Alex: I agree with most of what you outlined with a few additional comments:
- Regarding your fourth point (and to some extent, your third point), there is an interpretation on this topic (which I requested back in 1996, which an OSHA response in 1997): https://www.osha.gov/laws-regs/standardinterpretations/1997-05-12-0 - Regarding your fifth point, I would clarify that there is no government agency mandated requirement for an NRTL “certification” for the manufacturer. The employer (hospital, medical provider, etc.) is regulated under OSHA, subject to the above interpretation. Also, the some insurance companies may require the use of NRTL listed equipment as a condition of coverage for the facility where the equipment is used (I would include this as part of the market driven requirements which you mentioned). Hope that helps. Ken On Wednesday, July 23, 2025 at 12:18:21 PM EDT, Alex Grob <[email protected]> wrote: Hello Boštjan, There are a couple of overlapping questions in your post below. - 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. - 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. - 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). - 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. - 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 | | | | | | | | | | 140 East Rawson Ave, Suite 301, Oak Creek, WI 53154 USA | | | | Experts in Product Safety 60601-1.com | | MECA is Accredited by the FDA under the ASCA Program: Click here forMore Info | 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 This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. 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