1、September 2012 Translation by DIN-Sprachendienst.English price group 6No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).I
2、CS 11.160!$F|“1913589www.din.deDDIN EN 1865-4Patient handling equipment used in road ambulances Part 4: Foldable patient transfer chair;English version EN 1865-4:2012,English translation of DIN EN 1865-4:2012-09Krankentransportmittel im Krankenkraftwagen Teil 4: Klappbare Patiententragesessel;Englis
3、che Fassung EN 1865-4:2012,Englische bersetzung von DIN EN 1865-4:2012-09Equipements dambulances pour le transport des patients Partie 4: Chaise de transport;Version anglaise EN 1865-4:2012,Traduction anglaise de DIN EN 1865-4:2012-09Together with DIN EN 1865-1:2010-12, DIN EN 1865-2:2010-12, DIN EN
4、 1865-3:2012-09 andDIN EN 1865-5:2012-09 supersedes DIN EN 1865:1999-12Supersedes: see belowwww.beuth.deIn case of doubt, the German-language original shall be considered authoritative.Document comprises 9 pages08.12 DIN EN 1865-4:2012-09 2 A comma is used as the decimal marker. National foreword Th
5、is standard has been prepared by Technical Committee CEN/TC 239 “Rescue systems” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the Normenausschuss Rettungsdienst und Krankenhaus (Rescue Services and Hospital Standards Committee), Working Committee NA 053-01
6、-02 AA Krankenkraftwagen und deren medizinische und technische Ausstattung. Amendments This standard differs from DIN EN 1865:1999-12 as follows: a) EN 1865:1999 has been subdivided into 5 parts depending on the particular stretcher system; b) foldable patient transport chairs are to be fitted with
7、a mechanism to assist the descent and/or ascent of steps, to minimise the need for manually carrying the patient and chair; c) specifications relating to foldable patient transfer chairs have been rendered more precise (e.g. the mass has been changed from 10 kg to no more than 15 kg); d) the patient
8、 restraint-systems shall secure the patient, but at the same time shall permit treatment of the patient; e) general requirements with specific provisions have been included taking into account risk management principles; f) the standard has been modified to meet the Medical Device Directive 93/42/EE
9、C requirements. Previous editions DIN FANOK 25: 1936-06 DIN 13025: 1955x-07, 1971-03 DIN 13025-1: 1991-04, 1992-04 DIN 13025-2: 1991-04 DIN 13040: 1965-07,1989-05 DIN 13043: 1991-04 DIN 13047: 1986-07 DIN 13048-1: 1989-09 DIN 13048-2: 1993-01 DIN EN 1865: 1999-12 EUROPEAN STANDARD NORME EUROPENNE EU
10、ROPISCHE 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 Krankentransportmittel im Krankenkr
11、aftwagen - 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 national standard without any a
12、lteration. 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). A version in any other language
13、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, Es
14、tonia, 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. Management Centre: Avenue Marnix 17, B-1000 Brussels 2012 CEN Al
15、l rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 1865-4:2012: EEUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG EN 1865-4:2012 (E) 2 Contents Page Foreword 31 Scope 42 Normative referenc
16、es 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 .64.11 Deformation of the backrest lying-sitting ar
17、ea .65 Marking .6Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices .7DIN EN 1865-4:2012-09 EN 1865-4:2012 (E) 3 Foreword This document (EN 1865-4:2012) has been prepared by Technical Committee CEN/TC 239 “Re
18、scue 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 shall be withdrawn at the latest by October
19、 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 1865:1999. With respect to EN 1865:1999, the follow
20、ing 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 than 15 kg; c) the patient restraint-systems
21、 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 the European Commission and the European Fr
22、ee 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 equipment used in road ambulances, which will consi
23、st 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 CEN/CENELEC Internal Regulations, the nation
24、al 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, Lithuania, Luxembourg, Malta, Netherlands, N
25、orway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. DIN EN 1865-4:2012-09 EN 1865-4:2012 (E) 4 1 Scope This European Standard defines the minimum requirements for the design and performance of foldable patient transfer chairs, which are us
26、ed 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 normatively referenced in this document and are i
27、ndispensable 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 1021-1, Furniture Assessment of the ignitab
28、ility 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 handling equipment EN ISO 14971, Medical
29、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 position to the road ambulance, but not t
30、o 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 Examples of mechanisms to assist the desc
31、ent 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 transfer chairs are operated and mainta
32、ined 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 condition. Handles on devices shall lock in th
33、eir 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. DIN EN 1865-4:2012-09 EN 1865-4:2012 (E) 5 All patient restraint-systems shall have a quick release system. Patient rest
34、raint-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 ground; maximum height of 550 mm, measu
35、red 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 capacity The loading capacity shall
36、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 and a minimum of two wheels of a di
37、ameter 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, putrid resistant, easy to clean, wa
38、shable, 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 1021-1. 4.9 Deformation of the frame
39、 There shall be no remaining deformation of the frame when tested in accordance with EN 1865-1:2010, 5.8.1. DIN EN 1865-4:2012-09 EN 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 area There shall be no remaini
40、ng 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. DIN EN 1865-4:2012-09 EN 1865-4:2012 (E) 7 Annex ZA (informativ
41、e) 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 means of conforming to Esse
42、ntial 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 clauses of this standard giv
43、en 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/EEC on Medical devices
44、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 connection 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. DIN EN 1865-4:2012-09
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