Patient handling equipment used in road ambulances - Part 2: Power assisted stretcher

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 required by staff operating the equipment.

Krankentransportmittel im Krankenkraftwagen - Teil 2: Kraftunterstützte Krankentrage

Diese Europäische Norm legt die Mindestanforderungen an die Ausführung und Gebrauchstauglichkeit von kraftunterstützten Krankentragen fest, die im Krankenkraftwagen für die Behandlung und den Transport von Patienten verwendet werden. Es ist das Ziel, für die Sicherheit des Patienten zu sorgen und die körperliche Anstrengung des Personals, das dieses Transportmittel bedient, zu minimieren.

Spécifications d'équipements pour le transport de patient dans les ambulances routières - Partie 2: Brancard motorisé

La présente norme européenne définit les exigences minimales requises en matière de conception et de performances des brancards motorisés utilisés dans les ambulances pour le traitement et le transport des patients afin de réduire les efforts physiques des personnels utilisant ces équipements et d’assurer la sécurité du patient.

Oprema za ravnanje s pacienti v reševalnih vozilih - 2. del: Nosila s pomožnim pogonom

Ta evropski standard določa minimalne zahteve za konstruiranje in zmogljivost bolniških nosil s pomožnim pogonom v reševalnih vozilih za ravnanje s pacienti in njihov prevoz. Njegov namen je zagotoviti varnost pacienta in čim bolj zmanjšati fizični napor osebja pri ravnanju s to opremo.

General Information

Status
Published
Publication Date
19-Apr-2015
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
19-Mar-2015
Due Date
24-May-2015
Completion Date
20-Apr-2015

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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Oprema za ravnanje s pacienti v reševalnih vozilih - 2. del: Nosila s pomožnim pogonomKrankentransportmittel im Krankenkraftwagen - Teil 2: Kraftunterstützte KrankentrageSpécifications d'équipements pour le transport de patient dans les ambulances routières - Partie 2: Brancard motoriséPatient handling equipment used in road ambulances - Part 2: Power assisted stretcher43.160Vozila za posebne nameneSpecial purpose vehicles11.160First aidICS:Ta slovenski standard je istoveten z:EN 1865-2:2010+A1:2015SIST EN 1865-2:2010+A1:2015en,de01-maj-2015SIST EN 1865-2:2010+A1:2015SLOVENSKI
STANDARDSIST EN 1865-2:20101DGRPHãþD



SIST EN 1865-2:2010+A1:2015



EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 1865-2:2010+A1
March 2015 ICS 11.160 Supersedes EN 1865-2:2010English Version
Patient handling equipment used in road ambulances - Part 2: Power assisted stretcher
Spécifications d'équipements pour le transport de patient dans les ambulances routières - Partie 2: Brancard motorisé
Krankentransportmittel im Krankenkraftwagen - Teil 2: Kraftunterstützte Krankentrage This European Standard was approved by CEN on 2 July 2010 and includes 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 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 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, 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, Switzerland, Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR 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 ESIST EN 1865-2:2010+A1:2015



EN 1865-2:2010+A1:2015 (E) 2 Contents Page Foreword .3 Introduction .4 1 Scope .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 capacity.7 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 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 Directive 93/42/EEC on Medical Devices and of EU Directive 2006/42/EC on Essential Health and Safety Requirements" . 10 Bibliography . 12
SIST EN 1865-2:2010+A1:2015



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 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 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 1865-2:2010." The start and finish of text introduced 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 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: General stretcher systems and patient handling equipment; — Part 2: Power assisted stretcher [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, 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, Switzerland, Turkey and the United Kingdom. SIST EN 1865-2:2010+A1:2015



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 equipment. SIST EN 1865-2:2010+A1:2015



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 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 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 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, 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 62366:2007) !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 15223-1:2012)" 3 Terms and definition For the purposes of 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 operation of the stretcher to reduce the physical effort required by operatives SIST EN 1865-2:2010+A1:2015



EN 1865-2:2010+A1:2015 (E) 6 4 Requirements 4.1 General When operated and maintained in accordance with the manufacturer's 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 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; — 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. 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 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 undercarriag
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