EN ISO 19054:2006

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

• Status: Published
• Publication Date: 20-Jun-2006
• ICS: 11.040.99 - Other medical equipment
• Technical Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Drafting Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Current Stage: 9092 - Decision on results of review/2YR ENQ - revise - Review Enquiry
• Start Date: 07-May-2008
• Completion Date: 07-May-2008
• 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: SIST EN ISO 19054:2006 - Rail systems for supporting medical equipment (ISO 19054:2005)

Relations

• Replaces: EN 12218:1998 - Rail systems for supporting medical equipment
• Effective Date: 22-Dec-2008
• Replaces: EN 12218:1998/A1:2002 - Rail systems for supporting medical equipment
• Effective Date: 22-Dec-2008
• Amended By: EN ISO 19054:2006/A1:2016 - Rail systems for supporting medical equipment (ISO 19054:2005/Amd 1:2016)
• Effective Date: 26-Feb-2014

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 19054:2006
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
SIST EN ISO 19054:2006 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 19054:2006

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SIST EN ISO 19054:2006
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.

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SIST EN ISO 19054:2006
EN ISO 19054:2006 (E)
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

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SIST EN ISO 19054:2006
EN ISO 19054:2006 (E)
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.
3

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SIST EN ISO 19054:2006
EN ISO 19054:2006 (E)
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 mean
...