Certifications

Our electro medical products line have OCP (Organismo de Certificação do Produto – INMETRO) certification, through the certifier TÜV - SÜD, which attest that NBTech products were tested and follow the following norms:

 

- ABNT NBR IEC 60601-1:2010

 

- ABNT NBR IEC 60601-1-2:2017

 

- ABNT NBR IEC 60601-1-4:2004

 

- ABNT NBR IEC 60601-1-6:2011

 

- ABNT NBR IEC 60601-1-8:2014

 

- ABNT NBR IEC 60601-2-52:2013

 

- ABNT NBR ISO 62366:2016

 

The certifier TÜV – SÜD also attest the conformity of NBTech in the compliance with standards:

 

ABNT NBR ISO 9001:2015

ABNT NBR ISO 13485:2016

ABNT NBR ISO 14040:2009

ABNT NBR ISO 14971:2009

Ordinance 54:2016 INMETRO

Ordinance 274:2014 INMETRO

Resolution RDC Nº 16/2013 ANVISA 

 

See more information in the link or request our commercial department for our certifications.

 

Consult the certification on INMETRO website clicking below:

 

The ISO 9001:2015 certification contemplates the quality of the products through the entire management and production process within the industrial chain, from the raw material quality management to the conception, project, development, fabrication and commercialization of the products. This provides to the client the ensurement of purchasing a high quality and secure product, following the most rigid standards in normative resolutions.

 

The ISO 13485:2016 certification is a specific certification for health and medical equipment and devices, being utilized together. But, the real importance of ISO 13485:2016 certification is the respectability and reliability attributed to the Industry and its products, since the management systems of this certification are developed and used worldwide, based on extremely rigid international norms.

 

NBTech searches for excellence in everything it does. 

 

The NBTech products follow a specific ANVISA regulamentation, which determines the need of registers, to ensure not only the health, but also the security of the patients. 

 

According to the law n.º 6380/76, no product of interest to health, whether national or imported, may be industrialized, exposed for sale or used if it does not count with a register specific in the Health Ministry.

Specifically for Risk Class I and II medical equipment, Normative Instruction No. 13 of October 22, 2009 is also adopted.

 

With regard to the registration of these devices, ANVISA Resolution RDC No. 24, of May 21, 2009, provides the rules and procedures for registration.

 

See in the website below: