If ME equipment of any kinds should have NRTL mark when sold in North America?

[Roland chung]

Hello folks,

Please help to clarify that if ME equipment of any kinds should have NRTL mark when sold in North America. I have even seen some ME equipments without NRTL mark in US market.

Thanks and kind regards,
Roland

[Pads38]

The requirement for a NRTL mark comes from the US Occupational Safety and Health Administration (OSHA). Basically, all electrical equipment that is INSTALLED in a US workplace must carry a NRTL mark.

But a piece of equipment that is simply plugged-in is not installed so is not covered. So a wall mounted (wired in) light may need the mark whilst a plug in EKG monitor does not, strictly, need it. However, many health care establishments insist on everything having the mark and will not buy a device that does not have it.

[Roland chung]

Thank you for the input.

Yes, I know OSHA takes charge of the NRTL mark. OSHA's jurisdiction is limited to safety of employees in the workplace. I have no idea if there is an official list shows what kinds of products must a NRTL mark bear.

I have another question related to FDA clearance. As we know, FDA has recognized AAMI ES60601-1:2005 and 2nd edition of 60601-1 will be accepted until June 30,2013. I am applying for FDA clearance and the products have been tested per 60601-1_2nd + US deviations. Do I need to re-test the products per AAMI/ANSI 60601-1: 2005 after the transitional period (June 30,2013)? I heard that FDA would only require new products to meet the new standard. If so, what is the definition of new product? Can I get an official version?

[Peter Selvey]

Generally medical equipment falls under the voluntary section of OSHA's regulation, i.e. an NRTL mark is not required for regulatory purpose.

I heard once that NRTL marks can influence the insurance fees an organization pays against the injury of workers. If for example, a hospital purchasing policy only allows NRTL marked equipment, they can get lower fees. Not sure if it is true but it makes sense.

[MIREGMGR]

With regard to permanently installed (i.e. wired-in) electrical equipment, essentially all US jurisdictions enforce a building/electrical code as a part of their regulation of fire and structural safety. Most US local electrical codes are based-by-adoption on a model code published by a national organization...the most prominent by far being the National Electrical Code (NEC). The NEC is published, and updated roughly every three years, by the National Fire Protection Association (NFPA). Among its other requirements, the NEC mandates that permanently installed/wired electrical equipment, and in some uses plug-connected equipment as well, must have an NRTL mark indicating suitability.

Many insurors of commercial and industrial establishments require that building and electrical codes must be complied with. Sometimes claims will be denied when investigation shows that an applicable code was not complied with.

This requirement has nothing to do with OSHA requirements, and long predates the creation of OSHA.

[Roland chung]

Thank you, guys.

Could somebody give an opinion on my FDA clearance question?

I have another question related to FDA clearance. As we know, FDA has recognized AAMI ES60601-1:2005 and 2nd edition of 60601-1 will be accepted until June 30,2013. I am applying for FDA clearance and the products have been tested per 60601-1_2nd + US deviations. Do I need to re-test the products per AAMI/ANSI 60601-1: 2005 after the transitional period (June 30,2013)? I heard that FDA would only require new products to meet the new standard. If so, what is the definition of new product? Can I get an official version?

[raymond02302]

No, change of consensus standard dose not have any reretroactively effect on the status of the product's clearance.

you can refer to the information below (extracted from "Guidance for Industry and FDA Staff Frequently Asked Questions on Recognition of Consensus Standards" issued on Sep 17,2007)

9. Will changes in a recognized standard affect my previously cleared or approved product?
No. Changes in a recognized standard do not retroactively affect a product’s clearance or approval status.

[MIREGMGR]

Note however that in the event that a single change or series of changes to an existing device crosses the threshold for filing of a product-change 510(k), standards revisions may become applicable to the device. This is murky territory, since the re-examination process is not rigorously guided. The standards compliance section of the 510(k) is an obvious problem area, but other problems may exist as well. My understanding is that a risk analysis filed with a product-change 510(k) will have to analyze safety and effectiveness in regard to current Recognized Consensus Standards, whether or not those standards were applied to the original design.

Also note that this area is ripe for radical change if/when harmonization goes forward. There is certain to have to be a negotiation between FDA and EU, for instance, regarding who will change what requirements to achieve harmonization, and I think the general expectation is that each side will revise a few areas. My guess is that this is an area where the FDA will willingly adopt the MDD approach. I'd further expect that starting soon, such changes will begin to be supposedly-unilaterally adopted by FDA one at a time, based on their knowledge of behind-the-scenes discussions, so as to diminish the mass of changes that will occur at the time of eventual official harmonization.