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Nomenclature on Standards: +A1:2020 or /AMD1:2020

  • 1.  Nomenclature on Standards: +A1:2020 or /AMD1:2020

    This message was posted by a user wishing to remain anonymous
    Posted 19-Apr-2021 17:54
    This message was posted by a user wishing to remain anonymous

    When referring to amendments on standards, what is correct?

    • +A1:2020 or
    • /AMD1:2020

    For example, is it

    • IEC 62366-1:2015 + A1:2020 or
    • IEc 62366-1:2015/AMD1:2020


  • 2.  RE: Nomenclature on Standards: +A1:2020 or /AMD1:2020

    Posted 20-Apr-2021 04:32
    I think you will find it used interchangeably.  Depending on the source you are referring, I have seen it done both ways.  I am not sure of a "legitimate" way but may others have a specific reference on how these should be specified.  Myself sometimes I like to keep it simple and just refer to current version, e.g. IEC 62366-1:2020.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: Nomenclature on Standards: +A1:2020 or /AMD1:2020

    Posted 20-Apr-2021 09:26

    It is very important to cite the exact version of a standard used. Far too often, I see companies cite standards without the version, then, after the standard changes, the company can't easily determine the standard used.

    Also, some regulatory regions make changes. For example, ISO 13485:2016 and EN ISO 13485:2016 are not the same. In addition, the current version is EN ISO 13485:2016/AC:2018 which includes a correction to the base EU version.

    If you check the IEC Webstore page it lists IEC 62366-1:2015/AMD1:2020. This is a 38 page document and is, I believe the amendment only, not the base document as amended.

    On the IEC page there is a history of the document.

    IEC 62366-1:2015+AMD1:2020 CSV is the consolidated version, It includes both the base standard and the amendment and is 246 pages. IEC also uses versions; this is version 1.1. Its predecessors are version 1.0.

    The version 1.0 predecessors include IEC 62366-1:2015/COR1:2016 and IEC 62366-1:2015.



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    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
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    Original Message


  • 4.  RE: Nomenclature on Standards: +A1:2020 or /AMD1:2020

    Posted 20-Apr-2021 10:02
    I agree with Dan, in this case, it is critical to be as precise as possible when referring to the country if you are using country standards.

    I prefer not to use country standards, on my first cut when possible, by using International standards (IEC/ISO/ASTM) starting as the majority of the requirements are covered in these standards and then I add in the national requirements for the applicable countries.  I do a very thorough analysis for any project to determine the applicable national standard deviations, and regulatory laws, guidances, directives, regulations, etc. that may apply to the product under consideration.  This is an early step in the project that should be done by all.  But I don't see this being done by many when I talk to many out there in industry which is hard to understand.

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


  • 5.  RE: Nomenclature on Standards: +A1:2020 or /AMD1:2020

    This message was posted by a user wishing to remain anonymous
    Posted 20-Apr-2021 17:15
    This message was posted by a user wishing to remain anonymous

    Thank you for the replies. I did not realize that the "/"  means the amendment only whereas the "+" and the "CSV" imply the amendment and the preceding standard it amended . So the two bulleted items above are NOT the same and cannot be used interchangeably. Learn something new everyday!

    Now it is between:

    +A1:2020 CSV or
    +AMD1:2020 CSV

    BSI seems to prefer the first option, IEC and ISO webstore use the second option, but it takes up more space in a table.
    Original Message


  • 6.  RE: Nomenclature on Standards: +A1:2020 or /AMD1:2020

    Posted 21-Apr-2021 10:05

    Cite the standard you are using as exactly on the standard.

    If you are using a BSI standard it probably starts with "BSI EN ISO", "BSI EN", or "BSI EN IEC".

    Each standards organization adds their identify by an additional prefix. However, for a long time Cenelec didn't include "IEC", but seems to have changed.

    When you have an EN standard, a member standards body publishes it. However, the base standard and any Z-annexes don't change from the issuing standards body.

    There is a convention, as a result, to drop the country prefix, and start with EN. The publishing country is not relevant to the technical content. Because of cost, many companies obtain standards from Estonia.



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    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
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    Original Message


  • 7.  RE: Nomenclature on Standards: +A1:2020 or /AMD1:2020

    Posted 21-Apr-2021 10:34
    There can be country requirements within Europe that are critical when it comes to Electrical requirements especially to mains side issues like the electrical panel so national electrical code requirements, etc. and so some national standards do have national deviations that are important to be aware of.   This fall under the IEC CB Scheme.

    PS under the CENELEC side of things for EN standards it is still rare to see reference to EN standards that they reference the IEC standards as EN IEC XXXX standards I am still seeing them as EN XXXX.  So, that one point I slightly disagree with Dan on.  Just what I see.   But agree with what he says on the above post otherwise.


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


  • 8.  RE: Nomenclature on Standards: +A1:2020 or /AMD1:2020

    Posted 24-Apr-2021 14:19

    I found some examples of EN IEC standards. I had been working on the EMC directive for a product that is not a medical device. I found these on the CENELEC website and picked some 2021 examples.

    EN IEC 61058-2-1:2021 Switches for appliances - Part 2-1: Particular requirements for cord switches

    EN IEC 61010-2-034:2021 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-034: Particular requirements for measurement equipment for insulation resistance and test equipment for electric strength



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    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
    ------------------------------

    Original Message


  • 9.  RE: Nomenclature on Standards: +A1:2020 or /AMD1:2020

    Posted 24-Apr-2021 14:26
    Probably something with inconsistencies between Directives / Regulations but who knows??????

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


  • 10.  RE: Nomenclature on Standards: +A1:2020 or /AMD1:2020

    Posted 25-Apr-2021 08:58
    And this one referenced in EN ISO 14971:2012 - EN IEC 60812:2018.

    ------------------------------
    Michael Wienholt RAC
    Owner & Principal Consultant
    FDA Consulting, LLC
    Raleigh NC
    United States
    ------------------------------

    Original Message


  • 11.  RE: Nomenclature on Standards: +A1:2020 or /AMD1:2020

    Posted 26-Apr-2021 08:53
    How is it possible to find a standard referenced in EN ISO 14971:2012 that is published six years after the publication? I think there must be some error in your statement because it is an impossible situation. EN ISO 14971:2012 cannot be revised to include a 2018 standard (six years after publication of the 2012) without a date change to EN ISO 14971:2012.

    I am not aware of any such revision.

    ------------------------------
    Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
    Principal Consultant
    Edwin Bills Consultant
    Overland Park KS
    United States
    elb@edwinbillsconsultant.com
    ------------------------------

    Original Message


  • 12.  RE: Nomenclature on Standards: +A1:2020 or /AMD1:2020

    Posted 26-Apr-2021 09:00
    Thank you, Edwin for pointing out the factual error. The reference is to IEC 60812. I have cited the current EN version of the standard.

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    Michael Wienholt RAC
    Owner & Principal Consultant
    FDA Consulting, LLC
    Raleigh NC
    United States
    ------------------------------

    Original Message


  • 13.  RE: Nomenclature on Standards: +A1:2020 or /AMD1:2020

    This message was posted by a user wishing to remain anonymous
    Posted 13-May-2021 15:17
    This message was posted by a user wishing to remain anonymous

    Bringing this thread back to see if folks agree with me that there is an error on BSI Compliance Navigator:

    They have BS EN 62366‑1:2015+A1:2020. It's large so seems to be the consolidated version, not just the amendment.

    However, they say at the top: International relationships: IEC 62366-1:2015/AMD1:2020 Identical

    I believe this last statement is in error because it says it is identical to the amendment only, not the consolidated version. I believe the identical version is instead IEC 62366-1:2015+AMD1:2020 CSV

    Is my observation of this error correct?
    Original Message


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