1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN 1865-1:2010Patient handling equipment used in road ambulancesPart 1: Specification for general stretcher systems and patient handling equipmentLicensed Copy: Wang Bin, ISO/
2、EXCHANGE CHINA STANDARDS, 06/01/2011 08:12, Uncontrolled Copy, (c) BSIBS EN 1865-1:2010 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN 1865-1:2010.T o g e t h e r w i t h B S E N 1 8 6 5 - 2 : 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 B SEN 1865
3、-5, it supersedes BS EN 1865:2000, which will be withdrawnon publication of BS EN 1865-3, 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
4、to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. BSI 2010 ISBN 978 0 580 59952 1 ICS 11.160; 43.160 Compliance with a British Standard cannot confer immunity fromlegal obligations.This British S
5、tandard was published under the authority of theStandards Policy and Strategy Committee on 31 October2010. Amendments issued since publicationDate T e x t a f f e c t e dLicensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 06/01/2011 08:12, Uncontrolled Copy, (c) BSIBS EN 1865-1:2010EUROPEAN STAND
6、ARD NORME EUROPENNE EUROPISCHE NORM EN 1865-1 August 2010 ICS 11.160; 43.160 Supersedes EN 1865:1999English Version Patient handling equipment used in road ambulances - Part 1: Specification for general stretcher systems and patient handling equipment Spcifications dquipements pour le transport de p
7、atient dans les ambulances routires - Partie 1: Systmes gnraux et quipement pour le transport de patient Krankentransportmittel im Krankenkraftwagen - Teil 1: Festlegung fr allgemeine Krankentragesysteme und Krankentransportmittel This European Standard was approved by CEN on 2 July 2010. CEN member
8、s 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
9、 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 translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the
10、 same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland
11、, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2010 CEN All rights of exploitation in any form and by any
12、 means reserved worldwide for CEN national Members. Ref. No. EN 1865-1:2010: ELicensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 06/01/2011 08:12, Uncontrolled Copy, (c) BSIBS EN 1865-1:2010EN 1865-1:2010 (E) 2 Contents Page Foreword 5Introduction .61 Scope 72 Normative references 73 Terms and d
13、efinitions .74 Requirements .84.1 General 84.2 Main stretcher 84.2.1 General 84.2.2 Dimensions .84.2.3 Mass 94.2.4 Loading capacity94.2.5 Frame 94.2.6 Lying part of the stretcher . 104.2.7 Restraint system . 114.2.8 Flammability Toxicity burning gases 114.2.9 Deformation of the frame . 114.2.10 Fixa
14、tion 114.2.11 Deformation of the lying area 114.2.12 Resistance to torsion . 114.2.13 Splaying of the wheels . 114.3 Chair stretcher . 114.3.1 Dimensions 114.3.2 Mass . 114.3.3 Loading capacity. 114.3.4 Frame . 124.3.5 Lying-sitting part. 124.3.6 Restraint system . 124.3.7 Flammability Toxicity burn
15、ing gases 124.3.8 Deformation of the frame . 124.3.9 Fixation 124.3.10 Deformation of the lying-sitting area 124.3.11 Resistance to torsion . 124.3.12 Splaying of the wheels . 124.4 Transfer mattress 124.4.1 Dimensions 124.4.2 Mass . 124.4.3 Loading capacity. 134.4.4 Handles 134.4.5 Lying part . 134
16、.4.6 Restraint system . 134.4.7 Flammability Toxicity burning gases 134.4.8 Deformation . 134.4.9 Fixation 134.4.10 Deformation of the lying area 134.4.11 Resistance to torsion . 134.4.12 Splaying of the wheels . 134.5 Carrying sheet . 144.5.1 Dimensions 14Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA
17、 STANDARDS, 06/01/2011 08:12, Uncontrolled Copy, (c) BSIBS EN 1865-1:2010EN 1865-1:2010 (E) 3 4.5.2 Mass 144.5.3 Loading capacity . 144.5.4 Handles . 144.5.5 Lying part . 144.5.6 Restraint system 144.5.7 Flammability Toxicity burning gases . 144.5.8 Deformation of the handles 144.5.9 Fixation . 144.
18、5.10 Deformation of the lying area . 144.5.11 Resistance to torsion 144.5.12 Splaying of the wheels 154.6 Pick up stretcher . 154.6.1 Dimensions 154.6.2 Mass 154.6.3 Loading capacity . 154.6.4 Frame 154.6.5 Lying part . 154.6.6 Restraint system 154.6.7 Flammability Toxicity burning gases . 154.6.8 D
19、eformation of the frame 154.6.9 Fixation . 164.6.10 Locking . 164.6.11 Deformation of the lying area . 164.6.12 Resistance to torsion 164.6.13 Splaying of the wheels 164.7 Vacuum mattress . 164.7.1 Construction 164.7.2 Dimensions 164.7.3 Mass 164.7.4 Loading capacity . 174.7.5 Handles . 174.7.6 Rest
20、raint system 174.7.7 Flammability Toxicity burning gases . 174.7.8 Deformation . 174.7.9 Fixation . 174.7.10 Shrinkage . 174.7.11 Deformation of the lying area . 174.8 Long spinal board . 174.8.1 Dimensions 174.8.2 Mass 184.8.3 Loading capacity . 184.8.4 Construction 184.8.5 Lying part . 184.8.6 Res
21、traint system 184.8.7 Flammability Toxicity burning gases . 184.8.8 Deformation . 184.8.9 Fixation . 184.8.10 Deformation of the lying area . 184.8.11 Resistance to torsion 184.8.12 Splaying of the wheels 184.9 Foldable carrying chair . 194.9.1 Dimensions 194.9.2 Mass 194.9.3 Loading capacity . 194.
22、9.4 Frame 194.9.5 Sitting part 194.9.6 Restraint system 194.9.7 Flammability Toxicity burning gases . 194.9.8 Deformation of the frame 19Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 06/01/2011 08:12, Uncontrolled Copy, (c) BSIBS EN 1865-1:2010EN 1865-1:2010 (E) 4 4.9.9 Fixation 194.9.10 Lo
23、cking 204.9.11 Deformation of the backrest lying-sitting area 204.9.12 Resistance to torsion . 204.9.13 Splaying of the wheels . 204.10 Non-foldable carrying chair (sedan chair) . 204.10.1 Dimensions 204.10.2 Mass . 204.10.3 Loading capacity. 204.10.4 Frame . 204.10.5 Sitting part . 204.10.6 Restrai
24、nt system . 214.10.7 Flammability Toxicity burning gases 214.10.8 Deformation of the frame . 214.10.9 Fixation 214.10.10 Deformation of the sitting area 214.10.11 Resistance to torsion . 214.10.12 Splaying of the wheels . 215 Test methods . 225.1 Main stretcher . 225.1.1 Permanent deformation of the
25、 frame 225.1.2 Fixation inside the ambulance 225.1.3 Permanent deformation of the lying area . 235.1.4 Resistance to twisting/torsion . 235.1.5 Splaying of the wheels . 245.2 Chair stretcher 245.2.1 Permanent deformation of the frame 245.2.2 Permanent deformation of the lying-sitting area . 245.2.3
26、Resistance to twisting/torsion . 245.2.4 Splaying of the wheels . 245.3 Transfer mattress 245.3.1 Deformation . 245.3.2 Deformation of the lying area 265.4 Carrying sheet . 275.4.1 Strength of the handles 275.4.2 Permanent deformation of the lying area . 285.5 Pick up stretcher . 285.5.1 Permanent d
27、eformation of the frame 285.5.2 Resistance to twisting/torsion . 285.6 Vacuum mattress and pump 295.6.1 Deformation . 295.6.2 Shrinkage . 295.6.3 Deformation of the lying area 295.7 Long spinal board . 305.7.1 Permanent deformation of the frame and lying area 305.7.2 Resistance to twisting/torsion .
28、 305.8 Foldable carrying chair 305.8.1 Permanent deformation of the frame and backrest lying-sitting area 305.9 Non-foldable carrying chair (sedan chair) . 315.9.1 Permanent deformation of the frame and sitting area 315.9.2 Fixation inside the ambulance 315.9.3 Splaying of the wheels . 316 Marking 3
29、1Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC concerning Medical Devices . 32Bibliography . 33Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 06/01/2011 08:12, Uncontrolled Copy, (c) BSIBS EN 1865-1:2010EN 1865-1:2
30、010 (E) 5 Foreword This document (EN 1865-1:2010) 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 t
31、he latest by February 2011, and conflicting national standards 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
32、 or all such patent rights. Together with EN 1865-2, EN 1865-3, 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 Di
33、rective(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: Specification for general stretcher
34、 systems and patient handling equipment Part 2: Power assisted 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 orga
35、nizations of 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, Po
36、rtugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 06/01/2011 08:12, Uncontrolled Copy, (c) BSIBS EN 1865-1:2010EN 1865-1:2010 (E) 6 Introduction This European Standard incorporates specifications for: main s
37、tretcher 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 am
38、bulances. 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. NOTE Standardisation work will continue with the aim of ensuring the safe transfer of patients a
39、nd equipment without compromising continuity of patient care and the safety of staff. Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 06/01/2011 08:12, Uncontrolled Copy, (c) BSIBS EN 1865-1:2010EN 1865-1:2010 (E) 7 1 Scope This European Standard defines minimum requirements for the design an
40、d 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. 2 Normative references The following referenced documents a
41、re 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, Furniture Assessment of the ignitability of mattresses and upholstered bed
42、bases Part 1: Ignition source: Smouldering cigarette EN 980, Symbols for use in the labelling of medical devices EN 1021-1, Furniture Assessment of the ignitability of upholstered furniture Part 1: Ignition source smouldering cigarette EN 1041, Information supplied by the manufacturer of medical dev
43、ices EN 1789:2007+A1:2010, Medical vehicles and their equipment Road ambulances EN ISO 14971, Medical devices Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) 3 Terms and definitions For the purposes of this document, the following terms and definition
44、s 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
45、, 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 3.5 pick up stretcher lifting device, intended to
46、 be used for movement of seriously injured people on to other transport devices Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 06/01/2011 08:12, Uncontrolled Copy, (c) BSIBS EN 1865-1:2010EN 1865-1:2010 (E) 8 3.6 vacuum mattress device intended primarily to provide immobilization for the pat
47、ient during transportation 3.7 long spinal board device designed for lifting and immobilising patients 3.8 foldable carrying chair device intended to handle and carry a patient in a sitting position to the road ambulance but not to be used to transport a patient within the ambulance 3.9 non-foldable
48、 carrying chair device intended to handle and carry a patient in a sitting position to the road ambulance and to be used to transport a patient within the ambulance 4 Requirements 4.1 General When lifting and carrying devices are operated and maintained in accordance with manufacturer instructions they 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 taking account of
