IEC 60601-1 Amendment 1 3rd Edition and Brazil ABNT NBR IEC 60601-1:2010

[lboll]

Did Brazil incorporate all of Amendment 1 from 60601-1 3rd edition into their standard ABNT IEC 60601-1:2010?

 

[Marcelo]

Re: 60601-1 Amendment 1 3rd Edition and Brazil ABNT NBR IEC 60601-1:2010

No, ABNT NBR IEC 60601-1:2010 is from 2010 (seem a little obvious ), and Amendment 1 is from 2012.

We are publishing the Brazilian version of Amendment 1 in a few months.

 

[Roland chung]

Hi Marcelo,

According to the IN 3/2011, ABNT NBR IEC 60601-1:2010 must be implemented as of Jan 01, 2014. But I heard that ABNT NBR IEC 60601-1:1997 is required for sphygmomanometers since no laboratories in Brazil have been accredited by INMETRO for ABNT NBR IEC 80601-2-30.

I want to know how many kinds of medical devices that still require 2nd edition in Brazil. I try to find something through searching the Website of INMETRO and ANVISA, but get nothing.

Regards,
Roland

 

[Marcelo]

Historically, the only way to know that is to verify at the INMETRO website each lab accreditation, and which standards they are accredited to.

However, ANVISA changed this and recently published NOTA T?CNICA N? 02/2014/GQUIP/GGTPS/ANVISA
1. Objeto: Exigibilidade da certifica??o compuls?ria pelas Normas T?cnicas listadas na Instru??o Normativa IN 9/2013, which details when mandatory certification is required.

Their website is not working at the moment, but when it gets back you can access this there.

 

[Roland chung]

Historically, the only way to know that is to verify at the INMETRO website each lab accreditation, and which standards they are accredited to.

It sounds strange to me. The scope of laboratories may be different. It seems we have to search all of the laboratories.

 

[Marcelo]

It sounds strange to me. The scope of laboratories may be different. It seems we have to search all of the laboratories.

Exactly!

 

[Roland chung]

One more question:

Is existing equipment "grandfathered" in Brazil regarding new standards, just like the United States and Canada?

 

[Marcelo]

Is existing equipment "grandfathered" in Brazil regarding new standards, just like the United States and Canada?

No, certificates are valid for 5 years, after that, you have to retest to current standards.

 

[valr31]

Hi,
Thanks for the post,

I got a look at the ABNT published norms and was not able to find the IEC 60601-1:2005 + Amendement 1:2012.

Is that a recognized standard in Brazil or can we use the IEC 60601-1:2005 ABNT NBR IEC 60601-1:2010 ?

thanks for your feedback.

ValR31

 

[Marcelo]

I got a look at the ABNT published norms and was not able to find the IEC 60601-1:2005 + Amendement 1:2012.

Hello ValR31 and welcome to the Cove!

As mentioned, we do not have a consolidated general standard + amendment version.

Also, our implementation of the amendment is late and has not been published yet (it will probably go to public consultation this month).

So right now we only have ABNT NBR IEC 60601-1:2010 (which is equivalent to IEC 60601-1:2005).

Is that a recognized standard in Brazil or can we use the IEC 60601-1:2005 ABNT NBR IEC 60601-1:2010 ?

We don´t have "recognized" standards in Brazil, we have mandatory standards under mandatory certification, which, in the case of medical electrical equipment, are described in Normative Instruction 11/2014 (INSTRUÇÃO NORMATIVA N° 11, DE 16 DE DEZEMBRO DE 2014).