Re: [PSES] CLASSIFIED MARK

Wed, 23 Jul 2025 10:10:53 -0700

I did see a recent decision about products no longer being able to be listed, but only classified, to 60601-1 if they are not actually medical equipment. UL has a document on their web site about this. 

Mike Sherman 
Sherman PSC LLC
On 07/23/2025 10:09 AM CDT Jim Bacher, WB8VSU <[email protected]> wrote:
 
 
Boštjan, if it's used in the work environment it falls under OSHA. Their rules have changed over the years, current rules are at:
 
 
The USA National Electric Code implies anything that attaches to the grid needs a NRTL certification. Some location enforce the requirements, others do not. 
 
You didn't say if your product was electrical or electronic. 
 
Jim Bacher, WB8VSU
JBRC Consulting LLC 
Product EMC & Regulatory Consultant
IEEE Life Senior Member
 

On July 22, 2025 6:02:54 AM Boštjan Glavič <[email protected]> wrote:

Dear all,
 
customer has been informed by an NRTL that they are no longer able to issue NRTL mark for medical product. They can issue only CLASSIFIED MARK.
 
Is there any new rule about it?
 
Probably NRTL mark for medical product is not required - only FDA approval, correct?
 
Thank you for your thoughts.
 
Best regards,
Boštjan
 
 
 

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