Hi,
We are medical device company and our products have INMETRO certification issued to ABNT NBR IEC 60601-1:2010 + Emenda 1: 2016. Since the medical device has radio in it, for Brazil market we are told that the device will need ANATEL certification.
For ANATEL certification, our test lab is telling us that the medical device needs to be tested to:
1) Anatel act 1120 (EMC)
2) Anatel ACT 950 (for Safety testing)
I don't understand why do we need to test to ACT 950 when the device is already tested to ABNT NBR IEC 60601-1. Is testing to ACT 950 required.
Thanks for your help in advance!
We are medical device company and our products have INMETRO certification issued to ABNT NBR IEC 60601-1:2010 + Emenda 1: 2016. Since the medical device has radio in it, for Brazil market we are told that the device will need ANATEL certification.
For ANATEL certification, our test lab is telling us that the medical device needs to be tested to:
1) Anatel act 1120 (EMC)
2) Anatel ACT 950 (for Safety testing)
I don't understand why do we need to test to ACT 950 when the device is already tested to ABNT NBR IEC 60601-1. Is testing to ACT 950 required.
Thanks for your help in advance!