ISO1050DW / IEC 60601-1 ed3 A1

Franck VINIT

Prodigy 20 points

The component ISO1050DW is it compliant with the IEC 60601-1 ed3 A1? I don't find its certification.

Thanks in advance.

over 9 years ago

0 Saleem Marwat over 9 years ago

TI__Genius 11675 points

ISO1050DW is certified according to IEC 60601-1 Ed 3 up 125 Vrms 2 MOPP. Please see CSA certificate starting page 32 of the link below:

0 Franck VINIT over 9 years ago

Prodigy 20 points

Hello,
Yes but my design must be compliant with the IEC 60601-1 ed3 with amendement A1 not the IEC 60601-1 ed3. The amendement A1 has been published in 2012 and contains significant modifications. This is why I am surprised to not find this amendement in your certificate.
Could you please check if this component has been certified also for the Amendement A1 ? It is very important for us.
Thanks in advance

0 Saleem Marwat over 9 years ago in reply to Franck VINIT

TI__Genius 11675 points

I'm checking with the certification agency if amendment 1 will require additional testing at component level? and whether those requirements can be handled at system-level?

I expect to hear back next week as my agency contact is out of office this week.

0 Saleem Marwat over 9 years ago in reply to Saleem Marwat

TI__Genius 11675 points

I just heard back from CSA. This device still meets the requirements of IEC 60601-1 3rd Ed Amendment 1 because the provisions in amendment 1 don't impact these components.

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ISO1050DW / IEC 60601-1 ed3 A1