+Amendment 2:2012
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 15223‐1:2012, Medical devices — Symbols to be used with medical device labels, labelling and
information to be supplied — Part 1: General requirements
ISO/DIS 14644‐1:2010, Cleanrooms and associated controlled environments -- Part 1: Classification of air
cleanliness by particle concentration
ISO 17664:2004, 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
ISO 80601‐2‐67:2014, Medical Electrical Equipment — Part 2-67: Particular requirements for basic
safety and essential performance of oxygen conserving equipment
IEC 60601‐1:2005, Medical electrical equipment – Part 1: General requirements for basic safety and
essential performance
Amendment 1:2012
IEC 62366:2007, Medical devices – Application of usability engineering to medical devices
+Amendment 1:2014
EN 15986:2011, Symbol for use in the labelling of medical devices - Requirements for labelling of medical
devices containing phthalates
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 3744:2010, ISO 4135:2001,
ISO 7396‐1:2007, IEC 60601‐1:2005+Amendment 1:2012, IEC 60601‐1‐2:2007,
IEC 60601‐1‐6:2010+Amendment 1:2013, IEC 60601‐1‐8:2006+Amendment 1:2012,
IEC 60601‐1‐11:2010, IEC 62366:2007+Amendment 1:2014 and the following apply.
NOTE An index of defined terms is found beginning on page 38.
Addition:
201.3.201
FLOW-DIRECTION-SENSITIVE COMPONENT
component or ACCESSORY through which gas flow has to be in one direction only for proper functioning
or PATIENT safety
[ISO 4135:2001, definition 3.1.7, modified]
ISO 80601-2-69:2014(E)
201.3.202
MAXIMUM LIMITED PRESSURE
P
LIM max
highest pressure at the outlet of the OXYGEN CONCENTRATOR during NORMAL USE or under SINGLE FAULT
CONDITION
201.3.203
OXYGEN CONCENTRATOR
ME EQUIPMENT, which by selective removal of constituents of ambient air, increases the concentration of
oxygen in the output gas
201.4 General requirements
IEC 60601-1:2005+Amendment 1:2012, Clause 4 applies, except as follows:
201.4.3 ESSENTIAL PERFORMANCE
IEC 60601-1:2005+Amendment 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
Delivery of oxygen, in both NORMAL CONDITION and SINGLE FAULT CONDITION, within
201.12.1.101
the performance levels as indicated in the instructions for use or generation of
201.12.1.102
an ALARM CONDITION
201.12.1.103
power supply failure TECHNICAL ALARM CONDITION 201.11.8.101.1
INTERNAL ELECTRICAL POWER SOURCE nears depletion TECHNICAL ALARM 201.11.8.101.2
CONDITION
low oxygen concentration TECHNICAL ALARM CONDITION 201.12.4.102
malfunction TECHNICAL ALARM CONDITION 201.13.2.101
Start‐up period TECHNICAL ALARM CONDITION 201.12.4.4.101.2
a
Subclause 202.6.2.1.10 indicates methods of evaluating delivered oxygen concentration as
acceptance criteria following specific tests required by this standard.

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):
The gas pathways of an OXYGEN CONCENTRATOR or its parts or ACCESSORIES shall be subject to the
requirements for APPLIED PARTS according to this subclause. An OXYGEN CONCENTRATOR or its parts or
ACCESSORIES that can come into contact with the PATIENT shall be subject to the requirements for APPLIED
PARTS according to this subclause.
ISO 80601-2-69:2014(E)
201.5 General requirements for testing of ME EQUIPMENT
IEC 60601-1:2005+Amendment 1:2012, Clause 5 applies, except as follows:
Addition:
201.5.101 Additional requirements for general requirements for testing of ME EQUIPMENT
201.5.101.1 * ME EQUIPMENT testing errors
For the purposes of this standard, tolerances declared in the ACCOMPANYING DOCUMENTS shall include the
uncertainty of the measurement used to determine the specification.
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
IEC 60601-1:2005+Amendment 1:2012, Clause 6 applies.
201.7 ME EQUIPMENT identification, marking and documents
IEC 60601-1:2005+Amendment 1:2012, Clause 7 applies, except as follows:
201.7.1.2 * Legibility of markings
IEC 60601-1:2005+Amendment 1:2012, 7.1.2 applies, except as follows:
Replacement (at the end of the second sentence of the second paragraph of the compliance check):
Replace ‘1 m’ with ‘1 m and for BODY-WORN ME EQUIPMENT 0,5 m’
Additional subclauses:
201.7.2.4.101 Additional requirements for ACCESSORIES
ACCESSORIES supplied separately shall fulfil the requirements of 201.7.2.101 and shall be marked with an
indication of any limitations or adverse effects of the ACCESSORY on the BASIC SAFETY or ESSENTIAL
PERFORMANCE of an OXYGEN CONCENTRATOR, if applicable. If marking the ACCESSORY is not practicable, this
information may be placed in the instructions for use.
Check compliance by inspection and inspection of the RISK MANAGEMENT FILE for any limitations or adverse
effects of the ACCESSORY.
201.7.2.13.101 Additional requirements for physiological effects
Any natural rubber latex‐containing components in the gas pathways or ACCESSORIES shall be marked as
containing latex. Such marking shall be CLEARLY LEGIBLE. Symbol 5.45 from ISO 15223‐1:2012, (Table
201.D.1.101, symbol 3) may be used. The instructions for use shall also disclose any natural rubber
latex‐containing components.
Check compliance by inspection.
201.7.2.17.101 Additional requirements for protective packaging
The indication of single use shall be consistent for a MODEL OR TYPE REFERENCE. The packaging for a MODEL
OR TYPE REFERENCE that is for single use shall be marked accordingly.
ISO 80601-2-69:2014(E)
Packages shall be CLEARLY LEGIBLE and shall be marked as follows.
a) with a description of the contents.
b) with an identification reference to the batch, type or serial number or symbol 5.1.5 or symbol
5.1.7 from ISO 15223-1:2012 (Table 201.D.1.101, symbol 1 or symbol 2).
c) with, for packages containing natural rubber latex, the word "LATEX", or symbol 5.35 from
ISO 15223-1:2012 (Table 201.D.1.101, symbol 3).
Check compliance by inspection.
201.7.2.101 Additional requirements for marking on the outside of ME EQUIPMENT or
ME EQUIPMENT parts
The marking of ME EQUIPMENT, parts or ACCESSORIES shall be CLEARLY LEGIBLE and shall include the
following
a) any particular storage and/or handling instructions.
b) any particular warnings and/or precautions relevant to the immediate operation of the OXYGEN
CONCENTRATOR.
If applicable, the marking of OPERATOR‐accessible ME EQUIPMENT, parts or ACCESSORIES shall be CLEARLY
LEGIBLE and shall include the following:
c) an arrow indicating the direction of the flow for FLOW-DIRECTION-SENSITIVE COMPONENTS that are
OPERATOR-removable without the use of a TOOL.
d) a warning against removal of the ACCESS COVER by unauthorized persons.
Check compliance by inspection.
201.7.4.3 * Units of measurement
IEC 60601-1:2005+Amendment 1:2012, 7.4.3 applies, except as follows:
Amendment (add to the bottom as a new row in Table 1):
Gas volume and flowrate specifications for gas delivered to the PATIENT shall be expressed at ATPD
(ambient temperature and pressure, dry).
NOTE For the purposes of this standard, ATPD is local atmospheric pressure and temperature, dry.
201.7.5 Safety signs
IEC 60601-1:2005+Amendment 1:2012, 7.5 applies, except as follows:
Amendment (add before the compliance test):
The following safety signs shall be CLEARLY LEGIBLE from the intended position of the OPERATOR and shall
include the following markings:
a) safety sign ISO 7010-P002 (Table 201.D.2.101, safety sign 1) or a warning to the effect of “No
Smoking”.
b) safety sign ISO 7010-P003 (Table 201.D.2.101, safety sign 2) or a warning to the effect of “No
Open Flame”.
ISO 80601-2-69:2014(E)
201.7.9.1 Additional general
IEC 60601-1:2005+Amendment 1:2012, 7.9.1 applies, except as follows:
Amendment (replace the first dash with):
– Name or trade name and address of
 the MANUFACTURER; and
 where the MANUFACTURER does not have an address within the locale, an authorized
representative within the locale,
to which the RESPONSIBLE ORGANIZATION can refer;
201.7.9.2 Instructions for use
IEC 60601-1:2005+Amendment 1:2012, 7.9.2 applies, except as follows:
Additional subclauses:
201.7.9.2.1.101 Additional general requirements
The instructions for use shall include the following:
a) a statement of the time required from switching on the OXYGEN CONCENTRATOR until it can be
relied upon to deliver the set flowrate and concentration of oxygen;
b) a statement that the air intake as well as the exhaust of the OXYGEN CONCENTRATOR should be
located in a well-ventilated area;
c) a statement advising the OPERATOR of actions to take when the OXYGEN CONCENTRATOR indicates
an abnormal condition;
d) a statement that the OXYGEN CONCENTRATOR should be located so as to avoid pollutants or fumes;
e) if the OXYGEN CONCENTRATOR, its parts or ACCESSORIES are intended for single use, information on
known characteristics and technical factors known to the MANUFACTURER that could pose a RISK if
the OXYGEN CONCENTRATOR, its parts or ACCESSORIES would be
...