Inspections

Electromedical devices

Inspections to verify the maintenance of electrical and functional safety requirements of electromedical devices and their related systems.

Our service

Electromedical devices are essential equipment for the safety of patients and healthcare professionals. As ECO Certificazioni, we carry out periodic safety inspections to ensure that this equipment operates correctly and complies with the technical standards required by the regulations in force.

We operate directly at the places of use (medical practices, clinics, laboratories and aesthetic centres) to ensure that each device and electrical system maintains over time the safety conditions required by CEI EN 62353 and by Italian Presidential Decree 462/01.

Steps Required

The safety inspection aims to assess the continued compliance with the electrical and functional safety requirements of electromedical devices and their associated systems.

Our activities include:

technical and documentary checks of the equipment;
inspection of the electrical system and the earthing system;
insulation tests and continuity testing of protective conductors;
measurement of leakage and touch currents;
verification of the correct operation of safety devices.

The inspections apply to a wide range of environments and equipment, including:

medical, dental, ophthalmic and veterinary practices;
pharmacies, private clinics, analysis laboratories, gyms, spas and aesthetic centres;
dental chairs, sterilisers, pharmaceutical refrigerators, weighing scales, aesthetic and diagnostic
equipment, electrically powered gym machinery.

Inspection Frequency

The Inspection Frequency is established by the Employer on the basis of the risk assessment, taking into account the type of equipment, its condition of use, the manufacturer’s instructions and the guidelines of the Italian Electrotechnical Committee (CEI).

As a general rule, an annual or biennial inspection is recommended in order to maintain a consistent level of safety and compliance with the applicable regulations.

Failure to comply with these obligations entails the penalties provided for by Art. 87 of Italian Legislative Decree 81/2008, including fines (from €1,000 to €10,000) or arrest in the event of violations.

Through our periodic inspections, every healthcare facility or wellness centre can ensure the highest level of safety for patients and operators.

Regulatory Framework

The Employer is required to ensure that patients are provided with equipment that complies with safety requirements, as established by the regulations in force.

Such equipment must be:

Suitable for health and safety;
Appropriate and adaptable to the work carried out;
Subject to regular maintenance in order to maintain safety standards over time (Art. 71, paragraph 1, Italian Legislative Decree 81/2008).

Medical Devices Regulation (EU) 2017/745 (MDR)

In force since 26 May 2020, the MDR replaced the previous Directives:

93/42/EEC (medical devices);
90/385/EEC (active implantable medical devices).