1、BSI Standards PublicationPatient handling equipmentused in road ambulancesPart 2: Power assisted stretcherBS EN 1865-2:2010+A1:2015BS EN 1865-2:2010+A1:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN 1865-2:2010+A1:2015. It supersedes BS EN 1865-2:2010, whi
2、ch is withdrawn.The start and finish of text introduced or altered by amendment is indicated in the text by tags.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 entr
3、usted 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 Britis
4、h Standards Institution 2015. Published by BSI Standards Limited 2015ISBN 978 0 580 86227 4ICS 11.160Compliance 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 2
5、011.Amendments/corrigenda issued since publicationDate Text affected30 April 2015 Implementation of CEN amendment A1:2015EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 1865-2:2010+A1 March 2015 ICS 11.160 Supersedes EN 1865-2:2010English Version Patient handling equipment used in road ambulanc
6、es - Part 2: Power assisted stretcher Spcifications dquipements pour le transport de patient dans les ambulances routires - Partie 2: Brancard motoris Krankentransportmittel im Krankenkraftwagen - Teil 2: Kraftuntersttzte Krankentrage This European Standard was approved by CEN on 2 July 2010 and inc
7、ludes Amendment 1 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
8、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 membe
9、r 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, Fran
10、ce, 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 COMIT EUROPEN DE NORMALISATION EUROPISCHES KO
11、MITEE FR 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 EEN 1865-2:2010+A1:2015 (E) 2 Contents Page Foreword 3 Introduction .4 1 Sco
12、pe 5 2 Normative references 5 3 Terms and definition .5 4 Requirements .6 4.1 General 6 4.2 Main stretcher 6 4.2.1 General 6 4.2.2 Dimensions .6 4.2.3 Mass 6 4.2.4 Loading capacity7 4.2.5 Frame 7 4.2.6 Power source .8 4.2.7 Lying part of the stretcher 8 4.2.8 Restraint system 8 4.2.9 Flammability To
13、xicity burning gases .8 4.2.10 Deformation of the frame 9 4.2.11 Fixation .9 4.2.12 Deformation of the lying area .9 4.2.13 Resistance to torsion 9 4.2.14 Splaying of the wheels 9 5 Marking .9 Annex ZA !(informative) Relationship between this European Standard and the Essential Requirements of EU Di
14、rective 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+A1:2015EN 1865-2:2010+A1:2015 (E)EN 1865-2:2010+A1:2015 (E) 2 Contents Page Foreword 3 Introduction .4 1 Scope 5 2 Normative references 5 3 Terms
15、and definition .5 4 Requirements .6 4.1 General 6 4.2 Main stretcher 6 4.2.1 General 6 4.2.2 Dimensions .6 4.2.3 Mass 6 4.2.4 Loading capacity7 4.2.5 Frame 7 4.2.6 Power source .8 4.2.7 Lying part of the stretcher 8 4.2.8 Restraint system 8 4.2.9 Flammability Toxicity burning gases .8 4.2.10 Deforma
16、tion of the frame 9 4.2.11 Fixation .9 4.2.12 Deformation of the lying area .9 4.2.13 Resistance to torsion 9 4.2.14 Splaying of the wheels 9 5 Marking .9 Annex ZA !(informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices a
17、nd of EU Directive 2006/42/EC on Essential Health and Safety Requirements“ . 10 Bibliography . 12 EN 1865-2:2010+A1:2015 (E) 3 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
18、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 elem
19、ents 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 20 December 2014. !This document supersedes EN 1865-2:2010.“ The start and finish of text i
20、ntroduced 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 i
21、nformative 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
22、 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
23、, 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, Switzerla
24、nd, Turkey and the United Kingdom. BS EN 1865-2:2010+A1:2015EN 1865-2:2010+A1:2015 (E)EN 1865-2:2010+A1:2015 (E) 4 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 suc
25、h handling equipment. BS EN 1865-2:2010+A1:2015EN 1865-2:2010+A1:2015 (E)EN 1865-2:2010+A1:2015 (E) 4 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 eq
26、uipment. EN 1865-2:2010+A1:2015 (E) 5 1 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 re
27、quired 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 application. For dated references, only the edition cited applies. For undated references, the latest edition of th
28、e 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 d
29、evices !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 fo
30、r 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
31、 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)“ 3 Terms and definition For the purposes of
32、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
33、 operation of the stretcher to reduce the physical effort required by operatives BS EN 1865-2:2010+A1:2015EN 1865-2:2010+A1:2015 (E)EN 1865-2:2010+A1:2015 (E) 6 4 Requirements 4.1 General When operated and maintained in accordance with the manufacturers instructions, power assisted stretchers shall
34、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;
35、 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
36、. 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 cl
37、ean, 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
38、 compatible. 4.2.2 Dimensions Dimensions shall be measured from the outermost edges: length: !(1 950 12050+) mm“; width: !(550 6020+) mm“ ; height: maximum 300 mm from loading holding assembly to unloaded lying part. This height dimension does not apply to stretchers with monoblock undercarriages. I
39、f 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
40、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+A1:2015EN 18
41、65-2:2010+A1:2015 (E)EN 1865-2:2010+A1:2015 (E) 6 4 Requirements 4.1 General When operated and maintained in accordance with the manufacturers 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 m
42、anagement 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 r
43、adius 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 s
44、hall 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 c
45、onsist 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: !(1 950 12050+) mm
46、“; width: !(550 6020+) 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 undercar
47、riage. 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
48、. 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. EN 1865-2:2010+A1:2015 (E) 7 4.2.4 Loading capacity The loading capacity shall be a minimum of 150 kg. 4.2.5 Frame 4.2.5.1 General The frame
49、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 fr
