MEASUREMENTS AND TESTING
Medical use local inspections
CEI Standard 64-7/8, Presidential Decree 462/01, and Article 86 of Legislative Decree 81/08
The inspections of electrical systems in medical use areas are essential to ensure the safety of patients and healthcare staff. Italian regulations, particularly CEI Standard 64-8/7, Presidential Decree 462/01, and Article 86 of Legislative Decree 81/08, specify the requirements for the design, installation, and inspection of these systems. Tesi Project is capable of providing a comprehensive solution for both initial inspections and necessary periodic maintenance, in compliance with the relevant regulations.
For medical use areas, CEI Standard 64-8 defines them as: "Any area intended for diagnostic, therapeutic, surgical, surveillance, or rehabilitation purposes, including aesthetic treatments (Hospitals, Clinics, Nursing homes, Medical diagnostic centers, Beauty centers, Medical offices, Dental offices, Medical rooms located within other facilities (e.g., infirmaries), Physiotherapy clinics, etc.)."
Medical use areas are commonly divided into three distinct groups based on their functions:
Group 0 medical areas are those where electromedical devices with applied parts are used.
Group 1 medical areas are those where the applied parts of electromedical devices are connected to the patient in a non-invasive or invasive manner but not in the cardiac area.
Group 2 medical areas are those where the applied parts involve the cardiac area.
Medical use areas in all groups must be subjected to electrical system inspections according to CEI Standard 64-8 Section 710. The frequency of inspections should be determined based on the type of medical area where the inspections are conducted.
Initial, Periodic, and Extraordinary Inspections:
(CEI Standard 64-8/6 and CEI Standard 64-8/710)
Periodic Grounding and Lightning Protection Inspections
(CEI Standard 0-14 and Presidential Decree 462/2001) - Inspections every two years
Routine and Extraordinary Maintenance
(CEI Standard 0-10 and not included in cases 1 and 2)
The inspections are conducted using specific instruments such as Insulation Testers to measure insulation resistance, Thermographic instruments to identify overheating or hidden issues in electrical connections, and Impedance Analyzers to measure the fault loop impedance and continuity of grounding circuits.
The results of the inspections must be documented and made available to the supervisory authority in the Verification and Maintenance Register. Inspections pursuant to Article 86 of Legislative Decree 81/08 do not replace the inspections required by Presidential Decree 462/01.
Reference Regulations:
Electrical systems in medical use areas are regulated by CEI Standards 64-8 and 64-8/7. These standards set the criteria for the design, installation, and maintenance of systems, ensuring they meet necessary safety standards. European directives and national regulations complement these standards, providing a comprehensive regulatory framework.
CEI Standard 64-8/6 and 64-8/7:
Specifies the technical characteristics of electrical systems in medical use areas.
Includes requirements for the design and installation of these systems.
Presidential Decree 462/2001:
Governs the inspection and maintenance of electrical systems.
Mandates periodic inspections of grounding systems, lightning protection devices, and electrical systems in explosion-hazardous areas.
Article 86 of Legislative Decree 81/08:
Requires employers to subject electrical systems to periodic inspections.
States that inspections must be conducted by competent personnel in accordance with current regulations.