FR Frankreich
  • S10S - Medizinprodukte

Medical devices emitting ionising radiation

Order issued pursuant to Article R5211-24 of the Public Health Code and specifying the essential requirements applicable to medical devices emitting ionising radiation

The purpose of this draft order is to specify the conditions for implementing the essential requirements relating to the design and construction of medical devices emitting ionising radiation, pursuant to Article 60(3) of Directive 2013/59/EURATOM. It provides for requirements in terms of transmitting information on the dose delivered to the patient according to the type of equipment considered.

Taking into account the recasting of the EURATOM directives, this draft Order amends the provisions of the Order of 15 March 2010 by increasing the obligation to inform the user of the radiation dose delivered to the patient according to radiation protection issues, in light of new techniques available. It revisits the requirement for a dose information system imposed by Article R5211-22 of the Public Health Code so that equipment used to guide radio-guided interventional practices may be equipped with a device (or function) for evaluating the radiation dose delivered to the patient throughout and at the end of the radiological procedure. For equipment used in radiodiagnostics and for planning and verification purposes in radio-guided interventional practices, this function shall be limited to information at the end of the procedure.

It is also expected that this equipment should allow the required information to be transferred to the patient’s examination report on the medical device. Furthermore, specific rules are envisaged for high-energy radiotherapy equipment.

This draft Order provides for the deletion of the phrase ‘insofar as is possible’ (‘dans la mesure du possible’ in the original French version) in 11.2.2. and 11.5.1 of II of the Order of 15 March 2010, currently worded as follows: ‘(...) 11.2.2. Where devices are intended to emit potentially dangerous visible or invisible radiation, they must be equipped, insofar as is possible, with audible and/or visual indicators indicating the radiation emitted. (…)

11.5.1. Devices designed to emit ionising radiation must be designed and manufactured to ensure that, insofar as is possible, the quantity, geometry and quality of the radiation emitted can be adjusted and controlled according to the intended purpose; (...)’.