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BS EN 13718-1:2014

$102.76

Medical vehicles and their equipment. Air ambulances – Requirements for medical devices used in air ambulances

Published By Publication Date Number of Pages
BSI 2014 22
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This European Standard specifies general requirements for medical devices carried in air ambulances and used therein and outside hospitals and clinics in situations where the ambient conditions can differ from normal indoor conditions. This European Standard does not cover the requirements for approval and registration of the vehicle and the training of the staff which is the responsibility of the authority/authorities in the country where the ambulance is to be registered.

PDF Catalog

PDF Pages PDF Title
5 Foreword
6 Introduction
7 1 Scope
2 Normative references
8 3 Terms and definitions
4 Requirements for medical devices for air ambulances
4.1 General
9 4.2 Patient and personnel safety
4.3 User interface
4.4 Environmental conditions and performance of medical devices intended for use in air ambulances
4.4.1 Functional temperature range
10 4.4.2 Humidity
4.4.3 Variable atmospheric pressures
4.5 Electrically-powered medical devices
4.5.1 General
4.5.2 Medical devices with 12 V DC power input
4.5.3 Medical devices with 24 V DC power input
11 4.5.4 Medical devices with 230 V AC power input
4.5.5 Short time voltage drop
4.5.6 Internal electrical power source
4.5.7 Electromagnetic interference of medical devices
4.6 Medical gas supply
4.6.1 General
4.6.2 Gas leakage
4.6.3 Pressure regulators and flow metering devices
12 4.6.4 Pneumatic power
4.6.5 Cylinder valves
4.6.6 Low pressure hose assemblies
4.7 Mechanical strength
4.7.1 General
4.7.2 Vibration and bump
4.7.3 Free fall
4.8 Fixation of medical devices in air ambulances
4.9 Fire resistance
13 4.10 Information to be supplied by the manufacturer
5 Test methods
5.1 General
5.2 Ambient conditions
5.3 Test method for durability of markings and colour coding
5.4 Free fall
15 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices
Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC on Medical devices
17 Bibliography
BS EN 13718-1:2014
$102.76