EN ISO 19054:2006
(Main)Rail systems for supporting medical equipment (ISO 19054:2005)
Rail systems for supporting medical equipment (ISO 19054:2005)
ISO 19054:2005 specifies basic requirements to ensure compatibility between rail systems complying with this International Standard and medical equipment in order to facilitate the transfer of medical equipment from one rail system to another. The specifications for rail systems include dimensions, strength and information to be supplied by the manufacturer.
ISO 19054:2005 applies only to rail systems intended to be mounted horizontally.
ISO 19054:2005 does not specify either the structures to which a rail system can be attached or the types of medical equipment that can be supported nor does it apply to overhead rail systems for supporting curtains and infusion devices.
Schienensysteme zum Halten medizinischer Geräte (ISO 19054:2005)
Diese Internationale Norm legt grundlegende Anforderungen fest, um die Kompatibilität zwischen den dieser Internationalen Norm entsprechenden Schienensystemen und medizinischen Geräten sicherzustellen, um das Umhängen eines medizinischen Gerätes von einem Schienensystem auf ein anderes zu erleichtern. Die Festlegungen für Schienensysteme beinhalten Maße, Stabilität und Informationen des Herstellers.
Diese Internationale Norm gilt nur für Schienensysteme, die horizontal montiert werden sollen.
Diese Internationale Norm enthält keine Festlegungen zu den Konstruktionen, an die die Schienensysteme angebracht werden können, und auch nicht zu den Arten der medizinischen Geräte, die gehalten werden sollen.
Diese Internationale Norm gilt nicht für an der Decke befindliche Schienensysteme zum Halten von Vorhängen und Infusionsgeräten.
ANMERKUNG 1 Einige medizinische Geräte können an eine Schiene mit Hilfe von Vorrichtungen befestigt werden, die nicht im Anwendungsbereich dieser Internationalen Norm liegen.
ANMERKUNG 2 Es wird angenommen, dass spezielle Normen erarbeitet werden, die Anwendungsbereiche abdecken, für die die in dieser Internationalen Norm festgelegten Schienensysteme nicht geeignet sind.
Systèmes de rails de support pour appareils médicaux (ISO 19054:2005)
L'ISO 19054:2005 spécifie les exigences de base en vue d'assurer la compatibilité entre les systèmes de rails conformes à la présente Norme internationale et les appareils médicaux, afin de permettre l'interchangeabilité des appareils médicaux d'un système de rails à un autre. Les spécifications relatives aux systèmes de rails comprennent les dimensions, la résistance et les informations à fournir par le fabricant.
L'ISO 19054:2005 s'applique uniquement aux systèmes de rails destinés à être montés horizontalement.
L'ISO 19054:2005 internationale ne spécifie ni les structures ni les types de matériel médical qu'ils doivent porter ni ne s'applique aux tringles et potences servant à soutenir des rideaux et des dispositifs de perfusion.
Tračni nosilci za pritrditev medicinske opreme (ISO 19054:2005)
Ta mednarodni standard določa osnovne zahteve za zagotavljanje združljivosti med tlačnimi nosilci, ki izpolnjujejo zahteve tega mednarodnega standarda, in medicinsko opremo za lažji prenos medicinske opreme z enega tračnega nosilca na drugega. Specifikacije za tračne nosilce vključujejo dimenzije, moč in informacije, ki jih zagotovi proizvajalec. Ta mednarodni standard se uporablja samo za tračne nosilce za vodoravno montažo. Ta mednarodni standard ne določa konstrukcij, na katere se pritrdi tračne nosilce, ali vrst medicinske opreme, ki je lahko podprta. Ta mednarodni standard se ne uporablja za nadzemne tračne nosilce za podporo zaves in infuzijske opreme.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2006
1DGRPHãþD
SIST EN 12218:2000
SIST EN 12218:2000/A1:2002
7UDþQLQRVLOFL]DSULWUGLWHYPHGLFLQVNHRSUHPH ,62
Rail systems for supporting medical equipment (ISO 19054:2005)
Schienensysteme zum Halten medizinischer Geräte (ISO 19054:2005)
Systemes de rails de support pour appareils médicaux (ISO 19054:2005)
Ta slovenski standard je istoveten z: EN ISO 19054:2006
ICS:
11.040.99 Druga medicinska oprema Other medical equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 19054
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2006
ICS 11.040.99 Supersedes EN 12218:1998
English Version
Rail systems for supporting medical equipment (ISO
19054:2005)
Systèmes de rails de support pour appareils médicaux (ISO Schienensysteme zum Halten medizinischer Geräte (ISO
19054:2005) 19054:2005)
This European Standard was approved by CEN on 9 June 2006.
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, Romania,
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
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 19054:2006: 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 Medical devices.4
Foreword
The text of ISO 19054:2005 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 19054:2006 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 December 2006, and conflicting national standards
shall be withdrawn at the latest by June 2008.
This document supersedes EN 12218:1998.
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, Romania, Slovakia, Slovenia,
Spain, Sweden, Switzerland and United Kingdom.
Endorsement notice
The text of ISO 19054:2005 has been approved by CEN as EN ISO 19054:2006 without any
modifications.
Annex ZA
(informative)
Relationship between this European Standard and the Essential Requirements
of EU Directive 93/42/EEC Medical devices
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 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 — Correspondence between this European Standard and Directive 93/42/EEC Medical
devices
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) of Qualifying remarks/Notes
EN Directive 93/42/EEC
4.1 1
4.2 2
4.3 2
4.3.1 4, 7.1
4.3.2 4, 7.1
4.4 9.2, 12.6
5.1.1 9.1
5.1.2 9.1
5.1.3 9.1
5.2.2 9.1
5.2.7 3, 12.7.1
5.2.7.1 12.7.1
5.2.7.2 12.7.1
5.2.7.3 3, 12.7.1
5.2.8 3, 12.7.1
5.3 3, 9.1, 12.7.1
5.4 3, 9.1, 12.7.1
5.4.3 9.1
5.4.7 3, 12.7.1
5.4.8 12.7.1
5.5.1 9.1
5.5.2 3, 9.1, 12.7.1
5.6.1 9.1
5.6.2 12.7.1
5.7.1 9.1
5.7.2 3, 9.1, 12.7.1
5.8.1 9.1
5.8.2 12.7.1
5.9 3, 12.7.1
6.1 13.1
6.1 a) 13.4
6.1 b) 13.3 a), 13.6 a)
6.1.c) 13.3 b), 13.6 a)
6.1 d) 13.3 d), 13.5
6.1 e) 13.3 m)
6.2 a) 13.1
6.2 b) 13.3 k)
7.1.2 3, 12.7.1
7.1.4 13.1
7.1.5 13.1
7.2 2, 3, 13.6 d)
8.1 13.6 c), 13.6 d)
8.2 13.1, 13.6 c), 13.6 d)
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.
INTERNATIONAL ISO
STANDARD 19054
First edition
2005-07-01
Rail systems for supporting medical
equipment
Systèmes de rails de support pour équipement médical
Reference number
ISO 19054:2005(E)
©
ISO 2005
ISO 19054:2005(E)
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ii © ISO 2005 – All rights reserved
ISO 19054:2005(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 1
4 General Requirements. 4
4.1 Safety . 4
4.2 * Alternative construction . 4
4.3 Materials . 4
4.4 Electrical requirements . 4
5 Rail system requirements . 4
5.1 Rail supports . 4
5.2 Rail. 4
5.3 Joining of rails . 9
5.4 Rail clamp . 9
5.5 Equipment mount holder . 11
5.6 Equipment mount . 12
5.7 Equipment mount pin holder. 13
5.8 Equipment mount pin. 14
5.9 * Mechanical characteristics of the rail after installation . 14
6 Marking, labelling and packaging . 15
7 Testing, commissioning and certification.16
7.1 Tests after installation. 16
7.2 Certification of the installed rail system. 16
8 Information to be supplied by the manufacturer. 16
8.1 Upon delivery of rail and supports . 16
8.2 Upon delivery of other components of the rail system . 17
Annex A (informative) Example of a form for certification of the rail system. 18
Annex B (informative) Rationale .19
Annex C (informative) Special national and regional conditions for electrical installations . 20
Bibliography . 21
ISO 19054:2005(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 19054 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 6, Medical gas systems.
iv © ISO 2005 – All rights reserved
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