1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN 1865-3:2012Patient handling equipmentused in road ambulancesPart 3: Heavy duty stretcherCopyright European Committee for Standardization Provided by IHS under license with
2、CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN 1865-3:2012 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN 1865-3:2012.Together with BS EN 1865-1:2010, BS EN 1865-2:2010, BS EN1865-4:2012 and BS EN 1865-5:2012, it sup
3、ersedes BS EN 1865:2000,which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/239, Rescue systems.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessar
4、yprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2012. Published by BSI StandardsLimited 2012ISBN 978 0 580 70210 5ICS 11.160Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was publish
5、ed under the authority of theStandards Policy and Strategy Committee on 30 June 2012.Amendments issued since publicationDate Text affectedCopyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from
6、IHS-,-,-BS EN 1865-3:2012EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 1865-3 June 2012 ICS 11.160 Supersedes EN 1865:1999English Version Patient handling equipment used in road ambulances - Part 3: Heavy duty stretcher Spcifications dquipements pour le transport de patient dans les ambulance
7、s routires - Partie 3: Brancard Krankentransportmittel im Krankenkraftwagen - Teil 3: Schwerlastkrankentrage This European Standard was approved by CEN on 10 May 2012. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European St
8、andard 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 the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (Engl
9、ish, 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 Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium,
10、Bulgaria, Croatia, Cyprus, 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 C
11、OMMITTEE FOR STANDARDIZATION 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 1865-3:2012: ECopyright European C
12、ommittee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN 1865-3:2012EN 1865-3:2012 (E) 2 Contents Page Foreword 3Introduction .51 Scope 52 Normative references 53 Terms and definitions .54 Requirements
13、 .64.1 General 64.2 Dimensions .64.3 Mass 74.4 Loading capacity74.5 Frame 74.6 Restraint systems 84.7 Flammability toxicity burning gases 84.8 Deformation of the frame 84.9 Fixation .94.10 Deformation of the lying area .94.11 Resistance to torsion 94.12 Splaying of the wheels 95 Test methods 95.1 Pe
14、rmanent deformation of the frame .95.2 Fixation inside the ambulance 105.3 Permanent deformation of the lying area . 105.4 Resistance to twisting/torsion . 115.5 Splaying of the wheels . 116 Marking 11Annex ZA (informative) Relationship between this European Standard and the Essential Requirements o
15、f EU Directive 93/42/EEC on Medical Devices 12Bibliography . 14Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN 1865-3:2012EN 1865-3:2012 (E) 3 Foreword This document (EN 18
16、65-3:2012) 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 December 2012, and conflic
17、ting national standards shall be withdrawn at the latest by December 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 docume
18、nt together with the EN 1865-1:2010, EN 1865-2:2010, EN 1865-4:2012 and EN 1865-5:2012 supersedes EN 1865:1999. With respect to EN 1865:1999 the following changes were made: a) it shall be possible to increase the width of the lying part to minimum of 750 mm; b) the weight of the device was changed
19、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; e) the power source of the stretcher was defined; f) permanent deformation test of the frame shall be done with 400 kg in
20、stead 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 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/
21、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 Essential Health and Safety Requirements (EHSRs). This document has been prepared under a mandate given to CEN by the European
22、 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 integral part of this document. This European Standard is a part of EN 1865, Patient handling equipment used in road amb
23、ulances, 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 Part 4: Foldable patient transfer chair Part 5: Stretcher support Copyright European Committee for Standardization Provided b
24、y IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN 1865-3:2012EN 1865-3:2012 (E) 4 According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European
25、 Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, 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 a
26、nd the United Kingdom. Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN 1865-3:2012EN 1865-3:2012 (E) 5 Introduction In this European Standard, reference is made to EN 1789,
27、 which specifies design requirements and test methods for road ambulances, which are relevant for checking requirements for such handling equipment. 1 Scope This European Standard specifies minimum requirements for the design and performance of heavy duty stretchers used in road ambulances for the t
28、reatment and transportation of patients. It aims 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 applica
29、tion. 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, Furniture Assessment of the ignitability of mattresses and upholstered bed bases Part 1: Ignition source: Smouldering cigare
30、tte EN 980, Symbols for use in the labelling of medical devices EN 1041, Information supplied by the manufacturer of medical devices EN 1789:2007+A1:2010, Medical vehicles and their equipment Road ambulances EN 1865-1, Patient handling equipment used in road ambulances Part 1: General stretcher syst
31、ems and patient handling equipment EN 60601-1-2, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral standard: Electromagnetic compatibility Requirements and tests (IEC 60601-1-2) EN 62366, Medical devices Application of usability enginee
32、ring to medical devices (IEC 62366) 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 term and definition apply. 3.1 heavy duty stretcher stretcher designed for the treatment and transp
33、ortation of patients where the weight or dimensions of the patient exceed those of the operating capability of the main stretcher Note 1 to entry: The term “main stretcher“ is defined in EN 1865-1. Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleN
34、o reproduction or networking permitted without license from IHS-,-,-BS EN 1865-3:2012EN 1865-3:2012 (E) 6 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 using risk m
35、anagement principles in accordance with EN ISO 14971 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 on board; have pati
36、ent 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 resistant, stain resist
37、ant, 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. It shall be designed so that during loading and unloading the maximum burden on a
38、ny 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 9502050+) mm To accommodate tal
39、l patients it may be possible to increase the length of the stretcher by a further 200 mm. width: (550 20) 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 part. This height dimension does n
40、ot 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 stretcher support to the lying par
41、t 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. Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or network
42、ing permitted without license from IHS-,-,-BS EN 1865-3:2012EN 1865-3:2012 (E) 7 4.3 Mass Stretcher part: 23 kg Undercarriage including stretcher: 65 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
43、 kg. 4.5 Frame 4.5.1 General The frame shall be in sturdy lightweight non twisting construction enabling use of cardiopulmonary resuscitation. All corners of the frame shall be radiused for greater safety. It shall be possible to lock and secure the stretcher against lateral, longitudinal, vertical
44、and oblique movements. All mechanisms shall be constructed to prevent damage to the user and the patient. 4.5.2 Stretcher parts 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 t
45、he 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 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 stretch
46、er is carried at angles. It shall allow the fixation and use of a carrying harness. c) The stretcher shall have either a water 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
47、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
48、shall be ensured. f) The fixed stretcher shall be easy to release from the stretcher fastener or the undercarriage. NOTE There should be a facility to attach a support for infusion. 4.5.3 Undercarriage a) The undercarriage shall be fitted with 4 wheels with a diameter of at least 100 mm. At the foot end there shall be a minimum of two wheels that swivel 360 degrees and at least two wheels shall be fitted with a brake. b) The undercarriage shall be designed for loading and unloading at a maximu
