IEC 60601-1 Clause 7.9.3.1

[jawad shahid]

Dear All,
I am trying to get IEC-60601-1 standard Certification for Otoscopes. i am stuck at Clause 7.9.3.1 which says (All characteristics of ME Equipment - Range(s), accuracy, precision of displayed values (or where they can be found) )
remembering that the product that i am trying the certification is a simple ME Otoscope B/F Applied part, which function is to emits a Led light on the site of observation and given i clear vision to the observer so it don't not display any range of values or display any values.
please guide what should i do regarding this clause as its been a headache for me

 

[Peter Selvey]

There should be some specifications you can put in the instructions for use like magnification, illumination level (lux @ 2cm), typical battery life.

 

[Riya Gupta]

Hi all,
I am looking for IEC 60601 compliance for my device. If i get compliance with IEC 60601-1-2 EMC tests, then do i also need to get tests done for IEC 60601-1.
kindly throw some light on this.

Thanks,

 

[Peter Selvey]

Yes, they are completely different standards, IEC 60601-1 is the general standard and covers things like marking, IFU, electrical safety, mechanical safety, temperatures and so on, while IEC 60601-1-2 is a "collateral" standard just for EMC, and there may be other applicable standards as well in the series.

Recommend to do a search for "IEC 60601 series" and you should find an overview of the standards.

 

[Riya Gupta]

thanks a lot @Peter Selvey for your quick response.