EN 1865-1:2010

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Specifikacija za opremo za ravnanje s pacienti v reševalnih vozilih - 1. del: Specifikacija za splošne sisteme nosil in opremo za ravnanje s pacientiKrankentransportmittel im Krankenkraftwagen - Teil 1: Festlegung für allgemeine Krankentragensysteme und KrankentransportmittelEquipements d'ambulance pour le transport de patients - Partie 1: Spécifications de systèmes généraux de brancards et équipement pour le transport de patientsPatient handling equipment used in road ambulances - Part 1: Specification for general stretcher systems and patient handling equipment43.160Vozila za posebne nameneSpecial purpose vehicles11.160First aidICS:Ta slovenski standard je istoveten z:EN 1865-1:2010SIST EN 1865-1:2010en,fr,de01-oktober-2010SIST EN 1865-1:2010SLOVENSKI
STANDARDSIST EN 1865:20001DGRPHãþD

EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE 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 systemsand patient handling equipment
Spécifications d'équipements pour le transport de patient dans les ambulances routières - Partie 1: Systèmes généraux et équipement pour le transport de patient
Krankentransportmittel im Krankenkraftwagen - Teil 1: Festlegung für allgemeine Krankentragesysteme und Krankentransportmittel 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 alteration. 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 translation 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
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................................................................................................................................... 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 burning 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 ............................................................................................................................................. 134.4.6 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 .......................................................................................................................................... 14SIST EN 1865-1:2010

Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC concerning Medical Devices . 32Bibliography . 33 SIST EN 1865-1:2010

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 and equipment without compromising continuity of patient care and the safety of staff. SIST EN 1865-1:2010

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 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 normal and single fault condition. Carrying handles on devices for handling of patients shall permit fixation in extended positions. All equipment for the handling of patients shall be free of any sharp edges. The minimum radius should be 0,5 mm. All patient restraint-systems shall have a quick release system. The lying-sitting part shall be made of a strong material which is bacterial resistant, fungal resistant, stain resistant, putrid resistant, easy to clean and disinfect, 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. It shall be designed so that the full weight of the patient and the carried stretcher part will only be lifted/carried by the personnel for the minimum period of time. 4.2.2 Dimensions Dimensions shall be measured from the outermost edges.
 Stretcher part: length:
(1 9502050+−) mm; width: (550 ± 20) mm; SIST EN 1865-1:2010

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 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 the frame of the undercarriage when located in the ambulance shall not exceed length and width of the stretcher part. 4.2.3 Mass The mass excluding mattress and patient restraints shall not be more than:  Stretcher part: 23 kg;  Undercarriage including stretcher: 51 kg max (combined weight);  Stretcher part with integrated undercarriage: monoblock 45 kg. NOTE In all cases the mass should be as low as possible.
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 shall be a 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 swing-down side rails are mounted, 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 longitudinal frame such that they lock and do not twist when they are stowed or in use. They shall be designed to minimise the risk of injuries to hands and wrists when being operated or when the stretcher is carried in a non-horizontal position. The stretcher shall allow the fixation and use of a carrying harness. c) The stretcher shall either 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 intended 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. SIST EN 1865-1:2010

4.2.7 Restraint system The stretcher shall have a minimum of two quick-release patient restraints capable of accepting a device for restraining children. 4.2.8 Flammability − Toxicity burning gases There shall be no progressive smouldering or flaming ignition when tested in accordance with EN 597-1. 4.2.9 Deformation of the frame The frame shall not bend or break when tested in accordance with 5.1.1. 4.2.10 Fixation The fixation shall be in accordance with 4.5.9 of EN 1789:2007+A1:2010. There shall be no deformation of the fixation when tested in accordance with 5.1.2 in this document. 4.2.11 Deformation of the lying area There shall be no deformation of the lying area when tested in accordance with 5.1.3.
4.2.12 Resistance to torsion There shall be no remaining deformation due to torsion when tested in accordance with 5.1.4. 4.2.13 Splaying of the wheels The wheels shall not splay more than 2 mm in total during the test specified in 5.1.5 and there shall be no permanent deformation. 4.3 Chair stretcher 1)
4.3.1 Dimensions The dimensions of the chair stretcher shall be as follows:  Length: (1 900 ± 50) mm;  Width: (550 ± 30) mm. 4.3.2 Mass The mass shall be not more than 23 kg. NOTE The mass should be as low as possible. 4.3.3 Loading capacity The loading capacity shall be a minimum of 150 kg.
1) If the chair stretcher is a structural part of the main stretcher, the requirements of 4.2 apply. SIST EN 1865-1:2010

Not applicable. 4.3.10 Deformation of the lying-sitting area There shall be no remaining deformation of the lying-sitting area when tested in accordance with 5.2.2.
4.3.11 Resistance to torsion There shall be no remaining deformation to torsion when tested in accordance with 5.2.3.
4.3.12 Splaying of the wheels The wheels shall not splay more than 2 mm in total during the test specified in 5.2.4 and there shall be no permanent deformation. 4.4 Transfer mattress 4.4.1 Dimensions The dimensions of the transfer mattress of the lying area shall be as follows:
 Length: (1 9502050+−) mm;  Width: maximum 500 mm;  Height: maximum 100 mm. 4.4.2 Mass The mass shall be not more than 10 kg. SIST EN 1865-1:2010

4.4.4 Handles The transfer mattress shall be equipped with at least four handles on each longitudinal side, the handles shall be designed to give a comfortable and safe grip. 4.4.5 Lying part Both sides of the transfer mattress shall have a different function: one side shall provide a lying comfort equivalent to a foam filling of minimum 40 mm with density 30 kg/m³ to 40 kg/m³, the other side shall provide the mattress with sufficient rigidity to transfer the patient with at least two persons, one at each longitudinal side. The mattress shall be capable of being adapted to form the lying part of the stretcher. The lying part shall be constructed in such a way that prevents the ingress of fluids. The material shall be easy to clean, washable, petrol-oil resistant and allow preliminary x-ray diagnostics. It shall withstand temperatures ranging from - 30 °C to + 70 °C. 4.4.6 Restraint system Not applicable. 4.4.7 Flammability − Tox
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