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PREDSTANDARD
januar 2005
Sistemi za koncentriranje kisika za uporabo s sistemi napeljav za medicinske
pline (ISO/DIS 10083:2004)
(istoveten prEN ISO 10083:2004)
Oxygen concentrator supply systems for use with medical gas pipeline systems
(ISO/DIS 10083:2004)
ICS 11.040.10 Referenčna številka
OSIST prEN ISO 10083:2005(en;fr;de)
© Standard je založil in izdal Slovenski inštitut za standardizacijo. Razmnoževanje ali kopiranje celote ali delov tega dokumenta ni dovoljeno
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EUROPEAN STANDARD
DRAFT
prEN ISO 10083
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2004
ICS
English version
Oxygen concentrator supply systems for use with medical gas
pipeline systems (ISO/DIS 10083:2004)
Systèmes d'approvisionnement concentrateurs d'oxygène
pour utilisation dans des réseaux de distribution de gaz
médicaux (ISO/DIS 10083:2004)
This draft European Standard is submitted to CEN members for parallel enquiry. It has been drawn up by the Technical Committee
CEN/TC 215.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN 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 Management Centre 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.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2004 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN ISO 10083:2004: E
worldwide for CEN national Members.
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prEN ISO 10083:2004 (E)
Foreword
This document (prEN ISO 10083:2004) has been prepared by Technical Committee ISO/TC
121 "Anaesthetic and respiratory equipment" in collaboration with Technical Committee
CEN/TC 215 "Respiratory and anaesthetic equipment", the secretariat of which is held by
BSI.
This document is currently submitted to the parallel Enquiry.
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.
Endorsement notice
The text of ISO 10083:2004 has been approved by CEN as prEN ISO 10083:2004 without
any modifications.
2
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prEN ISO 10083:2004 (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.
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. 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.
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DRAFT INTERNATIONAL STANDARD ISO/DIS 10083
ISO/TC 121/SC 6 Secretariat: ANSI
Voting begins on: Voting terminates on:
2004-10-07 2005-03-07
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION • МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ • ORGANISATION INTERNATIONALE DE NORMALISATION
Oxygen concentrator supply systems for use with medical gas
pipeline systems
Systèmes d'approvisionnement concentrateur d'oxygène pour utilisation dans des réseaux de distribution de
gaz médicaux
[Revision of first edition (ISO 10083:1992)]
ICS 11.040.10
ISO/CEN PARALLEL ENQUIRY
The CEN Secretary-General has advised the ISO Secretary-General that this ISO/DIS covers a subject
of interest to European standardization. In accordance with the ISO-lead mode of collaboration as
defined in the Vienna Agreement, consultation on this ISO/DIS has the same effect for CEN
members as would a CEN enquiry on a draft European Standard. Should this draft be accepted, a
final draft, established on the basis of comments received, will be submitted to a parallel two-month FDIS
vote in ISO and formal vote in CEN.
In accordance with the provisions of Council Resolution 15/1993 this document is circulated in
the English language only.
Conformément aux dispositions de la Résolution du Conseil 15/1993, ce document est distribué
en version anglaise seulement.
To expedite distribution, this document is circulated as received from the committee secretariat.
ISO Central Secretariat work of editing and text composition will be undertaken at publication
stage.
Pour accélérer la distribution, le présent document est distribué tel qu'il est parvenu du
secrétariat du comité. Le travail de rédaction et de composition de texte sera effectué au
Secrétariat central de l'ISO au stade de publication.
THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS THEREFORE SUBJECT TO CHANGE AND MAY NOT BE
REFERRED TO AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, TECHNOLOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN NATIONAL REGULATIONS.
© International Organization for Standardization, 2004
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ISO/DIS 10083
PDF disclaimer
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Copyright notice
This ISO document is a Draft International Standard and is copyright-protected by ISO. Except as permitted
under the applicable laws of the user's country, neither this ISO draft nor any extract from it may be
reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic, photocopying,
recording or otherwise, without prior written permission being secured.
Requests for permission to reproduce should be addressed to either ISO at the address below or ISO's
member body in the country of the requester.
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Tel. + 41 22 749 01 11
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Reproduction may be subject to royalty payments or a licensing agreement.
Violators may be prosecuted.
©
ii ISO 2004 – All rights reserved
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ISO/DIS 10083
Contents Page
Foreword.v
Introduction.vi
1 Scope .1
2 Normative references.1
3 Terms and definitions .2
4 General Requirements.4
4.1 Safety .4
4.2 R Alternative construction .5
4.3 Materials.5
4.4 System design.6
4.5 Specifications for oxygen 90+ .6
4.6 Cylinder filling.6
5 Sources of supply .6
5.1 General.7
5.2 Primary source of supply .7
5.3 Secondary source of supply .7
5.4 Reserve source of supply.8
5.5 Sources of supply with cylinders .8
5.6 Location of oxygen concentrator supply systems .8
6 Requirements for components.8
6.1 Oxygen concentrator unit.8
6.2 Oxygen Monitors.9
6.3 Pressure-relief valves. 10
6.4 Shut-off valves. 10
6.5 Sample port. 10
7 Monitoring and alarm systems. 10
7.1 General. 10
7.2 Monitoring and alarm signals. 10
7.3 Operating alarms. 11
7.4 Information signals . 11
8 Marking . 11
9 Installation. 11
9.1 General. 11
9.2 Electrical Systems. 12
10 Testing, commissioning and certification . 12
10.1 General. 12
10.2 Tests and procedures. 12
10.3 Specific tests. 12
10.4 Commissioning and certification . 14
11 Information to be supplied by the manufacturer . 14
11.1 Instructions for installation . 14
11.2 Instructions for use . 14
11.3 Instructions for preventive maintenance. 15
11.4 ‘As installed’ drawings. 15
11.5 Electrical schematics. 15
11.6 Certificates of inspection, performance testing or qualification. 15
© ISO 2004 – All rights reserved iii
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ISO/DIS 10083
12 Implementation of use of oxygen 90+ . 15
12.1 Acceptance of oxygen 90+ . 15
12.2 Timing. 15
12.3 Mixing of oxygen 90+ and oxygen. 16
12.4 Calibration of medical equipment . 16
12.5 Labelling of terminal units . 16
12.6 Compliance with ISO 7396-1 . 16
Annex A (informative) Schematic representations of oxygen concentrator supply systems. 17
Annex B (informative) General guidelines for locations of supply systems. 25
Annex C (informative) Guidelines for emergency procedures . 27
C.1 General . 27
C.2 Communication. 27
C.3 Conservation of gas supplies . 27
C.4 Remedial actions . 28
C.5 Training. 28
C.6 Additional cylinder reserves. 28
Annex D (informative) Procedure for testing and commissioning . 29
D.1 Introduction . 29
D.2 General . 29
D.3 Procedure . 29
Annex E (informative) Typical forms for certification of an oxygen concentrator supply system. 30
Annex F (informative) Recommended minimum requirements for preventive maintenance. 34
F.1 General . 34
F.2 Organization . 34
F.3 Retesting. 35
F.4 Documentation. 35
Annex G (informative) Recommendations for installation . 36
Annex H (informative) Risk and risk management . 37
Annex I (informative) Recommendations for sizing and capacity . 38
Annex J (informative) Recommendations for filling cylinders with oxygen 90+. 39
J.1 General . 39
J.2 Filling system control . 39
J.3 Manifolds . 39
J.4 Connectors . 39
J.5 Termination of filling. 39
Annex K (informative) Rationale . 40
Bibliography . 41
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC Medical Devices . 42
iv © ISO 2004 – All rights reserved
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ISO/DIS 10083
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 10083 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 6, Medical gas systems
This second edition cancels and replaces the first edition (1992), which has been technically revised.
Annexes A, B, C, D, E, F, G, H, I, J, K, L and M are given for information only.
© ISO 2004 – All rights reserved v
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ISO/DIS 10083
Introduction
This purpose of this International Standard is to specify minimum safety and performance requirements for
oxygen concentrator supply systems used to deliver oxygen 90+ to a pipeline distribution system. Oxygen 90+
is a generic term, developed by the subcommittee and intended to include the range of oxygen concentrations
produced by oxygen concentrator supply systems. National, regional or local regulations may stipulate the
minimum concentration of oxygen to be produced by an oxygen concentrator supply system, or the range of
concentrations which the supply system shall produce.
Oxygen concentrators can be used to deliver oxygen-enriched air to a medical gas pipeline system as a
substitute for medical oxygen. Oxygen concentrators may be combined with sources of supply containing
100% medical oxygen (i.e. in cylinders or cryogenic vessels).
Oxygen concentrators can supply a product gas with an oxygen concentration variable within a specified
range (e.g. 93 ± 3%) depending on the characteristic of the concentrator and the flow supplied. The oxygen
concentration supplied will therefore vary from 90 to 100% in normal operating conditions.
The selection of oxygen 90+ is a decision of the healthcare facility and outside the scope of this standard. This
standard should not be construed as an endorsement or recommendation of one concentration of oxygen over
another. The use of supply systems with oxygen concentrators may require the approval of regional or
national authorities.
A supply system with oxygen concentrators can be installed at the time of the installation of the pipeline
distribution system or as a replacement or augmentation of an existing supply system. A supply system with
oxygen concentrators can be supplied as a package and may be installed by a third party. In this case the
manufacturer of the oxygen concentrator supply system must provide the installer with appropriate information
for installation and testing before connecting the supply system to the pipeline distribution system and before
use.
Objectives of this standard are to ensure the following:
- appropriate introduction of an oxygen concentrator supply system into a health care facility;
- acceptable quality of the oxygen 90+ delivered by the system;
- continuous supply of oxygen 90+;
- use of suitable materials;
- cleanliness of components;
- correct installation;
- provision of appropriate control, monitoring and alarm systems for the supply system;
- testing, commissioning and certification.
It is intended for use by those persons involved in the design, construction, inspection or operation of health
care facilities. Those persons involved in the design, manufacture, calibration or testing of equipment intended
to be connected to a pipeline system supplied by an oxygen concentrator supply system should also be aware
of the contents of this document.
Annex K contains rationale statements for some of the requirements of ISO 10083. It is included to provide
additional insight into the reasoning that led to the requirements and recommendations that have been
incorporated in this International Standard. The clauses and subclauses marked with R after their number
have corresponding rationale contained in annex K. It is considered that knowledge of the reasons for the
requirements will not only facilitate the proper application of this International Standard, but will expedite any
subsequent revisions.
vi © ISO 2004 – All rights reserved
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DRAFT INTERNATIONAL STANDARD ISO/DIS 10083
Oxygen concentrator supply systems for use with medical gas
pipeline systems
1 Scope
1.1 This standard specifies requirements for design and installation of an oxygen concentrator supply
system for use with a pipeline distribution system.
1.2 Oxygen concentrators for domiciliary use are excluded from the scope of this standard.
NOTE Requirements for oxygen concentrators for domiciliary use are specified in ISO 8359.
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.
ISO 407:1991, Small medical gas cylinders - Pin-index yoke-type valve connections.
ISO 3746:1995, Acoustics – Determination of sound power levels of noise sources using sound pressure –
Survey method using an enveloping measurement surface over a reflecting plane.
ISO 5145:1990, Cylinder valve outlets for gases and gas mixtures - - Selection and dimensioning.
ISO 5359:2000, Low-pressure hose assemblies for use with medical gases.
ISO 7396-1:2002, Medical gas pipeline systems – Part 1: Pipelines for compressed medical gases and
vacuum.
ISO/TR 7470:1998, Valve outlets for gas cylinders -- List of provisions which are either standardized or in use.
ISO 9703-1:1992, Anaesthesia and respiratory care alarm signals – Part 1: Visual alarm signals.
ISO 14971:2000, Medical devices – Risk management -- Part 1: Application of risk analysis.
ISO 15001:2003, Anaesthetic and respiratory equipment---compatibility with oxygen.
ISO 21969, High-pressure flexible connections for use with medical gases.
EN 286-1:2002, Simple unfired pressure vessels designed to contain air or nitrogen – Part 1: Pressure
vessels for general purposes.
© ISO 2004 – All rights reserved 1
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ISO/DIS 10083
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
commissioning
proof of function to verify that the agreed system specification is met and is accepted by the user or his
representative
3.2
control equipment
those items necessary to maintain the oxygen 90+ supply within the specified operating parameters
Examples are pressure regulators, pressure-relief valves, alarms, sensors and oxygen monitors.
3.3 cylinder bundle
pack or pallet of cylinders linked together with a single connector for filling and emptying
3.4
gas-specific
having characteristics which prevent connections between different gas services
3.5
manifold
device for connecting the outlet(s) of one or more cylinders or cylinder bundles of the same medical gas to the
pipeline system
3.6
manufacturer
the natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device
before it is placed on the market under his own name, regardless of whether these operations are carried out
by that person himself or on his behalf by a third party
3.7
medical gas pipeline system
complete system which comprises a supply system, a monitoring and alarm system and a pipeline
distribution system with terminal units at the points where medical gases or vacuum may be
required
3.8
nominal distribution pressure
pressure which the medical gas pipeline system is intended to deliver at the terminal units
3.9
non-return valve
valve which permits flow in one direction only
3.10
operating alarm
alarm to indicate to technical staff that it is necessary to replenish the supply or to correct a malfunction
3.11
oxygen concentrator
device which produces oxygen 90+ from ambient air by extraction of nitrogen
3.12
oxygen concentrator supply system
supply system containing one or more oxygen concentrators
2 © ISO 2004 – All rights reserved
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ISO/DIS 10083
3.13
oxygen concent
...