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IEC 62133 - CB Scheme Required by FDA 510k

#1
Hello,

Our company has a Class 2 electro-medical device with TUV for 60601 testing that will eventually go for 510k review. The unit runs off of a rechargeable li-ion battery, which has been certified to IEC 62133 by a lab that isn't IECEE recognized to support the CB Scheme. TUV is telling us that without the CB scheme that they will not accept the battery for testing with the device.

My question is whether the FDA requires the CB Scheme or would it be acceptable to have TUV notate that the battery wasn't tested by a lab that could provide CB and just provide the IEC 62133 testing directly to FDA during 510k review?

Thanks
 

Al Rosen

Staff member
Super Moderator
#2
Hello,

Our company has a Class 2 electro-medical device with TUV for 60601 testing that will eventually go for 510k review. The unit runs off of a rechargeable li-ion battery, which has been certified to IEC 62133 by a lab that isn't IECEE recognized to support the CB Scheme. TUV is telling us that without the CB scheme that they will not accept the battery for testing with the device.

My question is whether the FDA requires the CB Scheme or would it be acceptable to have TUV notate that the battery wasn't tested by a lab that could provide CB and just provide the IEC 62133 testing directly to FDA during 510k review?

Thanks
FDA does not require the CB scheme. For the FDA, you can perform all the testing and submit the data. A CB will not accept test results from a lab which is not a CB.
 
#4
I would like to know your expertise regarding the 60601 CB reports. Although there are 50 CB Scheme member countries, it is not always necessary for approval of products. Could you reveal in which country is essential to have 60601 CB report?
 
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