Conformity certificates are documents issued by certification bodies or accredited entities that attest that a product, process or system complies with certain norms, regulations or specific standards. These certificates are used to demonstrate that a product and/or service meets quality, safety performance and other criteria established by technical standard or applicable regulations.
Evaluating the conformity of a product means verifying that it is produced according to the minimum necessary requirements. INMETRO, a Brazilian federal agency linked to the Ministry of Economy – is, Brazil, the Brazilian body responsible for establishing conformity assessment programs.
INMETRO is responsible for implementing metrology, quality and compliance policies in Brazil. It designs, develops and applies the technical standards necessary to guarantee the safety, quality and efficiency of the products and services offered in the Brazilian market.
The INMETRO Certificate is often associated with products that are subject to regulation and mandatory certification, such as home appliances, toys, tires, safety equipment, light bulbs, among others, including electromedical equipment, through Ordinance 344/2020. Obtaining the certificate involves laboratory tests, conformity analyzes and evaluations according to the norms established by INMETRO or by bodies accredited by it.
In the Brazilian Conformity Assessment System, there are two types of certification: Voluntary Certification – which the company defines whether or not to certify its product – and Compulsory, in which a regulation determines that the company can only produce/market a product after it is certified. The specific legislation dealing with Certification is RDC No. 27, of June 21, 2011.
The Resolution 27/2011 establishes that the procedures for compulsory certification of equipments under the Sanitary Surveillance regime for:
- equipment for medical, dental, laboratory or physiotherapy purposes, used directly or indirectly for diagnosis, treatment, rehabilitation and monitoring of human beings;
- equipment for beautification and aesthetic purposes.
Equipment outside these classifications is voluntarily certified.
ABNT NBR IEC 60601-1 discusses the general requirements for basic safety and essential performance of medical electrical equipment, not being applicable to in vitro diagnostic equipment that does not fit the definition of ME EQUIPMENT, which are addressed by the IEC 61010 series and implantable parts of active implantable health products, addressed by the ISO 14708 series.
The Regulatory Standard deals with the basic safety requirements and essential performance of electrical medical equipment and serves to ensure that no individual electrical, mechanical or functional failure poses a risk to whoever is operating or the patients who will receive treatment or will undergo an examination or procedure.
