1、May 2015 Translation by DIN-Sprachendienst.English price group 9No 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).ICS 11.
2、160!%Bw“2315884www.din.deDDIN EN 1865-2Patient handling equipment used in road ambulances Part 2: Power assisted stretcher;English version EN 1865-2:2010+A1:2015,English translation of DIN EN 1865-2:2015-05Krankentransportmittel im Krankenkraftwagen Teil 2: Kraftuntersttzte Krankentrage;Englische Fa
3、ssung EN 1865-2:2010+A1:2015,Englische bersetzung von DIN EN 1865-2:2015-05Spcifications dquipements pour le transport de patient dans les ambulances routires Partie 2: Brancard motoris;Version anglaise EN 1865-2:2010+A1:2015,Traduction anglaise de DIN EN 1865-2:2015-05SupersedesDIN EN 1865-2:2010-1
4、2www.beuth.deIn case of doubt, the German-language original shall be considered authoritative.Document comprises 14 pages 04.15 DIN EN 1865-2:2015-05 2 A comma is used as the decimal marker. National foreword This document (EN 1865-2:2010+A1:2015) has been prepared by Technical Committee CEN/TC 239
5、“Rescue systems” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the DIN-Normenausschuss Rettungsdienst und Krankenhaus (DIN Standards Committee Rescue Services and Hospital), Working Committee NA 053-01-02 AA Krankenkraftwagen und deren medizinische und tech
6、nische Ausstattung. Amendments This standard differs from DIN EN 1865-2:2010-12 as follows: a) normative references have been updated; b) the length and width tolerances of the stretcher have been changed; c) the total mass of the main stretcher has been increased to 75 kg; d) Annex ZA (informative)
7、 concerning the relationship between this European Standard and the essential requirements of EU Directives 93/42/EEC and 2006/42/EEC has been updated. 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 D
8、IN 13043: 1991-04 DIN 13047: 1986-07 DIN 13048-1: 1989-09 DIN 13048-2: 1993-01 DIN EN 1865: 1999-12 DIN EN 1865-2: 2010-12 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 1865-2:2010+A1 March 2015 ICS 11.160 Supersedes EN 1865-2:2010English Version Patient handling equipment used in road ambula
9、nces - Part 2: Power assisted stretcher Spcifications dquipements pour le transport de patient dans les ambulances routires - Partie 2: Brancard motoris Krankentransportmittel im Krankenkraftwagen - Teil 2: Kraftuntersttzte Krankentrage This European Standard was approved by CEN on 2 July 2010 and i
10、ncludes Amendment 1 approved by CEN on 20 December 2014. 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 reference
11、s 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 made by translation under the responsibility of a CEN mem
12、ber 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, Fr
13、ance, 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 COMIT EUROPEN DE NORMALISATION EUROPISCHES
14、KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 1865-2:2010+A1:2015 EEN 1865-2:2010+A1:2015 (E) 2 Contents Page Foreword 3 Introduction .4 1 S
15、cope 5 2 Normative references 5 3 Terms and definition .5 4 Requirements .6 4.1 General 6 4.2 Main stretcher 6 4.2.1 General 6 4.2.2 Dimensions .6 4.2.3 Mass 6 4.2.4 Loading capacity7 4.2.5 Frame 7 4.2.6 Power source .8 4.2.7 Lying part of the stretcher 8 4.2.8 Restraint system 8 4.2.9 Flammability
16、Toxicity burning gases .8 4.2.10 Deformation of the frame 9 4.2.11 Fixation .9 4.2.12 Deformation of the lying area .9 4.2.13 Resistance to torsion 9 4.2.14 Splaying of the wheels 9 5 Marking .9 Annex ZA !(informative) Relationship between this European Standard and the Essential Requirements of EU
17、Directive 93/42/EEC on Medical Devices and of EU Directive 2006/42/EC on Essential Health and Safety Requirements“ . 10 Bibliography . 12 DIN EN 1865-2:2015-05 EN 1865-2:2010+A1:2015(E)3 Foreword This document (EN 1865-2:2010+A1:2015) has been prepared by Technical Committee CEN/TC 239 “Rescue syste
18、ms”, 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 September 2015, and conflicting national standards shall be withdrawn at the latest by September 2015.
19、 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 includes Amendment 1 approved by CEN on 20 December 2014. !This documen
20、t supersedes EN 1865-2:2010.“ The start and finish of text introduced or altered by amendment is indicated in the text by tags !“. 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 E
21、U 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 consists of the following parts: Part 1: General stretcher systems and
22、patient handling equipment; Part 2: Power assisted stretcher the present document; Part 3: Heavy duty stretcher; Part 4: Foldable patient transfer chair; Part 5: Stretcher support.“ According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are
23、 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, Por
24、tugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. DINEN 1865-2:2015-05EN 1865-2:2010+A1:2015 (E) 4 Introduction In this standard reference is made to EN 1789 which specifies design requirements and test methods for road ambulances, which are relevant for
25、checking requirements for such handling equipment. DINEN 1865-2:2015-05EN 1865-2:2010+A1:2015 (E) 5 1 Scope This European Standard defines minimum requirements for the design and performance of power assisted stretchers used in road ambulances for the treatment and transportation of patients. It aim
26、s to ensure patient safety and 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 indispensable for its application. For dated references, only the edition c
27、ited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.“ !EN 597-1:1994“, Furniture - Assessment of the ignitability of mattresses and upholstered bed bases - Part 1: Ignition source: Smouldering cigarette !deleted text“ !EN 1041:2008+A
28、1:2013“, Information supplied by the manufacturer of medical devices !EN 1789:2007+A2:2014“, Medical vehicles and their equipment Road ambulances !EN 1865-1:2010“, Patient handling equipment used in road ambulances Part 1: General stretcher systems and patient handling equipment !EN 60601-1-2:2014,
29、Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral Standard: Electromagnetic disturbances Requirements and tests (IEC 60601-1-2:2014)“ !EN 62366:2008“, Medical devices Application of usability engineering to medical devices (IEC 62366:20
30、07) !EN ISO 14971:2012“, Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) !EN ISO 15223-1:2012, Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (
31、ISO 15223-1:2012)“ 3 Terms and definition For the purposes of this document, the following terms and definitions apply. 3.1 power assisted stretcher device designed for the conveyance of sick and/or injured persons or those in labour in transit in a recumbent position in safety and in comfort whilst
32、 facilitating treatment and providing powered movements in the operation of the stretcher to reduce the physical effort required by operatives DINEN 1865-2:2015-05EN 1865-2:2010+A1:2015 (E) 6 4 Requirements 4.1 General When operated and maintained in accordance with the manufacturers instructions, p
33、ower assisted stretchers shall 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 14971:2012“. Power assisted stretchers shall also: allow patients to be secured so that any movement during am
34、bulance transport is minimized; be free of sharp edges that could cause injury to persons or damage to other equipment on board. The minimum radius should be 0,5 mm. For all patients transported in the patient compartment, patient restraint-systems shall be available. All patient restraint-systems s
35、hall have quick release systems. Patient restraint-systems for all patient handling equipment shall secure the patient, but at the same time shall permit treatment of the patient. The lying-sitting part shall be made of a strong material which is bacterial resistant, fungal resistant, stain resistan
36、t, putrid resistant, easy to clean, washable, waterproof and petrol-oil resistant. 4.2 Main stretcher 4.2.1 General The main stretcher shall consist of a stretcher part that can be used either alone or in combination with an integrated or detachable undercarriage. The power assisted stretcher and am
37、bulance loading system shall be compatible. 4.2.2 Dimensions Dimensions shall be measured from the outermost edges: length: !(1 950 12050+) mm“; width: !(550 6020+) mm“ ; height: maximum 300 mm from loading holding assembly to unloaded lying part. This height dimension does not apply to stretchers w
38、ith monoblock undercarriages. If a monoblock is not available, the stretcher shall be constructed such that it is detachable from the undercarriage. Where a stretcher support is used the measurement shall be taken from the top surface of the stretcher support to the lying part of the stretcher. Unde
39、rcarriage: length and width of the frame of the undercarriage when located in the ambulance shall not exceed length and width of the stretcher. 4.2.3 Mass The total mass excluding mattress and patient restraints shall be not more than !75 kg“. NOTE In all cases the mass should be as low as possible.
40、 DIN EN 1865-2:2015-05 EN 1865-2:2010+A1:2015(E)7 4.2.4 Loading capacity The loading capacity shall be a minimum of 150 kg. 4.2.5 Frame 4.2.5.1 General The frame shall be in sturdy lightweight non twisting construction enabling use of cardiopulmonary resuscitation. All corners of the frame shall be
41、radiused for greater safety. It shall be possible to lock and secure the stretcher and undercarriage against lateral, longitudinal, vertical movements. All mechanisms shall be constructed to prevent damage to the user and the patient. 4.2.5.2 Stretcher parts a) If side rails are fitted, they shall h
42、ave a minimum length of 500 mm and a minimum height between 150 mm and 200 mm measured from the top of the stretcher frame to the top of the side rail. b) If longitudinal handles are incorporated they shall be fitted to the ends of the longitudinal frame such that they lock and do not twist when the
43、y are stowed or in use. They shall be designed to minimize the risk of injuries to the hands and wrists when being operated or the stretcher is carried at angles. It shall allow the fixation and use of a carrying harness. c) The stretcher shall have a water and scratch resistant paint finish or be m
44、anufactured of corrosion resistant material. Both shall be unaffected by disinfectants. d) If intended to be used without undercarriage there shall be four wheels with a minimum diameter of 100 mm suitably placed to ensure stability. e) If intended to be used with undercarriage the stretcher shall b
45、e able to be fixed to the undercarriage without using supplementary means. A safe handling and lowering of the undercarriage shall be ensured. f) The fixed stretcher shall be easy to release from the stretcher fastener. NOTE There should be a facility to attach a support for infusion. 4.2.5.3 Underc
46、arriage a) The undercarriage shall be fitted with four wheels with a diameter of at least 100 mm. There shall be a minimum of two 360 swivel wheels at the foot end and at least two wheels shall be fitted with a brake. b) The undercarriage shall have variable height between the lowest and upper posit
47、ion and be able to hold the rated load capacity in any position. c) All the functions of the stretcher shall remain completely unimpaired when it is connected to the undercarriage. d) The undercarriage shall either be provided with a waterproof and scratch resistant finish or be made of corrosive re
48、sistant material or similar surface. If the undercarriage is used with a separable stretcher it shall be possible both to connect the undercarriage to the stretcher and to separate them easily. The stretcher shall be secured to the undercarriage in such a manner that unintentional separation of the undercarriage and stretcher cannot occur. It shall be possible to DIN EN 1865-2:2015-05 EN 1865-2:2010+A1:2015 (E) 8 load and unload the undercarriage and stretcher so as to ensure the safety and comfort of the
