DIN EN 1865-1-2015 Patient handling equipment used in road ambulances - Part 1 General stretcher systems and patient handling equipment German version EN 1865-1 2010+A1 2015《道路救护车使.pdf

1、August 2015 Translation by DIN-Sprachendienst.English price group 15No 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

2、 11.160!%E2“2341590www.din.deDDIN EN 1865-1Patient handling equipment used in road ambulances Part 1: General stretcher systems and patient handling equipment;English version EN 1865-1:2010+A1:2015,English translation of DIN EN 1865-1:2015-08Krankentransportmittel im Krankenkraftwagen Teil 1: Allgem

3、eine Krankentragesysteme und Krankentransportmittel;Englische Fassung EN 1865-1:2010+A1:2015,Englische bersetzung von DIN EN 1865-1:2015-08Spcifications dquipements pour le transport de patient dans les ambulances routires Partie 1: Systmes gnraux de brancards et quipement pour le transport de patie

4、nts;Version anglaise EN 1865-1:2010+A1:2015,Traduction anglaise de DIN EN 1865-1:2015-08SupersedesDIN EN 1865-1:2010-12www.beuth.deIn case of doubt, the German-language original shall be considered authoritative.Document comprises 37 pages07.15 DIN EN 1865-1:2015-08 2 A comma is used as the decimal

5、marker. National foreword This document (EN 1865-1:2010+A1:2015) has been prepared by Technical Committee CEN/TC 239 “Rescue systems” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the DIN-Normenausschuss Rettungsdienst und Krankenhaus (DIN Standards Committ

6、ee Rescue Services and Hospital), Working Committee NA 053-01-02 AA Krankenkraftwagen und deren medizinische und technische Ausstattung. Amendments This standard differs from DIN EN 1865-1:2010-12 as follows: a) normative references have been updated; b) Annex ZA (informative) concerning the relatio

7、nship between this European Standard and the essential requirements of EU Directive 93/42/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 13047: 1986-07 DIN 13048-1: 1989-09 D

8、IN 13043: 1991-04 DIN 13048-2: 1993-01 DIN EN 1865: 1999-12 DIN EN 1865-1: 2010-12 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 1865-1:2010+A1 May 2015 ICS 11.160 Supersedes EN 1865-1:2010English Version Patient handling equipment used in road ambulances - Part 1: General stretcher systems a

9、nd patient handling equipment Spcifications dquipements pour le transport de patient dans les ambulances routires - Partie 1: Systmes gnraux de brancards et quipement pour le transport de patients Krankentransportmittel im Krankenkraftwagen - Teil 1: Allgemeine Krankentragesysteme und Krankentranspo

10、rtmittel This European Standard was approved by CEN on 2 July 2010 and includes Amendment 1 approved by CEN on 26 March 2015. 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 w

11、ithout 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). A version in any oth

12、er 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, Cyprus, Czech Republic,

13、 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, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMM

14、ITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES 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 1865-1:2010+A1:2015 EEN 1

15、865-1:2010+A1:2015 (E)2 Contents Page Foreword 6 Introduction .7 1 Scope 8 2 Normative references 8 3 Terms and definitions .8 4 Requirements .9 4.1 General 9 4.2 Main stretcher 9 4.2.1 General 9 4.2.2 Dimensions .9 4.2.3 Mass . 10 4.2.4 Loading capacity. 10 4.2.5 Frame . 10 4.2.6 Lying part of the

16、stretcher . 11 4.2.7 Restraint system . 12 4.2.8 Flammability Toxicity burning gases 12 4.2.9 Deformation of the frame . 12 4.2.10 Fixation 12 4.2.11 Deformation of the lying area 12 4.2.12 Resistance to torsion . 12 4.2.13 Splaying of the wheels . 12 4.3 Chair stretcher . 12 4.3.1 Dimensions 12 4.3

17、.2 Mass . 12 4.3.3 Loading capacity. 13 4.3.4 Frame . 13 4.3.5 Lying-sitting part. 13 4.3.6 Restraint system . 13 4.3.7 Flammability Toxicity burning gases 13 4.3.8 Deformation of the frame . 13 4.3.9 Fixation 13 4.3.10 Deformation of the lying-sitting area 13 4.3.11 Resistance to torsion . 13 4.3.1

18、2 Splaying of the wheels . 13 4.4 Transfer mattress 13 4.4.1 Dimensions 13 4.4.2 Mass . 14 4.4.3 Loading capacity. 14 4.4.4 Handles 14 4.4.5 Lying part . 14 4.4.6 Restraint system . 14 4.4.7 Flammability Toxicity burning gases 14 4.4.8 Deformation . 14 4.4.9 Fixation 14 4.4.10 Deformation of the lyi

19、ng area 14 4.4.11 Resistance to torsion . 15 4.4.12 Splaying of the wheels . 15 DINEN 1865-1:2015-08EN 1865-1:2010+A1:2015 (E)3 4.5 Carrying sheet . 15 4.5.1 Dimensions 15 4.5.2 Mass 15 4.5.3 Loading capacity . 15 4.5.4 Handles . 15 4.5.5 Lying part . 15 4.5.6 Restraint system 15 4.5.7 Flammability

20、Toxicity burning gases . 15 4.5.8 Deformation of the handles 15 4.5.9 Fixation . 15 4.5.10 Deformation of the lying area . 16 4.5.11 Resistance to torsion 16 4.5.12 Splaying of the wheels 16 4.6 Pick up stretcher . 16 4.6.1 Dimensions 16 4.6.2 Mass 16 4.6.3 Loading capacity . 16 4.6.4 Frame 16 4.6.5

21、 Lying part . 16 4.6.6 Restraint system 16 4.6.7 Flammability Toxicity burning gases . 17 4.6.8 Deformation of the frame 17 4.6.9 Fixation . 17 4.6.10 Locking . 17 4.6.11 Deformation of the lying area . 17 4.6.12 Resistance to torsion 17 4.6.13 Splaying of the wheels 17 4.7 Vacuum mattress . 17 4.7.

22、1 Construction 17 4.7.2 Dimensions 17 4.7.3 Mass 18 4.7.4 Loading capacity . 18 4.7.5 Handles . 18 4.7.6 Restraint system 18 4.7.7 Flammability Toxicity burning gases . 18 4.7.8 Deformation . 18 4.7.9 Fixation . 18 4.7.10 Shrinkage . 18 4.7.11 Deformation of the lying area . 18 4.8 Long spinal board

23、 . 19 4.8.1 Dimensions 19 4.8.2 Mass 19 4.8.3 Loading capacity . 19 4.8.4 Construction 19 4.8.5 Lying part . 19 4.8.6 Restraint system 19 4.8.7 Flammability Toxicity burning gases . 19 4.8.8 Deformation . 19 4.8.9 Fixation . 19 4.8.10 Deformation of the lying area . 20 4.8.11 Resistance to torsion 2

24、0 4.8.12 Splaying of the wheels 20 4.9 Foldable carrying chair . 20 4.9.1 Dimensions 20 4.9.2 Mass 20 4.9.3 Loading capacity . 20 4.9.4 Frame 20 DIN EN 1865-1:2015-08 EN 1865-1:2010+A1:2015 (E) 4 4.9.5 Sitting part . 20 4.9.6 Restraint system . 20 4.9.7 Flammability Toxicity burning gases 21 4.9.8 D

25、eformation of the frame . 21 4.9.9 Fixation 21 4.9.10 Locking 21 4.9.11 Deformation of the backrest lying-sitting area 21 4.9.12 Resistance to torsion . 21 4.9.13 Splaying of the wheels . 21 4.10 Non-foldable carrying chair (sedan chair) . 21 4.10.1 Dimensions 21 4.10.2 Mass . 21 4.10.3 Loading capa

26、city. 21 4.10.4 Frame . 22 4.10.5 Sitting part . 22 4.10.6 Restraint system . 22 4.10.7 Flammability Toxicity burning gases 22 4.10.8 Deformation of the frame . 22 4.10.9 Fixation 22 4.10.10 Deformation of the sitting area 22 4.10.11 Resistance to torsion . 22 4.10.12 Splaying of the wheels . 22 5 T

27、est methods . 23 5.1 Main stretcher . 23 5.1.1 Permanent deformation of the frame 23 5.1.2 Fixation inside the ambulance 23 5.1.3 Permanent deformation of the lying area . 24 5.1.4 Resistance to twisting/torsion . 24 5.1.5 Splaying of the wheels . 25 5.2 Chair stretcher 25 5.2.1 Permanent deformatio

28、n of the frame 25 5.2.2 Permanent deformation of the lying-sitting area . 25 5.2.3 Resistance to twisting/torsion . 25 5.2.4 Splaying of the wheels . 25 5.3 Transfer mattress 25 5.3.1 Deformation . 25 5.3.2 Deformation of the lying area 27 5.4 Carrying sheet . 28 5.4.1 Strength of the handles 28 5.4

29、.2 Permanent deformation of the lying area . 29 5.5 Pick up stretcher . 29 5.5.1 Permanent deformation of the frame 29 5.5.2 Resistance to twisting/torsion . 29 5.6 Vacuum mattress and pump 30 5.6.1 Deformation . 30 5.6.2 Shrinkage . 30 5.6.3 Deformation of the lying area 30 5.7 Long spinal board .

30、31 5.7.1 Permanent deformation of the frame and lying area 31 5.7.2 Resistance to twisting/torsion . 31 5.8 Foldable carrying chair 31 5.8.1 Permanent deformation of the frame and backrest lying-sitting area 31 5.9 Non-foldable carrying chair (sedan chair) . 32 5.9.1 Permanent deformation of the fra

31、me and sitting area 32 5.9.2 Fixation inside the ambulance 32 5.9.3 Splaying of the wheels . 32 DIN EN 1865-1:2015-08 EN 1865-1:2010+A1:2015 (E) 5 6 Marking . 32 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC concerning Med

32、ical Devices 33 Bibliography 35 DIN EN 1865-1:2015-08 EN 1865-1:2010+A1:2015 (E) 6 Foreword This document (EN 1865-1:2010+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 nati

33、onal standard, either by publication of an identical text or by endorsement, at the latest by November 2015, and conflicting national standards shall be withdrawn at the latest by November 2015. Attention is drawn to the possibility that some of the elements of this document may be the subject of pa

34、tent 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 2015-03-26. The start and finish of text introduced or altered by amendment is indicated in the text by tags ! “. !This document superse

35、des EN 1865-1:2010“. 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(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of

36、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 the present document; Part 2: Power assisted stretcher; Part 3: Heavy duty stretche

37、r; Part 4: Foldable patient transfer chair; Part 5: Stretcher support.“ According to the CEN-CENELEC Internal Regulations, the national standards organisations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denma

38、rk, 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, Sweden, Switzerland, Turkey and the United Kingdom. DIN EN 1865-1:2

39、015-08 EN 1865-1:2010+A1:2015 (E)7 Introduction This European Standard incorporates specifications for: main stretcher undercarriage; chair stretcher; transfer mattress; carrying sheet; pick up stretcher; vacuum mattress and pump; long spinal board; foldable carrying chair; non-foldable carrying cha

40、ir. Stretcher systems and patient handling equipment covered by this standard EN 1865-1 are for use in road ambulances. In this 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 requirements f

41、or such handling equipment. NOTE Standardisation work will continue with the aim of ensuring the safe transfer of patients and equipment without compromising continuity of patient care and the safety of staff. DIN EN 1865-1:2015-08 EN 1865-1:2010+A1:2015 (E) 8 1 Scope This European Standard defines

42、minimum requirements for the design and performance of stretchers and other patient handling equipment used in road ambulances for the handling and carrying of patients. It aims to ensure patient safety and minimize the physical effort required by staff operating the equipment. 2 Normative reference

43、s 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. !EN 597-1:1994“, Furniture - Assessment of the

44、ignitability of mattresses and upholstered bed bases - Part 1: Ignition source: Smouldering cigarette !deleted text“ !EN 1021-1:2014“, Furniture - Assessment of the ignitability of upholstered furniture - Part 1: Ignition source smouldering cigarette !EN 1041:2008+A1:2013“, Information supplied by t

45、he manufacturer of medical devices !EN 1789:2007+A2:2014“, Medical vehicles and their equipment - Road ambulances !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

46、 be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2012)“ 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 main stretcher main device for the conveyance of a sick and/or in

47、jured person or those in labour with the purpose to transport patients in safety and in comfort whilst facilitating treatment 3.2 chair stretcher device designed to handle and carry a patient in a sitting or lying position, including conveying a patient in the vehicle 3.3 transfer mattress device in

48、tended to facilitate the transfer of the patient from one stretcher to another 3.4 carrying sheet special sheet to handle and carry a patient in a lying or sitting position DIN EN 1865-1:2015-08 EN 1865-1:2010+A1:2015 (E) 9 3.5 pick up stretcher lifting device, intended to be used for movement of seriously injured people on to other transport devices 3.6 vacuum mattress device intended primarily to provide immobilization for the patient during transportation 3.7 long spinal board device desig