Class II heating pad - does the power supply have to have IEC 60601-1 testing??

XRAY_3121

Compliance and Regulatory Rx Distributor
#1
I'm dealing with a private label heating pad that the manufacturer tested the power supply to IEC 62368-1 instead of 60601-1. I was under the impression that the power supply was a component of the medical device and therefore should be tested to a medical device standard? These power supplies run hot. Does anyone know if they are required to be tested to 60601-1? And I have another heating pad that is ETL certified based on UL130 - but is registered as a Class II medical device. It too has not have IEC 60601-1 testing. Any comments would be appreciated!

Thanks,
Matthew
 
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yodon

Leader
Super Moderator
#2
Not an expert here but maybe this will get the ball rolling.

When you submit your *system* for 60601-1 testing, the power supply will go with it. If the lab reviews the power supply test data (ostensibly from an accredited lab) and sees that it meets the 60601-1 requirements, then I believe they could accept it without further testing.
 

XRAY_3121

Compliance and Regulatory Rx Distributor
#3
Hi Yodon,
I appreciate the response! I guess I'm trying to understand if it's acceptable to test the power supply to a different standard. My opinion (if I were the manufacturer) is that it is inherently part of the device. I think the manufacturers are viewing it as a separate component. The power supply is certified by UL, but I question the standard it was tested to.
1659018581797.png

Can they test the PS to an IT standard, test the heating pad to proper ISO standard, and sell together as a single product?
 

yodon

Leader
Super Moderator
#4
May well depend on the intended use environment. If hospital, probably not (as the snippet mentions "business equipment"). You can probably ask your test lab.
 

ca_moni

Involved In Discussions
#5
This question would have been better addressed in IEC 60601-1 subforum, anyway ... as far as I know, the use of power supply certified according to an appropriate standard (not IEC 60601-1) is allowed : the medical device (here the heating pad) shall be compliant with IEC 60601-1 and the combination of the power supply and the medical device shall be regarded as a ME system and shall comply with the related prescriptions of the IEC 60601-1 standard.
 

XRAY_3121

Compliance and Regulatory Rx Distributor
#6
This question would have been better addressed in IEC 60601-1 subforum, anyway ... as far as I know, the use of power supply certified according to an appropriate standard (not IEC 60601-1) is allowed : the medical device (here the heating pad) shall be compliant with IEC 60601-1 and the combination of the power supply and the medical device shall be regarded as a ME system and shall comply with the related prescriptions of the IEC 60601-1 standard.

Thanks cs_moni, that is very helpful. I was not aware there was a 60601-1 sub forum, I appreciate the tip.
 
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