DRAFT ÖNORM EN

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1 DRAFT ÖNORM EN Edition: Rescue systems Transportation of incubators Part 1: Interface conditions Rettungssysteme Inkubatortransport Teil 1: Anforderungen an Schnittstellen Systèmes de sauvetage Transport d'incubateurs Partie 1: Conditions d'interface Publisher and printing Austrian Standards Institute/ Österreichisches Normungsinstitut (ON) Heinestraße 38, 1020 Wien Copyright Austrian Standards Institute All rights reserved. No part of this publication may be reproduced or utilized in any form or by any means electronic, mechanical, photocopying or any other data carries without prior permission! Internet: Sale and distribution of national and foreign standards and technical regulations via Austrian Standards plus GmbH Heinestraße 38, 1020 Wien Internet: 24-Hours-Webshop: Tel.: Fax: Note: Because of possible comments, the final version of this ÖNORM can differ from the present Draft. Please send your comments (in writing) by to Austrian Standards Institute. ICS ; Identical (IDT) with pren : Supersedes ÖNORM EN : responsible Committee ON-K 194 Rescue service

2 DRAFT ÖNORM EN :2009 Explanations concerning Draft The present Draft European Standard EN has been submitted to CEN members for voting. In case of a positive result of the voting as required by CEN/CENELEC regulations, this Draft will be published as EN. Like all member organizations of CEN, Austrian Standards Institute is basically obliged to implement European Standards in Austria and to withdraw conflicting standards. Austrian Standards Institute herewith submits this Draft of a European Standard as Draft ÖNORM to public enquiry and information. Comments on this Draft Please find below some practical instructions intended to offer you and the responsible committee assistance for the processing of comments and proposals for modification: Form Structure Language Script/Format Dispatch Aspects concerning patent law For your comments/proposals for change, please use the relevant form available from Internet. Download under Please use a new line for each comment. This facilitates the attribution of the comments received to the different clauses and chapters of the respective Draft. Please formulate technical comments on European Standards if possible in English, since English is the common working language of the most European standardizing bodies. Editorial and/or linguistic proposals for change/improvement of German versions of European Standards shall (certainly) be submitted in German. Please use the script Arial with 9 pt font size. Please do not change the formats. Please send your comments by to the responsible Committee Manager (andrea.redelsteiner@as-institute.at) The recipients of this Draft ÖNORM are requested to add information on any patent rights known to their comments and to provide supporting documentation, if available.

3 EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM DRAFT pren August 2009 ICS ; Will supersede EN :2003 English Version Rescue systems - Transportation of incubators - Part 1: Interface conditions Systèmes de sauvetage - Transport d'incubateurs - Partie 1: Conditions d'interface Rettungssysteme - Inkubatortransport - Teil 1: Anforderungen an Schnittstellen This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee CEN/TC 239. 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 CEN Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, 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. Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to provide supporting documentation. 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: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. pren :2009: E

4 pren :2009 (E) ÖNORM DRAFT Contents Page Foreword...3 Introduction Scope Normative references Terms and definitions Requirements Interface between transport incubator system and vehicle or craft Fixation Electricity Gas supply...9 Annex A (informative) Rationale regarding power use A.1 Rationale to subclause : Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EC Directive 93/42/EEC Bibliography

5 ÖNORM DRAFT pren :2009 (E) Foreword This document (pren :2009) has been prepared by Technical Committee CEN/TC 239 Rescue systems, the secretariat of which is held by DIN. This document is currently submitted to the CEN Enquiry. This document will supersede EN :2003. EN consists of the following parts, under the general title Rescue systems Transportation of incubators: Part 1: Interface conditions Part 2: System requirements 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 EC Directive(s). For relationship with EC Directive(s), see informative Annex ZA, which is an integral part of this document. 3

6 pren :2009 (E) ÖNORM DRAFT Introduction This European Standard gives the requirements for the interfaces required in the transport of an incubator. These include those between the incubator and the vehicle or craft as well as those between the various items of equipment used to make up the transport incubator system. They are essential in order to ensure interchangeability and a safe and effective function in different vehicles, allowing the uninterrupted care of patients. Requirements for the system are given in Part 2 (EN :2004). Fixation, monitoring, supply of gas and electricity shall be maintained through the use of the same standard interfaces as defined in this document. 4

7 ÖNORM DRAFT pren :2009 (E) 1 Scope This European Standard specifies the requirements for the interface between the vehicle or craft and the incubator and the associated equipment, needed for care and treatment of infants, used in emergency or planned transport. This standard does not give requirements for the vehicles, crafts, devices or incubators as such; these requirements are found in other standards. However, transport incubators are normally combined with other equipment to form a transport incubator system. 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. This European Standard incorporates by dated or undated reference, provisions from other publications. These normative references are cited at the appropriate places in the text and the publications are listed hereafter. For dated references, subsequent amendments to or revisions of any of these publications apply to this European Standard only when incorporated in it by amendment or revision. ISO :2008, Terminal units for medical gas pipeline systems Part 1: Terminal units for use with compressed medical gases and vacuum ISO :2007, Medical gas pipeline systems Part 2: Anaesthetic gas scavenging disposal systems EN ISO :2007, Medical gas pipeline systems Part 1: Pipeline systems for compressed medical gases and vacuum ISO :2008, Terminal units for medical gas pipeline systems Part 2: Terminal units for anaesthetic gas scavenging systems ENV Medical gas pipeline systems Part 6: Dimensions of probes for terminal units for compressed medical gases and vacuum EN ISO :2004, Inhalational anaesthesia systems Part 4: Anaesthetic vapour delivery devices EN ISO :2007, Inhalational anaesthesia systems Part 2: Anaesthetic breathing systems EN ISO :2007, Inhalational anaesthesia systems Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems EN ISO 407:2004, Small medical gas cylinders Pin-index yoke-type valve connections EN 1789:2007, Medical vehicles and their equipment. Road ambulances EN 1865:1999, Specifications for stretchers and other patient handling equipment used in road ambulances EN :2008, Medical vehicles and their equipment. Air ambulances. Requirements for medical devices used in air ambulances EN :2008, Medical vehicles and their equipment. Air ambulances. Operational and technical requirements of air ambulances EN :2004, Rescue systems - Transportation of incubators Part 2: System requirements 5