BS EN 1865-1:2010+A1:2015 BS EN 1865-1:2010 BSI Standards Publication Patient handling equipment used in road ambulances Part 1: General stretcher systems and patient handling equipment BS EN 1865-1:2010+A1:2015 BRITISH STANDARD National foreword This British Standard is the UK implementation of EN 1865-1:2010+A1:2015 It supersedes BS EN 1865-1:2010, which is withdrawn The start and finish of text introduced or altered by amendment is indicated in the text by tags Tags indicating changes to CEN text carry the number of the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 87512 ICS 11.160; 43.160 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 October 2010 Amendments/corrigenda issued since publication Date Text affected 30 June 2015 Implementation of CEN amendment A1:2015 EUROPEAN STANDARD EN 1865-1:2010+A1 NORME EUROPÉENNE EUROPÄISCHE NORM May 2015 ICS 11.160 Supersedes EN 1865-1:2010 English Version Patient handling equipment used in road ambulances - Part 1: General stretcher systems and patient handling equipment Spécifications d'équipements pour le transport de patient dans les ambulances routières - Partie 1: Systèmes généraux de brancards et équipement pour le transport de patients Krankentransportmittel im Krankenkraftwagen - Teil 1: Allgemeine Krankentragesysteme und Krankentransportmittel This European Standard was approved by CEN on July 2010 and includes Amendment 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 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 1865-1:2010+A1:2015 E BS EN 1865-1:2010+A1:2015 EN 1865-1:2010+A1:2015 (E) EN 1865-1:2010+A1:2015 (E) Contents Page Foreword Introduction Scope Normative references Terms and definitions 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 4.3 4.3.1 4.3.2 4.3.3 4.3.4 4.3.5 4.3.6 4.3.7 4.3.8 4.3.9 4.3.10 4.3.11 4.3.12 4.4 4.4.1 4.4.2 4.4.3 4.4.4 4.4.5 4.4.6 4.4.7 4.4.8 4.4.9 4.4.10 4.4.11 4.4.12 Requirements General Main stretcher General Dimensions .9 Mass 10 Loading capacity 10 Frame 10 Lying part of the stretcher 11 Restraint system 12 Flammability − Toxicity burning gases 12 Deformation of the frame 12 Fixation 12 Deformation of the lying area 12 Resistance to torsion 12 Splaying of the wheels 12 Chair stretcher 12 Dimensions 12 Mass 12 Loading capacity 13 Frame 13 Lying-sitting part 13 Restraint system 13 Flammability − Toxicity burning gases 13 Deformation of the frame 13 Fixation 13 Deformation of the lying-sitting area 13 Resistance to torsion 13 Splaying of the wheels 13 Transfer mattress 13 Dimensions 13 Mass 14 Loading capacity 14 Handles 14 Lying part 14 Restraint system 14 Flammability − Toxicity burning gases 14 Deformation 14 Fixation 14 Deformation of the lying area 14 Resistance to torsion 15 Splaying of the wheels 15 BS EN 1865-1:2010+A1:2015 EN 1865-1:2010+A1:2015 (E) EN 1865-1:2010+A1:2015 (E) 4.5 4.5.1 4.5.2 4.5.3 4.5.4 4.5.5 4.5.6 4.5.7 4.5.8 4.5.9 4.5.10 4.5.11 4.5.12 4.6 4.6.1 4.6.2 4.6.3 4.6.4 4.6.5 4.6.6 4.6.7 4.6.8 4.6.9 4.6.10 4.6.11 4.6.12 4.6.13 4.7 4.7.1 4.7.2 4.7.3 4.7.4 4.7.5 4.7.6 4.7.7 4.7.8 4.7.9 4.7.10 4.7.11 4.8 4.8.1 4.8.2 4.8.3 4.8.4 4.8.5 4.8.6 4.8.7 4.8.8 4.8.9 4.8.10 4.8.11 4.8.12 4.9 4.9.1 4.9.2 4.9.3 4.9.4 Carrying sheet 15 Dimensions 15 Mass 15 Loading capacity 15 Handles 15 Lying part 15 Restraint system 15 Flammability − Toxicity burning gases 15 Deformation of the handles 15 Fixation 15 Deformation of the lying area 16 Resistance to torsion 16 Splaying of the wheels 16 Pick up stretcher 16 Dimensions 16 Mass 16 Loading capacity 16 Frame 16 Lying part 16 Restraint system 16 Flammability − Toxicity burning gases 17 Deformation of the frame 17 Fixation 17 Locking 17 Deformation of the lying area 17 Resistance to torsion 17 Splaying of the wheels 17 Vacuum mattress 17 Construction 17 Dimensions 17 Mass 18 Loading capacity 18 Handles 18 Restraint system 18 Flammability − Toxicity burning gases 18 Deformation 18 Fixation 18 Shrinkage 18 Deformation of the lying area 18 Long spinal board 19 Dimensions 19 Mass 19 Loading capacity 19 Construction 19 Lying part 19 Restraint system 19 Flammability − Toxicity burning gases 19 Deformation 19 Fixation 19 Deformation of the lying area 20 Resistance to torsion 20 Splaying of the wheels 20 Foldable carrying chair 20 Dimensions 20 Mass 20 Loading capacity 20 Frame 20 BS EN 1865-1:2010+A1:2015 EN 1865-1:2010+A1:2015 (E) EN 1865-1:2010+A1:2015 (E) 4.9.5 Sitting part 20 4.9.6 Restraint system 20 4.9.7 Flammability − Toxicity burning gases 21 4.9.8 Deformation 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 capacity 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 5.1 5.1.1 5.1.2 5.1.3 5.1.4 5.1.5 5.2 5.2.1 5.2.2 5.2.3 5.2.4 5.3 5.3.1 5.3.2 5.4 5.4.1 5.4.2 5.5 5.5.1 5.5.2 5.6 5.6.1 5.6.2 5.6.3 5.7 5.7.1 5.7.2 5.8 5.8.1 5.9 5.9.1 5.9.2 5.9.3 Test methods 23 Main stretcher 23 Permanent deformation of the frame 23 Fixation inside the ambulance 23 Permanent deformation of the lying area 24 Resistance to twisting/torsion 24 Splaying of the wheels 25 Chair stretcher 25 Permanent deformation of the frame 25 Permanent deformation of the lying-sitting area 25 Resistance to twisting/torsion 25 Splaying of the wheels 25 Transfer mattress 25 Deformation 25 Deformation of the lying area 27 Carrying sheet 28 Strength of the handles 28 Permanent deformation of the lying area 29 Pick up stretcher 29 Permanent deformation of the frame 29 Resistance to twisting/torsion 29 Vacuum mattress and pump 30 Deformation 30 Shrinkage 30 Deformation of the lying area 30 Long spinal board 31 Permanent deformation of the frame and lying area 31 Resistance to twisting/torsion 31 Foldable carrying chair 31 Permanent deformation of the frame and backrest lying-sitting area 31 Non-foldable carrying chair (sedan chair) 32 Permanent deformation of the frame and sitting area 32 Fixation inside the ambulance 32 Splaying of the wheels 32 BS EN 1865-1:2010+A1:2015 EN 1865-1:2010+A1:2015 (E) EN 1865-1:2010+A1:2015 (E) Marking 32 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC concerning Medical Devices 33 Bibliography 35 BS EN 1865-1:2010+A1:2015 EN 1865-1:2010+A1:2015 (E) EN 1865-1:2010+A1:2015 (E) 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 national 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 patent 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 supersedes 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 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 stretcher; — 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, 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 1865-1:2010+A1:2015 EN 1865-1:2010+A1:2015 (E) EN 1865-1:2010+A1:2015 (E) 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 chair 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 for 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 BS EN 1865-1:2010+A1:2015 EN 1865-1:2010+A1:2015 (E) EN 1865-1:2010+A1:2015 (E) Scope This European Standard defines 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 Normative references 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 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 the 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 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 terms and definitions apply 3.1 main stretcher main device for the conveyance of a sick and/or injured 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 intended 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 BS EN 1865-1:2010+A1:2015 EN 1865-1:2010+A1:2015 (E) EN 1865-1:2010+A1:2015 (E) 5.1.3 Permanent deformation of the lying area Dimensions in millimetres Figure For the test of permanent deformation the stretcher shall be loaded with a sandbag of 150 kg according to Figure Unload the lying area and examine for deflection and/or failures There shall be no remaining deformation or defects 5.1.4 Resistance to twisting/torsion Dimensions in millimetres Figure To run the test on resistance against torsion the non-loaded stretcher shall be fixed at one end in the middle of the fully extended handles, on the other side the longitudinal bars shall be laid on a test stand At this free end 24 BS EN 1865-1:2010+A1:2015 EN 1865-1:2010+A1:2015 (E) EN 1865-1:2010+A1:2015 (E) a lever shall be fitted out to the fully extended 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 5.1.5 Splaying of the wheels To run 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 is loaded evenly with 250 kg (e.g with six sandbags) 5.2 5.2.1 Chair stretcher Permanent deformation of the frame Secure chair handles on support Suspend chair stretcher by the handles as if the chair stretcher was being carried Secure chair stretcher handles to the supports with restraint straps to prevent the handles from sliding off the supports Load the chair with 250 kg distributing the weight in the chair stretcher much as a patient's weight would be distributed Unload chair stretcher and examine for deflections and/or failures There shall be no remaining deformation or defects 5.2.2 Permanent deformation of the lying-sitting area The test of the chair stretcher in reclined position shall be in accordance with 5.1.3 5.2.3 Resistance to twisting/torsion The test for resistance to torsion shall be in accordance with 5.1.4 5.2.4 Splaying of the wheels Load the chair stretcher in chair position with 250 kg Tip chair back on wheels as if transporting a patient and roll the chair over smooth surfaces, door-sills, minor obstructions, and any other types of surfaces that might be expected during intended use Unload chair stretcher and examine for deflections and/or failures There shall be no remaining deformation or defects 5.3 5.3.1 Transfer mattress Deformation The transfer mattress is subject to static tests in accordance with Figures and Apply a force of F = 500 N between all opposite carrying loops as shown in example in Figure for the middle loops 25 BS EN 1865-1:2010+A1:2015 EN 1865-1:2010+A1:2015 (E) EN 1865-1:2010+A1:2015 (E) Figure Apply a force of F = 000 N between the outer and middle loops of each side as shown in Figure 26 BS EN 1865-1:2010+A1:2015 EN 1865-1:2010+A1:2015 (E) EN 1865-1:2010+A1:2015 (E) Figure There shall be no broken threads upon completion of the above test 5.3.2 Deformation of the lying area Secure the transfer mattress handles, along the length of the transfer mattress, to support Transfer mattress will be suspended from the supports Load transfer mattress with 250 kg, distributing the weight evenly along the length of the transfer mattress Unload mattress and examine for failures There shall be no remaining deformation or defects 27 BS EN 1865-1:2010+A1:2015 EN 1865-1:2010+A1:2015 (E) EN 1865-1:2010+A1:2015 (E) 5.4 Carrying sheet 5.4.1 Strength of the handles The carrying sheet is subject to static tests in accordance with Figure and a) Apply a force of F = 500 N between all opposite carrying handles as shown in example in Figure for the middle handles b) Apply a force of F = 000 N between the outer and middle handles of each side as shown in Figure There shall be no broken threads upon completion of the above tests Figure 28 BS EN 1865-1:2010+A1:2015 EN 1865-1:2010+A1:2015 (E) EN 1865-1:2010+A1:2015 (E) Figure 5.4.2 Permanent deformation of the lying area Secure carrying sheet handles, along the length of the carrying sheet, to support Carrying sheet will be suspended from the supports Load carrying sheet with 250 kg, distributing the weight evenly along the length of the carrying sheet Unload sheet and examine for failures There shall be no remaining deformation or defects 5.5 5.5.1 Pick up stretcher Permanent deformation of the frame Place fully extended stretcher on supports positioned 300 mm from the ends of the stretcher Load stretcher with 250 kg, distributing the weight evenly along the length of the stretcher Unload stretcher and examine for deflections and/or failures by telescoping the frame in and out operating the end latches and pin locks There shall be no remaining deformation or defects 5.5.2 Resistance to twisting/torsion The test for resistance to torsion shall be in accordance with 5.1.4 29 BS EN 1865-1:2010+A1:2015 EN 1865-1:2010+A1:2015 (E) EN 1865-1:2010+A1:2015 (E) 5.6 Vacuum mattress and pump 5.6.1 Deformation For rigidity and density the mattress shall be placed on a stand: a) the pressure inside the vacuum mattress shall be reduced by 500 hPa; b) after 30 min, the remaining pressure difference shall be at least 300 hPa; c) the mattress (after opening the valve) shall be shaped to a human body by means of a test person of (75 ± 5) kg body weight, and a height of (175 ± 5) cm; d) the pressure inside the vacuum mattress shall be reduced again by 500 hPa; e) the test person shall be removed; f) the mattress is then placed according to Figure with a load of 50 kg applied on a surface of 350 mm diameter centred in the middle of the mattress; g) after h the remaining pressure difference shall be at least 300 hPa and the deflection shall not exceed 100 mm Dimensions in millimetres Key Deflection Figure 5.6.2 Shrinkage Place the mattress in flat position on a flat surface Measure the mattress in the middle longitudinally and middle transversally The pressure inside the mattress shall then be reduced by 500 hPa Measure the size of the mattress, at same places as before, whilst under this vacuum pressure 5.6.3 a) 30 Deformation of the lying area The pressure inside the vacuum mattress shall be reduced by 500 hPa and then suspended by means of its external handles (instead of loops) and a load of 250 kg applied as shown in Figure 9; BS EN 1865-1:2010+A1:2015 EN 1865-1:2010+A1:2015 (E) EN 1865-1:2010+A1:2015 (E) b) after 15 there shall be no visible damage and/or failure; c) the same applies if the mattress is provided with a protective coating/cover and if the latter is intended to be used in combination with the patient Figure 5.7 5.7.1 Long spinal board Permanent deformation of the frame and lying area Place the long spinal board on supports positioned 300 mm from the ends of the spinal board Load spinal board with 250 kg, distributing the weight evenly along the length of the spinal board Unload the spinal board and examine for deflections 5.7.2 Resistance to twisting/torsion The test for resistance to torsion shall be in accordance with 5.1.4 5.8 5.8.1 Foldable carrying chair Permanent deformation of the frame and backrest lying-sitting area Place carrying chair handles on supports Suspend carrying chair by the handles as if the carrying chair was being carried Secure the carrying chair handles to the supports with restraint straps to prevent the handles from sliding off the supports Load the carrying chair with a weight of 250 kg distributing this in the carrying chair much as a patient's weight would be distributed Following this test, tip the carrying chair back on wheels as if transporting a patient and roll the carrying chair over smooth surfaces, door-sills, minor obstructions, and any other types of surfaces the carrying chair might be rolled across Unload the carrying chair and examine for deflections and/or failures There shall be no remaining deformation or defects 31 BS EN 1865-1:2010+A1:2015 EN 1865-1:2010+A1:2015 (E) EN 1865-1:2010+A1:2015 (E) 5.9 Non-foldable carrying chair (sedan chair) 5.9.1 Permanent deformation of the frame and sitting area Place extended sedan chair handles on supports, suspending carrying chair by the handles as if the carrying chair was being carried Secure the carrying chair handles to the supports with restraint straps to prevent the handles from sliding off the supports Load the carrying chair with 250 kg, distributing the weight in the carrying chair much as a patient's weight would be distributed Unload the non-foldable carrying chair and examine for deflections and/or failures 5.9.2 Fixation inside the ambulance When installed in the ambulance and used for the transportation of the patient in a sitting position it is essential to regard it as a permanent seat in accordance with Directive 70/156/EEC 5.9.3 Splaying of the wheels Load the carrying chair with 250 kg Place the carrying chair on wheels as if transporting a patient and roll the carrying chair over smooth surfaces, door-sills, minor obstructions, and any other types of surfaces the carrying chair might be rolled across Unload the carrying chair and examine for deflections and/or failures There shall be no remaining deformation or defects 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" 32 BS EN 1865-1:2010+A1:2015 EN 1865-1:2010+A1:2015 (E) EN 1865-1:2010+A1:2015 (E) ! Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC concerning 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 EU Directive 93/42/EEC 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 normative clauses of this standard confers, within the limits of the scope of this standard, a presumption of conformity with the relevant Essential Requirements of that Directive and associated EFTA regulations Table ZA.1 lays out which clauses of this standard are likely to support the relevant requirements of Directive 93/42/EEC Compliance with these clauses of this standard provides one means of conforming with the specific Essential Requirements of the Directive concerned and associated EFTA regulations Table ZA.1 — Relationship between this standard and Directive 93/42/EEC on Medical Devices Clause(s)/subclause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC 4.1, 4.2.5, 4.2.6, 4.2.8, 4.3.4, 4.3.5, 4.3.7, 4.4.5, 4.4.7, 4.5.5, 4.5.7, 4.6.4, 4.6.5, 4.6.7, 4.7.1, 4.7.7, 4.8.5, 4.8.7, 4.9.4, 4.9.5, 4.9.7, 4.10.4, 4.10.5, 4.10.7 7.1, first and second indents 4.1, 4.2.5, 4.2.6, 4.3.5, 4.4.5, 4.5.5, 4.6.5, 4.7.1, 4.8.5, 4.9.5, 4.10.5 7.3, first part 4.1, 4.2.6, 4.3.5, 4.4.5, 4.5.5, 4.6.5, 4.7.1, 4.8.5, 4.9.5, 4.10.5 8.1 Clause (all subclauses), Clause (all subclauses) 9.2, first indent 4.2.8, 4.3.7, 4.4.7, 4.5.7, 4.6.7, 4.7.7, 4.8.7, 4.9.7, 4.10.7 9.3 Clause (all subclauses), Clause (all subclauses) 12.7.1 Qualifying remarks/Notes Toxicity is not covered 33 BS EN 1865-1:2010+A1:2015 EN 1865-1:2010+A1:2015 (E) EN 1865-1:2010+A1:2015 (E) WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard." 34 BS EN 1865-1:2010+A1:2015 EN 1865-1:2010+A1:2015 (E) EN 1865-1:2010+A1:2015 (E) Bibliography [1] Council Directive 70/156/EEC of February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers [2] Council Directive 93/42/EEC of 14 June 1993 concerning medical devices 35 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 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