EN 13718 Medical Vehicles and Equipment - Air Ambulances

The European standard “EN 13718 Medical vehicles and equipment - Air ambulances” consists of the following subsections published under the same title:

• The standard "EN 13718-1 Part 1: Requirements for medical devices used in air ambulances" describes the general requirements for medical devices carried in air ambulances and used outside hospitals and clinics, where environmental conditions may differ from normal indoor conditions. This standard does not cover vehicle approval and registration and personnel training requirements, which are the responsibility of the authority(ies) in the country where the ambulance will be registered.

For the purposes of this standard, the following terms and definitions apply:

• Air ambulance refers to aircraft normally designed to be operated by two medical personnel, equipped and intended for the transport of at least one stretcher patient who will receive medical treatment during transport.
• Interface refers to the means or place of interaction between one or more medical devices, ambient conditions, the user, the patient and, when relevant, various types of ambulances.
• Interoperability refers to the ability to connect various medical devices fixed to patients to the connections of related medical devices (including the ability to connect powered medical devices to various types of ambulances).
• A medical device means an instrument, device, appliance, material or other item, including any software necessary for its proper implementation, whether used alone or in combination, designed by the manufacturer to diagnose, prevent, monitor, treat or alleviate disease or injury in humans.
• Portable refers to portable equipment that, once installed and put into service, is intended to be moved from one location to another while being carried by one or more people.

Manufacturers of all medical devices intended for use in air ambulances must ensure that the requirements of this standard are met.

Risks associated with medical devices to patient and staff safety must be minimized using a risk management process in accordance with EN ISO 14971, taking into account the intended application of the devices and known and foreseeable hazards under both normal and fault conditions. When risk analyses are performed, they should reflect storage, installation, operation under normal use, and maintenance in accordance with the manufacturer's instructions and the air ambulance's environmental conditions.

The user interface of a medical device must be easy to use in an air ambulance. Detailed information on how to design an easy-to-use medical device is provided in EN 62366-1 and EN 60601–1–6. A medical device designated as portable must be transportable both inside and outside the aircraft and must be portable by a single person.

The manufacturer of the medical device must conduct a risk assessment regarding the manual handling of the medical device inside and outside the air ambulance. Several accepted risk assessment methods can be used, including the key element method, manual handling assessment tables, and the EN 1005-2 standard. Buttons, switches, displays, controls, and similar equipment must be accessible and legible under the intended operating conditions. Intended operating conditions are described in the EN 13718-2 standard. Medical devices with alarms and signals must provide a clear visual signal under the intended operating conditions.

• The standard “EN 13718-2 Part 2: Operational and technical requirements for air ambulances” describes the performance and equipment requirements for air ambulances, including requirements for interfaces to medical devices used for the transport and treatment of sick or injured persons.

This standard applies to air ambulances capable of transporting at least one person on a stretcher. Requirements are specified for different categories of air ambulances based on their intended use: helicopter emergency medical service, helicopter intensive care medical service, and fixed-wing air ambulance.

In general, air ambulances should be designed to provide rapid and safe transportation of medical personnel to individuals requiring medical care outside of hospitals, between hospitals, and between hospitals. Transporting intensive care patients requires specially trained personnel. Air ambulances should be designed to accommodate personnel and provide a safe and healthy work environment. Air ambulances should provide treatment for at least one patient on a stretcher.

Air ambulances must be equipped with medical devices complying with Annex A and other life-support equipment complying with Annex B to provide continuous patient care. Equipment and systems must be selected and designed to ensure interchangeability and interoperability. The installation of medical devices and equipment must comply with applicable airworthiness requirements.

The EN 13718 standards are considered essential because they define critical safety and performance requirements for medical devices and equipment. These standards are considered particularly important for the following reasons:

• Ensures safety in air medical transport: These standards set minimum safety standards for equipment used in air ambulances, reducing the risk of in-flight failure. They focus on how the equipment is mounted and secured, and are crucial for patient and crew safety during turbulence or emergency maneuvers.
• Harmonized across Europe: These standards provide a common framework for manufacturers, service providers, and regulators. They help ensure that air ambulances across countries meet consistent, interoperable standards.
• Protects patients and medical staff: Ensures that medical equipment used in helicopters or aircraft is suitable for the unique conditions of flight (e.g., pressure changes, vibrations, electromagnetic interference). Supports patient care and staff safety by specifying ergonomic and hygiene requirements.
• Facilitates regulatory compliance: Compliance with EN 13718 standards is often required for CE marking and national aviation and health authorities. It helps air ambulance services prove that their equipment and procedures meet essential European health and safety requirements.
• Improves emergency medical outcomes: These standards encourage the use of reliable, tested, and appropriate medical equipment that can function effectively during air transport. They increase the chances of successful patient stabilization and transfer in critical care scenarios.

Our organization, which has been supporting businesses across all sectors for years through a wide range of testing, measurement, analysis, and evaluation activities, has a strong team of employees who closely follow global developments in science and technology and are constantly improving themselves. In this context, we also provide testing services in accordance with the "EN 13718 Medical vehicles and equipment - Air ambulances" standard.