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  • 1.  CB Test (IEC 60601-1)

    This message was posted by a user wishing to remain anonymous
    Posted 03-Feb-2022 10:20
    This message was posted by a user wishing to remain anonymous

    Dear RAPS members,

    I have a question regarding  CB test requirements w.r.t applied standards. Is it normal for the test lab to request document compliance as per a withdrawn standard? They say certain standards under the CB scheme are still not state of the art.

    Does anyone experience a similar request?

    Thanks!


  • 2.  RE: CB Test (IEC 60601-1)

    Posted 04-Feb-2022 09:09
    Yes, this is very common. If a standard has a "dated reference", that is a reference such as 60601-1-6:2010+A1:2013, the lab is required to use that specific version of the standard. If the reference is undated, such as IEC 60086-4, then the most recent version of the standard should be used. There are many reasons why the standards committees use dated reference but I wont go into that here.

    There are a few ways around this:
    1. Ask the lab for compliance to both standards - In some instances this is much easier than others.
    2. Depending on your applicable standard, you may be able to leverage "alternative risk control measures" such as 4.5 in 60601-1. This would allow you to use your risk management process to justify compliance with the state of the art standard.

    If I can be of any further assistance, please reach out.

    ------------------------------
    Wade Munsch
    Regulatory Affairs Manager
    Biotex, Inc.
    Houston TX
    United States
    Website: www.biotexmedical.com
    ------------------------------

    Original Message


  • 3.  RE: CB Test (IEC 60601-1)

    Posted 05-Feb-2022 03:04
    Wade is a good person to ask questions on CB scheme as he used to work at a test lab in his prior life to being in "industry".  One of the issues he didn't mention that becomes a problem with EU standards that are Harmonized, so per say currently more the Medical Device DIrective Harmonizd Standards as there are no 60601 based Harmonized standards under the MDR yet, they don't allow for undated references which then becomes a amjor issue. 

    But that issue is sort of being addressed but is a tough nut to crack as the EC/EU really doesn't like to break from undated references as noted in a draft document that was discussed at the EC Medical Device Coordination Group (MDCG) Subgroup on Standards (Working Group 2) that met on 28 Jan 2022.  The topic that was discussed was the "Cookbook" for writing harmonized standards under MDR/IVDR by CLC TC62 (Basically CENELEC version of IEC TC62 which is the technical committee for IEC 60601 series of standards).  In the MDCG WG2 they discussed that first developing this "cookbook" for the development of harmonized standards for electrical medical devices (which has been the intent of CLC TC62's prior to the discussion at MDCG WG2 mtg as it has been worked on for awhile) and then potentially adopting the concept being extended to other types of standards for medical devices.  But I hope to see some success with the 60601 series of standards first as the 60601 series of standards hit some major road blocks with the harmonization process in the last 5 - 7 years of the MDD Harmonization process so maybe things will be smoother now but I'm not holding my breath knowing all that I know and have seen of the process and the players.  Sorry I really wish I could be more optimistic about the process just I have seen too many roadblocks come up and the cookbook draft I've seen is better than it was about a year ago but it sure needs to get over a lot of roadblocks still to make it really successful and useful for manufacturers to be happy with the process, would be my belief and opinion.  

    There are undated references to standards in the 60601 series because the standards writers want to rely on the most recent version of a standard in some cases (like for Lithium batteries, IEC 62133 is undated so you have to stay up to date with the most recent standard) once the referenced standard (the normative standard, i.e. IEC 62133) gets updated instead of waiting for the standard (say IEC 60601-1 being updated which may have to wait 5 - 10 years or more before it is updated and then that reference may be even that much older so things snow ball).  In clause 2 of IEC 60601-1 Normative references says: "...    For undated references, the latest edition of the referenced document (including any amendments) applies."

    ------------------------------
    Leonard (Leo) Eisner, P.E.
    The "IEC 60601 Guy"
    Principal Consultant, Eisner Safety Consultants
    Phone: (503) 244-6151
    Mobile: (503) 709-8328
    Email: Leo@EisnerSafety.com
    Website: www.EisnerSafety.com
    ------------------------------

    Original Message


  • 4.  RE: CB Test (IEC 60601-1)

    This message was posted by a user wishing to remain anonymous
    Posted 08-Feb-2022 08:59
    This message was posted by a user wishing to remain anonymous

    Thanks a lot for your feedback!
    The standard that the lab was referring to was IEC 62366-1 for usability.

    Also, do you have experience with IEC 60601-1-9 requirements for Brazil?
    Original Message


  • 5.  RE: CB Test (IEC 60601-1)

    Posted 08-Feb-2022 09:41
    I would be happy to discuss your needs with you further if you want to reach out to me directly (wade.munsch@biotexmedical.com).

    ------------------------------
    Wade Munsch
    Regulatory Affairs Manager
    Biotex, Inc.
    Houston TX
    United States
    Website: www.biotexmedical.com
    ------------------------------

    Original Message


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