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  • 1.  IEC 60601 & UL

    Posted 22-Jul-2011 15:32

    Lilian Llull
    Techlink International
    Sunny Isles FL
    United States

    I need import several Powerd Muscle Stimulaters (regulation # 890.5860 product codes NFO / NYX). We are in the process to start preparing the 510K's.  The manufacture has the mandatory performace stardand IEC 60601. I don't find anywhere the 21 CRF a reference of UL being a legal mandatory performance standard.
    It is not clear to me if is necessary or not to test these products with UL in order to obtain 510k clearance.
    I also was told that IEC60601 and UL60601 are the same test. Is thais correct? 
    My question is:  ISO 13485 and IEC60601 standards are sufficient to obtaing s 510k's?  Would the FDA turn our submission down for not having UL even if we are SE in every other aspect?

    Thank you very much for your help!

  • 2.  RE:IEC 60601 & UL

    Posted 24-Jul-2011 17:21
    Hi Lillian,

    UL is certainly qualified to complete your IEC 60601 requirements (I presume you are speaking to 60601-1 only), but you are not required to test with them for your 510(k). They are one of the most nationally known test organization, but I always advise geting 2-3 quotations. The test company should make no difference in the evaluation of your 510(k), but you must prove that the proposed device is as safe as the predicate device, which it seems in this case would be partially through electrical safety testing.

    FDA does not include ISO 13485 as a recognized concensus standard and should have no relavence in your 510(k) submission, as this is a quality management standard not a product related standard. 

    IEC 60601 and UL 60601 are essentially the same UL will incorporate any US national differences, as should most test organizations.

    Wherever you end up having the products tested, be sure that the test reports are well documented and reference current versions of the standards as FDA has become increasingly more stringent in their reviews. The FDA would not turn down your submission for not using UL to conduct the test, but if the reports are poorly written and the results are not clear to a reader then you could encounter some resistance on proving SE especially when it comes to the safety aspects of the comparison.

    Jon Ward
    AJW Technology Consultants, Inc.
    Apollo Beach FL
    United States

  • 3.  RE:IEC 60601 & UL

    Posted 25-Jul-2011 12:27
    Jon's message is correct for IEC 60601-1 2nd Edition, however the Third Edition added some requirements that were not specifically called out in the 2nd Edition. 

    Now, all of the applicable Collateral (IEV 60601-1-XX) and Particular Standards (IEC 60601-2-XX) are required for compliance to the standard.  This was not a specific requirement in the Second Edition. Examples are the Usability Collateral, IEC 60601-1-6 and Alarms Collateral IEC 60601-1-8, and the applicable Particular standard for your product ( e.g. IEC 60601-2-52 Medical Beds).  There are some tools you may use to assure a quicker path to compliance in the IECEE Test Report Forms available at the IECEE web page from the main IEC website
    One Collateral Standard that was widely used, IEC 60601-1-4 no longer exists in the Third Edition as a separate document.  It has been  combined into the main standard as IEC 60601-1 Clause 14.  I have seen companies continue to cite it in their product documentation, but this is an incorrect reference and should be removed.

    The additional Third Edition requirements on Risk Management (compliance with ISO 14971, have required the certifying bodies like UL to review the product risk management file, and the Test Report Forms specify exactly what will be examined by UL or other certifying body.  That allows a company to assure the RIsk Management File is complete and ready for review.

    In the US while FDA does not require the use of IEC 60601-1, it is a Recognized Standard under the FDA's Recognized Standard program.  This program also notes that the Collateral and Particular Standards are part of the total recognition.

    A through the back door requirement is the requirement for a product safety mark under the Building Codes to place a product in a healthcare facility.  The common path is the adoption of NFPA 99 in the local or state code.  The product safety mark for electro-medical products is applied through compliance with IEC 60601-1.

    There are still a few bumps in the road ahead in the switch from the 2nd Edition to the Third Edition.  In Canada and the EU this must be accomplished by the end of May 2012.  In the US the FDA has chosen June 10, 2013.  OSHA, which certifies National Recognized Test Labs (NRTL) like UL and ETL has not decided yet about recognition of IEC 60601-1 3rd Edition.  Because of the momentum in the rest of the world chances are they will recognize it by the FDA's date in 2013.

    Hopefully, this explanation has added to your information in making an informed decision.

    Edwin Bills RAC
    Principal Consultant
    Bilanx Consulting LLC
    Sumter SC
    United States