Why make your dental practice or laboratory safe and compliant? What is the IEC 62353 standard? And what can SEPATEC do for you?

Why make your dental office or laboratory safe and compliant?

In recent years, law enforcement has exponentially increased controls in the dental field, with hundreds of practices and laboratories closed , and equipment seized for hundreds of millions of euros. Certainly, the media coverage given by newspapers and television broadcasts has further put the entire sector under scrutiny.

Among the various irregularities, the most punished is the failure to comply with the rules regarding safety in the workplace (Legislative Decree 81/08).

Furthermore, irregularities have emerged due to the fact that in dental practices an average of 30 devices are used on patients, and 70% of these have a lifespan of more than 7 years, resulting in electrical, structural and functional degradation .

Over time, laboratory equipment is subject to to the wear of the components , with the consequent increase in electrical safety risks, which are even higher on instruments that use aggressive chemical reagents. For example, if the protective earth connection is interrupted, this cannot be perceived by the operator, except in the case of electrocution. Correct use of the device, combined with periodic maintenance and checks, It is essential in order to find and resolve all electrical hazards to which it may be subjected, directly or indirectly.

Checking the functionality of the equipment in the dental laboratory allows operators to work safely and avoid risks while using the equipment.

What is IEC 62353?

IEC 62353 is the standard that establishes the rules and terms for carrying out electrical safety and emission checks on medical electrical equipment compliant with the CEI 62-5 standard, applied before commissioning, after maintenance, inspection, repair, and during checks to evaluate the safety of such equipment.

The electrical check it is necessary (And mandatory pursuant to Legislative Decree 81/08 – consolidated law on safety at work), as the devices concerned They are used by medical personnel and are, to all intents and purposes, work tools ; therefore the law obliges the employer (whether the owner of the facility or the healthcare manager) to periodically schedule such checks.

In essence, the law provides that the devices present in the dental office or laboratory, s are properly insulated and equipped with earth leakage systems , with the aim of preventing both operators and patients from suffering electrocutions.

This regulation requires that an electrical check be carried out on the appliances every 2 years at the most.

If these conditions are not met, the sanctions against the employer and the manager are:

• imprisonment from three to six months or a fine from 2,740 to 7,014 euros (art. 71 co. 1, 2, 4, 7, 8 of Legislative Decree 81/08)
  
• imprisonment from two to four months or a fine from 1,096 to 5,260 euros (art. 71 co. 3 points 3.1.3, 3.1.4, 3.1.5, 3.1.6, 3.1.7, 3.2.1 of Annex VI