Hello Boštjan,
There are a couple of overlapping questions in your post below.
1. Classification is a commonly used type of "certification" of electrical
medial devices by NRTLs. Each NRTL can determine their own words to use to
describe their "certification". Generally, Classification means that only some
aspects of the equipment are covered by the certification. Some NRTLs use this
because they do not evaluate the medical applications and associated hazards as
part of the certification. For example, a Listed toaster oven likely has all
the relevant hazards covered by the product standard. For an X-Ray system the
product standards don't deal with the fact that exposure to radiation is a
hazard...even when used correctly an X-Ray system can still cause harm
(including death) to the patient. Some NRTLs differentiate between these types
of certifications by using Classified instead of Listed or Certified. Usually,
the NRTL Mark has some words associated with the Classification such as "for
electrical, mechanical and thermal hazards only".
* In summary, a Classification by an NTRL is equivalent to a Listing
from the perspective of meeting an OSHA requirement.
1. The FDA is the regulatory body for medical devices (electrical or not) in
the US. An NRTL "certification" is not required for an FDA Approval.
1. The need for an NRTL "certification" for any medical device has been
debated with varying interpretations for at least the last 25 years I have been
in the medical device industry. I work for a testing laboratory that tests
mainly to IEC 60601-1 for medical electrical equipment; we have many customers
that do not get a US NRTL certification for their electrical medical devices.
These customers are able to sell their medical devices in the US usually
without any issues.
* For large medical devices (e.g., X-Ray, MRI) where they are
permanently connected to the building wiring having an NRTL certification is
likely mandated by the installation site or local AHJ (building / electrical
inspector).
1. There is a general OSHA requirement regarding electrical / electronic
products operating above 50 V needing an NRTL "approval", but some read this
section of the regulation as also allowing other options or not applying
specifically to the device, but to its external enclosure and/or power cord. I
try to stay out of these discussions because they are all interpretation /
opinion, I have never found an official (OSHA) interpretation on this topic.
1. Even if there is no mandated requirement for an NRTL "certification" from
a legal / market access perspective, many hospitals, hospital chains and GPOs
require a certification mark on devices they purchase. Having an NTRL
certification may be a market-based requirement rather than a regulatory one.
I hope this helps.
Regards,
Alex
Alex Grob
Chief Biomedical Engineer & Quality Manager
Direct: 262-672-6022
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From: Boštjan Glavič <[email protected]>
Sent: Tuesday, July 22, 2025 5:03 AM
To: [email protected]
Subject: [PSES] CLASSIFIED MARK
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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