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  • 1.  ANSI/AAMI membership - purchase of standards

    This message was posted by a user wishing to remain anonymous
    Posted 24-Jan-2020 09:58
    This message was posted by a user wishing to remain anonymous

    Hi all, 
    I need to buy several ANSI/AAMI standards (60601, 62304, HE75) that are recognized by FDA and I am considering becoming member of ANSI or AAMI to access some discounts. Also, I noticed that AAMI has a database ("all standards collection" https://my.aami.org/store/subscription.aspx?id=S-IA) that as far as I understand make me access several standards (and also new versions of standards if they come up during my yearly subscription). I don't know if ANSI has something similar.
    My question is: what are pros and cons to buy standards and become member of one (e.g., AAMI) rather than the other (ANSI)?
    Do you access exactly the same content and same number of standards? And what about prices? Any price benefit of using one rather than the other?
    Thanks in advance to anyone that has experience on this topic and can provide suggestions.


  • 2.  RE: ANSI/AAMI membership - purchase of standards

    This message was posted by a user wishing to remain anonymous
    Posted 03-Feb-2020 10:09
    This message was posted by a user wishing to remain anonymous

    Hi all again, 
    anybody that can share his/her experience on the database above or any other smart way to buy standards in start-ups with limited budget?
    Thanks in advance for your help.
    Original Message


  • 3.  RE: ANSI/AAMI membership - purchase of standards

    Posted 04-Feb-2020 02:03
    I don't think ANSI has quite the same db and membership as ANSI and AAMI are very different organizations.

    ANSI is the US National Committee for many of the Standards Development Organizations (SDOs) like AAMI which is one of them. NFPA, ASTM and many others are SDOs.  I am an AAMI corporate member and I have also been an individual member at different times and have signed up for the standards db (or in the past the standards CD) and to me it is a great deal because there is a huge amount of medical device standards in the db that the FDA and many other regulators use that you will need that AAMI publishes that as they update you have access to and also when they publish as new.  Any standard that AAMI is the lead SDO for ISO and IEC you will have access to like IEC 60601-1, IEC 60601-2-2,  IEC 60601-2-58, ISO 13485, ISO 14971, IEC 62366-1, AAMI IEC TIR 62366-2, ISO 62366-2 and many more are available on the list of standard plus the uniquely AAMI standards such as HE75, TIR51, TIR50, and much more.

    ------------------------------
    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: ANSI/AAMI membership - purchase of standards

    This message was posted by a user wishing to remain anonymous
    Posted 04-Feb-2020 09:09
    This message was posted by a user wishing to remain anonymous

    Thank you very much Leonard. Very helpful.
    Best regards.
    Original Message


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