Is INMETRO certification suitable for medical device components?

Hello all,

Could someone tell me if stand-alone power supply can be certified to ABNT NBR IEC 60601-1 and get the INMETRO certificate. Since the power supply is used only as a component of medical equipment or system, I do not know if INMETRO certification is suitable for medical components?

Thanks,
Roland

Hi,

If you plan to sell the Power supply as a stand alone product and not as a part of any end system, then Yes it can be certified to 60601-1 - making it a medical grade power supply. But if you ever decide to use this certified power supply in another product then, it will need to be tested again as part of the end product as well.

Deepa

Hello.

Well, I`m not an expert on that, but I think the INMETRO does not certificate medical equipment. In Brazil this kind of certification is done by ANVISA.

Best Regards

Well, I`m not an expert on that, but I think the INMETRO does not certificate medical equipment. In Brazil this kind of certification is done by ANVISA

Click to expand...

INMETRO surely certifies the medical equipment. In brief, INMETRO is for certification and ANVISA is for registration.

All,

There is already a thread open for discussing INMETRO certification. - Medical Device Approval in Brazil - Understanding INMETRO and ANVISA

Hope this helps,
Ray

Why don't you ask INMETRO? Seems to me they should be able to answer the question about what they do better than anyone else could.