1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN 1865-5:2012Patient handling equipmentused in road ambulancesPart 5: Stretcher supportBS EN 1865-5:2012 BRITISH STANDARDNational forewordThis British Standard is the UK impl
2、ementation of EN 1865-5:2012.Together with BS EN 1865-1:2010, BS EN 1865-2:2010, BS EN1865-3:2012 and BS EN 1865-4:2012, it supersedes BS EN 1865:2000,which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/239, Rescue systems.A list of organizations represe
3、nted on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2012. Published by BSI StandardsLimited 2012ISBN 978 0 580 702
4、08 2ICS 11.160Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 30 June 2012.Amendments issued since publicationDate Text affectedBS EN 1865-5:2012EUROPEAN STANDARD
5、NORME EUROPENNE EUROPISCHE NORM EN 1865-5 June 2012 ICS 11.160 Supersedes EN 1865:1999English Version Patient handling equipment used in road ambulances - Part 5: Stretcher support Spcifications dquipements pour le transport de patient dans les ambulances routires - Partie 5: Table support brancard
6、Krankentransportmittel in Krankenkraftwagen - Teil 5: Festlegungen zur Krankentragenaufnahme 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 Standard the statu
7、s 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, Ger
8、man). 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, Croati
9、a, 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 COMMITTEE FOR STA
10、NDARDIZATION 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 1865-5:2012: EBS EN 1865-5:2012EN 1865-5:2012 (E)
11、2 Contents Page Foreword 31 Scope 42 Normative references 43 Terms and definitions .44 Requirements .54.1 Edges 54.2 Loading capacity54.3 Interface on ambulance floor or/and sidewall and stretcher support tray 54.4 Fixation on ambulance floor or/and sidewall and stretcher support tray54.5 Powered st
12、retcher support .64.6 Shock-absorbing stretcher support.64.7 EMC .64.8 Test method for fixation on ambulance floor or/and sidewall and stretcher support tray 64.8.1 General 64.8.2 Dynamic testing .7Annex A (informative) Test summary . 10Annex B (informative) Optional requirements . 11B.1 Sliding tes
13、t . 11B.2 Sideways movement 11B.3 Sliding tray (backwards and forward movement) . 11Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices 12Bibliography . 14BS EN 1865-5:2012EN 1865-5:2012 (E) 3 Foreword This do
14、cument (EN 1865-5:2012) 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
15、, and conflicting 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
16、. This document together with the EN 1865-1:2010, EN 1865-2:2010, EN 1865-3:2012 and EN 1865-4:2012 supersedes EN 1865:1999. With respect to EN 1865:1999 the following changes were made: a) the stretcher support was introduced as a new item; b) the standard has been modified/integrated to meet the M
17、edical Device Directive requirements; c) the standard has been modified t/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 Fr
18、ee 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
19、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 According to the CEN/CENELEC Internal Regulations, the national standards organizations of
20、 the following countries are bound to implement this European 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, Roma
21、nia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. BS EN 1865-5:2012EN 1865-5:2012 (E) 4 1 Scope This European Standard specifies the minimum requirements for the design and performance of stretcher supports that are installed in road ambulances to hold the main stre
22、tcher or incubator systems in accordance with EN 1865-1, EN 1865-2 and EN 13976-2 to ensure patient and operators safety and to minimise the physical effort required by staff operating the equipment. In this European Standard reference is made to EN 1789. 2 Normative references The following documen
23、ts, 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 1789:2007+A1:2010, Medica
24、l vehicles and their equipment Road ambulances EN 60601-1 (all subparts), Medical electrical equipment Part 1: General requirements for basic safety and essential performance (IEC 60601-1) ISO 6487, Road vehicles Measurement techniques in impact tests Instrumentation 3 Terms and definitions For the
25、purposes of this document, the following terms and definitions apply. 3.1 stretcher support device that is fitted to the floor and/or sidewall of an ambulance, on which a stretcher or incubator is located Note 1 to entry: Stretcher supports may be manually/power operated and may include a shock abso
26、rbing system. Note 2 to entry: The stretcher support may be equipped with special devices to reduce the effect of acceleration forces of the vehicle to the stretcher or incubator during transportation. Note 3 to entry: The stretcher support may be equipped with devices such as a tilting and extendab
27、le top tray, a fixed or folding ramp. 3.2 stretcher support with manual operation support that can only be moved by using manual force of the operator 3.3 powered stretcher support support that is completely or partially power-operated by means of actuators (electrical, hydraulic, pneumatic, etc.) 3
28、.4 shock absorbing stretcher support support with pneumatic, hydraulic, hydro-pneumatic or mechanical suspension(s) Note 1 to entry: It is designed to cushion the effect of road surfaces, thus providing better comfort for the patient. BS EN 1865-5:2012EN 1865-5:2012 (E) 5 3.5 residual deflection sum
29、 expressed in millimetres of permanent deformation and sliding displacement in test direction 4 Requirements 4.1 Edges In order to reduce risk of injury to patients, staff and equipment, there shall be no exposed sharp edges. 4.2 Loading capacity Stretcher supports shall be able to perform all their
30、 functions when loaded with a minimum mass of 220 kg. This load corresponds to the sum of the maximum weight allowed for the stretcher, undercarriage, minimum stretcher loading capacity (see EN 1865-1:2010, 4.2.3 and 4.2.4) and the fixation brackets. Over this weight the stretcher support might not
31、perform all functions, however, it shall be possible to load/ unload the stretcher with a load of 300 kg. NOTE If the manufacturer declares a higher loading capacity, then tests described in Annex B should be performed using the manufacturers advised maximum admissible loading. 4.3 Interface on ambu
32、lance floor or/and sidewall and stretcher support tray The stretcher support manufacturer shall supply the installer with the following data: a) mass and dimensions of the stretcher support; b) position of the centre of gravity with regard to ambulance floor or/and sidewall and the top tray, at the
33、maximum available height; c) position of the fixing points with regard to the centre of gravity, including number of fixing points, type and mechanical characteristics of the connection devices to be used in order to allow the correct positioning of the floor/wall plate reinforcement; d) to withstan
34、d a minimum load of 220 kg according to 4.2; e) identification of the position on the tray where the connecting devices can be fitted (e.g. bolts) without adding any reinforcement. 4.4 Fixation on ambulance floor or/and sidewall and stretcher support tray The fixation shall be in accordance with EN
35、1789:2007+A1:2010, 4.5.9. When tested in accordance with 4.8, there shall be no residual deflection exceeding the values given in Table 1. Table 1 Residual deflection Test axis Maximum deflection value (mm) X+ / X- 125 Y+ / Y- 125 Z 200BS EN 1865-5:2012EN 1865-5:2012 (E) 6 After the test, the stretc
36、her support shall conserve its integrity but not necessarily its functionality. NOTE It is recognized that during the test some components may break. 4.5 Powered stretcher support In the event of power failure, it shall be possible to operate the powered stretcher support manually. If the powered sy
37、stem is fully automated, then an emergency stop button shall be provided in an accessible position. 4.6 Shock-absorbing stretcher support Shock-absorbing supports shall have automatic selfadjusting and self-levelling suspension according to the loaded weight. The maximum time from the activation to
38、completion of the readjustment shall be no greater than 20 s. It shall be possible to lock the shock-absorbing function and set stretcher support in rigid and horizontal position to allow cardiopulmonary resuscitation. In order to avoid sudden, uncontrolled dangerous movements in the event of an ele
39、ctrical power failure it shall be possible to unload the patient and therefore: a) gas accumulators of the stretcher support shall not remain under-pressure; b) the stretcher support shall smoothly discharge the suspension and set the stretcher support in the lowest available position. 4.7 EMC Any e
40、lectrical or electronic items shall conform to EN 60601-1. NOTE If electrical and/or electronic items are used within the system, they should conform to the European Directive 2004/108/EC and any future updates. 4.8 Test method for fixation on ambulance floor or/and sidewall and stretcher support tr
41、ay 4.8.1 General Verification of conformity to 4.4 shall be made with centre of gravity of the dummy assembly adjusted at minimum 700 mm height, when possible, or at full height of the stretcher support when its height is lower. Verification shall be carried out by dynamic testing. NOTE The notified
42、 body which has to confirm the compliance with EN 1789:2007+A1:2010, 4.5.9, in accordance with EN 1789:2007+A1:2010, 5.3 should a) be acknowledged by government authorities according to article 14 of the Directive 70/156/EEC and should be competent in the field of dynamic testing; b) have an acknowl
43、edgement for the Directives 77/541/EEC and 74/408/EEC, and for Directive 96/79/EC. The sample submitted for test shall be identical to or have the same characteristics and behaviour during the test as would the production item. BS EN 1865-5:2012EN 1865-5:2012 (E) 7 The stretcher support shall be loa
44、ded with a test mass of 126 kg (see Figure 1) which is then secured according to the manufacturer recommendation. Fixation of the stretcher support on the test rig shall be done in accordance with the manufacturers recommendation. A test summary for completion by the test house is given in informati
45、ve Annex A. 4.8.2 Dynamic testing 4.8.2.1 Measurement equipment and test conditions The signal filtration for acceleration shall be CFC 60 according to ISO 6487. The position of sensors and measurement chains for the acceleration on trolley shall be according to ISO 6487. The deceleration measuremen
46、t considered is the average deceleration of both right and left sensors at the centre of gravity equivalent to that of a trolley. The test shall be made using a test mass of 126 kg (equivalent to 51 kg for the stretcher and 75 kg for the patient) as shown in Figure 1. Dimensions in millimetres Figur
47、e 1 Test massBS EN 1865-5:2012EN 1865-5:2012 (E) 8 The measurement of the residual deflection shall be done by defining before the test three reference points for X and Y axes at both extremities and at the centre axis on the external part of the table top in the test direction and six reference poi
48、nts at both extremities and at the centre axis on the external part of the table top in the Z direction (see Figure 2). The deflection of these three/six points after the test shall be measured. None of the three measurements shall exceed the allowed deflection values (see Table 1). a) Axis X+/X- b)
49、 Axis Y+/Y- c) Axis Z+/Z- Key 1 before test 2 after test 3 test direction D deflection Dmax maximum deflection allowed deflection value NOTE For the Z axis drawing, points are situated on the upper and lower part of the table top. Figure 2 Deflection of reference points BS EN 1865-5:2012EN 1865-5:2012 (E) 9 4.8.2.2 Procedure The dynamic test shall be carried out using a test rig approved by the notified body and the following test method: The test assembly shall be accelerated/decelerated in the longitudinal
