What is BS EN 13718-1 about?
BS EN 13718 discusses standards for medical vehicles and their equipment for air ambulances. BS EN 13718-1 focuses on the requirements for medical devices used in air ambulances.
BS EN 13718-1 is part of a series of documents that 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. BS EN 13718-1 gives minimum requirements for interfaces and compatibility of medical devices used in air ambulances.
Note: BS EN 13718-1 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.
Who is BS EN 13718-1 for?
BS EN 13718-1 on medical devices is useful for:
- Air ambulance manufacturers
- Manufacturers of medical devices
- Manufacturers of the aircraft installation
- Medical electrical equipment manufacturers
Why should you use BS EN 13718-1?
BS EN 13718-1 gives requirements for medical devices when used in situations where the ambient conditions differ from the normal indoor conditions prevailing within the health care system.
Risks associated with medical devices shall be minimized, using guidelines given in BS EN 13718-1 taking account of the intended application of the devices and of known and foreseeable hazards in both normal and fault conditions. When risk analyses are performed, they shall reflect storage, installation, operation in normal use, and maintenance according to the instructions of the manufacturer and the ambient conditions of an air ambulance.
BS EN 13718-1 helps medical devices manufacturers to follow proper test procedures and standards for air ambulances (as per the specification for aerospace applications). Also, you can demonstrate the reliability of your products and build trust in their use throughout the aerospace supply chain by adhering to BS EN 13718-1
What’s changed since the last update?
BS EN 13718-1:2014+A1:2020 supersedes BS EN 13718-1:2014. BS EN 13718-1:2014+A1:2020 includes some technical changes with respect to BS EN 13718-1:2014. These include:
- A new subclause 4.5.4 "Medical devices with 230 V AC power input" was introduced
- Subclause 4.5.4 "Pneumatic power supply" (now subclause 4.6.4) was revised
- Subclause 4.8 "Fire resistance" (now subclause 4.9) was revised
- Unclear issues were clarified in this part of the standard and between the two parts of the standard (requirements for patient's compartment illumination, respectively)
- The standard was modified/integrated to meet the Medical Devices Directive 93/42/EEC requirements