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Does US OSHA NRTL Program make 60601 compliance mandatory?

Discussion in 'IEC 60601 - Medical Electrical Equipment Safety' started by MarkMeer, Dec 4, 2015.

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  1. MarkMeer

    MarkMeer Well-Known Member

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    Bit of a rant here... but I'm hoping I've gone wrong somewhere and someone can correct me...

    So here's the situation (as I see it):
    1. Compliance to 60601 is intended to be a voluntary tool to demonstrate safety and effectiveness.
    2. Much of the hospital/clinical market in the US follows OSHA regulations, and hence has purchasing policies requiring an NRTL mark on purchased medical devices.
    3. In order to mark a medical-device with an NRTL mark, you have to have the device tested to 60601 by an accredited test-lab.

    CONCLUSION: Testing to 60601 (by an accredited test-lab) is de-facto mandatory for organizations seeking to enter the US clinical market.

    Please tell me I've misinterpreted the situation.... :(
    If this is in fact the case, this is a serious barrier to entry for small organizations for at least a couple of reasons:
    1. It requires full compliance testing to not just the base standard (60601-1), but all collaterals as well.
    2. It necessitates that all tests be performed by an accredited test-lab (expensive).

    So, even if the (active) device is simple and safe to begin with - and most safety tests could be easily carried out in-house - a small company must pay tens of thousands for (essentially) the same tests to be carried out by an NRTL?

    Seems to me an unfortunate situation, that disadvantages small businesses...
    MM.
     
  2. Esh14

    Esh14 New Member

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    Hi Markmeer,

    May I know besides the testing to 60601 compliance, what are the testing that we will need to perform to ensure the product safety?
     
  3. MarkMeer

    MarkMeer Well-Known Member

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    Hi Esh14, and Welcome.

    Perhaps this is not the best thread for this question... but the short (albeit unsatisfying) answer is: it depends.

    Ultimately it is up to you to "ensure" product safety through risk management and design decisions.

    What kind of testing you choose to do to gather evidence of safety depends on factors such as:
    - What type of product (medical device?, consumer?, electronics?, battery-operated?, wireless?, radiating?...etc.)
    - What intended use?
    - What markets?

    I suggest perhaps starting a new thread, and detailing these considerations. You'll get more feedback that way.
    Cheers!
    MM
     
  4. Peter Selvey

    Peter Selvey Member

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    With regards to the original post: I think there is a business opportunity for a test lab to offer NRTL marks that basically restrict themselves to the scope of OSHA, rather than the labs that go for the full 601-1 approach. It means the potential for reasonable cost, reasonable scope testing. The OSHA rules allow for this:

    29 CFR 1910.5(d) In the event a standard protects on its face a class of persons larger than employees, the standard shall be applicable under this part only to employees and their employment and places of employment.

    This means that OSHA is about the workers in the health care facility, not the patients. Any requirement which is specifically for the patient can be excluded. In practice, basic items like electric shock might be included; but there could still be a clear limit for excluding complex, highly specialized requirements that are difficult to evaluate by a third party laboratory and specifically for the patient.

    In fact, most of the agencies partly do this, but in a fuzzy, possibly illegal way.

    For example, UL might quote to test some expensive collaterals and particulars, and higher fees to cover risk management, PEMS, IEC 62304 etc, but at the end of the day, they include a disclaimer on their reports and the UL Mark that the scope is for "ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY". And they engineers that do the work are rarely qualified for the full scope: it is impossible to have genuine ability to handle performance, clinical issues, risk, software, electronic protection systems and more, for the wide variety of medical devices that exist. If anything were every to go wrong (e.g. patient wrong diagnosis or treatment), UL's lawyers would quickly point out that it is outside of their scope.

    It means, they charge (a lot) for all this wider evaluation, but then don't take responsibility for it. I am almost sure there are some laws somewhere in the US that make this illegal.

    I pick on UL only because their information is public, the others also the same.

    And the engineers that work in this area are also hurting - they would love to restrict their work to a reasonable scope that is within their genuine experience and qualification. It's only the guys at the top that are eyeing a pot of gold from ever expanding IEC 60601-1 standards ...

    So ... anyone interested? New business?
     
  5. MarkMeer

    MarkMeer Well-Known Member

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    This is a great idea. ...but though I hate to be a pessimist, I have a feeling you can anticipate some obstacles...

    First of all, OSHA must recognize the test lab under their NRTL program. It wouldn't surprise me at all if the NRTL program, with respect to medical devices, simply means 60601 compliance, full-stop (without caveats like 29 CFR 1910.5(d)).

    Granted, I don't know this for certain...but if this is the case, to get this idea off the ground would first mean negotiating a revision of the program to specify which 60601 clauses can be excluded.
     

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