Electromedical appliances are considered “medical equipment” and belong to the category of work equipment.
All work equipment in the sense of “every machine, appliance, instrument or unit meant to be used for working” is subject to the safety inspections prescribed by the Italian decree-law 81/08, namely:
And it has to be ensured that they are designed, constructed, installed, used and maintained in such a way as to protect workers from all electrical risks (Article 80 of Italian law-decree 81/08).
ECO Next performs safety inspections on electromedical equipment in order to assess that the safety requirements prescribed by the relevant technical standards are fulfilled.
The employer has to provide the workers with the equipment that meets the requirements described in Article 70 of the Italian law-decree 81/08; equipment suitable for health and safety purposes and appropriate to the kind of work that is to be done or suitable for these purposes (art. 71 para.1 decree-law 81/08). He also has to make sure, that the equipment is properly maintained in order to guarantee the preservation of the safety requirements over time.
Regulation on Medical Devices (EU) 2017/745 (MDR), that abrogates Directive 93/42/EEC (MDD) and subsequent amendments and supplements and that came into force on May 25, 2017, with first step on November 26, 2017 (Notified Bodies) and definite deadline on the abrogation of Directive 93/42/EEC (medical devices) and Directive 90/385/EEC (active implantable medical devices), both enclosed in the regulation, with effect from 26 May 2020.
Reference standards: EN 62353 (CEI 62-148)
The periodicity of maintenance is decided by the employer himself, on the grounds of the risk assessment, with regard to the type of equipment, its condition, specific risks and the manufacturer’s instructions specified in the user manual, as well as according to the guidelines issued by the Italian Electrotechnical Committee CEI, which suggest annual/biennial maintenance intervals.
If the employer fails to observe these regulations, he will be subject to the penalties described in article 87, which range from imprisonment of two to six months or the payment of a fine of between 1,000.00 and 10,000.00 EURO for each violation.