1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN 1865-2:2010Patient handling equipmentused in road ambulancesPart 2: Power assisted stretcherLicensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 15/04/2011 03:36, Uncontr
2、olled Copy, (c) BSIBS EN 1865-2:2010 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN 1865-2:2010.T o g e t h e r w i t h B S E N 1 8 6 5 - 1 : 2 0 1 0 , B S E N 1 8 6 5 - 3 , B S E N 1 8 6 5 - 4 a n d 1865:2000, which will be withdrawn on publication of BS EN 18
3、65-3, BS EN 1865-4 and BS EN 1865-5.The UK participation in its preparation was entrusted to TechnicalCommittee CH/239, Rescue systems.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovis
4、ions of a contract. Users are responsible for its correctapplication. BSI 2011 ISBN 978 0 580 61620 4 ICS 11.160 Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31
5、 January 2011. Amendments issued since publicationDate T e x t a f f e c t e dB S E N 1 8 6 5 - 5 i t s u p e r s e d e s B S E N,Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 15/04/2011 03:36, Uncontrolled Copy, (c) BSIBS EN 1865-2:2010EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 1
6、865-2 August 2010 ICS 11.160 Supersedes EN 1865:1999English Version Patient handling equipment used in road ambulances - Part 2: Power assisted stretcher Spcifications dquipements pour le transport de patient dans les ambulances routires - Partie 2: Brancard motoris Krankentransportmittel im Kranken
7、kraftwagen - Teil 2: Kraftuntersttzte Krankentrage This European Standard was approved by CEN on 2 July 2010. 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 alter
8、ation. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN 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 tran
9、slation under the responsibility of a CEN member into its own language and notified to the CEN 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, Fran
10、ce, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR
11、 NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2010 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 1865-2:2010: ELicensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 15/04/2011 03:36, Uncontrolled Copy, (c) BSIBS
12、EN 1865-2:2010EN 1865-2:2010 (E) 2 Contents Page Foreword 3Introduction .41 Scope 52 Normative references 53 Terms and definition .54 Requirements .54.1 General 54.2 Main stretcher 64.2.1 General 64.2.2 Dimensions .64.2.3 Mass 64.2.4 Loading capacity64.2.5 Frame 74.2.6 Power source .84.2.7 Lying par
13、t of the stretcher 84.2.8 Restraint system 84.2.9 Flammability Toxicity burning gases .84.2.10 Deformation of the frame 84.2.11 Fixation .94.2.12 Deformation of the lying area .94.2.13 Resistance to torsion 94.2.14 Splaying of the wheels 95 Marking .9Annex ZA (informative) Relationship between this
14、European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices 10Bibliography . 11Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 15/04/2011 03:36, Uncontrolled Copy, (c) BSIBS EN 1865-2:2010EN 1865-2:2010 (E) 3 Foreword This document (EN 1865-2:2010) has been p
15、repared 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 February 2011, and conflicting national standar
16、ds shall be withdrawn at the latest by February 2011. 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. Together with EN 1865-1, EN 1865
17、-3, EN 1865-4 and EN 1865-5 this document supersedes EN 1865:1999. 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 infor
18、mative 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: Specification for general stretcher systems and patient handling equipment Part 2: Power assist
19、ed stretcher Part 3: Heavy duty stretcher (at draft stage) Part 4: Mechanical assisted transfer chair (at draft stage) Part 5: Stretcher support (at draft stage) According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement
20、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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerl
21、and and the United Kingdom. Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 15/04/2011 03:36, Uncontrolled Copy, (c) BSIBS EN 1865-2:2010EN 1865-2:2010 (E) 4 Introduction In this standard reference is made to EN 1789 which specifies design requirements and test methods for road ambulances, wh
22、ich are relevant for checking requirements for such handling equipment. Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 15/04/2011 03:36, Uncontrolled Copy, (c) BSIBS EN 1865-2:2010EN 1865-2:2010 (E) 5 1 Scope This European Standard defines minimum requirements for the design and performance
23、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. 2 Normative references The following referenced documents are indispensable for the appl
24、ication 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, Furniture Assessment of the ignitability of mattresses and upholstered bed bases Part 1: Ignition source
25、: Smouldering cigarette EN 980, Symbols for use in the labelling of medical devices EN 1041, Information supplied by the manufacturer of medical devices EN 1789:2007+A1:2010, Medical vehicles and their equipment Road ambulances EN 1865-1, Patient handling equipment used in road ambulances Part 1: Sp
26、ecification for general stretcher systems and patient handling equipment EN 60601-1-2, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral standard: Electromagnetic compatibility Requirements and tests (IEC 60601-1-2:2007, modified) EN 62
27、366, Medical devices Application of usability engineering to medical devices (IEC 62366:2007) EN ISO 14971, Medical devices Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) 3 Terms and definition For the purposes of this document, the following terms a
28、nd 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 reduc
29、e the physical effort required by operatives 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 manage
30、ment principles in accordance with EN ISO 14971. Power assisted stretchers shall also: Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 15/04/2011 03:36, Uncontrolled Copy, (c) BSIBS EN 1865-2:2010EN 1865-2:2010 (E) 6 allow patients to be secured so that any movement during ambulance transport
31、 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 r
32、elease 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 resista
33、nt, 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 s
34、ystem shall be compatible. 4.2.2 Dimensions Dimensions shall be measured from the outermost edges: length: (1 9502050+) mm; width: (550 20) mm; height: maximum 300 mm from loading holding assembly to unloaded lying part. This height dimension does not apply to stretchers with monoblock undercarriage
35、s. 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
36、 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 65 kg. NOTE In all cases the mass should be as low as possible. 4.2.4 Loading capacity The l
37、oading capacity shall be a minimum of 150 kg. Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 15/04/2011 03:36, Uncontrolled Copy, (c) BSIBS EN 1865-2:2010EN 1865-2:2010 (E) 7 4.2.5 Frame 4.2.5.1 General The frame shall be in sturdy lightweight non twisting construction enabling use of cardio
38、pulmonary 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.
39、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 longi
40、tudinal frame such that they lock and do 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 sh
41、all 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 i
42、ntended 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
43、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 sh
44、all 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 waterpr
45、oof 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 undercarr
46、iage in such a manner that unintentional separation of the undercarriage and stretcher cannot occur. It shall be possible to load and unload the undercarriage and stretcher so as to ensure the safety and comfort of the patient and the operators. Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS,
47、 15/04/2011 03:36, Uncontrolled Copy, (c) BSIBS EN 1865-2:2010EN 1865-2:2010 (E) 8 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 bat
48、tery 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 i
49、ndicate 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 stretchers 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 huma
