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Did you know that electromedical equipment needs certifications by Inmetro and Anvisa in Brazil?
04 de July
The equipment under the Health Surveillance regime, usually called electromedical, needs the INMETRO certification in Brazil.
It is considered equipment under the Health Surveillance regime those with medical, dental, laboratory or physiotherapy purposes, used direct or indirect to diagnosis, treatment, rehabilitation and monitoring in humans, and equipment with aesthetic purposes, including its parts and accessories.
The reference ordinance is the Inmetro Ordinance 384, of December 18th, 2020, and the main norms involved are NBR IEC 60601 and NBR ISO 80601, relating to electromedical equipment, NBR ISO 13485, relating to quality management system and NBR ISO 14971, relating to application of risk management to health products.
When to purchase a hospital bed, ask the manufacturer or the seller for the Inmetro certificate, or through their CNPJ, check the link:
If it is certificated, it’s possible to access its certificates and expiration dates. Without this certification, the manufacturer is prohibited from produce, sell and distribute electromedical equipment, because it doesn't follow the fabrication’s security and quality norms.
The tests include the project and full production cycle, from the prototype test to the CB certification, laboratory test to evaluate ergonomy, electric security, mechanical and functional, as well software tests.
Demand certificated equipment, it means security for your team and patients.
