SIST EN ISO 19054:2006/A1:2017
(Amendment)Rail systems for supporting medical equipment (ISO 19054:2005/Amd 1:2016)
Rail systems for supporting medical equipment (ISO 19054:2005/Amd 1:2016)
DOW = DAV + 36 months
Schienensysteme zum Halten medizinischer Geräte (ISO 19054:2005/Amd 1:2016)
Systèmes de rails de support pour appareils médicaux (ISO 19054:2005/Amd 1:2016)
Tračni nosilci za pritrditev medicinske opreme (ISO 19054:2005/Amd 1:2016)
General Information
Relations
Overview
EN ISO 19054:2006/A1:2016 (ISO 19054:2005/Amd 1:2016) is a CEN-adopted amendment to the international standard covering rail systems for supporting medical equipment. The amendment was approved by CEN in November 2016 and updates technical requirements and conformity assessment language. The standard addresses design and safety aspects of rails used to suspend, locate or move medical devices in clinical environments (e.g., ceiling- or wall-mounted support rails).
Note: this document was offered for citation in the Official Journal but was not cited because of an issue with Annex ZA; the responsible technical committee has been contacted for follow-up.
Key topics and technical requirements
- Scope: requirements for rail systems intended to support medical equipment in healthcare settings, focusing on mechanical safety and material properties.
- Amendment highlights:
- Contact-area hardness requirement - Clause 5.2.6 (as amended): “The Brinell hardness of the rail contact area shall be not less than 70 HBW 2,5/62,5, as determined in accordance with ISO 6506-1.” Manufacturers must make evidence available on request.
- Conformity evidence - Annex B (B.5.2.6) clarifies that evidence of conformity shall be made available upon request during conformity assessment to relevant authorities, notified bodies or competent authorities.
- Regulatory linkage: Annex ZA (informative) maps the standard to essential requirements of EU Directive 93/42/EEC (medical devices). The Annex ZA content is a key reason for the standard’s citation status in the Official Journal.
Applications
- Selection, specification and testing of ceiling-, wall- or track-mounted support rails for medical devices (infusion pumps, monitors, booms, pendant systems).
- Ensuring long-term wear resistance and mechanical compatibility between rails and trolleys or carriers.
- Supporting procurement and acceptance testing by hospitals and healthcare facility engineers.
- Providing objective technical criteria for safety assessments during installation and maintenance.
Who uses this standard
- Medical device and hospital equipment manufacturers designing rail-mounted systems or accessories.
- Healthcare facility engineers, installers and maintenance teams responsible for mounting and servicing equipment.
- Regulatory bodies, notified bodies and conformity assessors evaluating compliance with medical device legislation.
- Procurement specialists and safety officers specifying equipment for clinical environments.
Related standards
- ISO 6506-1 - Metallic materials - Brinell hardness test (referenced for hardness measurement).
- ISO 19054 core document (ISO 19054:2005) - full standard text and core requirements.
This amendment provides a focused technical update (hardness and conformity evidence) that helps manufacturers, installers and assessors ensure safe, durable rail systems for medical equipment. Keywords: rail systems for supporting medical equipment, ISO 19054, EN ISO 19054:2006/A1:2016, Brinell hardness, conformity assessment, Annex ZA, medical device rail.
Frequently Asked Questions
SIST EN ISO 19054:2006/A1:2017 is a amendment published by the Slovenian Institute for Standardization (SIST). Its full title is "Rail systems for supporting medical equipment (ISO 19054:2005/Amd 1:2016)". This standard covers: DOW = DAV + 36 months
DOW = DAV + 36 months
SIST EN ISO 19054:2006/A1:2017 is classified under the following ICS (International Classification for Standards) categories: 11.040.99 - Other medical equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN ISO 19054:2006/A1:2017 has the following relationships with other standards: It is inter standard links to SIST EN ISO 19054:2006. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN ISO 19054:2006/A1:2017 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC; Standardization Mandates: M/023. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
You can purchase SIST EN ISO 19054:2006/A1:2017 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of SIST standards.
Standards Content (Sample)
SLOVENSKI STANDARD
01-februar-2017
7UDþQLQRVLOFL]DSULWUGLWHYPHGLFLQVNHRSUHPH ,62 $PG
Rail systems for supporting medical equipment (ISO 19054:2005/Amd 1:2016)
Schienensysteme zum Halten medizinischer Geräte (ISO 19054:2005/Amd 1:2016)
Systèmes de rails de support pour appareils médicaux (ISO 19054:2005/Amd 1:2016)
Ta slovenski standard je istoveten z: EN ISO 19054:2006/A1:2016
ICS:
11.040.99 Druga medicinska oprema Other medical equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 19054:2006/A1
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2016
EUROPÄISCHE NORM
ICS 11.040.99
English Version
Rail systems for supporting medical equipment (ISO
19054:2005/Amd 1:2016)
Systèmes de rails de support pour appareils médicaux Schienensysteme zum Halten medizinischer Geräte
(ISO 19054:2005/Amd 1:2016) (ISO 19054:2005/Amd 1:2016)
This amendment A1 modifies the European Standard EN ISO 19054:2006; it was approved by CEN on 30 November 2016.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This amendment 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 CEN-CENELEC Management Centre has the
same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 19054:2006/A1:2016 E
worldwide for CEN national Members.
Contents Page
Eurpopean foreword . 3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC [OJ L 169] aimed to be covered . 4
Eurpopean foreword
This document (EN ISO 19054:2006/A1:2016) 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 Amendment to the European Standard EN ISO 19054:2006 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by June 2017, and
conflicting national standards shall be withdrawn at the latest by June 2017.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
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, Bulgaria, Croatia,
Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands,
Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 19054:2005/Amd1:2016 has been approved by CEN as EN ISO 19054:2006/A1:2016
without any modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC [OJ L 169] aimed to be covered
This European Standard has been prepared under a Commission’s standardization request [M/023
concerning the development of European Standards related to medical devices] / [M/295 concerning
the development of European Standards related to medical devices] / [reference number and title of
any other standardization request as relevant] to provide one voluntary means of conforming to
essential requirements of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices [OJ
L 160].
Once this standard is cited in the Official Journal of the European Union under that Directive,
...
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