SIST EN ISO 18777:2009

SLOVENSKI STANDARD
01-julij-2009
1DGRPHãþD
SIST EN ISO 18777:2005
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Transportable liquid oxygen systems for medical use - Particular requirements (ISO
18777:2005)
Flüssigsauerstoffsysteme für medizinische Anwendungen - Besondere Anforderungen
(ISO 18777:2005)
Systèmes transportables d'oxygène liquide à usage médical - Exigences particulières
(ISO 18777:2005)
Ta slovenski standard je istoveten z: EN ISO 18777:2009
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 18777
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2009
ICS 11.040.99 Supersedes EN ISO 18777:2005
English Version
Transportable liquid oxygen systems for medical use - Particular
requirements (ISO 18777:2005)
Systèmes transportables d'oxygène liquide à usage Flüssigsauerstoffsysteme für medizinische Anwendungen -
médical - Exigences particulières (ISO 18777:2005) Besondere Anforderungen (ISO 18777:2005)
This European Standard was approved by CEN on 24 February 2009.
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 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 Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 18777:2009: E
worldwide for CEN national Members.

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

Foreword
The text of ISO 18777:2005 has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and
respiratory equipment” of the International Organization for Standardization (ISO) and has been taken over as
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 September 2009, and conflicting national standards shall be
withdrawn at the latest by March 2010.
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 18777:2005.
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 EC Directives.
For relationship with EC Directives, 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, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 18777:2005 has been approved by CEN as a EN ISO 18777:2009 without any modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC on 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 clauses of this
standard given in Table ZA. confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA. - Relationship between this European Standard and the Essential Requirements of EU
Directive 93/42/EEC
Clause(s)/sub- Essential Requirements (ERs) of Qualifying remarks/Notes
clause(s) of this EN Directive 93/42/EEC
4 All
5 All
- 6a This relevant Essential
Requirement is not addressed in
this European Standard
6 13, 13.2
6.1 13.1, 13.3, 13.4, 13.5
6.1, 6.8 13.3 (a): This relevant Essential
Requirement is not fully
addressed in this European
Standard
- 13.6 (q) This relevant Essential
Requirement is not addressed in
this European Standard
6.3 10.2, 10.3, 12.8, 12.9
6.8 13.1, 13.3, 13.4, 13.6
6.8.2 aa) 2) 7.5 (3rd paragraph) This relevant Essential
Requirement is not fully
addressed in this European
Standard
- 12.1a) This relevant Essential
Requirement is not addressed in
this European Standard.
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
Warning – Other requirements and other EU Directives may be applicable to the products falling within the
scope of this International standard.

INTERNATIONAL ISO
STANDARD 18777
First edition
2005-02-15
Transportable liquid oxygen systems for
medical use — Particular requirements
Systèmes transportables d'oxygène liquide à usage médical —
Exigences particulières
Reference number
ISO 18777:2005(E)
©
ISO 2005
ISO 18777:2005(E)
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ii © ISO 2005 – All rights reserved

ISO 18777:2005(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. 8
11 Not used. 9
12 Not used. 9
13 General. 9
14 Requirements related to classification . 9
15 Limitation of voltage and/or energy . 9
16 Enclosures and protective covers . 9
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. 10
23 Surfaces, corners and edges. 10
24 Stability in normal use. 10
25 Expelled parts. 11
26 Vibration and noise. 11
27 Pneumatic and hydraulic power. 11
28 Suspended masses. 11
29 X-Radiation . 11
30 Alpha, beta, gamma, neutron radiation and other particle radiation. 11
31 Microwave radiation. 11
32 Light radiation (including lasers) . 11
33 Infrared radiation. 12
ISO 18777:2005(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.12
41 Requirements and tests for category APG equipment, parts and components thereof .12
42 Excessive temperatures .12
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 .14
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.15
53 Environmental tests .15
54 General .15
55 Enclosures and covers .15
56 Components and general assembly.16
57 Mains parts, components and layout.16
58 Protective earthing – Terminals and connections .16
59 Construction and layout .16
101 Additional requirements .16
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 18777:2005(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 18777 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 18777:2005(E)
Introduction
This International Standard specifies requirements for liquid oxygen systems which are used as a source of
supply for oxygen therapy.
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 identifying the hazards that the requirement addresses.
Clauses and subclauses marked with * after their number have 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;
 description of type of document change and test methods: italic type;
vi © ISO 2005 – All rights reserved

ISO 18777:2005(E)
 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 18777:2005(E)

Transportable liquid oxygen systems for medical use —
Particular requirements
1 Scope
IEC 60601-1:1988, Clause 1, applies except as follows:
Amendments (add at end of 1.1):
1.1
This International Standard specifies requirements for the safety and essential performance of transportable
liquid oxygen systems which are used as a supply source for oxygen therapy. These devices usually consist
of a portable unit to be carried by or with the patient whilst in use and the vessel used to refill the portable
unit. These devices are mostly used in home care applications and in health care facilities/institutions. These
devices are often used without professional supervision.
Liquid oxygen vessels used as a supply source for oxygen pipeline systems are excluded from this
International Standard.
The requirements of this International Standard which replace or modify the requirements of
IEC 60601-1:1998 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 Internatinal 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.
EN 980:2003, Graphical symbols for use in the labelling of medical devices
EN 1041:1998, Information supplied by the manufacturer with medical devices
EN 1251-1:2000, Cryogenic vessels — Transportable vacuum insulated vessels of not more than 1 000 litres
volume — Part 1: Fundamental requirements
EN 1251-2:2000, Cryogenic vessels — Transportable vacuum insulated vessels of not more than 1 000 litres
volume — Part 2: Design, fabrication, inspection and testing
EN 1251-3:2000, Cryogenic vessels — Transportable vacuum insulated vessels of not more than 1 000 litres
volume — Part 3: Operational requirements
ISO 18777:2005(E)
ISO 4135:2001, Anaesthetic and respiratory equipment — Vocabulary
ISO 7000, Graphical symbols for use on equipment — Index and synopsis
ISO 15001:2003, Anaesthetic and respiratory equipment — Compatibility with oxygen
ISO 18779, Medical devices for conserving oxygen and oxygen mixtures — Particular requiremenrts
EN 13544-2:2002, Respiratory therapy equipment — Part 2: Tubing and connectors
IEC 60601-1:1988 + A1:1991 + A2:1995 + corrigendum 1995 mod), Medical electrical equipment — Part 1:
General requirements for safety
IEC 60529:2001, Degrees of protection provided by enclosures (IP code)
IEC 60079-4:1975, Electrical apparatus for explosive gas atmospheres — Part 4: Method of test for ignition
temperature
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
applied part
part of the transportable liquid oxygen system intended to be connected to the patient and which in normal
use
 necessarily comes into physical contact with the patient for the transportable liquid oxygen system to
perform its function or
 can be brought into contact with the patient or
 needs to be touched by the patient.
[Adapted from IEC 60601-1:1988]
3.2
base unit
mobile device that is a vacuum-insulated cryogenic vessel intended to store oxygen and maintain it in the
liquid state for the purpose of refilling portable units and that can also include an internal vaporizer and a flow
control for the direct supply of gaseous oxygen to the patient
3.3
expected service life
period during which the performance of the transportable liquid oxygen system 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
liquid oxygen transfer connector
connector used to transfer liquid oxygen from the base unit to the portable unit or to refill the base unit
3.5
portable unit
portable device including a vacuum-insulated cryogenic vessel to maintain liquid oxygen at cryogenic
temperatures, an internal vaporizer and a flow control to provide gaseous oxygen to the patient
2 © ISO 2005 – All rights reserved

ISO 18777:2005(E)
3.6
transportable liquid oxygen system
system comprising one or more portable units and compatible base units for oxygen therapy
4 General requirements and general requirements for tests
IEC 60601-1:1988, Clauses 3 and 4 apply, except as follows:
Addition:
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, EN 1041 and EN 1251-1.
6.1 Marking on the outside of equipment or equipment parts
Replacement:
d) if the size of the portable unit does not permit the complete marking as specified throughout this clause,
at least the following shall be marked on the portable unit:
 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);
 the total weight when full.
Additions:
aa) the manufacturer shall mark the transportable liquid oxygen system 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 transportable liquid oxygen system;
ISO 18777:2005(E)
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 as appropriate;
cc) labels should be clearly legible at a distance of 1 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) the total weight of the base unit when full;
ff) the transportable liquid oxygen system and its parts shall be marked regarding their proper disposal,
as adequate.
6.3 Markings of controls and instruments
Additions:
The control for setting the oxygen delivered to the patient shall be clearly marked with regard to flow.
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:
6.8.2 d) cleaning, disinfection and sterilization.
Addition at the end of the list of items:
 any pre-use cleaning or disinfecting procedures for the transportable liquid oxygen system and
any accessories including any specific procedure(s) necessary before the transportable liquid
oxygen system is transferred to another patient;
 the methods and products for cleaning, disinfecting or sterilizing and the recommended frequencies;
 any limitations on the number of cleaning, disinfecting or sterilizing cycles.
6.8.2 aa)
Additions:
The instruction for use shall include the following as far as applicable.
The following requirements are grouped under an appropriate headline as they usually appear in the
instruction for use. This has been done for convenience of the people involved in this. This does not mean that
the required information in the instruction for use is to be presented in the order as listed below.
1) Intended use
 A statement of the intended uses (i.e. purpose) of the transportable liquid oxygen system and an
explanation on how the transportable liquid oxygen system accomplishes that purpose;
4 © ISO 2005 – All rights reserved

ISO 18777:2005(E)
 a description of the principles of operation of the transportable liquid oxygen system, including the
settings of the transportable liquid oxygen system.
2) Precautions and hazards
 A warning with regard to safe handling of oxygen;
 a warning with regard to the effect that the base unit or the portable system shall not be positioned within
3 m of any open flame and that the base unit and portable unit shall not be placed closer than 20 cm
from any source of ignition (appropriate examples of sources of ignition should be provided);
 a warning statement to the effect that the room or any other place where the transportable liquid
oxygen system is refilled or used should be provided with the air exchange necessary to prevent
accumulation of oxygen;
 a warning statement to the effect that the transportable liquid oxygen system should not be covered;
 a warning statement to the effect that the transportable liquid oxygen system should not be used if the
liquid oxygen connector of the portable unit is not compatible with the base unit;
 a statement as to what to do in case of a leak at the liquid oxygen transfer connector;
 precautions to minimize hazards due to exposure to toxic materials from the transportable liquid
oxygen system occasioned by abnormal conditions;
 a warning statement to the effect that transportation or use in public transportation systems might be
restricted with a recommendation to consult with the transportation company prior to use the public
transportation system.
NOTE This statement might need to be more stringent for air or sea transportation.
 The location of all latex-based components;
 advice of other hazards and risks associated with the transportable liquid oxygen system;
 a warning statement to the effect that, the transportable liquid oxygen system should be used only as
prescribed by the physician;
 an advisory statement to the effect that if continuity of oxygen supply is required, monitoring to ensure an
adequate supply of oxygen to the patient should be used and/or a secondary oxygen supply should be
available all the time during therapy.
3) Information on the transportable liquid oxygen system
 The range of oxygen flow settings delivered to the patient;
 the accuracy of the oxygen flow setting;
 the 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(s) specified by the manufacturer;
 information on how oxygen supply to the patient is ensured in case of transportable liquid oxygen
system failure and the flow delivered to the patient under that condition;
ISO 18777:2005(E)
 an explanation of the function and meaning of each alarm and indicator provided with the transportable
liquid oxygen system.
4) Operating information
 Clear, simple diagrams and illustrations of the fully assembled and ready-to-operate transportable liquid
oxygen system;
 the steps required to prepare the transportable liquid oxygen system for operation;
 a detailed description including illustrations and diagrams if necessary, of the filling procedure of the
portable unit;
 an instruction to close the flow control valve when the transportable liquid oxygen system is empty;
 a warning statement to the effect that the base unit and the portable unit should be purged and the
liquid oxygen transfer connector clean;
 the procedure necessary to determine the state of the battery;
 diagrams, illustrations or photographs showing associated proper connection of the patient to the
transportable liquid oxygen system and other associated equipment;
 drawings or photographs of all controls, alarms and indicators provided with the transportable liquid
oxygen system;
 an explanation of the use of the controls, alarms and indicators;
 a step-by-step procedure for checking proper functioning of all controls, indicators and alarms;
 a graph or a table indicating the duration of oxygen delivery at set flows under the conditions specified by
the manufacturer;
 a list of error messages, if applicable, their meaning and the corrective steps that can be taken by the
operator;
 a troubleshooting guide for use when there are indications of a transportable liquid oxygen system
malfunction during checkout and/or operation;
 procedures to follow in the event of a transportable liquid oxygen system alarm condition;
 warnings concerning the precautions necessary to avoid possible misoperation or unsafe use of the
transportable liquid oxygen system;
 connection and proper use of remote alarm units, including recommended placement and the importance
of the operator being able to access the patient when an alarm is activated;
 legible reproductions of all required labels and hazard warnings on the device;
 a description of the state of the transportable liquid oxygen system when it may be appropriate to
contact the health care professional;
 information on how to secure the portable unit and the base unit during transportation to ensure
integrity of the device and to ensure that no spillage of liquid oxygen occurs;
 information concerning the disposal of the device and its components (e.g. battery).
6 © ISO 2005 – All rights reserved

ISO 18777:2005(E)
5) Operator maintenance instructions
 The methods and materials for cleaning and disinfecting the transportable liquid oxygen system;
 a schedule of operator-initiated maintenance including any specific procedure necessary before the
transportable liquid oxygen system is transferred to another patient;
 battery care and maintenance procedures, including instructions for recharging or replacement;
 a description of periodic visual inspections that should be performed by the operator.
6) Patient information
 A listing of accessories intended for application to the patient (e.g. masks or nasal cannulas)
recommended by the manufacturer and instructions on how they are to be fitted;
 the circumstances related to the use of the transportable liquid oxygen system 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 storage;
 a description of known or recognizable conditions of the environment that may affect the safe and
effective use or operation of the transportable liquid oxygen system, including the following items:
 the effects of lint, dust, sun, artificial light, heat or humidity;
 the effects and possible sources of electromagnetic (conducted and radiated) interference;
 the effects and causes of electrostatic discharge;
 a list of other devices that pose potential electrical problems;
 the effects of fluctuation(s) in electrical supply mains or battery voltage;
 other sources of interference;
 the 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 (for the base unit see EN 1251-3);
 a list of facilities, that provide service and their locations;
 the expected service life of the transportable liquid oxygen system;
 the shelf life and expected service life of sensors;
 information concerning the disposal of the transportable liquid oxygen system or components thereof.
ISO 18777:2005(E)
6.8.3 Technical description
Additions:
aa) the technical description shall include the following:
 a description of equipment required for the use of the transportable liquid oxygen system and any
specifications necessary for cables, tubing, batteries and any other accessories;
 step-by-step procedures to prepare the transportable liquid oxygen system for initial and
subsequent use;
 a description of how to secure the transportable liquid oxygen system for transport including
information about the maximum forces the securing system is able to accommodate;
 step-by-step procedures recommended for determining whether the transportable liquid oxygen
system is susceptible to the levels of electromagnetic interference occurring at the use location, a
recommendation to repeat the testing periodically, and the recommended action to be taken if the
transportable liquid oxygen system fails the test;
 a warning statement to the effect that the base and portable unit should be purged with oxygen prior
to first being filled with liquid oxygen;
 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.
10 Environmental conditions
IEC 60601-1:1988, Clause 10 applies, except as follows:
10.1 Transport and storage
Replacement:
The transportable liquid oxygen system (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.
8 © ISO 2005 – All rights reserved

ISO 18777:2005(E)
10.2.1 Environment
Replacement:
 an ambient temperature range of:
− 10 °C to + 40 °C for the portable device;
+ 10 °C to + 40 °C for the base unit;
 a relative humidity range of:
15 % to 95 %, non-condensing for the portable unit;
30 % to 75 % non-condensing for the base unit.
10.2.2 Power supply
When powered from line voltages, the device should opera
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