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

D

drewsky1

#41
Thank you for your response. I think there may have been some communication gap as you suggest as this is what was told to me not directly from the consultant. I will discuss with consultant directly and hopefully get clarification this week and let you know. I appreciate your input.
 
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Peter Selvey

Staff member
Super Moderator
#42
It's a while back, but there is an nice history from Mike (Post #33) on NRTL and OSHA, which triggered a question or two.

I always thought the NRTL scope was the same as OSHAs, i.e. limited to workers and not patients. But according to that post (#33), this is not true.

For medical this is rather important since there are a lot of issues which are outside of OSHA's competence, like performance and clinical safety. For NRTL accreditation audits, this means OSHA's auditors would need to have a suitable background to verify that the NRTL's are competent, which is not practical for OSHA.

Although performance/clinical already existed in the 2nd edition, it's more obvious and broadly applied in the 3rd edition.

Perhaps this is the real reason OSHA is reluctant to take on the 3rd edition?

It's been reported that OSHA is slow to adopt the 3rd ed because it does not like risk management, but that does not ring true. I'm sure risk management is being adopted in many other areas (e.g. machinery) and OSHA would be happily engaging in this trend like many other agencies.

Rather, it seems far more likely OSHA is reluctant because the medical standards are growing beyond what they can practically handle in a laboratory accreditation scheme.

Anybody have any relevant information to share?
 
D

drewsky1

#43
After further investigation, the consultant has indicated that if we decide to remove the exisiting UL symbol from our labeling after UL has tested our device to the 3rd edition of IEC60601-1, it would still be required that they would need to audit our manufacturing facility at a fee. As we would remove the UL symbol from our labeling, we would not contract a service agreement with them and don't feel this is necessary. However the consultant disagrees. Are you familair with this scenario at all?
 
M

MIREGMGR

#44
After further investigation, the consultant has indicated that if we decide to remove the exisiting UL symbol from our labeling after UL has tested our device to the 3rd edition of IEC60601-1, it would still be required that they would need to audit our manufacturing facility at a fee. As we would remove the UL symbol from our labeling, we would not contract a service agreement with them and don't feel this is necessary. However the consultant disagrees. Are you familair with this scenario at all?
That scenario is a contract matter, not determined by regulatory requirements. I would guess that the earlier contract between your firm and UL under which the existing UL symbol was applied may have contained language that UL regards as establishing a continuing or surviving obligation. I'd suggest that you work with your lawyer to determine how to proceed.
 
D

drewsky1

#45
Thank you. Next step is to review all current contracts with UL and contact legal if necessary.
 
W

Waterman956

#46
Not many if any hospitals will accept a electro-mechanical device without UL, ETL, TUV or CSA safety mark on it.

Any of these marks are accepted by law. If your testing was done by an accredit lab for your CE Mark you are almost home. Then all you will need is test to national differences for USA and Canada if going for Canada.

If your CE test was not done by an accredited lab the accredited labs may or may not accept the test reports.
 
#47
Apology for using older thread.

We have a customer who sells his final products to USA market. Their final products are UL recognized.

We do the assembly for the sub-assemblies. The materials used are UL listed etc.

My question is: as we need to provide traceablity for UL, does this need to be to the component level -- 100% ? That is - to know every single component of our sub-assembly can be traced back to the batch no to our suppliers? We have traceability in place but not 100%. That is - we can't know exact batch no. of the let's say wire used.
 
#49
Thank you for the reply.

I was following the instructions as written in the UL_traceability_requirements document

as well as the info on the web page (Electornicsweekly), where they state, you must basically have 100% traceability system in place.

I'm struggling to understand, in case we assemble a part, which is used in a UL "certified" product, we must provide proof/traceability for let's say all injection moulded parts, wires, etc...

So from UL's requirements perspective, I'm wondering if it would be enough to confirm the usage of "UL material" for our assembly or would we need to provide all possible documentation as well as lot numbers of materials used for each shippment...

I was trying to obtain more info from UL but just got general information. No companies near by are familiar with UL..
 

Al Rosen

Staff member
Super Moderator
#50
Thank you for the reply.

I was following the instructions as written in the UL_traceability_requirements document

as well as the info on the web page (Electornicsweekly), where they state, you must basically have 100% traceability system in place.

I'm struggling to understand, in case we assemble a part, which is used in a UL "certified" product, we must provide proof/traceability for let's say all injection moulded parts, wires, etc...

So from UL's requirements perspective, I'm wondering if it would be enough to confirm the usage of "UL material" for our assembly or would we need to provide all possible documentation as well as lot numbers of materials used for each shippment...

I was trying to obtain more info from UL but just got general information. No companies near by are familiar with UL..
I think that the requirement is for the critical items listed in the report. You should discuss this with the UL engineer working on your project.
 
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