OSIST prEN ISO 10083:2005

Oxygen concentrator supply systems for use with medical gas pipeline systems (ISO/FDIS 10083:2006)

Message from D Upstone (Secretary of CEN/TC 215) - 2006-05-31:
Dear Ashok,
I attach document CEN/TC215 N 1092 giving the results of the parallel Formal Vote and a covering letter from the Secretariat of CEN/TC215. You will see that the document passed in ISO but failed in CEN. According to the Guidelines on the Vienna Agreement, these results should be discussed by CEN and ISO including representatives of the TCs concerned (which in the case of ISO is ISO/TC121/SC6 – Chairman Dr David Peel, Secretary Dr Susan Dorsch, ISO programme manager Mr Tim Hancox).
The recommendation of the Chairman and Secretary of CEN/TC215 is that the CEN project should be cancelled and the document should be published as an ISO-only standard. I trust N1092 gives sufficient information and justification to proceed along these lines. Please let me know if you require anything further from me. As far as I can see, none of the pre-formatted resolutions cover this case, i.e. mandated item, not covered by or

Versorgungssysteme mit Sauerstoff-Konzentratoren zur Verwendung mit Rohrleitungssystemen für medizinische Gase (ISO/FDIS 10083:2006)

1.1   Diese Internationale Norm legt Anforderungen für die Gestaltung und Installation eines Versorgungssystems mit Sauerstoff Konzentratoren fest, das zusammen mit einem Rohrverteilersystem für medizinische Gase nach ISO 7396 1 verwendet wird.
1.2   Sie gilt nur für Versorgungssysteme mit Sauerstoff Konzentratoren, die mit Sauerstoff angereicherte Luft mit einer Sauerstoffkonzentration nicht unter 90 % herstellen (siehe 4.5.1).
1.3   Sauerstoff Konzentratoren für den häuslichen Gebrauch liegen nicht im Anwendungsbereich dieser Internationalen Norm.
ANMERKUNG   Anforderungen an Sauerstoff Konzentratoren für den häuslichen Gebrauch sind in ISO 8359 festgelegt.

Systemes d'approvisionnement concentrateur d'oxygene pour utilisation dans des réseaux de distribution de gaz médicaux (ISO/FDIS 10083:2006)

Sistemi za koncentriranje kisika za uporabo s sistemi napeljav za medicinske pline (ISO/DIS 10083:2004)

General Information

• Status: Not Published
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 98 - Abandoned project (Adopted Project)
• Start Date: 03-Aug-2012
• Due Date: 08-Aug-2012
• Completion Date: 03-Aug-2012
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: prEN ISO 10083 - Oxygen concentrator supply systems for use with medical gas pipeline systems (ISO/FDIS 10083:2006)

Standards Content (Sample)

SLOVENSKI OSIST prEN ISO 10083:2005

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
©  Standard je založil in izdal Slovenski inštitut za standardizacijo. Razmnoževanje ali kopiranje celote ali delov tega dokumenta ni dovoljeno

EUROPEAN STANDARD
DRAFT
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.

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.
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.

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

ISO/DIS 10083
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ii ISO 2004 – All rights reserved

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.
...