1、May 2015 Translation by DIN-Sprachendienst.English price group 11No 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!%B_a“2316062www.din.deDDIN EN 1865-3Patient handling equipment used in road ambulances Part 3: Heavy duty stretcher;English version EN 1865-3:2012+A1:2015,English translation of DIN EN 1865-3:2015-05Krankentransportmittel im Krankenkraftwagen Teil 3: Schwerlastkrankentrage;Englische Fassung EN
3、1865-3:2012+A1:2015,Englische bersetzung von DIN EN 1865-3:2015-05Equipement dambulances pour le transport de patients Partie 3: Brancard bariatrique;Version anglaise EN 1865-3:2012+A1:2015,Traduction anglaise de DIN EN 1865-3:2015-05SupersedesDIN EN 1865-3:2012-09www.beuth.deIn case of doubt, the G
4、erman-language original shall be considered authoritative.Document comprises 17 pages 04.15 DIN EN 1865-3:2015-05 2 A comma is used as the decimal marker. National foreword This document (EN 1865-3:2012+A1:2015) has been prepared by Technical Committee CEN/TC 239 “Rescue systems” (Secretariat: DIN,
5、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 technische Ausstattung. Amendments This
6、standard differs from DIN EN 1865-3:2012-09 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 80 kg; d) Annex ZA (informative) concerning the relationship between
7、 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 DIN 13043: 1991-04 DIN 13047: 1986-0
8、7 DIN 13048-1: 1989-09 DIN 13048-2: 1993-01 DIN EN 1865: 1999-12, DIN EN 1865-3: 2012-09 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 1865-3:2012+A1 March 2015 ICS 11.160 Supersedes EN 1865-3:2012English Version Patient handling equipment used in road ambulances - Part 3: Heavy duty stretche
9、r Equipement dambulances pour le transport de patients - Partie 3 : Brancard bariatrique Krankentransportmittel im Krankenkraftwagen - Teil 3: Schwerlastkrankentrage This European Standard was approved by CEN on 10 May 2012 and includes Amendment 1 approved by CEN on 20 December 2014. CEN members ar
10、e 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 references concerning such national standards may be obtained on application to
11、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 member into its own language and notified to the CEN-CENELEC Management Ce
12、ntre 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, Lithua
13、nia, 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 KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1
14、000 Brussels 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 1865-3:2012+A1:2015 EEN 1865-3:2012+A1:2015 (E) 2 Contents Page Foreword 3 Introduction .5 1 Scope 6 2 Normative references 6 3 Terms and definitions .6 4 Requiremen
15、ts .7 4.1 General 7 4.2 Dimensions .7 4.3 Mass 8 4.4 Loading capacity8 4.5 Frame 8 4.5.1 General 8 4.5.2 Stretcher parts .8 4.5.3 Undercarriage .8 4.5.4 Power source .9 4.6 Restraint systems 9 4.7 Flammability toxicity burning gases 9 4.8 Deformation of the frame 9 4.9 Fixation 10 4.10 Deformation o
16、f the lying area 10 4.11 Resistance to torsion . 10 4.12 Splaying of the wheels . 10 5 Test methods . 10 5.1 Permanent deformation of the frame 10 5.1.1 Stretcher frame . 10 5.1.2 Undercarriage frame . 11 5.2 Fixation inside the ambulance 11 5.3 Permanent deformation of the lying area . 11 5.4 Resis
17、tance to twisting/torsion . 12 5.5 Splaying of the wheels . 12 6 Marking 12 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices 13 Bibliography . 15 DIN EN 1865-3:2015-05 EN 1865-3:2012+A1:2015(E)3 Foreword Th
18、is document (EN 1865-3:2012+A1:2015) has been prepared 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
19、September 2015, and conflicting national standards shall be withdrawn at the latest by September 2015. 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 suc
20、h patent rights. This document includes Amendment 1 approved by CEN on 20 December 2014. !This document supersedes EN 1865-3:2012.“ The start and finish of text introduced or altered by amendment is indicated in the text by tags !“. With respect to EN 1865:1999 the following changes were made: a) it
21、 shall be possible to increase the width of the lying part to minimum of 750 mm; b) the weight of the device was changed from 51 kg to maximum 65 kg; c) the capacity was changed from 150 kg to minimum 250 kg; d) the undercarriage, if power assisted, has no limits in height or in variable positions;
22、e) the power source of the stretcher was defined; f) permanent deformation test of the frame shall be done with 400 kg instead of 250 kg and if the lateral extensions are fitted 75 kg shall be evenly set on each extension; g) permanent deformation test of the frame shall be done with 250 kg instead
23、of 150 kg; h) splaying of the wheels test shall be done with 400 kg instead of 250 kg; i) the standard has been modified/integrated to meet the Medical Device Directive 93/42/EEC requirements j) the standard has been modified/integrated to comply with the Machinery Directive 2006/42/EC and its Essen
24、tial Health and Safety Requirements (EHSRs). 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. For relationship with EU Directive, see informative Annex ZA, which is an
25、 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 patient handling equipment; Part 2: Power assisted stretcher; Part 3: Heavy duty stretcher t
26、he present document; DINEN 1865-3:2015-05EN 1865-3:2012+A1:2015 (E) 4 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 bound to implement this European Standard:
27、 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,
28、Sweden, Switzerland, Turkey and the United Kingdom. DIN EN 1865-3:2015-05 EN 1865-3:2012+A1:2015(E)5 Introduction In this European Standard, reference is made to !EN 1789:2007+A2:2014“, which specifies design requirements and test methods for road ambulances, which are relevant for checking requirem
29、ents for such handling equipment. DINEN 1865-3:2015-05EN 1865-3:2012+A1:2015 (E) 6 1 Scope This European Standard specifies minimum requirements for the design and performance of heavy duty stretchers used in road ambulances for the treatment and transportation of patients. It aims to ensure patient
30、 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 cited applies. For un
31、dated 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+A1:2013“, Information su
32、pplied 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, Medical electrical equi
33、pment 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 62366:2007)“ !EN ISO 14971:2012,
34、 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 (ISO 15223-1:2012)“ 3 Terms an
35、d definitions For the purposes of this document, the following term and definition apply. 3.1 heavy duty stretcher stretcher designed for the treatment and transportation of patients where the weight or dimensions of the patient exceed those of the operating capability of the main stretcher Note 1 t
36、o entry: The term “main stretcher“ is defined in !EN 1865-1:2010“. DIN EN 1865-3:2015-05 EN 1865-3:2012+A1:2015(E)7 4 Requirements 4.1 General Heavy duty stretchers shall be operated and maintained according to the instructions of the manufacturer. Risks shall be reduced to an acceptable level by us
37、ing risk management principles in accordance with !EN ISO 14971:2012“ in normal and single fault condition. Heavy duty stretchers shall: be manually or power operated; guarantee a safe and smooth operation; be free of sharp edges or deformation that could cause damage to persons or other equipment o
38、n board; have patient restraint-systems available; these restraint-systems shall have quick release systems; immobilize the patient, but at the same time shall permit treatment of the patient; ensure that the lying-sitting part is made of a strong material, which is bacterial resistant, fungal resis
39、tant, stain resistant, putrid resistant, easy to clean, washable and petrol-oil resistant. The heavy duty stretcher shall be designed to transport patients with a weight that exceeds the load capacity of the main stretcher in !EN 1865-1:2010“. It shall be designed so that during loading and unloadin
40、g the maximum burden on any personnel is half of the total weight of patient and stretcher and for the minimum possible time and in an optimal ergonomic position so that back bending is minimized. 4.2 Dimensions Dimensions shall be measured from the outermost edges. Stretcher part: length: !(1 95012
41、050+)“ mm To accommodate tall patients it may be possible to increase the length of the stretcher by a further 200 mm. width: !(550 6020+) mm“ It shall be possible to increase the width of the lying part to a minimum of 750 mm. height: maximum 300 mm from loading holding assembly to unloaded lying p
42、art. This height dimension does not apply to stretchers with 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 s
43、tretcher support to the lying part of the stretcher. Undercarriage: length and width of the frame of the undercarriage when located in the ambulance shall not exceed length and width of the stretcher part. DIN EN 1865-3:2015-05 EN 1865-3:2012+A1:2015(E)8 4.3 Mass Stretcher part: 23 kg Undercarriage
44、including stretcher: !80 kg“ max. (combined weight) NOTE In all cases the mass should be as low as possible. 4.4 Loading capacity The loading capacity shall be a minimum of 250 kg. 4.5 Frame 4.5.1 General The frame shall be in sturdy lightweight non twisting construction enabling use of cardiopulmon
45、ary resuscitation. All corners of the frame shall be radiused for greater safety. It shall be possible to lock and secure the stretcher against lateral, longitudinal, vertical and oblique movements. All mechanisms shall be constructed to prevent damage to the user and the patient. 4.5.2 Stretcher pa
46、rts a) If side rails are mounted, they shall have a minimum length of 500 mm and a 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 th
47、at they lock and do not twist when they are stowed or in use. They shall be designed to minimise 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 either a wat
48、er and scratch resistant paint finish or be manufactured of corrosion resistant material. Both versions shall be unaffected by disinfectants. d) If intended to be used without undercarriage there shall be 4 wheels with a minimum diameter of 100 mm suitably placed to ensure stability. e) If intended to be used with undercarriage the stretcher shall be able to be fixed to the undercarriage without using supplementary means. A safe handling and lowering of the undercarriage shall be ensured. f) The f
