ESTART and compliance with IEC TS 60601-4-2

[shimonv]

Hi Everyone,
The eSTAR template requires that I upload a report that demonstrates compliance with IEC TS 60601-4-2.
We have an EMC report that includes a references IEC TS 60601-4-2 under "Methods and Procedures".


Does it make sense that will just upload a document pointing to IEC 60601-1-2, and the appropriate section?
I still fine the internal logic of eSTAR somewhat confusing.

Thanks in advance for your help!

Shimon

 

[Al_Z1]

This standard was discussed here
Performance Testing for 60601-4-2 - Elsmar Cove Quality and Business Standards Discussions
Don't think, that will be of help, though.
And I still can't understand requirements to comply with the guidance standard.

 

[EmiliaBedelia]

The eSTAR template has a lot of duplicative sections IMO. Having done one myself recently, I would actually rather print everything out and mail off the 2 copies to CDRH rather than deal with the Standards or Biocompatibility portions ever again.

If you have already uploaded a report that meets the requirement in a different section, I would upload a cover letter with some sort of fluff paragraph that says something like, "Company Name has verified the Device per IEC TS 60601-4-2. Report #XYZ attached to Section ABCDE includes the requirements from IEC TS 60601-4-2 and specifies this standard in the methods. Refer to Attachment XYZ for additional detail".

If there is a summary section for that section I would also explicitly mention it there as well so that the reviewer doesn't have to click around and open additional attachments.