EN 1865-3-2012 en Patient handling equipment used in road ambulances - Part 3 Heavy duty stretcher (Incorporates Amendment A1 2015)《病人搬运设备》.pdf

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1、BSI Standards PublicationBS EN 1865-3:2012Patient handling equipmentused in road ambulancesPart 3: Heavy duty stretcherBS EN 1865-3:2012+A1:2015BS EN 1865-3:2012+A1:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN 1865-3:2012+A1:2015. It supersedes BS EN 186

2、5-3:2012, which is withdrawn.The start and finish of text introduced or altered by amendment is indicated in the text by tags.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 prepara

3、tion 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 applicatio

4、n. The British Standards Institution 2015. Published by BSI Standards Limited 2015ISBN 978 0 580 86228 1ICS 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

5、 30 June 2012.Amendments/corrigenda issued since publicationDate Text affected31 March 2015 Implementation of CEN amendment A1:2015EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 1865-3:2012+A1 March 2015 ICS 11.160 Supersedes EN 1865-3:2012English Version Patient handling equipment used in roa

6、d ambulances - Part 3: Heavy duty stretcher Equipement dambulances pour le transport de patients - Partie 3 : Brancard bariatrique Krankentransportmittel im Krankenkraftwagen - Teil 3: Schwerlastkrankentrage This European Standard was approved by CEN on 10 May 2012 and includes Amendment 1 approved

7、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 concerning such national st

8、andards 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

9、 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, Hungar

10、y, 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 KOMITEE FR NORMUNG CEN-CENELE

11、C 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 1865-3:2012+A1:2015 EEN 1865-3:2012+A1:2015 (E) 2 Contents Page Foreword 3 Introduction .5 1 Scope 6 2 Normative references

12、 6 3 Terms and definitions .6 4 Requirements .7 4.1 General 7 4.2 Dimensions .7 4.3 Mass 8 4.4 Loading capacity8 4.5 Frame 8 4.5.1 General 8 4.5.2 Stretcher parts .8 4.5.3 Undercarriage .8 4.5.4 Power source .9 4.6 Restraint systems 9 4.7 Flammability toxicity burning gases 9 4.8 Deformation of the

13、frame 9 4.9 Fixation 10 4.10 Deformation of the lying area 10 4.11 Resistance to torsion . 10 4.12 Splaying of the wheels . 10 5 Test methods . 10 5.1 Permanent deformation of the frame 10 5.1.1 Stretcher frame . 10 5.1.2 Undercarriage frame . 11 5.2 Fixation inside the ambulance 11 5.3 Permanent de

14、formation of the lying area . 11 5.4 Resistance to twisting/torsion . 12 5.5 Splaying of the wheels . 12 6 Marking 12 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices 13 Bibliography . 15 BS EN 1865-3:2012+

15、A1:2015EN 1865-3:2012+A1:2015 (E)EN 1865-3:2012+A1:2015 (E) 2 Contents Page Foreword 3 Introduction .5 1 Scope 6 2 Normative references 6 3 Terms and definitions .6 4 Requirements .7 4.1 General 7 4.2 Dimensions .7 4.3 Mass 8 4.4 Loading capacity8 4.5 Frame 8 4.5.1 General 8 4.5.2 Stretcher parts .8

16、 4.5.3 Undercarriage .8 4.5.4 Power source .9 4.6 Restraint systems 9 4.7 Flammability toxicity burning gases 9 4.8 Deformation of the frame 9 4.9 Fixation 10 4.10 Deformation of the lying area 10 4.11 Resistance to torsion . 10 4.12 Splaying of the wheels . 10 5 Test methods . 10 5.1 Permanent defo

17、rmation of the frame 10 5.1.1 Stretcher frame . 10 5.1.2 Undercarriage frame . 11 5.2 Fixation inside the ambulance 11 5.3 Permanent deformation of the lying area . 11 5.4 Resistance to twisting/torsion . 12 5.5 Splaying of the wheels . 12 6 Marking 12 Annex ZA (informative) Relationship between thi

18、s European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices 13 Bibliography . 15 EN 1865-3:2012+A1:2015 (E) 3 Foreword This document (EN 1865-3:2012+A1:2015) has been prepared by Technical Committee CEN/TC 239 “Rescue systems”, the secretariat of which is held by

19、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 September 2015, and conflicting national standards shall be withdrawn at the latest by September 2015. Attention is drawn to the possibility th

20、at 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 20 December 2014. !This document supersedes EN 1865-3:2012.“ The start a

21、nd finish of text introduced or altered by amendment is indicated in the text by tags !“. With respect to EN 1865:1999 the following changes were made: a) it shall be possible to increase the width of the lying part to minimum of 750 mm; b) the weight of the device was changed from 51 kg to maximum

22、65 kg; c) the capacity was changed from 150 kg to minimum 250 kg; d) the undercarriage, if power assisted, has no limits in height or in variable positions; e) the power source of the stretcher was defined; f) permanent deformation test of the frame shall be done with 400 kg instead of 250 kg and if

23、 the lateral extensions are fitted 75 kg shall be evenly set on each extension; g) permanent deformation test of the frame shall be done with 250 kg instead of 150 kg; h) splaying of the wheels test shall be done with 400 kg instead of 250 kg; i) the standard has been modified/integrated to meet the

24、 Medical Device Directive 93/42/EEC requirements j) the standard has been modified/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 Eu

25、ropean Free 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 consis

26、ts of the following parts: Part 1: General stretcher systems and patient handling equipment; Part 2: Power assisted stretcher; Part 3: Heavy duty stretcher the present document; BS EN 1865-3:2012+A1:2015EN 1865-3:2012+A1:2015 (E)EN 1865-3:2012+A1:2015 (E) 4 Part 4: Foldable patient transfer chair; P

27、art 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, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republi

28、c 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 1865-3:2012+A1:2015EN 1865-3:2012+A1:2015 (E)EN 1865-3

29、:2012+A1:2015 (E) 4 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, Bulgaria, Croatia, Cyprus, Czec

30、h 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

31、. EN 1865-3:2012+A1:2015 (E) 5 Introduction In this European 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. BS EN 1865-3:2012+A1:2015EN 1865-3:2

32、012+A1:2015 (E)EN 1865-3:2012+A1:2015 (E) 6 1 Scope This European Standard specifies minimum requirements for the design and performance of heavy duty stretchers used in road ambulances for the treatment and transportation of patients. It aims to ensure patient safety and minimize the physical effor

33、t required 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

34、 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 1041:2008+A1:2013“, Information supplied by the manufacturer of medical d

35、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

36、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 ma

37、nagement 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 definitions For the purposes of this

38、document, the following term and definition apply. 3.1 heavy duty stretcher stretcher designed for the treatment and transportation of patients where the weight or dimensions of the patient exceed those of the operating capability of the main stretcher Note 1 to entry: The term “main stretcher“ is d

39、efined in !EN 1865-1:2010“. BS EN 1865-3:2012+A1:2015EN 1865-3:2012+A1:2015 (E)EN 1865-3:2012+A1:2015 (E) 6 1 Scope This European Standard specifies minimum requirements for the design and performance of heavy duty stretchers used in road ambulances for the treatment and transportation of patients.

40、It aims to ensure patient safety and minimize the physical effort required 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 edit

41、ion 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 1041:2008

42、+A1:2013“, Information supplied by the manufacturer of medical devices !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

43、, Medical electrical equipment Part 1-2: General requirements for 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 62366:2

44、007)“ !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

45、15223-1:2012)“ 3 Terms and definitions For the purposes of this document, the following term and definition apply. 3.1 heavy duty stretcher stretcher designed for the treatment and transportation of patients where the weight or dimensions of the patient exceed those of the operating capability of th

46、e main stretcher Note 1 to entry: The term “main stretcher“ is defined in !EN 1865-1:2010“. EN 1865-3:2012+A1:2015 (E) 7 4 Requirements 4.1 General Heavy duty stretchers shall be operated and maintained according to the instructions of the manufacturer. Risks shall be reduced to an acceptable level

47、by using risk management principles in accordance with !EN ISO 14971:2012“ in normal and single fault condition. Heavy duty stretchers shall: be manually or power operated; guarantee a safe and smooth operation; be free of sharp edges or deformation that could cause damage to persons or other equipm

48、ent on board; have patient restraint-systems available; these restraint-systems shall have quick release systems; immobilize the patient, but at the same time shall permit treatment of the patient; ensure that the lying-sitting part is made of a strong material, which is bacterial resistant, fungal

49、resistant, stain resistant, putrid resistant, easy to clean, washable and petrol-oil resistant. The heavy duty stretcher shall be designed to transport patients with a weight that exceeds the load capacity of the main stretcher in !EN 1865-1:2010“. It shall be designed so that during loading and unloading the maximum burden on any personnel is half of the total weight of patient and stretcher and for the minimum possible time and in an optimal ergonomic position so that back bending is minimized. 4.2 Dime