Laboratories of Electromedical equipments

Accreditation of this laboratory by Cgcre is based on NBR IEC 60601-1, which characterizes safety tests involving several aspects, such as leakage currents, excessive temperatures, mechanical support, construction aspects, and adequate components, among others.

In conjunction with this standard there are specific norms that govern each type of equipment (NBR IEC 60601-2). In other words, an electric scalpel is based on the performance of tests related to the general norm as well as those covered by the specific standard NBRIEC 60601-2-2.

The laboratory is also authorized to test equipment for compliance with standards edited by UL – Underwriters Laboratories, enabling Brazilian companies to test their products in Brazil and obtain UL approval for export to the American market.

This process involves a Product Certification Agency (OCP) or Accredited Certification Agency (OCC), which is approached by manufacturers to assess the quality system implemented in the company and subsequently hires the laboratory to check the manufactured product.

Based on two ordinances (2.043 and 2.663), the Ministry of Health in conjunction with INMETRO made the certification of electromedical equipment mandatory in order to register and sell these devices in the national market.

LABELO’s electromedical testing laboratory was funded in 1996 as an integral part of its testing facilities.

General safety requirements
Following a number of audits, and due to the resulting development and accreditation of the laboratory, we are currently qualified to test several different types of electromedical equipment, namely: NBR IEC 60601-1
Specific requirements for electrosurgical equipment NBR IEC 60601-2-2
Specific requirements for Defirbrillators/Cardioverters NBR IEC 60601-2-4
Specific requirements for ultrasound equipment NBR IEC 60601-2-5
Specific requirements for electrostimulators NBR IEC 60601-2-10
Specific requirements for hemodialysis equipment NBR IEC 60601-2-16
Specific requirements for endoscopy equipment NBR IEC 60601-2-18
Specific requirements for incubators for newborns NBR IEC 60601-2-19
Specific requirements for transport incubators NBR IEC 60601-2-20
Specific requirements for electrocardiographs NBR IEC 60601-2-25
Specific requirements for electroencephalography NBR IEC 60601-2-26
Specific requirements for cardiac monitors NBR IEC 60601-2-27
Specific requirements for hospital beds NBR IEC 60601-2-38
Specific requirements for electromyography NBR IEC 60601-2-40
Specific requirements for surgical tables NBR IEC 60601-2-46
Specific requirements for multifunctional monitors NBR IEC 60601-2-49
As such, all equipment that are either directly or indirectly associated to a healthcare facility – hospitals, clinics and similar institutions – must comply with the requirements presented and the compatible standards in order to receive certification, registration and be eligible for marketing.