EN ISO 18779:2005

SLOVENSKI STANDARD
01-junij-2005
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Medical devices for conserving oxygen and oxygen mixtures - Particular requirements
(ISO 18779:2005)
Dosiersysteme für Sauerstoff und Sauerstoffgemische - Besondere Anforderungen (ISO
18779:2005)
Economiseurs médicaux d'oxygene et de mélanges oxygénés - Exigences particulieres
(ISO 18779:2005)
Ta slovenski standard je istoveten z: EN ISO 18779:2005
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 18779
NORME EUROPÉENNE
EUROPÄISCHE NORM
February 2005
ICS 11.040.10
English version
Medical devices for conserving oxygen and oxygen mixtures -
Particular requirements (ISO 18779:2005)
Economiseurs médicaux d'oxygène et de mélanges Spargeräte für Sauerstoff und Sauerstoffgemische -
oxygénés - Exigences particulières (ISO 18779:2005) Besondere Anforderungen (ISO 18779:2005)
This European Standard was approved by CEN on 28 January 2005.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2005 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 18779:2005: E
worldwide for CEN national Members.

Foreword
This document (EN ISO 18779:2005) has been prepared by Technical Committee CEN/TC 215 "Respiratory
and anaesthetic equipment", the secretariat of which is held by BSI, in collaboration with Technical
Committee ISO/TC 121 "Anaesthetic and respiratory equipment”.

This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by August 2005, and conflicting national standards shall be withdrawn
at the latest by August 2005.
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, Cyprus, Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland
and United Kingdom.
ANNEX ZA
(informative)
Relationship between this International Standard and the Essential
Requirements of EU Directive 93/42 EEC Medical devices

This International Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide one means of conforming to Essential Requirements of
the New Approach Directive 93/42 EEC Medical devices.

Once this standard is cited in the Official Journal of the European Communities under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the normative
clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a
presumption of conformity with the corresponding Essential Requirements of that Directive and associated
EFTA regulations.
WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
Table ZA.1 — Correspondence between this International Standard and Directive 93/42/EEC
Medical devices
Clause(s)/Subclause(s) of this Essential Requirements (Ers) Qualifying remarks/Notes
International Standard of EU Directive 93/42/EEC
4 All
5 All
6 13, 13.2
6.1 13.1, 13.3, 13.4, 13.5
6.3 10.2, 10.3, 12.8, 12.9
6.8 13.1, 13.3, 13.4, 13.6
6.101 12.9
7 12.6
8 12.6
9 12.6
10.1 5
10.2 5
13 12.6
14 12.6
15 12.6
16 12.6, 12.7
17 12.6
18 12.6
19 12.6
20 12.6
21 12.7
22 12.7
23 12.7
24 12.7
25 12.7
26 12.7.2, 12.7.3
27 12.8
28 12.7
29 11
36 9.2, 12.5
38 13
39 9.2, 9.3, 12.6, 12.7
40 9.2, 9.3, 12.6, 12.7
41 9.2, 9.3, 12.6, 12.7
42 12.7
43 9.3, 12.7
44.3 7.6, 12.6
44.6 7.6, 12.6
44.7 8.1
44.8 7.1, 7.3, 7.5, 9.3
45 12.7
46 9, 10, 12.9
47 12.5
48 7.1, 7.5
49 9.2, 12.8
50 10
51 10, 12.8
52 12.1, 12.6, 12.7, 12.8
53 5
54 9
55 9
56 9
56.3 9.1
56.7 12.2
57 12.6, 12.7
58 12.6, 12.7
101.2.1 9.2, 12.8
101.2.3 12.8
101.2.4 12.8
101.2.6 12.8
101.2.7 12.2
101.2.8 9.3, 12.6, 12.8
101.3 12.3, 12.8
INTERNATIONAL ISO
STANDARD 18779
First edition
2005-02-15
Medical devices for conserving oxygen
and oxygen mixtures — Particular
requirements
Économiseurs médicaux d'oxygène et de mélanges oxygénés —
Exigences particulières
Reference number
ISO 18779:2005(E)
©
ISO 2005
ISO 18779:2005(E)
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ii © ISO 2005 – All rights reserved

ISO 18779:2005(E)
Contents Page
Foreword. v
Introduction . vi
1 Scope. 1
2 Normative references . 1
3 Terms and definitions. 2
4 General requirements and general requirements for tests . 3
5 Classification. 3
6 Identification, marking and documents. 3
7 Power input. 8
8 Basic safety categories . 8
9 Removable protective means . 8
10 Environmental conditions. 9
11 Not used. 9
12 Not used. 9
13 General. 9
14 Requirements related to classification . 9
15 Limitation of voltage and/or energy . 10
16 Enclosures and protective covers . 10
17 Separation. 10
18 Protective earthing, functional earthing and potential equalization . 10
19 Continuous leakage currents and patient auxiliary currents . 10
20 Dielectric strength. 10
21 Mechanical strength . 10
22 Moving parts. 11
23 Surfaces, corners and edges. 11
24 Stability in normal use. 11
25 Expelled parts. 11
26 Vibration and noise. 11
27 Pneumatic and hydraulic power. 11
28 Suspended masses. 11
29 X-Radiation . 12
30 Alpha, beta, gamma, neutron radiation and other particle radiation. 12
31 Microwave radiation. 12
32 Light radiation (including lasers) . 12
33 Infrared radiation. 12
ISO 18779:2005(E)
34 Ultraviolet energy .12
35 Acoustical energy (including ultrasonics).12
36 Electromagnetic compatibility .12
37 Locations and basic requirements.12
38 Marking and accompanying documents.12
39 Common requirements for category AP and category APG equipment.12
40 Requirements and tests for category AP equipment, parts and components thereof.13
41 Requirements and tests for category APG equipment, parts and components thereof.13
42 Excessive temperatures .13
43 Fire prevention.13
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization,
disinfection and compatibility.13
45 Pressure vessels and parts subject to pressure .14
46 Human errors .15
47 Electrostatic charges .15
48 Biocompatibility.15
49 Interruption of the power supply .15
50 Accuracy of operating data .15
51 Protection against hazardous output.15
52 Abnormal operation and fault conditions.16
53 Environmental tests .16
54 General .16
55 Enclosures and covers .16
56 Components and general assembly.16
57 Mains parts, components and layout.16
58 Protective earthing – Terminals and connections .17
59 Construction and layout .17
101 Additional requirements .17
Annex AA (informative) Rationale .19
Annex BB (informative) Environmental aspects.22
Annex CC (informative) Index of defined terms.24
Bibliography.25

iv © ISO 2005 – All rights reserved

ISO 18779:2005(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 18779 was prepared by the European Committee for Standardization (CEN) Technical Committee
CEN/TC 215, Respiratory and anaesthetic equipment, in collaboration with Technical Committee ISO/TC 121,
Anaesthetic and respiratory equipment, Subcommittee SC 3, Lung ventilators and related equipment, in
accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
ISO 18779:2005(E)
Introduction
This International Standard specifies requirements for oxygen and oxygen mixture saving devices (called here
conserving devices) that are used to supply respiratory gases during therapy.
These devices are for domiciliary use only.
Annex AA contains a rationale for some of the requirements. It is included to provide additional insight into the
committee’s reasoning that led to a requirement and to identify the hazards that the requirement addresses.
Clauses and subclauses marked with an asterisk (*) after their number have a corresponding rationale
contained in Annex AA.
This International Standard is a Particular Standard based on IEC 60601-1:1988, including Amendments 1
(1991) and 2 (1995), hereafter referred to as the General Standard. The General Standard is the basic
standard for the safety of all medical electrical equipment used by or under the supervision of qualified
personnel in the general medical and patient environment; it also contains certain requirements for reliable
operation to ensure safety.
The General Standard has associated Collateral Standards and Particular Standards. The Collateral
Standards include requirements for specific technologies and/or hazards and apply to all applicable equipment,
such as medical electrical systems, EMC, radiation protection in diagnostic X-ray equipment, software, etc.
The Particular Standards apply to specific equipment types, such as medical electron accelerators, high
frequency surgical equipment, hospital beds, etc.
NOTE Definitions of Collateral Standard and Particular Standard can be found in IEC 60601-1:1988, 1.5 and A.2,
respectively.
To facilitate the use of this International Standard, the following drafting conventions have been applied.
This International Standard uses the same main clause titles and numbering as the General Standard, for
ease of cross-referencing of the requirements. The changes to the text of the General Standard, as
supplemented by the Collateral Standards, are specified by the use of the following words.
 “Replacement” means that the indicated clause or subclause of the General Standard is replaced
completely by the text of this International Standard.
 “Addition” means that the relevant text of this Particular Standard is a new element (e.g. subclause, list
item, note, table, figure) additional to the General Standard.
 “Amendment” means that an existing element of the General Standard is partially modified by deletion
and/or addition as indicated by the text of this Particular Standard.
To avoid confusion with any amendments to the General Standard itself, a particular numbering has been
employed for elements added by this International Standard: subclauses, tables and figures are numbered
starting from 101; additional list items are lettered aa), bb), etc. and additional annexes are lettered AA, BB,
etc.
In this International Standard, the following print types are used:
 requirements, compliance with which can be verified, and definitions: roman type;
 notes and examples: smaller roman type;
vi © ISO 2005 – All rights reserved

ISO 18779:2005(E)
 description of type of document change and test methods: italic type;
 terms defined in the General Standard IEC 60601-1:1988, Clause 2, or in this Particular Standard: bold
type.
Throughout this International Standard, text for which a rationale is provided in Annex AA is indicated by an
asterisk (*).
INTERNATIONAL STANDARD ISO 18779:2005(E)

Medical devices for conserving oxygen and oxygen mixtures —
Particular requirements
1 * Scope
IEC 60601-1:1988, Clause 1, applies except as follows:
Amendment (add at end of 1.1):
1.1
This International Standard specifies requirements for the safety and essential performance of portable
devices that supply the flow of oxygen or oxygen mixtures during therapy (e.g. long term oxygen therapy,
1)
analgesia). These devices are intended to conserve oxygen or oxygen mixtures by delivering these gases
intermittently on the patient's demand when used in home care applications. These devices are generally
used without continual professional supervision.
These devices are also used in health care facilities/institutions.
This International Standard covers two types of conserving devices (see 3.5 and 3.6): conserving devices
intended for continuous use and those not intended for continuous use.
This International Standard covers active devices only, e.g. pneumatically or electrically controlled devices,
and does not cover devices such as reservoir cannulas.
This International Standard also includes conserving devices which are part of a system, e.g. pressure
regulators, oxygen concentrators or liquid oxygen vessels.
The requirements of this International Standard which replace or modify the requirements of
IEC 60601-1:1988 and its Amendments 1 (1991) and 2 (1995) are intended to take precedence over the
corresponding general requirements.
1.4
Addition:
NOTE Planning and design of products complying with this International Standard can have environmental impact
during the product life cycle. Environmental aspects are addressed in Annex BB. Additional aspects of environmental
impact are addressed in ISO 14971.
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.

1) Referred to as “conserving devices” throughout the document.
ISO 18779:2005(E)
EN 980:2003, Graphical symbols for use in the labelling of medical devices
EN 1041:1998, Information supplied by the manufacturer with medical devices
ISO 4135:2001, Anaesthetic and respiratory equipment — Vocabulary
EN 13544-2:2003, Respiratory therapy equipment — Part 2: Tubing and connectors
IEC 60601-1:1988 + A1:1991 + A2:1995 and corrigendum 1995 mod), Medical electrical equipment — Part 1:
General requirements for safety
IEC 60529:2001, Degree of protection provided by enclosures (IP code)
IEC 60068-2-32:1975, Environmental testing — Part 2: Tests — Test Ed: Free fall. (A 1:1982 + A 2:1990)
IEC 60068-2-64:1993, Environmental testing — Part 2: Test methods — Test Fh: Vibration broad-band
random (digital control) and guidance
IEC 60079-4:1975, Electrical apparatus for explosive gas atmospheres — Part 4: Methods of test for ignition
temperature
ISO 7000, Graphical symbols for use on equipment — Index and synopsis
ISO 15001:2003, Anaesthetic and respiratory equipment — Compatibility with oxygen
3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:1988, ISO 4135 and the
following apply.
3.1
accuracy
quality that characterizes the ability of the conserving device to give indications approximating to the true
value of the quantity measured
3.2
applied part
part of the conserving device intended to be connected to the patient and which in normal use:
 necessarily comes into physical contact with the patient for the conserving device to perform its
function or
 can be brought into contact with the patient or
 needs to be touched by the patient
3.3
expected service life
period during which the performance of the conserving device or any of its components is expected to meet
the requirements of this International Standard when used and maintained according to the accompanying
documents
3.4
shelf life
period during which the conserving devices or any of its components are stored in its original container under
conditions in accordance with the accompanying documents
2 © ISO 2005 – All rights reserved

ISO 18779:2005(E)
3.5
2)
device for conserving oxygen and oxygen mixtures
portable device intended to increase the efficiency of the delivery of oxygen or oxygen mixtures to patients
3.6
conserving devices intended for continuous use
conserving device that includes means to ensure that the health of the patient will not be compromised
by a single fault condition or by the failure of oxygen or oxygen mixture supply
4 General requirements and general requirements for tests
IEC 60601-1:1988, Clauses 3 and 4 apply, except as follows:
Additions:
3.1 No safety hazard in normal use and in single fault condition
Add at the end of the subclause.
A conserving device intended for continuous use which fails to perform its function during normal use
and under single fault conditions without appropriate alarm is considered to present a safety hazard.
4.101 Other test methods
Test methods other than those specified in this International Standard, but of equal or greater accuracy may
be used to verify compliance with requirements.
5 Classification
IEC 60601-1:1988, Clause 5 applies, except as follows:
Replacement:
5.2 Applied part classification
The equipment and its applied parts shall be classified as type BF or type CF.
6 Identification, marking and documents
IEC 60601-1:1988, Clause 6 applies, except as follows
Addition:
Information and marking shall comply with EN 980 and EN 1041.

2) Referred to as “conserving devices” throughout the document.
ISO 18779:2005(E)
6.1 Marking on the outside of equipment or equipment parts
Replacement:
d) if the size of the conserving device does not permit the complete marking as specified throughout this
clause, at least the following shall be marked on the conserving device:
 the name of the manufacturer;
 a serial or lot or batch identifying number;
 symbol ISO 7000-0434 (or see Table D1, Symbol 14 in of IEC 60601-1:1988).
Additions:
aa) the manufacturer shall mark the conserving device with a caution to refer the user or operator to the
accompanying documents or symbol ISO 7000-0434 for the expected adverse effects on the
performance of the conserving device;
bb) packages for single use components shall be durably marked with the following words: “single use” or
“single patient use” or the symbol ISO 7000-1051;
cc) labels should be clearly legible at a distance of 0,5 m in a range of illumination from 100 lx to 1 500 lx by
an individual with a visual acuity of 1 (corrected if necessary);
dd) labels should be resistant to removal or blurring from disinfectants and other normal use of the device;
ee) on conserving devices for use in health care facilities/institutions only a warning to the effect that: “The
device is not for use in home care environment” shall be permanently labelled;
ff) the conserving device and its parts shall be marked regarding their proper disposal, as adequate.
6.3 Markings of controls and instruments
Additions:
All controls which increase or decrease a function shall be marked with a legible indication to inform the
operator which action(s) is (are) required to increase or decrease the controlled function.
Controls should be identified with their associated markings.
6.8 Accompanying documents
Additions:
6.8.2 * Instructions for use
Additions:
6.8.2d) Cleaning, disinfection and sterilization
Addition at the end of the list of items:
 any pre-use cleaning or disinfecting procedures for the conserving device and any accessories including
any specific procedure(s) necessary before the conserving device is transferred to another patient;
 methods and products for cleaning, disinfecting or sterilizing and the recommended frequencies;
 any limitations on the number of cleaning, disinfecting or sterilizing cycles.
4 © ISO 2005 – All rights reserved

ISO 18779:2005(E)
6.8.2aa)
Additions:
The instruction for use shall include the following as far as applicable:
NOTE The following requirements are grouped under an appropriate headline as they usually appear in the
instructions for use. This has been done for convenience of the people involved in this. This does not mean that the
required information in the instructions for use is to be presented in the order as listed below.
1) * Intended use
 a statement of the intended uses (i.e. if it is for continuous use or not, see 3.6) of the conserving device
and an explanation on how the conserving device accomplishes that purpose;
 a description of the type(s) of the oxygen source that is to be used (e.g. transportable liquid oxygen
system, gaseous oxygen supply or oxygen concentrator).
2) Precautions and hazards
 a warning statement of the hazards associated with oxygen equipment and therapy;
 precautions to minimize the risk of strangulation of the patient. This is accomplished by providing
instructions for routing of patient wires and tubing in the device labelling;
 precautions to minimize hazards due to exposure to toxic materials from the conserving device
occasioned by abnormal conditions (see Clause 10);
 the location of all latex-based components;
 advice on other hazards and risks associated with the conserving device;
 a warning statement to the effect that the device and its setting should be used only as prescribed.
3) Conserving device information
 a description of the types of trigger signal (e.g. flow, pressure) that the conserving device is able to
recognize;
 a description of the principles of operation of the conserving device, including the principles of oxygen or
oxygen mixture dosage, timing and the settings thereof;
 a statement that the setting has to be determined for each patient individually with the system to be used
and that settings from constant respiratory gases flow application might not be applicable;
 principle of operation, e.g. bolus or constant flow of oxygen and oxygen mixtures delivered to the patient;
 range of setting of oxygen and oxygen mixtures delivered to the patient;
 accuracy of the delivery of respirable gases to the patient with regard to the settings;
 range of breathing frequency specified for use;
 range of oxygen and oxygen mixture supply pressures specified for use;
 range of supply flows specified for use;
 range of electrical supply voltage and current specified for use;
ISO 18779:2005(E)
 type of battery to be used and expected operating time under the condition(s) specified by the
manufacturer;
 if re-chargeable batteries are used, information about the procedure to re-charge and the time necessary
to fully re-charge under the condition specified by the manufacturer;
 information on how oxygen and oxygen mixture supply to the patient is assured in a case of conserving
device failure and the amount of flow delivered to the patient under such a condition;
 explanation of the function and meaning of each alarm and indicator provided with the conserving device;
 a statement that the conserving device may not be able to detect all respiratory efforts of the patient.
4) Operating information
 clear, simple diagrams and illustrations of the fully assembled and ready-to-operate conserving device;
 steps required to prepare the conserving device for operation;
 the procedure necessary to determine the state of the battery;
 diagrams, illustrations or photos showing proper connection of the patient to the conserving device and
other equipment;
 proper connection of auxiliary devices;
 description of appropriate warm-up procedures and intervals;
 drawings or photos of all controls, alarms and indicators provided with the conserving device;
 explanation of the use of the controls, alarms and indicators;
 range of operation of the conserving device (e.g. flowrate, bolus setting);
 a step-by-step procedure for checking proper functioning of all controls, indicators and alarms;
 list of error messages, if applicable, their meaning and the corrective steps that can be taken by the
operator;
 a trouble shooting guide for use when there are indications of a conserving device malfunction during
checkout and/or operation;
 procedures to follow in the event of a conserving device alarm condition;
 warnings concerning the precautions necessary to avoid possible unsafe use of the conserving device;
 connection and proper use of remote alarm units, including recommended placement and the importance
of the operator being able to access the patient when the alarm is activated;
 legible reproductions of all required labels and hazard warnings on the conserving device;
 description of the circumstances when it might be appropriate to contact the provider of the conserving
device;
 information concerning the disposal of the conserving device and its components (e.g. battery).
6 © ISO 2005 – All rights reserved

ISO 18779:2005(E)
5) Operator maintenance instructions
 methods and materials for cleaning and disinfecting the conserving device;
 schedule of operator-initiated maintenance including any specific procedure(s) necessary before the
conserving device is transferred to another patient;
 battery care and maintenance procedures, including instructions for recharging or replacement;
 description of periodic visual safety inspections that should be performed by the operator.
6) Patient information
 a listing of accessories intended to be used for application to the patient (e.g. masks or nasal cannulas)
recommended by the manufacturer and instructions on how they are fitted to the conserving device;
 checking for proper operation;
 circumstances which might require sensor adjustment (e.g. change of tubing system);
 circumstances related to the use of the conserving device that could cause a hazardous situation (e.g.
bio-incompatibility, chemical or thermal injury).
7) Operating environment information
 the ranges of temperature, atmospheric pressure and humidity for operation and for storage;
 the time from switching “ON” to obtaining specified operating performance;
 description of known or recognizable conditions of the environment that can affect the safe and effective
operation of the conserving device, including the following items:
 facility information, including a description of what should be expected if electricity to the conserving
device is lost;
 effects of lint, dust, sun, artificial light, heat or humidity;
 effects and possible sources of electromagnetic (conducted and radiated) interference;
 effects and causes of electrostatic discharge;
 list of other devices that pose potential electrical problems;
 effects of fluctuation(s) in electrical supply mains or battery voltage;
 other sources of interference;
 steps that can be taken by the operator to identify and minimize environmental interference.
8) Service information
 the recommended methods and frequency of routine inspection, testing, calibration, repair and periodic
service;
 a list of facilities that provide service, and their locations;
 expected service life of the conserving device;
ISO 18779:2005(E)
 shelf life and expected service life of sensors;
 information concerning the disposal of the conserving device or components thereof.
6.8.3 Technical description
Additions:
aa) the technical description shall include the following:
 equipment specifications for the conserving device functions that are applicable to the operation and use
of the device;
 a statement as to whether or not pacemaker pulse rejection and defibrillator protection are included;
 a description of equipment required for conserving device use and any specifications necessary for
sensors, cables, tubing, batteries and any other accessories;
 step-by-step procedures to prepare the conserving device for initial and subsequent use;
 a recommendation to the effect that a risk assessment should be carried out prior to installation to assure
proper connection with other equipment;
 if a manual control of the sensitivity is provided, instructions as when and how to adjust the control for
optimal breath detection;
 step-by-step procedures recommended for determining whether the conserving device is susceptible to
the levels of electromagnetic interference occurring at the use location, a recommendation to periodically
repeat the testing, and recommended action to take if the conserving device fails the test;
 precautions and a schedule of maintenance and calibrations necessary.
6.101 Legibility
Safety indications shall be legible and correctly perceived by an individual with a visual acuity of 1 (corrected if
necessary) from a distance of 1 m at a range of illumination of 100 lx to 1 500 lx, when viewing the information,
markings, etc. perpendicular to and including 15° above, below, left and right of the normal line of sight of the
operator.
7 Power input
IEC 60601-1:1988, Clause 7 applies.
8 Basic safety categories
IEC 60601-1:1988, Clause 8 applies.
9 Removable protective means
IEC 60601-1:1988, Clause 9 applies.
8 © ISO 2005 – All rights reserved

ISO 18779:2005(E)
10 Environmental conditions
IEC 60601-1:1988, Clause 10 applies, except as follows:
10.1 Transport and storage
Replacement:
The conserving device (not including the battery) shall be capable, while packed for transport and storage, of
being exposed to an environmental temperature range of − 40 °C to + 70 °C and at relative humidity up to
95 %, non-condensing.
After such an exposure, the transportable liquid oxygen system shall meet the requirements of this
International Standard and shall remain operational.
10.2.1 Environment
Replacement:
 an ambient temperature range of − 10 °C to + 40 °C;
 a relative humidity range of 15 % to 95 %, non-condensing;
 for conserving devices for hospital use only, IEC 60601-1:1988 applies.
10.2.2 Power supply
When powered from mains voltages, the conserving device should operate within its specification, without
changing a voltage selection switch when voltage fluctuation does not exceed ± 20 % of the nominal voltage.
Addition:
10.3 Disposal
Consideration should be given to the disposal of packaging wastes.
11 Not used
IEC 60601-1:1988, Clause 11 applies.
12 Not used
IEC 60601-1:1988, Clause 12 applies.
13 General
IEC 60601-1:1988, Clause 13 applies.
14 Requirements related to classification
IEC 60601-1:1988, Clause 14 applies.
ISO 18779:2005(E)
15 Limitation of voltage and/or energy
IEC 60601-1:1988, Clause 15 applies.
16 Enclosures and protective covers
IEC 60601-1:1988, Clause 16 applies.
17 Separation
IEC 60601-1:1988, Clause 17 applies.
18 Protective earthing, functional earthing and potential equalization
IEC 60601-1:1988, Clause 18 applies.
19 Continuous leakage currents and patient auxiliary currents
IEC 60601-1:1988, Clause 19 applies.
20 Dielectric strength
IEC 60601-1:1988, Clause 20 applies.
21 Mechanical strength
IEC 60601-1:1988, Clause 21 applies, except as follows:
21.6 Portable and mobile equipment
Addition:
The conserving device is considered to be a portable and mobile piece of equipment and shall be capable of
withstanding the stresses caused by rough handling.
Compliance is checked by the tests a) and b) of IEC 60601-1:1988, and its amendments and the following
additional tests:
c) mechanical shock
Test the conserving device in accordance with IEC 60068-2-32 shock test (free fall), procedure 1, with the
following severity levels:
 hei
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