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CB Scheme IEC 61010 / IEC 60601...+ NRTL mark

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Tim LAWTON

#1
Dear All,

I'm new to this forum, although not new to Regulatory Affairs.

I am currently looking a the CB Schemes and also the different marks given by NRTL (National Recognisd Testing Laboratories), as well as the OSHA requirements for Medical Devices.

I know there exists no list that shows which NRTL mark is best suited to
which type of customer.
Clearly reputation shows that the best known marks are UL, CSA, ETL, TUV ...
However, there over the last few years become a large pricing difference between certain marks, or at least this is the case in France.

Has anyone been through the process of analysis, and come up with any conclusions.

Best regards

Tim

PS : I'm impressed with the level & quality of the forums associated.
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#3
Re: CB Scheme IEC 61010 / IEC 60601...+NRTL mark

I will try to shed some light.....

Each of the organizations listed (UL, CSA, ETL, TUV) are in fact NRTLs, but the mark is controlled as a part of the ISO Guide 65 accreditation that they carry.....

There may well be more NRTLs, but many do not issue marks for products as they do not certify the products.....the NRTL actually refers to the testing, not the certification.....

Each of these organizations have test labs as a part of the overall organization.....the labs are accredited (typically) to ISO/IEC 17025.....inspection after the listing is also a component of the listing and so each also has an inspection body that is (typically) accredited to ISO/IEC 17020.....the NRTL is a unique designation not specifically covered by ISO/IEC 17025.....

Each can test the product in their accredited lab, certify the product under their ISO Guide 65 accreditation, and then monitor them with the accredited inspection body.....the lab and agency provide reports to the certification arm to support the certification.....

Each can also test as a NRTL.....the reports again are fed into the certification body component of the organization.....or, the lab can test as a NRTL and simply provide the report to the customer.....

So, one question to ask is, do you need the mark, or only the NRTL report?

Hope this helps.

Hershal
 
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Tim LAWTON

#4
Dear Hershal,
You are correct in your description of the role of the NRTL.

Although, with regard to OSHA they consider that the NRTL’s follow the US regulations (within the 29 CFR 1910 etc). And personnaly, I am not sure of the differences between ISO17025 & the differences – but that is not really the objective of my posting.

However, your last point « do you need the mark, or only the NRTL report” should be taken a little further.
Let me make several statements/comments/questions, against which please feel free to comment :

- a « Testing Laboratory» in Europe is not necessary recognised as an NRTL recognised by OSHA.

- the CB Scheme of an IEC 61010-1 2nd Ed, with US derogations can be issued from a non recognised an NRTL, will this allow commercialisation in the US ?

- Products without the IEC 61010-1 2nd Ed (with US derogation) cannot be sold in the US ?

- There appears that there is no requirement that a medical device shall have the NRTL mark. The mark simplifies the “commercialisation” & presentation of the product to the customer - but is it sufficient just to have the report. NOTE : the mark requires annual inspection fees and in some case membership. Any thoughts ?


Best regards

Tim
 
T

Ttraveller

#5
It seems like every time I think I know the answer to who is cheapest and also timely things change. Currently UL & CSA are close to par and are taking a long time for a simple time for medical device safety projects per 60601 series of standard in the time frame of min 10 - 12 weeks. I have found a way around that by goinbg thru a lab that is a certified lab by all the big Test Agencies (i.e. Ul, CSA, Nemko, ETL, etc.). If you would like to discuss directly please feel free to download my vcard and contact me.
Leo Eisner
 
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