KANBrief 1/20

EN 1789 governing ambulances still not quite state of the art

In 1995, Germany's Federal Highway Research Institute noted a significantly elevated accident risk for ambulances (cf. Unterkofler, M.; Schmiedel, R. (1995): Verbesserung der Sicherheit bei Sondersignaleinsätzen: Info 34/95. Bergisch-Gladbach: Bundesanstalt für Straßenwesen (BASt)). Each year, an average of 3,500 traffic accidents, or one accident for every 2,000 operations, were recorded in the former West Germany. During journeys with sirens and flashing lights, a critical traffic situation arose on average once every 19 seconds. This was deemed sufficient reason to examine the design safety of ambulances and to improve EN 1789 (Medical vehicles and their equipment – Road ambulances).

EN 1789 serves as a point of reference for the construction, furnishings, equipment and testing of ambulances in Europe. Since Annex XI of Framework Directive 2007/46/EC on the approval of motor vehicles contains a direct reference to the standard, the latter falls within the harmonized scope of the European legal system. The standard is binding for testing and approval of the patient's compartment.

EN 1789 and the medical devices governed by it forms part of the EU's New Legal Framework (NLF) and is subject to the corresponding requirements upon product safety. Requirements for the safe design and furnishings of the patient's compartment can also be drawn from other legal sources:

  1. Recital 3 of 2007/46/EC aims at a high level of health protection and road safety in harmonized regulatory acts.
  2. Legislation of the German regional authorities governing the ambulance services requires the ambulances to satisfy the state of the art (and in some cases even higher standards), including for safety aspects.
  3. Section 3 of the German Product Safety Act (ProdSG) requires products not to endanger the safety and health of persons when the products are used as intended or in a foreseeable manner.

Requirements of EN 1789 concerning the workplace must also consider the criteria of the EU OSH Framework Directive (89/391/EEC) and OSH principles and observations contained for example in the German Ordinance on workplaces.

Revision of the standard: objective not yet reached
Work on revision of EN 1789 was launched some time ago and is to be completed by mid-2020. Based on the results of several workshops conducted with experts (delegates included representatives of operators, the VDSI and the German Social Accident Insurance Institutions), KAN submitted comprehensive comments to DIN in 2019 containing almost 100 separate points. Several important points were implemented at European level:

  • Operability of important equipment by persons whilst seated and wearing a seat belt
  • Signal to the driver when a seat belt is unfastened in the patient's compartment
  • Third-party testing of the restraint and fixation systems
  • Securing of the patient's compartment against unauthorised access
  • Specification of the maximum permissible payload on furnishings

In many areas however, the European standard was found to formulate only minimum criteria. This is due in part to differences between the ambulance services in the individual Member States: cost aspects or conditions attributable to the geography of a particular country give rise to differences between specifications for the vehicles. In the case of Germany, this means that the state of the art required by the regional authorities and the DIN regulations for standards work is not reached in all areas. Aspects affected include the following:

  • Ergonomics: steps, grab rails, interior height, etc.
  • Hygiene: absence of technical requirements for the implementation of Directive 98/24/EC (chemical agents)
  • Handling of loads (Directive 90/269/EEC of 29 May 1990 on the minimum health and safety requirements for the manual handling of loads and the German Ordinance on health and safety requirements for the manual handling of loads at work (LasthandhabV))
  • External lighting for safe working and visibility

The weight of 75 kg stated in the standard for drivers/staff/patients (including equipment) no longer reflects the situation in reality. Adjustments to European legislation (including Regulation (EU) No 1230/2012 implementing Regulation (EC) No 661/2009 of the European Parliament and of the Council with regard to type-approval requirements for masses and dimensions of motor vehicles and their trailers) and the standard are required and are supported by KAN.

The KAN Secretariat has assumed the chairmanship of a DIN working group which is to formulate a proposal for more comprehensive requirements upon the design of steps and access arrangements. Since safety is no longer considered by all stakeholders to be assured at the currently applicable deceleration rate of 10g, efforts are also to be made to improve the structural safety at critical points in the patient's compartment. The results of the working group will not be included in the standard until its next revision.

Preparation of a DGUV publication containing procurement recommendations for state-of-the-art ambulance furnishings is urgently needed and would be of high practical value for the operators. The concerns of the German ambulance services could be addressed much more specifically in this document.

Michael Robert