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SIST EN ISO 18777:2009
01-julij-2009
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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
SIST EN ISO 18777:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 18777:2009
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SIST EN ISO 18777:2009
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.
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SIST EN ISO 18777:2009
EN ISO 18777:2009 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4
2
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SIST EN ISO 18777:2009
EN ISO 18777:2009 (E)
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
EN ISO 18777:2009 by Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” the
secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by 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.
3
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SIST EN ISO 18777:2009
EN ISO 18777:2009 (E)
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.
4
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SIST EN ISO 18777:2009
EN ISO 18777:2009 (E)
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
5
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SIST EN ISO 18777:2009
EN ISO 18777:2009 (E)
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.
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SIST EN ISO 18777:2009
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
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SIST EN ISO 18777:2009
ISO 18777:2005(E)
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ii © ISO 2005 – All rights reserved
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SIST EN ISO 18777:2009
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 2005 – All rights reserved iii
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SIST EN ISO 18777:2009
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
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SIST EN ISO 18777:2009
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 2005 – All rights reserved v
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SIST EN ISO 18777:2009
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
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SIST EN ISO 18777:2009
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 (*).
© ISO 2005 – All rights reserved vii
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SIST EN ISO 18777:2009
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SIST EN ISO 18777:2009
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 2005 – All rights reserved 1
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SIST EN ISO 18777:2009
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
...