Public procurement notice: Voluntary Ex Ante Transparency Notice
Published: 2021-05-17
Buyer: Luftambulansetjenesten HF/v Sykehusinnkjøp HF
Country: NO
Contract type: Supplies
Procedure: Contract award without prior publication
CPV classification: 33100000
Estimated value: 4000000 NOK

Technical requirements: Luftambulansetjenesten HF (the Norwegian Air Ambulance Service) will establish an air ambulance service dedicated to transport of infection patients. For this purpose there is a need for equipment that isolates the patient from personnel and surrounding during transport, but that allows treatment under way. The equipment will be used for long distance transport in air ambulances as well as in transport by car ambulances throughout Europe.
It is anticipated that during 3 years another three new sets will be procured to replace the two that are in use/emergency use.
Luftambulansetjenesten HF (the Norwegian Air Ambulance Service) will establish an air ambulance service dedicated to transport of infection patients. For this purpose there is a need for equipment that isolates the patient from personnel and surrounding during transport, but that allows treatment under way. The equipment will be used for long distance transport in air ambulances as well as in transport by car ambulances throughout Europe.
It is anticipated that during 3 years another three new sets will be procured to replace the two that are in use/emergency use.
Safety requirements for medical equipment are described in EU directive 93/42/EU on medical equipment. These requirements are harmonised in Norway through the Regulations on medical equipment. The range of application for the regulations on medical equipment primarily applies to the manufacturer. Those who acquire and use medical equipment in Norway, are subject to the Regulation on handling of medical equipment. This regulation sets requirements that the business acquiring such equipment must ensure the equipment satisfies the Regulations on medical equipment, in addition to it being suitable for the area of use. The requirements of the Directive, and thus the regulations mentioned, are normally met and proven by complying with harmonised product standards or generic international or European standards. For use in air ambulances, this condition is complicated, in that the normal product standards do not favour the area of use and that the procured equipment also must be able to fulfil the Regulation for continual airworthiness. LAT HF uses the following standards as proof of fulfilment of the regulations Generic standards for safety of electromedical equipment.
NEK IEC 60601-1-12: Medical electrical equipment — Part 1-12: general requirements for basic safety and essential performance — collateral standard: requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment.
NS-EN 1789 Ambulances and ambulance equipment — road ambulances. The market surveys show that among the products on the market there is very little documentation that the product characteristics fulfil the standards or fulfil the regulations in another manner. The exception here is one product: EPIShuttle from EPIGuard. EPIShuttle is obviously designed with a view to actually satisfying product standards that apply to this area of use.
It is distinguished by satisfying: NEK IEC 60601-1-12 which describes minimum requirements pre-hospital use of medical equipment, as well as EUROCAE-Ed-14 which corresponds to RTCA DO-160 with regard to EMC safety. A competition in the market will need to use the standards mentioned above as requirements, and for aeronautical reasons also as mandatory requirements. Based on the Air Ambulance Service's knowledge of the market, only EPIShuttle from EPIGuard fulfils these strict requirements. We therefore find that EPIShuttle is the only product on the market that can meet the requirement that must be met in the service.
A contract will be entered into at the earliest 10 days after publication of this prior information notice.


Winner: EpiGuard AS
Award value: 4000000