1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN 1865-4:2012Patient handling equipmentused in road ambulancesPart 4: Foldable patient transfer chairBS EN 1865-4:2012 BRITISH STANDARDNational forewordThis British Standard
2、is the UK implementation of EN 1865-4:2012.Together with BS EN 1865-1:2010, BS EN 1865-2:2010, BS EN1865-3:2012 and BS EN 1865-5:2012, it supersedes BS EN 1865:2000,which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/239, Rescue systems.A list of organiz
3、ations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2012. Published by BSI StandardsLimited 2012ISBN
4、 978 0 580 70209 9ICS 11.160Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 30 June 2012.Amendments issued since publicationDate Text affectedBS EN 1865-4:2012EURO
5、PEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 1865-4 April 2012 ICS 11.160 Supersedes EN 1865:1999English Version Patient handling equipment used in road ambulances - Part 4: Foldable patient transfer chair Equipements dambulances pour le transport des patients -Partie 4 : Chaise de transport Kra
6、nkentransportmittel im Krankenkraftwagen - Teil 4: Klappbare Patiententragesessel This European Standard was approved by CEN on 25 February 2012. 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
7、 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 European Standard exists in three official versions (English, French, German).
8、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, Cyp
9、rus, 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, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDI
10、ZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2012 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 1865-4:2012: EBS EN 1865-4:2012EN 1865-4:2012 (E) 2 Cont
11、ents Page Foreword 31 Scope 42 Normative references 43 Terms and definitions .44 Requirements .44.1 General 44.2 Dimensions .54.3 Mass 54.4 Loading capacity54.5 Frame 54.6 Seat and Backrest 54.7 Restraint system 54.8 Flammability toxicity burning gases .54.9 Deformation of the frame 54.10 Locking .6
12、4.11 Deformation of the backrest lying-sitting area .65 Marking .6Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices .7BS EN 1865-4:2012EN 1865-4:2012 (E) 3 Foreword This document (EN 1865-4:2012) has been pr
13、epared by Technical Committee CEN/TC 239 “Rescue systems”, the secretariat of which is held by DIN. 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 October 2012, and conflicting national standards
14、 shall be withdrawn at the latest by October 2012. 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 supersedes EN 1865:19
15、99. With respect to EN 1865:1999, the following changes have been made: a) foldable patient transport chairs shall be fitted with a mechanism to assist the descent and/or ascent of steps, to minimise the need for manually carrying the patient and chair; b) the mass was changed from 10 kg to no more
16、than 15 kg; c) the patient restraint-systems shall secure the patient, but at the same time shall permit treatment of the patient; d) the standard has been modified/integrated to meet the Medical Device Directive 93/42/EEC requirements. This document has been prepared under a mandate given to CEN by
17、 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. This European Standard is a part of EN 1865, Patient handling equipme
18、nt used in road ambulances, which will consist in the future of the following parts: Part 1: General stretcher systems and patient handling equipment; Part 2: Power assisted stretcher; Part 3: Heavy duty stretcher; Part 4: Foldable patient transfer chair; Part 5: Stretcher support. According to the
19、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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
20、Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. BS EN 1865-4:2012EN 1865-4:2012 (E) 4 1 Scope This European Standard defines the minimum requirements for the design and performance of foldabl
21、e patient transfer chairs, which are used for the conveyance of patients to and/or from road ambulances. It aims to ensure patient safety and to minimize the physical effort required by staff operating the equipment. 2 Normative references The following documents, in whole or in part, are normativel
22、y referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN 980, Symbols for use in the labelling of medical devices EN 1021
23、-1, Furniture Assessment of the ignitability of upholstered furniture Part 1: Ignition source smouldering cigarette EN 1041, Information supplied by the manufacturer of medical devices EN 1865-1:2010, Patient handling equipment used in road ambulances Part 1: General stretcher systems and patient ha
24、ndling equipment EN ISO 14971, Medical devices Application of risk management to medical devices (ISO 14971) 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 foldable patient transfer chair device designed to transfer a patient in a sitting po
25、sition to the road ambulance, but not to be used to transport a patient within the ambulance 4 Requirements 4.1 General These chairs shall be fitted with a mechanism to assist the descent and/or ascent of steps in order to minimise the need for manual transportation of the patient and chair. NOTE Ex
26、amples of mechanisms to assist the descent and/or ascent of stairs are: rolling track belts that span one or more steps and include a means to slow the descent of the chair; a series of rotating wheels that spans each individual step so as to descend/ascend one step at a time. When foldable patient
27、transfer chairs are operated and maintained in accordance with manufacturer instructions, they should not present any high level of risk. Any identified risk shall be reduced to an acceptable level by using risk management principles in accordance with EN ISO 14971 in normal and single fault conditi
28、on. Handles on devices shall lock in their extended positions. All equipment for the handling of patients shall be free of any sharp edges or deformation that could cause injury to persons or damage to other equipment. BS EN 1865-4:2012EN 1865-4:2012 (E) 5 All patient restraint-systems shall have a
29、quick release system. Patient restraint-systems shall secure the patient, but at the same time shall permit treatment of the patient. 4.2 Dimensions The dimensions of the foldable patient transfer chair in open position shall be as follows: The seat: minimum height of 300 mm, measured from the groun
30、d; maximum height of 550 mm, measured from the ground; minimum width of 330 mm; minimum depth of 350 mm; The backrest: minimum height of 395 mm, measured from the seat; minimum width of 300 mm. 4.3 Mass The mass shall be not more than 15 kg. NOTE The mass should be as low as possible. 4.4 Loading ca
31、pacity The loading capacity shall be a minimum of 150 kg. 4.5 Frame The frame of the foldable patient transfer chair shall be a sturdy, lightweight construction. It shall be furnished with 2 non-slip handles on the lower frame, and 2 non-slip handles on the top frame. It shall also have a footrest a
32、nd a minimum of two wheels of a diameter 100 mm minimum at the rear. It shall be possible to store the foldable transfer chair in a folded position. 4.6 Seat and Backrest The patient seat and backrest shall be made of a strong material which is bacteria resistant, fungi resistant, stain resistant, p
33、utrid resistant, easy to clean, washable, waterproof and petrol-oil resistant. 4.7 Restraint system There shall be at least two quick-release patient restraints. 4.8 Flammability toxicity burning gases There shall be no progressive smouldering or flaming ignition when tested in accordance with EN 10
34、21-1. 4.9 Deformation of the frame There shall be no remaining deformation of the frame when tested in accordance with EN 1865-1:2010, 5.8.1. BS EN 1865-4:2012EN 1865-4:2012 (E) 6 4.10 Locking The hinges and locks shall not open spontaneously or bend. 4.11 Deformation of the backrest lying-sitting a
35、rea There shall be no remaining deformation of the backrest and lying-sitting area when tested in accordance with EN 1865-1:2010, 5.8.1. 5 Marking The foldable transfer chair covered by this European Standard shall be labelled in accordance with EN 980 and EN 1041. BS EN 1865-4:2012EN 1865-4:2012 (E
36、) 7 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on 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 mea
37、ns of conforming to Essential Requirements of the New Approach Directive 93/42/EEC on Medical Devices. Once this standard is cited in the Official Journal of the European Union under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clau
38、ses of this standard given in Table ZA.1 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.1 Correspondence between this European Standard and Directive 93/42
39、/EEC on Medical devices Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 4.6, 4.8 7.1 Covered as far as the first and second indents are concerned except for toxicity 4.6 7.3 4, all clauses 9.2 Covered for the risk of injury in connectio
40、n with physical features 4.8 9.3 4, all clauses 12.7.1 5 13WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. This page deliberately left blankThis page deliberately left blankBSI is the independent national body responsi
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