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  • 1.  IEC/CD 62304

    Posted 17-May-2017 15:57

    I learned today that IEC/CD 62304 Medical device software -- Software life cycle processes is deleted.

     

    This was to have been the second edition of the standard. The current version is IEC 62304:2006/Amd 1:2015.

     

    Why has the second edition been deleted?

     

     



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    Dan O'Leary
    Swanzey NH
    United States
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  • 2.  RE: IEC/CD 62304

    Posted 19-May-2017 02:24
    Hi Dan

    This is strange - where did you hear that? Actually I just received an email today that the ballot is closed (see below):


    The documents delivered with it didn't say anything regarding a possible deletion.

    Cheers, Beat

    ------------------------------
    Beat U. Steffen
    Founder, CEO
    confinis ag
    Duedingen
    Switzerland
    ------------------------------

    Original Message


  • 3.  RE: IEC/CD 62304

    Posted 19-May-2017 06:55

    I looked at the ISO website.

     

    For IEC 62304:2006, it as an active document with code 90.92 "International standard to be revised". There is also a diagram showing that it will be replaced by IEC/CD 62304.

     

    For IEC 62304:2006/Amd 1:2015, it is an active document with code 60.60 "International standard published". There is also a diagram showing that it will be replaced by IEC/CD 62304.

     

    For IEC/CD 62304, it has the code 30.98 "Project deleted". The diagram has the notation "Now Deleted".

     

    I did not check the IEC website, because the ISO and IEC usually mirror each other for many standards.



    ------------------------------
    Dan O'Leary
    Swanzey NH
    United States
    ------------------------------

    Original Message


  • 4.  RE: IEC/CD 62304

    Posted 19-May-2017 10:26
    I have an email in to the Secretariat, and she has committed to finding out more and letting me know. As soon as I hear something, I will post.


    Original Message


  • 5.  RE: IEC/CD 62304

    Posted 20-May-2017 12:08
      |   view attached
    Hello All,

    Here is the scoop.  The 2nd ed project originally was cancelled in Nov 2014 because it was decided that the scope of the standard had to broaden and also it needed to move to a different committee as the scope broadened to include Health informatics instead of just medical devices which moved it from a Quality Systems committee to a Health Informatics committee.

    The Committee Draft 1 (CD1) vote will close in a couple days on May 26, 2017.  The publication date is estimated at Dec 2019.  I am not sure if the project plan includes an estimate for a CD2 (not normal in all standards projects) but I suspect there will be a lot of comments on this document and therrefore likely a CD2.  I know the committee is meeting in June at AAM I standards week to work on resolutions to comments from this ballot.

    Attached is a slide from a presentation I just did this week in Toronto on a quick standards update segment. 

    If you need more info please  contact me directly at Leo@EisnerSafety.com.  I am on many of the standards committees for the IEC 60601 series of standards and the related standards like IEC 62366 &  62304 I have advance intelligence on and I have access to the conveners and secretariats of many of these standards so I can find out information that is not even public ont he IEC and ISO websites.  I am also a convener of an IEC/ISo standard and I am the US co-chair for IEC SC62D on for many of the Particular standards (IEC 60601-2-xx & IEC/ISO 80601-2-xx stds).  I am also involved heavily in home use healthcare equipment under IEC SC62A and IEC Syc AAL.

    Thx,

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

    Attachment(s)

    pdf
    62304 CD Draft 2nd ed status current May 2017.pdf   135 KB 1 version
    Original Message


  • 6.  RE: IEC/CD 62304

    Posted 21-May-2017 01:25
      |   view attached
    Hello Again,

    I was told I made a slight mistake and attached the wrong slide from my presentation (I put in a slide on the Amendment 2 of IEC 60601-1, 3rd ed. which is in process.).  So, I am attaching 2 slides one on the current version of the standard IEC 62304 ed. 1.1 and the status slide for the draft 2nd ed. of IEC 62304.  Also, see my previous post for more details.

    Cheers,

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

    Original Message


  • 7.  RE: IEC/CD 62304

    Posted 21-May-2017 11:07
    Thanks for the updated information Leo.


    Original Message


  • 8.  RE: IEC/CD 62304

    Posted 24-May-2017 15:57

    I'm confused again.

     

    Today I got an announcement from ANSI that says, "We would like to notify you about the new Amendment to the ANSI/AAMI/IEC 62304 - Medical Device Software - Software Life Cycle Processes standard …"

     

     

    When I went to the link, the standard listed is ANSI/AAMI/IEC 62304:2006/A1:2016.

     

    I infer that this is the same as IEC 62304:2006/Amd 1:2015.

     

    The fact that the amendments have different years, doesn't bother me, sometimes the standards bodies have slow processes.

     

    However, I'm surprised to get an announcement for a new amendment that came out last year.

     

    Could somebody confirm whether the US version is the same as the international version?



    ------------------------------
    Dan O'Leary
    Swanzey NH
    United States
    ------------------------------

    Original Message


  • 9.  RE: IEC/CD 62304

    Posted 25-May-2017 03:13
    Hi Dan,

    Yes, the ANSI/AAMI/IEC 62304:2006/A1:2016 standard is a full adoption of the IEC 62304:2006 / A1:2015 which is published as a Consolidated edition meaning both the edition 1 and it's amendment 1 are combined into one document which is called ed. 1.1.

    Hope that clears things up.

    Thx,

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

    Original Message


  • 10.  RE: IEC/CD 62304

    Posted 25-May-2017 08:04
    This helps.

    Thank you

    ------------------------------
    Dan O'Leary
    Swanzey NH
    United States
    ------------------------------

    Original Message


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