Do I need to have UL or TUV or other mark to sell device in USA

M

maple68

#11
Thanks NickM.

It looks we can choose any of the NRTLs. I'm just wondering if any difference on the cost.

Thanks again,
 
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M

MIREGMGR

#12
(...) here is a list of NRTL's that are accredited to certify to UL 60601-1 (...)
As if this topic weren't already overly detail-laden: for some products and issues it's important to keep sight that the US national standard is ANSI/AAMI ES60601-1:2005...which has some national deviations from IEC 60601-1:2005...and while UL 60601-1 used to be a specific standard that differed in yet a third direction, more recently it's been treated as more of a process or range of approval capabilities, adjusted by UL as appropriate for a specific project to fit the nature of the target product and its compliance requirements.
 
M

MIREGMGR

#13
(...) here is a list of NRTL's that are accredited to certify to UL 60601-1 in the US:
  • Canadian Standards Association (CSA)
  • Curtis-Straus LLC (CSL)
  • Intertek Testing Services NA, Inc. (ITSNA)
  • MET Laboratories, Inc. (MET)
  • National Technical Systems, Inc. (NTS)
  • QPS Evaluation Services Inc. (QPS)
  • SGS U.S. Testing Company, Inc. (SGSUS)
  • TÜV SÜD America, Inc. (TUVAM)
  • TÜV SÜD Product Services GmbH (TUVPSG)
  • TUV Rheinland of North America, Inc. (TUV)
  • Underwriters Laboratories Inc. (UL)
As a further detail...many people are familiar with the ETL mark. ETL was a pioneer in the obscure-competitor-of-UL space, as a certifier of electrical products. As a result of a merger, the ETL mark is now part of Intertek.
 
N

NickM

#14
Here are a few suggestions:

1) If you have any products already certified by an NRTL, start with that NRTL. If not, then do the following.
2) If you are in the US, then just get some quotes from a few of the NRTL's. You will probably find varying pricing and time estimates.
3) If you are outside the US, you may want to see which NRTL has more capabilities that is closer to where you are.
4) If you plan on selling in Canada, you will want to make sure your certification covers the Canadian requirements and that the test lab you are using is accredited by both OSHA and the SCC for your type of equipment.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#15
Here are a few suggestions:

3) If you are outside the US, you may want to see which NRTL has more capabilities that is closer to where you are.
4) If you plan on selling in Canada, you will want to make sure your certification covers the Canadian requirements and that the test lab you are using is accredited by both OSHA and the SCC for your type of equipment.
Excellent points. Since the OP mentioned having the product already CE-Marked, s/he should contact the Notified Body and see if they either are or have connections to a North American based NRTL, including a Health Canada approved CMDCAS CB.
 

somashekar

Staff member
Super Moderator
#16
Perhaps a mark having both c and us that indicates alignment to both countries requirements of the north america....
Like the cULus mark
 

Peter Selvey

Staff member
Super Moderator
#19
As many have already indicated, it's not mandatory for regulatory purpose but may be necessary for sales.

In choosing an NRTL (UL, TUVs, ETL CSA etc), you might quiz the NRTL on how they plan to handle the 3rd edition and requirements outside of OSHA's scope.

The NRTL rules are limited to occupational health and safety (i.e. workers in the health care environment, not the patient). Modern standards for medical devices have expanded far (far) beyond this scope, so it is important for NRTLs to set a reasonable boundary for their mark. Each NRTL will set their own policy, this policy will determine how expensive and complicated compliance testing and factory inspections will be.

Quiz the NRTL on this point. If they say they plan to limit to "basic safety" only (shock/fire/mechanical), sounds like a good NRTL. But make sure thier quotes, scope of tests and fees reflect this policy.

If they say they want to test everything, run away.

If they don't understand the question, run away.

And worst, if they quote and charge you to test everything but their reports quietly have a disclaimer on page 3 saying they only take responsibility for basic safety (yes, you know who you are ...), run away.
 
Last edited:
M

MIREGMGR

#20
Quiz the NRTL on this point. If they say they plan to limit to "basic safety" only (shock/fire/mechanical), sounds like a good NRTL. But make sure thier quotes, scope of tests and fees reflect this policy.

If they say they want to test everything, run away.
I, for one, would philosophically disagree with this. The company for which I work wants its products to be fully reviewed.

We do like third party relationships where we're on the same wavelength regarding finding practical ways to accomplish the underlying goal of a standard's application to medical devices, in those instances where the specific language of a standard isn't quite a good fit or wasn't well drafted. On the other hand, we don't like third party relationships where segments of the standard are excluded from review because it's easier for the third party, or they think they know better than us what we actually need and want.

And, note that if a key purpose of the review is to certify to European or US authorities that the device complies with the standard, and an auditor or reviewer detects that the third party excluded part of the standard from the review, your device clearance process is likely to grind to a halt.
 
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