SIST EN ISO 19054:2006
(Main)Rail systems for supporting medical equipment (ISO 19054:2005)
Rail systems for supporting medical equipment (ISO 19054:2005)
This International Standard 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. This International Standard applies only to rail systems intended to be mounted horizontally. This International Standard does not specify either the structures to which a rail system can be attached or the types of medical equipment that can be supported. This International Standard does not 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.
Systemes 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
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
2
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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 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
4
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SIST EN ISO 19054:2006
EN ISO 19054:2006 (E)
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.
5
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SIST EN ISO 19054:2006
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SIST EN ISO 19054:2006
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
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SIST EN ISO 19054:2006
ISO 19054:2005(E)
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ii © ISO 2005 – All rights reserved
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SIST EN ISO 19054:2006
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 2005 – All rights reserved iii
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SIST EN ISO 19054:2006
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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SIST EN ISO 19054:2006
ISO 19054:2005(E)
Introduction
This International Standard specifies basic requirements and dimensions for rail systems used for supporting
medical equipment. A rail system consists of a number of components that can be assembled into different
configurations.
Rail systems allow medical equipment such as flowmeters, suction devices and luminaires to be placed near
the patient. They can be mounted in many different locations in health care facilities and in ambulances and
other means of transportation and on many different pieces of equipment such as medical supply units, ceiling
pendants, trolleys, beds, ventilators and anaesthetic workstations.
Medical equipment can be attached to a rail by rail clamps directly or using other components of dimensions
which are specified in this International Standard. Rail clamps are required to be compatible with rails which
have dimensions specified in this International Standard.
Rail systems have to be fitted to different kinds of load-bearing structures which can vary from solid concrete
walls or thin plasterboard partitions to the covers of medical equipment. This can create hazards to the
equipment and to the patient. Patients with accompanying medical equipment are frequently moved either to
or within health care facilities. Lack of standardization of rail systems in different locations can create
hazardous situations in the transfer of the patient from one location to another.
Annex B contains rationale statements for some of the requirements of this International Standard. 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 an
asterisk (*) after their number have corresponding rationale contained in Annex B. 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.
© ISO 2005 – All rights reserved v
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SIST EN ISO 19054:2006
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SIST EN ISO 19054:2006
INTERNATIONAL STANDARD ISO 19054:2005(E)
Rail systems for supporting medical equipment
1 Scope
This International Standard 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.
This International Standard applies only to rail systems intended to be mounted horizontally.
This International Standard does not specify either the structures to which a rail system can be attached or the
types of medical equipment that can be supported.
This International Standard does not apply to overhead rail systems for supporting curtains and infusion
devices.
NOTE 1 Some medical equipment can be attached to the rail by means that are outside the scope of this International
Standard.
NOTE 2 It is expected that particular standards will be prepared to cover applications for which the rail systems
specified in this International Standard are unsuitable.
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 1302:2002, Geometrical Product Specifications (GPS) — Indication of surface texture in technical product
documentation
ISO 4135:2001, Anaesthetic and respiratory equipment — Vocabulary
ISO 6506-1:1999, Metallic materials — Brinell hardness test — Part 1: Test method
ISO 14971:2000, Medical devices — Application of risk management to medical devices
EN 980, Graphical symbols for use in the labelling of medical devices
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 4135 and the following apply.
3.1
commissioning
proof of function to verify that the agreed system specification is met and is accepted by the user or the
representative of the user
© ISO 2005 – All rights reserved 1
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SIST EN ISO 19054:2006
ISO 19054:2005(E)
3.2
equipment mount
component of a rail system used to attach medical equipment to an equipment mount holder
(See Figure 1)
3.3
equipment mount holder
component of a rail system to which an equipment mount can be attached and removed
(See Figure 1)
3.4
equipment mount pin
component of a rail system used to attach medical equipment to an equipment mount pin holder
(See Figure 1)
3.5
equipment mount pin holder
component of a rail system to which an equipment mount pin can be attached and removed
(See Figure 1)
3.6
installer
person with legal responsibility for the installation of a device
3.7
locking mechanism
part of the rail clamp used to lock and unlock the rail clamp to and from the rail contact area
3.8
manufacturer
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
3.9
rail
bar on which medical equipment can be attached or removed by use of a rail clamp
3.10
rail clamp
means of attaching or removing medical equipment or an equipment mount holder or an equipment mount pin
holder to or from a rail
3.11
rail clamp contact area
part of a rail clamp intended for direct contact with the rail
3.12
rail contact area
part of a rail intended for direct contact with the rail clamp contact area and the locking mechanism
3.13
rail end cap
component that is attached to the end of the rail and is intended to stop a clamp from sliding off the rail
2 © ISO 2005 – All rights reserved
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SIST EN ISO 19054:2006
ISO 19054:2005(E)
3.14
rail support
component of a rail system used to attach a rail to a structure or equipment
(See Figure 1)
3.15
rail system
assembly of components comprising at least a rail, rail supports and rail clamps
(See Figure 1)
3.16
single fault condition
condition in which a single means of protection against a hazard in equipment is defective or a single external
abnormal condition is present
Key
1 load-bearing structure 7 medical equipment
2 rail support 8 equipment mount pin holder
3 rail 9 equipment mount pin
4 rail clamp 10 permanent connection
5 equipment mount 11 operator connection
6 equipment mount holder
Figure 1 — Examples of connections of medical equipment to a rail system
© ISO 2005 – All rights reserved 3
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SIST EN ISO 19054:2006
ISO 19054:2005
...
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