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  • 1.  cb scheme mandatory?

    This message was posted by a user wishing to remain anonymous
    Posted 30-Apr-2021 08:55
    This message was posted by a user wishing to remain anonymous

    Hello,
    is CB scheme mandatory for 60601-1 reports for FDA submission?
    Thanks for your kind answers


  • 2.  RE: cb scheme mandatory?

    Posted 01-May-2021 06:03
    Hello Anon,

    CB Scheme is not mandatory for any regulatory agency, however, it does provide more acceptance of the testing which is done by an accredited testing facility.  Keep in mind the US FDA has a current recognised standard for IEC 60601-1 testing which is ANSI/AAMI ES60601-1 here: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=32316.  While CB Scheme will be helpful for US compliance, you should really make sure the testing laboratory is testing to ANSI/AAMI ES60601-1 specific to the U.S. requirements.  The 60601-1 testing report should have a section concerning Country Specific testing which lists the US and ES60601-1.

    ------------------------------
    Richard Vincins RAC
    Vice President Global Regulatory Affairs
    Oriel STAT A MATRIX - ENTERPRISE
    ------------------------------

    Original Message


  • 3.  RE: cb scheme mandatory?

    Posted 01-May-2021 16:38
    To expand a little more on Richard's. response see below:

    At a minimum you should be getting the CB Scheme TRF (Test Report Form) checklists the good test labs use as they are members of the CB Scheme (not all test labs are members of the CB scheme) with the national deviation (country-specific checklist) testing completed with passing results would be the main goal.  So, should look something like test to IEC 60601-1, 60601-1-2, & 60601-1-6
    Test IEC 62304 & 623666-1 (won't show up on certificate though)
    60601-1-8, 60601-1-9, 60601-1-10, 60601-1-11, 60601-1-12 (as applicable to the device) 
    Request national (country specific) deviations for  all the above standards.

    ------------------------------
    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 scheme mandatory?

    This message was posted by a user wishing to remain anonymous
    Posted 03-May-2021 08:31
    This message was posted by a user wishing to remain anonymous

    Thank you both. When we chose our testing lab, a RA collegue told me to give priority to NRTL certification than CB scheme, as this latter was not mandatory and was an extra burden and cost. So, we opted for an NRTL testing lab and asked the lab test according to ANSI/AAMI version of the standard (US deviation).

    Now we have just hired a consultant for the 510k assembly and the consultant asked for CB scheme. So now I am a little bit puzzled and I hope we didn't do a bad choice in the past.
    Please advise.
    Thanks
    Original Message


  • 5.  RE: cb scheme mandatory?

    Posted 05-May-2021 17:17
    You can ask your test lab that issues CB scheme reports (TRFs) for the TRFs without paying for the certificates usually for no additional charge.  The CB style TRFs is what most good test labs will use for their test reports for all their test reports.  You usually pay for the CB certificate.  I hope that helps clarify the issue.

    ------------------------------
    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


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