ISO 80601-2-69:2014

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 2014
©  ISO 2014
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Published in Switzerland
ii
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
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
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
– 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
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.
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.
"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 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]
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.
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.
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”.
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 reused;
f) a statement to the effect that the oxygen delivery settings of the oxygen concentrator should periodically
reassessed for the effectiveness of the therapy.
NOTE In some countries, the supervising clinician has the responsibility to periodically reassess the oxygen delivery
settings.
If applicable, the instructions for use shall disclose the following:
g) at least one type of humidifier which is suitable for use with the OXYGEN CONCENTRATOR and its
preferred location.
Check compliance by inspection.
201.7.9.2.2.101 Additional requirements for warnings and safety notices
The instructions for use shall include:
a) a warning statement to the effect that “WARNING: There is a risk of fire associated with oxygen
enrichment during oxygen therapy. Do not use the oxygen concentrator or accessories near sparks or
open flames.”
b) a warning statement to the effect that “WARNING: To ensure receiving the therapeutic amount of
oxygen delivery according to your medical condition [insert model and brand] must
 be used only after one or more settings have been individually determined or prescribed for you
at your specific activity levels.
 be used with the specific combination of parts and accessories that are in line with the
specification of the concentrator manufacturer and that were used while your settings were
determined.”
c) a warning statement to the effect that “WARNING: Use only water-based lotions or salves that are
oxygen-compatible before and during oxygen therapy. Never use petroleum or oil-based lotions or salves
to avoid the risk of fire and burns”.
d) a warning statement to the effect that “WARNING: Do not lubricate fittings, connections, tubing, or other
accessories of the oxygen concentrator to avoid the risk of fire and burns.”
e) a warning statement to the effect that “WARNING: Use only spare parts recommended by the
manufacturer to ensure proper function and to avoid the risk of fire and burns.”
f) a warning statement to the effect that “WARNING: Use of this device at an altitude above [insert
maximum RATED altitude] or outside a temperature of [insert RATED temperature range] or a relative
humidity above [insert maximum RATED relative humidity] is expected to adversely affect the flowrate and
the percentage of oxygen and consequently the quality of the therapy.”
g) a warning statement to the effect that “WARNING: Oxygen makes it easier for a fire to start and spread.
Do not leave the nasal cannula or mask on bed coverings or chair cushions, if the oxygen concentrator is
turned on, but not in use; the oxygen will make the materials flammable. Turn the oxygen concentrator off
when not in use to prevent oxygen enrichment.”
h) a warning statement to the effect that “WARNING: If you feel discomfort or are experiencing a medical
emergency while undergoing oxygen therapy, seek medical assistance immediately to avoid harm.”
i) a warning statement to the effect that “WARNING: Geriatric, paediatric or any other patient unable to
communicate discomfort can require additional monitoring and or a distributed alarm system to convey the
information about the discomfort and or the medical urgency to the responsible care giver to avoid harm.”
j) a warning statement to the effect that “WARNING: Smoking during oxygen therapy is dangerous and is
likely to result in facial burns or death. Do not allow smoking within the same room where the oxygen
concentrator or any oxygen carrying accessories are located.
If you intend to smoke, you must always turn the oxygen concentrator off, remove the cannula and
leave the room where either the cannula or mask or the oxygen concentrator is located. If unable to
leave the room, you must wait 10 minutes after you have turned the oxygen concentrator off before
smoking.”
k) a warning statement to the effect that “WARNING: Open flames during oxygen therapy are dangerous
and is likely to result in fire or death. Do not allow open flames within 2 m of the oxygen concentrator or
any oxygen carrying accessories.”
Check compliance by inspection of the instructions for use.
201.7.9.2.5.101 Additional requirements for ME EQUIPMENT description
The instructions for use shall include
a) a statement to the effect that the oxygen delivery setting has to be determined for each patient individually
with the configuration of the equipment to be used, including accessories.
b) a statement to the effect that the proper placement and positioning of the PATIENT interface is critical to the
effectiveness of the therapy.
EXAMPLE The proper placement and positioning of the prongs of the nasal cannula in the nose is critical
to the amount of oxygen delivered to the respiratory system of the patient.
c) a diagram for the connection of OPERATOR-detachable parts either supplied or recommended.
d) the RATED range of both the oxygen delivery flowrate and the concentration of oxygen as a function of
flowrate:
 at STPD (standard temperature and pressure dry) conditions; and
NOTE For the purposes of this standard, STPD is 101,3 kPa at an operating temperature of 20 °C, dry.
 over the RATED ranges of ambient temperature, humidity and atmospheric pressure.
201.7.9.2.8.101 * Additional requirements for start-up PROCEDURE
NOTE For the purposes of this standard, a start‐up PROCEDURE is a pre‐use functional test that is used to
determine whether the OXYGEN CONCENTRATOR is ready for use.
The instructions for use shall include:
a) details how the OPERATOR can check for proper operation of the OXYGEN CONCENTRATOR including a
qualitative test for system gas leakage and gas flowrate at the application ACCESSORY.
EXAMPLE 1 Connect the nasal cannula to the gas outlet connector of the oxygen concentrator or, if used, to
the bubble humidifier outlet connector per the manufacturer’s instructions. With the oxygen concentrator
turned on adjust the flowmeter to the desired flowrate. Gas should be flowing freely to the nasal cannula. You
should be able to hear or feel the flow of gas to the prongs of the nasal cannula. Wave your hand in front of the
prongs. If you do not feel the gas flowing, check the cannula connections for leaks.
EXAMPLE 2 Place the end of the nasal cannula under the surface of a half ‐full cup of water and look for the
bubbles.
b) how to functionally check the ALARM SIGNALS. Portions of this test may be automatically performed by the
OXYGEN CONCENTRATOR or may require OPERATOR action.
EXAMPLE Combination of the power‐on self‐test routines and OPERATOR action that functionally check the
ALARM SIGNALS.
c) a diagram for the set-up of OPERATOR-detachable parts either supplied or recommended by the
MANUFACTURER.
Check compliance by inspection.
201.7.9.2.9.101 Additional requirements for operating instructions
The instructions for use of an OXYGEN CONCENTRATOR shall include an explanation of the meaning of the
IP classification marked on the ENCLOSURE.
If applicable, the instructions for use shall include the PROCEDURE necessary to determine the remaining
capacity or operation time of the INTERNAL ELECTRICAL POWER SOURCE.
Check compliance by inspection.
201.7.9.2.12 Cleaning, disinfection, and sterilization
IEC 60601-1:2005+Amendment 1:2012, 7.9.2.12 applies, except as follows:
Amendment: (add after NORMAL USE)
and SINGLE FAULT CONDITION
Amendment: (add after bulleted list)
The instructions for use shall identify the portions of the gas pathways through the OXYGEN
CONCENTRATOR that can become contaminated with body fluids or expired gases during both NORMAL
CONDITION and SINGLE FAULT CONDITION.
201.7.9.2.13.101 Additional requirements for maintenance
The instructions for use shall include
a) the intervals at which cleaning PROCEDURES need to be performed and the items required for such
cleaning.
b) a statement to the effect that no lubricants other than those recommended by the manufacturer are to be
used.
c) if applicable, the INTERNAL ELECTRICAL POWER SOURCE care and maintenance PROCEDURES, including
instructions for recharging or replacement.
201.7.9.2.14.101 Additional requirements for ACCESSORIES, supplementary equipment, used
material
If applicable, the instructions for use shall disclose
a) any restrictions on the OPERATOR-accessible components on the OXYGEN CONCENTRATOR and within the
set-up of the application ACCESSORIES.
EXAMPLE 1 Where such components are FLOW‐DIRECTION‐SENSITIVE COMPONENTS.
b) any adverse effect of any recommended ACCESSORY on the ESSENTIAL PERFORMANCE or BASIC SAFETY of
the OXYGEN CONCENTRATOR.
EXAMPLE 2 Use of a paediatric cannula on an adult PATIENT.
Check compliance by inspection and inspection of the RISK MANAGEMENT FILE for any adverse effect of any
recommended ACCESSORY.
201.7.9.2.16.101 * Additional requirements for reference to the technical description
Where the technical description is supplied as a separate document from the instructions for use, then
the instructions for use shall, wherever appropriate, provide a cross‐reference to the additional
information available in the technical description.
Check compliance by inspection.
201.7.9.3.101 Additional requirements for the technical description
The technical description shall include
a) a description of the principles of operation of the OXYGEN CONCENTRATOR.
b) a pneumatic diagram of the OXYGEN CONCENTRATOR, including a diagram for the connection of OPERATOR-
detachable parts either supplied or recommended in the instructions for use.
c) a description of a method for SERVICE PERSONNEL to check the function of the ALARM SYSTEM for each of
the ALARM CONDITIONS specified in this standard, if not performed automatically during start-up. The
technical description shall disclose which checks are performed automatically.
Check compliance by inspection of the technical description.
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
IEC 60601-1:2005+Amendment 1:2012, Clause 8 applies, except as follows:
201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS
IEC 60601-1:2005+Amendment 1:2012, Clause 9 applies, except as follows:
Additional subclauses:
201.9.6.2.1.101 Additional requirements for audible acoustic energy
The A‐weighted SOUND PRESSURE LEVEL emitted by the OXYGEN CONCENTRATOR when tested in accordance
with the method in this subclause shall be disclosed in the instructions for use:
– for an OXYGEN CONCENTRATOR with a continuous flow mode, at a flowrate setting of 3 l/min or the
maximum flowrate setting if this is less than 3 l/min as well as for the maximum flowrate setting if
this setting is greater or equal than 4 l/min; and
– for an OXYGEN CONCENTRATOR with integrated oxygen CONSERVING EQUIPMENT, the maximum
demand flow rate setting of NORMAL USE.
The SOUND POWER LEVEL and the tested flowrate also shall be disclosed in the instructions for use.
Check compliance with the following test:
a) For an OXYGEN CONCENTRATOR with a continuous flow mode, place the OXYGEN CONCENTRATOR on the
sound-reflecting plane and attach 10 m ± 1 m of oxygen tubing.
b) Attach the sta
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