BS EN 1865-3:2012+A1:2015 BS EN 1865-3:2012 BSI Standards Publication Patient handling equipment used in road ambulances Part 3: Heavy duty stretcher BS EN 1865-3:2012+A1:2015 BRITISH STANDARD National foreword This British Standard is the UK implementation of EN 1865-3:2012+A1:2015 It supersedes BS EN 1865-3:2012, which is withdrawn The start and finish of text introduced or altered by amendment is indicated in the text by tags Tags indicating changes to CEN text carry the number of the CEN amendment For example, text altered by CEN amendment A1 is indicated by The UK participation in its preparation was entrusted to Technical Committee CH/239, Rescue systems A list of organizations represented on this committee can be obtained on request to its secretary This publication does not purport to include all the necessary provisions of a contract Users are responsible for its correct application © The British Standards Institution 2015 Published by BSI Standards Limited 2015 ISBN 978 580 86228 ICS 11.160 Compliance with a British Standard cannot confer immunity from legal obligations This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 June 2012 Amendments/corrigenda issued since publication Date Text affected 31 March 2015 Implementation of CEN amendment A1:2015 EUROPEAN STANDARD EN 1865-3:2012+A1 NORME EUROPÉENNE EUROPÄISCHE NORM March 2015 ICS 11.160 Supersedes EN 1865-3:2012 English Version Patient handling equipment used in road ambulances - Part 3: Heavy duty stretcher Equipement d'ambulances pour le transport de patients Partie : Brancard bariatrique Krankentransportmittel im Krankenkraftwagen - Teil 3: Schwerlastkrankentrage This European Standard was approved by CEN on 10 May 2012 and includes Amendment 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 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 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, 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 COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR 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 1865-3:2012+A1:2015 E BS EN 1865-3:2012+A1:2015 EN 1865-3:2012+A1:2015 (E) EN 1865-3:2012+A1:2015 (E) Contents Page Foreword Introduction Scope Normative references Terms and definitions 4.1 4.2 4.3 4.4 4.5 4.5.1 4.5.2 4.5.3 4.5.4 4.6 4.7 4.8 4.9 4.10 4.11 4.12 Requirements General Dimensions .7 Mass Loading capacity Frame General Stretcher parts .8 Undercarriage .8 Power source Restraint systems Flammability – toxicity burning gases Deformation of the frame Fixation 10 Deformation of the lying area 10 Resistance to torsion 10 Splaying of the wheels 10 5.1 5.1.1 5.1.2 5.2 5.3 5.4 5.5 Test methods 10 Permanent deformation of the frame 10 Stretcher frame 10 Undercarriage frame 11 Fixation inside the ambulance 11 Permanent deformation of the lying area 11 Resistance to twisting/torsion 12 Splaying of the wheels 12 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 BS EN 1865-3:2012+A1:2015 EN 1865-3:2012+A1:2015 (E) EN 1865-3:2012+A1:2015 (E) Foreword This 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 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 such patent rights This document includes Amendment 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 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; 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 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 Essential 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 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 [the present document]; BS EN 1865-3:2012+A1:2015 EN 1865-3:2012+A1:2015 (E) EN 1865-3:2012+A1:2015 (E) — 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: 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, Sweden, Switzerland, Turkey and the United Kingdom BS EN 1865-3:2012+A1:2015 EN 1865-3:2012+A1:2015 (E) EN 1865-3:2012+A1:2015 (E) 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 requirements for such handling equipment BS EN 1865-3:2012+A1:2015 EN 1865-3:2012+A1:2015 (E) EN 1865-3:2012+A1:2015 (E) 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 safety and minimize the physical effort required by staff operating the equipment 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 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+A1:2013", 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, 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 (IEC 62366:2007)" devices — Application of !EN ISO 14971:2012, Medical devices — Application (ISO 14971:2007, Corrected version 2007-10-01)" usability of risk engineering to medical devices management to medical devices !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)" 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 transportation of patients where the weight or dimensions of the patient exceed those of the operating capability of the main stretcher Note to entry: The term "main stretcher" is defined in !EN 1865-1:2010" BS EN 1865-3:2012+A1:2015 EN 1865-3:2012+A1:2015 (E) EN 1865-3:2012+A1:2015 (E) 4.1 Requirements 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 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 on 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 resistant, 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 unloading 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: +120 !(1 950 −50 )" mm To accommodate tall patients it may be possible to increase the length of the stretcher by a further 200 mm width: +60 !(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 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 stretcher 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 BS EN 1865-3:2012+A1:2015 EN 1865-3:2012+A1:2015 (E) EN 1865-3:2012+A1:2015 (E) 4.3 Mass — Stretcher part: 23 kg — Undercarriage including stretcher: !80 kg" max (combined weight) NOTE 4.4 In all cases the mass should be as low as possible 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 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 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 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 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 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 undercarriage there shall be 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 fixed stretcher shall be easy to release from the stretcher fastener or the undercarriage NOTE 4.5.3 There should be a facility to attach a support for infusion Undercarriage a) The undercarriage shall be fitted with 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 maximum height of 750 mm c) For manual undercarriages, these shall have a simple mechanism for height adjustment and shall have a minimum of levels (car position and fully unfolded) BS EN 1865-3:2012+A1:2015 EN 1865-3:2012+A1:2015 (E) EN 1865-3:2012+A1:2015 (E) d) For power assisted undercarriages, these shall have variable height between the lowest and upper position and be able to hold the rated load capacity in any position e) The supporting mechanism shall automatically stay in place when fully unfolded The operating controls shall be ergonomically designed to take into consideration human body dimensions, physical strength and anatomical and physiological requirements of human beings The operating controls shall be clearly and permanently labelled, preferably with graphical symbols, indicating their positions and settings If the controls can initiate movements which could be dangerous to persons, they shall be secured against unintentional operation All functions of the stretcher shall remain completely unimpaired when it is connected to the undercarriage f) The undercarriage shall have a water and scratch resistant paint finish or be manufactured of corrosion resistant material Both shall be unaffected by disinfectants g) If the undercarriage is used with a detachable stretcher it shall be possible either to connect or disconnect them The stretcher shall be secured in such a manner that unintentional separation of undercarriage and stretcher cannot occur It shall be possible to load and unload the undercarriage and stretcher to ensure the safety and comfort of the patient and the operators 4.5.4 Power source a) The undercarriage height adjustment mechanism shall have an integral safety feature to prevent stretcher collapsing in the event of failure (stretcher to lower at a controlled rate) If a battery is required to power the lifting mechanism then an override system shall be provided to allow the stretcher to be used manually b) If a battery is fitted it shall be supplied with a facility to charge from both the vehicle DC voltage or from an external AC power supply The system shall also indicate the battery power condition If electrical and electronic items are used, and connected to the ambulance electrical circuits, these should conform to the European Directive 2004/108/EC as amended If they are connected to the stretcher's internal power supply, then the electrical systems of the stretcher should conform to the European Directive 2006/28/EC c) 4.6 The operating controls shall be designed in accordance with the body dimensions, physical strength and anatomical and physiological requirements of human beings The operating controls shall be clearly and permanently labelled, preferably with graphical symbols, indicating their positions and settings according to !EN 60601-1-2:2014" and !EN 62366:2008" Restraint systems The stretcher shall have a minimum of two quick-release patient restraints capable of accepting a device for restraining children 4.7 Flammability – toxicity burning gases There shall be no progressive smouldering or flaming ignition when tested in accordance with !EN 5971:1994" 4.8 Deformation of the frame The frame shall not bend or break when tested in accordance with 5.1 BS EN 1865-3:2012+A1:2015 EN 1865-3:2012+A1:2015 (E) EN 1865-3:2012+A1:2015 (E) 4.9 Fixation The requirement of the fixation shall be in accordance with !EN 1789:2007+A2:2014", 4.5.9 There shall be no deformation of the fixation when tested in accordance with 5.2 4.10 Deformation of the lying area There shall be no remaining deformation of the lying area when tested in accordance with 5.3 4.11 Resistance to torsion There shall be no remaining deformation to torsion when tested in accordance with 5.4 4.12 Splaying of the wheels The wheels shall not splay more than mm in total during the test specified in 5.5 and there shall be no permanent deformation Test methods 5.1 5.1.1 Permanent deformation of the frame Stretcher frame Dimensions in millimetres Figure — Permanent bending deformation test of a heavy duty stretcher frame For the test of permanent deformation (bending), the stretcher shall be positioned with the fully extended, handles rested on support (see Figure 1) The test shall be performed on a flat firm ground The heavy duty stretcher shall be loaded evenly with 400 kg (e.g sandbags) according to Figure Where lateral extensions are fitted 75 kg of the load shall be evenly positioned on each of the extensions The sandbags shall not rest on the longitudinal bars 10 BS EN 1865-3:2012+A1:2015 EN 1865-3:2012+A1:2015 (E) EN 1865-3:2012+A1:2015 (E) The extension mechanism used to adjust between the inner and outer positions, shall remain fully operational when the sandbags are removed There shall be no remaining deformation or defects to the mechanism 5.1.2 Undercarriage frame Following this test, the stretcher bearing the 400 kg load shall be moved so that one wheel collides frontally with a 100 mm high, vertical and rigid obstacle at a speed of km/h Unload and examine for deflections and/or failures 5.2 Fixation inside the ambulance The requirement of the fixation shall be in accordance with !EN 1789:2007+A2:2014, 4.5.9 and 5.4" 5.3 Permanent deformation of the lying area Dimensions in millimetres Figure — Permanent deformation test of a heavy duty stretcher lying area For the test of permanent deformation the stretcher shall be loaded with a sandbag of 250 kg according to Figure Unload the lying area and examine for deflection and/or failures There shall be no remaining deformation or defects 11 BS EN 1865-3:2012+A1:2015 EN 1865-3:2012+A1:2015 (E) EN 1865-3:2012+A1:2015 (E) 5.4 Resistance to twisting/torsion Dimensions in millimetres Figure — Testing against torsion of a heavy duty stretcher To run the test on resistance against torsion the non-loaded stretcher shall be fixed at one end in the middle of the completely pulled out handles, on the other side the longitudinal bars shall be laid on a test stand At this free end a lever shall be fitted out to the pulled out handles The lever shall be loaded with 100 N according to Figure The longitudinal bar shall lift itself from the surface of the test stand by max 50 mm, measured from the upper edge of the test stand to the lower edge of the longitudinal bar No remaining deformation shall occur 5.5 Splaying of the wheels To carry out the splaying test of the wheels the stretcher/undercarriage shall be placed on a flat plane and moved forward and backward 500 mm each The stretcher shall be loaded evenly with 400 kg (e.g with sandbags) Marking The stretchers and other patient handling equipment covered by this European Standard shall be labelled in accordance with !EN ISO 15223-1:2012"and !EN 1041:2008+A1:2013" 12 BS EN 1865-3:2012+A1:2015 EN 1865-3:2012+A1:2015 (E) EN 1865-3:2012+A1:2015 (E) Annex ZA (informative) 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 Essential 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 given 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 Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC 4.5, 4.7 7.1 4.1, 4.5.2 c), 4.5.3 f) 7.3 (all subclauses) 8.1 (all subclauses), subclauses) (all 9.2 4.7 9.3 4.5.4 b) 12.2 (all subclauses), subclauses) (all Qualifying remarks/Notes Covered as far as the first and second indents are concerned except for toxicity Covered for the risk of injury in connection with physical features 12.7.1 13 WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard For devices which are also machinery within the meaning of Article 2(a) of Directive 2006/42/EC on Machinery, in accordance with Article of Directive 93/42/EEC the following Table ZA.2 details the relevant essential health and safety requirements of Directive 2006/42/EC on Machinery to the extent to which they are more specific than those of Directive 93/42/EEC along with the corresponding clauses of this European Standard Table ZA.2, however, does not imply any citation in the OJEU under the machinery directive and thus not provide presumption of conformity for the machinery directive Determination of whether a certain EHSR is “relevant” and thus applies to a particular device, pertains to the responsible parties (e.g manufacturer, notified bodies, competent authorities) in accordance with the applicable procedures 13 BS EN 1865-3:2012+A1:2015 EN 1865-3:2012+A1:2015 (E) EN 1865-3:2012+A1:2015 (E) Table ZA.2 — Relevant Essential Health and Safety Requirements from Directive 2006/42/EC on machinery that are addressed by this European Standard (according to Article of amended Directive 93/42/EEC) Clause(s)/sub-clause(s) of this EN Essential Health and Safety Requirements (EHSRs) of Directive 2006/42/EC Qualifying remarks/Notes 4.1 1.3.1 If a relevant hazard exists, the manufacturer has to cover this EHSR Covered by reference to !EN ISO 14971:2012" 4.1, 4.5.3 e), 4.12 1.3.7 If a relevant hazard exists, the manufacturer has to cover this EHSR Covered by these clauses and by reference to !EN ISO 14971:2012" 4.1, 4.5.4 a), 4.9 1.3.9 If a relevant hazard exists, the manufacturer has to cover this EHSR Covered by these clauses and by reference to !EN ISO 14971:2012" 4.1, 4.5.4 c), 4.6 1.4.3 If a relevant hazard exists, the manufacturer has to cover this EHSR Partly covered by these clauses and by reference to !EN ISO 14971:2012" as far as risk management is concerned - 1.6.2 If a relevant hazard exists, the manufacturer has to cover this EHSR Not covered by this standard - 1.6.3 If a relevant hazard exists, the manufacturer has to cover this EHSR Not covered by this standard - 3.6.2 To comply with this EHSR the manufacturer has to legibly and indelibly mark the machinery with the mass and nominal power Not covered by this standard 14 BS EN 1865-3:2012+A1:2015 EN 1865-3:2012+A1:2015 (E) EN 1865-3:2012+A1:2015 (E) Bibliography [1] EN 1021-1, Furniture — Assessment of the ignitability of upholstered furniture — Part 1: Ignition source smouldering cigarette [2] EN ISO 12100, Safety of machinery — General principles for design — Risk assessment and risk reduction (ISO 12100) [3] Council Directive 93/42/EEC of 14 June 1993 concerning medical devices [4] Directive 2004/108/EC of the European Parliament and of the Council of 15 December 2004 on the approximation of the laws of the Member States relating to electromagnetic compatibility and repealing Directive 89/336/EEC [5] Commission Directive 2006/28/EC of March 2006 amending, for the purposes of their adaptation to technical progress, Council Directive 72/245/EEC of 20 June 1972 relating to the radio interference (electromagnetic compatibility) of vehicles and Council Directive 70/156/EEC on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers [6] Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (recast) 15 This page deliberately left blank This page deliberately left blank NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW British Standards Institution (BSI) BSI is the national body responsible for preparing British Standards and other standards-related publications, information and services BSI is incorporated by Royal Charter British Standards and other standardization products are published by BSI Standards Limited About us Revisions We bring together business, industry, government, consumers, innovators and others to shape their combined experience and expertise into standards -based solutions 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