Electromedical equipment is “medical devices” and falls under the category of work equipment.
All work equipment, intended as “any machine, device, tool, or system defined to be used on the job”, falls under the safety verifications required by the Italian Lgs. Decree 81/08 therefore:
for which it is necessary to guarantee that they are engineered, constructed, installed, used, and maintained in such a way as to protect workers from all risks of an electrical nature (Art. 80 of Lgs. Decree 81/08).
The Employer is obliged to make available to workers equipment in conformity with the requirements laid out in Article 70 of Italian Lgs. Decree 81/08, suitable for health and safety purposes and adequate for the work to be carried out or adapted for the same purposes (Art. 71 paragraph.1 Italian Lgs. Decree 81/08), to subject them to suitable maintenance in order to guarantee the permanence of the safety requirements over time.
Medical Device Regulation (EU) 2017/745 (MDR), which abrogates Directive 93/42/EEC (MDD) and successive modifications and amendments, enacted on 25 May 2017, with the 1st step on 26 November 2017 (Notified Bodies) and definitive term with abrogation of Directive 93/42/EEC (medical devices) and Directive 90/385/EEC (active implantable medical devices), both of which are included in the regulation, beginning as of 26 May 2020.
Reference standard: CEI EN 62353 (CEI 62-148)
The periodicity of controls is established by the Employer, based on the risk assessment, in relation to the type of equipment, its usage condition, the specific risks involved and the indications of the manufacturer as outlined in the usage manual, as well as, for informative purposes, from guides of the Comitato Elettrotecnico Italiano (Italian Electro-technical Committee), which suggests annual/biennial periodicity.
Failure to fulfil these obligations will result in the Employer being sanctioned in keeping with the provisions outlined in Art.87, which range from between two and sixth months or incarceration or fines amounting from 1,000.00 to 10,000.00 Euro for each violation ascertained.