What is BS-EN-13718?

BS EN 13718 discusses the standards for medical vehicles and their air ambulance equipment, focusing on the requirements for medical equipment used in air ambulances. BS EN 13718-1 is part of a series of documents that set out the general requirements for medical equipment carried by air ambulances and for use in and around hospitals and clinics where environmental conditions may differ from normal indoor conditions.

BS EN 13718-1 Suitable for Whom?

Air ambulance manufacturer
Medical device manufacturer
Aircraft installation manufacturer
Manufacturer of medical electrical equipment

Why should I use BS EN 13718-1?

Minimize the risks associated with medical devices by using the guidelines given in BS EN 13718-1, taking into account the intended application of the device and known and foreseeable hazards under normal and fault conditions. The risk analysis shall reflect storage, installation, operation and maintenance during normal service in accordance with the manufacturer's instructions and the environmental conditions of the air ambulance.
BS EN 13718-1 helps medical device manufacturers to follow correct test procedures and standards for air ambulances (according to aerospace application specifications). In addition, you can demonstrate the reliability of your products by complying with BS EN 13718-1 and build trust in their use throughout the aerospace supply chain

Environmental conditions and performance of medical devices used in air ambulance

Temperature range

Medical devices should operate over the entire temperature range from 0°C to +40°C and should operate for at least 20 minutes at 5 °C after storage at room temperature (202)C. After storage under extreme temperature conditions of -20 ° C to +50 ° C, the medical device should work within the expected 10 minutes, and when the medical device is returned to room temperature (20±2) ° C, it should work for at least 20 minutes.

Humidity range

Medical devices shall function as intended between 15 % RH to 95 % RH (relative humidity) within the temperature range of-20 °C to +50 °C;  non-condensing and a water vapour partial pressure greater than 50 hPa is not required.  RTCA DO-160G:2010,3) Section 6 Category A, may be used to fulfil the requirement.

Variable atmosphere

The medical equipment shall function and present correct data as specified by the manufacturer at pressures between sea level and an altitude of 4 000 m. The operating range shall be stated, and if readings or performance vary, a table of correcting values shall be attached.  The table shall state, in accordance with the prevailing atmospheric conditions, the extent ofl discrepancy between the actual values and the values indicated by the device. The increments of pressure in the table should be sufficient to enable accurate corrections to be made overl the range of pressure.  As an example, for pressures between 600 hPa to 2 500 hPa, the correcting values should be presented in increments of 100 hPa.

JOEO altitude test chamber is a closed test equipment capable of simulating various environmental conditions. It can precisely control environmental parameters such as temperature, humidity, and air pressure to simulate various conditions that medical devices may encounter in actual use. By placing medical devices in altitude test chamber and testing them according to the requirements of BS EN 13718-1, it is possible to simulate the use of products in different environments and evaluate their performance and reliability. Our altitude test chamber meets DO160, ASTM, IEC 60068-2-39, MIL-STD-781, BS EN 13718-1 and other standards, and can simulate altitudes up to 150,000 feet while meeting the ambient temperature range of -70°C to +180°C. Humidity range 15 to 95%. All the test conditions of the medical device can be met through the altitude test chamber. If you need to learn about the test standards and test conditions related to other medical devices, and need any advice or assistance, we welcome you to contact our team online, and we will be ready to support you to ensure that your medical device meets the relevant standards and environmental conditions. For optimal performance and security.