Will buyers (hospitals) require IEC 60601, even when FDA does not?

D

dartas

#1
Hi everyone,

Here's my question. I hope this is the right forum.

My company is producing an electronic medical device for use in operating rooms. We have been advised by the FDA that we will be a class I device. As a result, it looks like we won't need to comply with IEC 60601-1 for their sake.

Is there any other reason to comply when selling strictly in the US? Will hospitals perhaps demand it, even though the FDA does not? I realize that we will likely need it for overseas sales, but we don't intend to sell the current version of the product outside the US. We will be designing a version 2 in the near future for international sales, and would like to wait until then for 60601-1 if possible.

Thanks in advance for any insight you can offer.
 
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M

MIREGMGR

#2
Essentially all hospitals in the US are subject to a state or city electrical code, enforced by a permitting and inspection process. Most such electrical codes, and particularly the (advisory in spite of the name) National Electrical Code published by NFPA and by far the most widely used code, essentially require that electrical equipment have an NRTL Listing or Labeling status, indicating that the equipment has been reviewed and determined to be safe. If your equipment is for permanent installation, the local inspector is likely to require such a status. If it is for plug power connection, the hospital itself often will have such a requirement based on the applicable electrical code, because the hospital's lawyers regard such conformance as providing a stronger liability stance, the hospital's top engineer regards it as indicative of greater safety, and the hospital's insurors regard it as correlated with lower claims.

Most NRTLs will expect an item of electrical medical equipment to conform to IEC 60601-1 as a condition of Listing or Labeling. Talk to your choice of NRTL for more specific information.
 
M

MIREGMGR

#4
The US norm is for what I discussed to be effectively required in a given electrical code enforcement jurisdiction.

However, since there are fifty to a hundred electrical code systems (each state, plus many larger cities) in the US, and each local code enforcement jurisdiction (generally speaking, any governmental jurisdiction large enough to legally quality as a city and large enough to have a professional fire department) has its own inspectors and its own enforcement policies, there could be an exception somewhere that I'm not familiar with.

"Mandatory" implies, at least to me, that something is required by a broadly applicable law. As I explained, that's not how US electrical codes work. The only exceptions to that would be in regard to workplaces where OSHA is applicable, with regard to the subset of the National Electrical Code that OSHA requires, and in regard to US military bases which have their own uniform electrical code requirements (based, I think, on the National Electrical Code).
 
T

tomshoup

#5
I second what MIREGMGR has said relative to 60601-1 being "mandatory." While it may not be mandatory from strictly a regulatory perspective, not complying with it could be a hindrance from a market perspective.

Some customers may refuse to buy the equipment if it does not have a mark on it from a NRTL, driven strictly by their own buying policies, labor agreements with unions, or local regulations. To get a NRTL mark, you'll have to comply with 60601-1 (actually the AAMI version, since it is harmonized to the US electrical code).

This is a good example of where understanding the device requirements from all perspectives is important.
 

Peter Selvey

Staff member
Super Moderator
#6
I've heard a different story but with the same result. For some equipment, NRTL marks are mandatory (written into the electrical code), but in general medical devices are excluded. Instead, it's basically OH&S insurance driven. Hospitals pay an insurance against workplace injuries, like any large organization. Insurance fees are reduced if electrical equipment has an NRTL mark. End result is the same, you will have trouble selling to hospitals if you don't have an NRTL mark, which is currently based on UL 60601-1:2003 (for equipment that deals direct with the patient, UL61010-1 for laboratory, and others as appropriate).

But it's not absolute, small health care facilities don't seem to care, and even large ones may have special procedures to accept non NRTL equipment.
 
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