Does IEC 61010-1 apply for Surgical Microscopes?

[leroybrown]

Hi there. My company is supplying teaching labs with surgical microscopes only intended for use in the teaching labs. These microscopes will only be used for surgical technique practice using prosthetics - no contact with real patients. Would 61010-1 apply here whereas 60601-1 normally applies to the microscopes that are used in the doctor's offices/exam rooms? I am also curious as to what other regulations might apply, i.e. LVD directive.
All help is greatly appreciated!
Thanks!

 

[Stijloor]

A Quick Bump!

Can someone help?

Thank you very much!!

 

[Peter Selvey]

For Europe it depends on the stated intended purpose, so if it is clearly stated, not intended for use on patients, then the MDD (and hence EN/IEC 60601-1) would not apply.

The LVD and EMC are expected to apply (assuming there is mains powered, normal electronics), and probably EN/IEC61010-1, etc you would need to check the scope statement in the standard to be sure.

 

[Marc]

Peter, We all appreciate your helping with this type of question.

Thank you,

Marc