BSI Standards Publication Patient handling equipment used in road ambulances Part 2 Power assisted stretcher BS EN 1865 2 2010+A1 2015 BS EN 1865 2 2010+A1 2015 BRITISH STANDARD National foreword This[.]
BS EN 1865-2:2010+A1:2015 BSI Standards Publication Patient handling equipment used in road ambulances Part 2: Power assisted stretcher BS EN 1865-2:2010+A1:2015 BRITISH STANDARD National foreword This British Standard is the UK implementation of EN 1865-2:2010+A1:2015 It supersedes BS EN 1865-2:2010, which is withdrawn The start and finish of text introduced or altered by amendment is indicated in the text by tags Tags indicating changes to CEN text carry the number of the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 86227 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 31 January 2011 Amendments/corrigenda issued since publication Date Text affected Implementation of CEN amendment A1:2015 EUROPEAN STANDARD EN 1865-2:2010+A1 NORME EUROPÉENNE EUROPÄISCHE NORM March 2015 ICS 11.160 Supersedes EN 1865-2:2010 English Version Patient handling equipment used in road ambulances - Part 2: Power assisted stretcher Spécifications d'équipements pour le transport de patient dans les ambulances routières - Partie 2: Brancard motorisé Krankentransportmittel im Krankenkraftwagen - Teil 2: Kraftunterstützte Krankentrage This European Standard was approved by CEN on July 2010 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 1865-2:2010+A1:2015 E BS EN 1865-2:2010+A1:2015 EN 1865-2:2010+A1:2015 (E) EN 1865-2:2010+A1:2015 (E) Contents Page Foreword Introduction Scope Normative references Terms and definition .5 4.1 4.2 4.2.1 4.2.2 4.2.3 4.2.4 4.2.5 4.2.6 4.2.7 4.2.8 4.2.9 4.2.10 4.2.11 4.2.12 4.2.13 4.2.14 Requirements General Main stretcher General Dimensions .6 Mass Loading capacity Frame Power source Lying part of the stretcher Restraint system Flammability – Toxicity burning gases .8 Deformation of the frame Fixation Deformation of the lying area .9 Resistance to torsion Splaying of the wheels Marking Annex ZA !(informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices and of EU Directive 2006/42/EC on Essential Health and Safety Requirements" 10 Bibliography 12 BS EN 1865-2:2010+A1:2015 EN 1865-2:2010+A1:2015 (E) EN 1865-2:2010+A1:2015 (E) Foreword This document (EN 1865-2:2010+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 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 1865-2:2010." 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 EU 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 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 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 1865-2:2010+A1:2015 EN 1865-2:2010+A1:2015 (E) EN 1865-2:2010+A1:2015 (E) Introduction In this standard reference is made to EN 1789 which specifies design requirements and test methods for road ambulances, which are relevant for checking requirements for such handling equipment BS EN 1865-2:2010+A1:2015 EN 1865-2:2010+A1:2015 (E) EN 1865-2:2010+A1:2015 (E) 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 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 devices — Application of usability engineering to medical devices (IEC 62366:2007) !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 (ISO 15223-1:2012)" 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 facilitating treatment and providing powered movements in the operation of the stretcher to reduce the physical effort required by operatives BS EN 1865-2:2010+A1:2015 EN 1865-2:2010+A1:2015 (E) EN 1865-2:2010+A1:2015 (E) Requirements 4.1 General When operated and maintained in accordance with the manufacturer's instructions, power 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 ambulance 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 shall 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 resistant, 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 ambulance loading system shall be compatible 4.2.2 Dimensions Dimensions shall be measured from the outermost edges: — length: width: +120 −50 ) mm"; +60 !(550 ± −20 ) mm" ; height: — !(1 950 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 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 BS EN 1865-2:2010+A1:2015 EN 1865-2:2010+A1:2015 (E) EN 1865-2:2010+A1:2015 (E) 4.2.4 Loading capacity The loading capacity shall be a minimum of 150 kg 4.2.5 4.2.5.1 Frame 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 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 have 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 not twist when they 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 manufactured 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 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 NOTE There should be a facility to attach a support for infusion 4.2.5.3 Undercarriage 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 position 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 resistant 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 BS EN 1865-2:2010+A1:2015 EN 1865-2:2010+A1:2015 (E) EN 1865-2:2010+A1:2015 (E) load and unload the undercarriage and stretcher so as to ensure the safety and comfort of the patient and the operators 4.2.6 Power source a) The undercarriage height adjustment mechanism shall have an integral safety feature to prevent the 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, see European Directive 2004/104/EC as amended If they are connected to the stretcher's internal power supply, then for the electrical systems of the stretcher see European Directive 2006/28/EC c) 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" 4.2.7 Lying part of the stretcher a) The lying area shall be flat over the complete surface and shall be made of sturdy lightweight construction The thorax area shall be manufactured of sturdy lightweight material which allows cardiopulmonary resuscitation without acting as a spring or giving way The materials shall be unaffected by disinfectants b) The lying area shall be non-slip and shall be covered with a transfer mattress, or a mattress that shall provide for patient comfort and also be firm enough to enable cardiopulmonary resuscitation to be undertaken The mattress shall be able to conform to the various treatment configuration provided by the stretcher The mattress shall be constructed in such a way that prevents ingress of patient fluids and facilitate infectious control cleaning In addition, the materials shall be unaffected by disinfectants The mattress on the lying part of the stretcher shall be fixed securely c) The lying area shall have an adjustable head-end/backrest with a minimum length of 600 mm It shall be possible to raise the backrest at least 75° and there shall be at least five fixing positions within this range It shall be possible to maintain the angle of adjustment under all normal cases of loading and unloading d) The lying area shall have an adjustable footrest with a minimum length of 900 mm It shall be possible to raise the leg section (shock position) at least 15° with a system to minimize the lifting effort of the operator It shall be possible to maintain the angle of adjustment under all normal cases of loading and unloading 4.2.8 Restraint system The stretcher shall be fitted with a harness and quick-release patient restraint(s) capable of fulfilling the test requirements specified in !EN 1789:2007+A2:2014" The stretcher shall be capable of accepting a device for restraining children that fulfils the test requirements specified in !EN 1789:2007+A2:2014" 4.2.9 Flammability – Toxicity burning gases There shall be no progressive smouldering or flaming ignition when tested in accordance with !EN 5971:1994" BS EN 1865-2:2010+A1:2015 EN 1865-2:2010+A1:2015 (E) EN 1865-2:2010+A1:2015 (E) 4.2.10 Deformation of the frame The frame shall not bend or break when tested in accordance with !EN 1865-1:2010, 5.1.1" 4.2.11 Fixation The requirement of the fixation shall be in accordance with !EN 1789:2007+A2:2014, 4.5.9" 4.2.12 Deformation of the lying area There shall be no remaining deformation of the lying area when tested in accordance with !EN 18651:2010, 5.1.3" 4.2.13 Resistance to torsion There shall be no remaining deformation of the lying area when tested in accordance with !EN 18651:2010, 5.1.4" 4.2.14 Splaying of the wheels The wheels shall not splay more than mm in total during the test specified in !EN 1865-1:2010, 5.1.5" and there shall be no permanent deformation Marking The power assisted stretcher covered by this European Standard shall be labelled in accordance with !EN ISO 15223-1:2012"and !EN 1041:2008+A1:2013" BS EN 1865-2:2010+A1:2015 EN 1865-2:2010+A1:2015 (E) EN 1865-2:2010+A1:2015 (E) Annex ZA !(informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices and of EU Directive 2006/42/EC on Essential Health and Safety Requirements 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)/subclause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Clause 4, all subclauses 7.1, first and second indents 4.1, 4.2.5, 4.2.7 7.3, first part only Clause 4, all subclauses 8.1 Clause 4, all subclauses 9.2, first indent 4.2.9 9.3 4.2.6 12.2 Clause 4, all subclauses 12.7.1 Qualifying remarks/Notes Toxicity is not covered Covered dimensional features for and physical, ergonomic 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 (EHSRs) 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 does 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 10 BS EN 1865-2:2010+A1:2015 EN 1865-2:2010+A1:2015 (E) EN 1865-2:2010+A1:2015 (E) Table ZA.2 — Correspondence between this European Standard and Directive 2006/42/EEC on Essential Health and Safety Requirements Clause(s)/subclause(s) of this EN Essential Health and Safety Requirements (EHSRs) Qualifying Remarks / Notes Directive 2006/42/EEC 1.2.4.3 Not covered by this standard 4.2.6 1.2.6 Partly covered by this clause (prevention of uncontrolled movement) Other parts not covered by this standard 4.1 1.3.1 Covered by reference EN ISO 14971:2012 4.2.5.2 1.3.7 Covered by these clauses and reference to EN ISO 14971:2012 1.3.9 Covered by these clauses and reference to EN ISO 14971:2012 1.4.3 Not covered by this standard 1.6.2 Not covered by this standard 1.6.3 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 4.2.5.3 to 4.1 4.2.5.2 4.2.5.3 Not covered by this standard WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard " 11 BS EN 1865-2:2010+A1:2015 EN 1865-2:2010+A1:2015 (E) EN 1865-2:2010+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 12100-2:2003, Safety of machinery — Basic concepts, general principles for design — Part 2: Technical principles (ISO 12100-2:2003) [3] Commission Directive 2004/104/EC of 14 October 2004 adapting to technical progress Council Directive 72/245/EEC relating to the radio interference (electromagnetic compatibility) of vehicles and amending 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 Text with EEA relevance [4] 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 (Text with EEA relevance) 12 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 Our British Standards and other publications are updated by amendment or revision The knowledge embodied in our standards has been carefully assembled in a dependable format and refined through our open consultation process Organizations of all sizes and across all 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