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ISO 15223-1:2021

  • 1.  ISO 15223-1:2021

    Posted 06-Jul-2021 06:13
    It has happened.... Stage 60.60 - PUBLISHED!!
    ISO 15223-1:2021,  Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements

    The new 4th edition of this standard includes 20 new symbols to support the requirements of the EU MDR, as well as additional pre-existing symbols for use on patient implant cards. The ISO version is available for purchase at ISO 15223-1:2021

    The EN version, available on the CEN and all 34 CEN member country websites, will contain the European Foreward and Annexes ZA & ZB.

    ISO remove preview
    ISO 15223-1:2021
    Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
    View this on ISO >




    ------------------------------
    Lena Cordie-Bancroft
    Leicester
    United Kingdom
    ------------------------------


  • 2.  RE: ISO 15223-1:2021

    Posted 06-Jul-2021 06:15
    Here is the link to an article I authored regarding the revision of ISO 15223-1.

    https://www.aami.org/news/article/iso-15223-1-and-the-role-of-symbols-in-communicating-critical-information

    ------------------------------
    Lena Cordie-Bancroft
    Victoria MN
    United States
    ------------------------------

    Original Message


  • 3.  RE: ISO 15223-1:2021

    Posted 07-Jul-2021 10:47
    Excellent article Lena!  Thank you for sharing. 

    Will the BS EN ISO 15223-1 version of this document likely be released this year?

    ------------------------------
    Alyssa Roelli
    Diversatek, Inc.
    Regulatory Projects Manager
    Milwaukee WI
    United States
    ------------------------------

    Original Message


  • 4.  RE: ISO 15223-1:2021

    Posted 07-Jul-2021 11:22
    Thank you, Alyssa.

    Yes, BS EN 15223-1 has been ratified by CEN and will be published this year. There isn't usually much if any of a delay for Vienna Agreement standards such as this, and it will be identical to the ISO version but with the addition of the European Foreword and Annexes ZA and ZB. You can see that status of the standard here: https://standards.cen.eu/dyn/www/f?p=204:110:0::::FSP_PROJECT,FSP_ORG_ID:68559,581003&cs=101FCCA39FB4DBE975B9828A7066FE9E6


    ------------------------------
    Lena Cordie-Bancroft
    Victoria MN
    United States
    ------------------------------

    Original Message


  • 5.  RE: ISO 15223-1:2021

    Posted 06-Jul-2021 06:23

    The symbols themselves can be purchased on the ISO Online Browsing Platform (OBP) https://www.iso.org/obp/ui



    ------------------------------
    Lena Cordie-Bancroft
    Victoria MN
    United States
    ------------------------------

    Original Message


  • 6.  RE: ISO 15223-1:2021

    Posted 07-Jul-2021 05:14
    Hello Lena

    Thank you for the update on the new edition of ISO 15233-1!

    Are you aware if a symbol indicating eIFU was in discussion for this update? Is my understanding correct that the 4th edition does not include a symbol for eIFU? Do you have a recommendation on how to indicate if a medical device is supplied with a electronic IFU?

    Thank you and kind regards,

    Hans

    ------------------------------
    Hans Strobel
    www.dokspot.io
    ------------------------------

    Original Message


  • 7.  RE: ISO 15223-1:2021

    Posted 07-Jul-2021 12:23
    Hi Hans,
    Great question - this was a topic of much discussion in the WG3 meetings!

    The revision to the 3rd edition (2016) incuded the added information to Symbol 5.4.3 indicating an instruction to consult an electronic instructions for use (eIFU), along with examples of the placement of the eIFU indicator. This eIFU indicator would be the manufacturer's URL or other indication that the IFU is available electronically.

    To further clarify this in the 4th edition (2021), the Title for Symbol 5.4.3 has been changed to "Consult instructions for use or consult electronic instructions for use". 

    The members of WG3 thought that rather than creating & validating another symbol, it was a better solution to provide the alternative meaning in the title as not everyone reads or is provided the description. The symbol is also registered in ISO 7000 as symbol 1641, Operator's manual; operating instructions. 

    If there is continued concern or need for a specific eIFU symbol, different from what is provided in ISO 15223-1, a recommendation for what that symbol might look like can be brought to the appropriate standards organization for consideration by the working group. Final approval and inclusion in the next version would follow the design and validation requirements of ISO 15223-2.



    ------------------------------
    Lena Cordie-Bancroft
    Victoria MN
    United States
    ------------------------------

    Original Message


  • 8.  RE: ISO 15223-1:2021

    Posted 07-Jul-2021 18:59
    Thank you for the clarification!

    ------------------------------
    Adi Michaeli
    Regulatory and Compliance Manager
    Vancouver BC
    Canada
    ------------------------------

    Original Message


  • 9.  RE: ISO 15223-1:2021

    Posted 08-Jul-2021 01:14
    Other than the few non ISO approved symbols that are not on the OBP since not registered by ISO which is a bummer.

    ------------------------------
    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: ISO 15223-1:2021

    Posted 08-Jul-2021 07:00
    For clarification, all symbols in 15223-1 that are validated and 'approved' for use. The ISO OBP is the electronic version of ISO 7000, and includes the symbols that can be placed on equipment to give information on how to use it. It includes symbols for all types of equipment, from automobiles and home entertainment products to earth-moving machinery and medical devices.  To be included in ISO 7000 and the OBP, a symbol must also be approved by ISO TC 145, which has very specific requirements for graphical symbols.

    Some of the symbols in ISO 15223-1:2021 do not meet these requirements (i.e., any symbols containing text), but have been designed and validated according to the requirements of ISO 15223-2. 



    ------------------------------
    Lena Cordie-Bancroft
    Victoria MN
    United States
    ------------------------------

    Original Message


  • 11.  RE: ISO 15223-1:2021

    Posted 08-Jul-2021 09:01
    https://www.iso.org/news/ref2692.html

    ------------------------------
    Lena Cordie-Bancroft
    Victoria MN
    United States
    ------------------------------

    Original Message


  • 12.  RE: ISO 15223-1:2021

    Posted 08-Jul-2021 10:35
    Hi Lena,

    Good clarification about the symbols for ISO 15223-1. Either the symbols are validated thru the ISO 15223-2 process or meet the exception of being registered under ISO 7000, ISO 7010 or IEC 60417 are exempt from the validation process of ISO 15223-2 per clause 4.1a.

    The confusion for people is they sometimes rely heavily on the ISO Online Browsing Platform (OBP) to find symbols and the symbols containing text are not registered thru ISO anymore (but previously may have been like the Sterile symbol 5.2.1 ISO 7000-2499 but the new sterilized using vaporized hydrogen peroxide 5.2.10 is not a registered ISO symbol because ISO doesn't recognize symbols with text anymore if I understand the rules properly??)

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


  • 13.  RE: ISO 15223-1:2021

    Posted 08-Jul-2021 11:38
    It's not an ISO policy. ISO TC 145 has specific criteria for graphic symbols. ISO TC 210 WG3 validates all symbols for ISO 15223-1 according to ISO 15223-2. Once they are validated and approved they are sent to ISO TC 145 for their review and approval, at which point they are assigned an ISO 7000 symbol number and put into the OBP. Symbols that do not get ISO TC 145 approval are still approved ISO symbols in ISO 15223-1. 

    I am clarifying this so people do not get the impression that a symbol is not valid or ok to use if it appears in ISO 15223-2 but NOT in ISO 7000.

    Also, as ISO 15223-1 is on the EU Commissions Standardization Request (M/575), it will become a harmonized standard to the MDR and can be used as a presumption of conformity to the GSPRs. This is where the EN version is necessary as it contains the Annexes ZA & ZB that show how the MDR requirements are covered.

    ------------------------------
    Lena Cordie-Bancroft
    Victoria MN
    United States
    ------------------------------

    Original Message


  • 14.  RE: ISO 15223-1:2021

    Posted 08-Jul-2021 12:57
    Greenlight has a webinar on this topic starting shortly.  I am sure it will be on-demand after the event too.

    https://www.greenlight.guru/webinar/iso-15223-1-edition-4-medical-device-symbols-labeling

    ------------------------------
    Alyssa Roelli
    Regulatory Projects Manager
    Milwaukee WI
    United States
    ------------------------------

    Original Message


  • 15.  RE: ISO 15223-1:2021

    Posted 09-Jul-2021 01:05
    The Greenlight Guru webinar on the topic was well attended live there were about 1200 people live and many many more signed up.  Alyssa is correct you can go to the Greenlight Guru website to find the get access to the presentation and the slide deck.  Lots of good questions during the session at the end.  I was surprised that the poll asking how many companies have done gap assessments to this version of the FDIS it was about 39% which means there are a lot of companies that have a lot of work to update their labeling/symbols for ISO 15223-1 and ISO 20417-1 among other things like the EU MDR.  I would suggest reviewing what other standards/regulations/laws/directives/guidances apply in addition to those just mentioned, also listen to the Greenlight Guru webinar for others mentioned, to your product including first identifying the applicable markets that apply to your product and do a full gap assessment of your labeling requirements including UDI requirements to comprehensively cover all labeling and information supplied by the manufacturer.

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


  • 16.  RE: ISO 15223-1:2021

    Posted 09-Jul-2021 09:16
    Thanks, Leo, and great job as usual. We were curious about transition timing and we are going to keep an eye for messaging from regulators on this.

    ------------------------------
    Edward Panek
    VP, QA/RA
    Med Device
    USN Veteran
    Research into Neural Nets - https://www.twitch.tv/edosani
    ------------------------------

    Original Message


  • 17.  RE: ISO 15223-1:2021

    Posted 10-Jul-2021 02:24
    Hi Ed,

    Glad you found the material useful.  For those that weren't on the webinar or haven't viewed it yet.  ISO doesn't allow transition periods for ISO standards, one of the differences with IEC standards as the IEC 60601-1, ed. 3.2 has a suggested 3 year transition period.

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


  • 18.  RE: ISO 15223-1:2021

    Posted 11-Jul-2021 04:09
    Dear all,
    Thank you for the informative discussion. As the ISO 15223-1:2021 has symbols of the economic operators EO according MDR I am curious if there was also a discussion about the new symbol for a further EO, the fulfilment provider, according the EU regulation 2019/1020? This regulation shall applied July, 01 resp. 16, 2021.
    Thank you in advance for your help.
    Margit

    ------------------------------
    Margit Widmann MD
    Director Regulatory
    Günsberg
    Switzerland
    ------------------------------

    Original Message


  • 19.  RE: ISO 15223-1:2021

    Posted 12-Jul-2021 07:18
    Hi Margit,
    By the time the 2019/1020 regulation was published, DIS ballot for ISO 15223-1 (4th edition) had already been closed and approved so ISO TC 210 WG3 was not able to consider the need for more symbols. As we begin the next round of work on the standard this is definitely one we will take into consideration. Any suggestions for what that symbol (or any others) might look like would be very helpful to committee.

    ------------------------------
    Lena Cordie-Bancroft
    Victoria MN
    United States
    ------------------------------

    Original Message


  • 20.  RE: ISO 15223-1:2021

    This message was posted by a user wishing to remain anonymous
    Posted 12-Jul-2021 07:52
    This message was posted by a user wishing to remain anonymous

    Thanks Leo for the webinar. I watched it live.

    During the webinar, you said you were going to explain what ISO approved meant. But I don't think I heard it, or I missed it. The part I'm confused about is that it seems it applies to certain symbols that are in ISO 15223-1 (standard by ISO), but aren't ISO approved? I think you said that any symbol with letters was not ISO approved, which I understood, but was there anything else?
    Original Message


  • 21.  RE: ISO 15223-1:2021

    Posted 12-Jul-2021 08:08
    PLEASE see my response from a couple days ago regarding this. I am a member of both ISO TC 145 and ISO TC 210, as well as the convenor for ISO TC 210 WG3, and want to assure you that ALL symbols in ISO 15223-1 ARE APPROVED FOR USE. However they do not meet the acceptance criteria for ISO TC 145 WG3 and ISO 7000, which has its own requirements that differ from ISO TC 210 WG3 and ISO 15223-1. This means that some 15223-1 symbols (i.e., VH2O2, UDI) will not appear in the ISO Online Browsing Platform.

    "ISO TC 145 has specific criteria for graphic symbols. ISO TC 210 WG3 validates all symbols for ISO 15223-1 according to ISO 15223-2. Once they are validated and approved they are sent to ISO TC 145 for their review and approval, at which point they are assigned an ISO 7000 symbol number and put into the OBP. Symbols that do not get ISO TC 145 approval are still approved ISO symbols in ISO 15223-1.

    I am clarifying this so people do not get the impression that a symbol is not valid or ok to use if it appears in ISO 15223-2 but NOT in ISO 7000.

    Also, as ISO 15223-1 is on the EU Commissions Standardization Request (M/575), it will become a harmonized standard to the MDR and can be used as a presumption of conformity to the GSPRs. This is where the EN version is necessary as it contains the Annexes ZA & ZB that show how the MDR requirements are covered."

    ------------------------------
    Lena Cordie-Bancroft
    Victoria MN
    United States
    ------------------------------

    Original Message


  • 22.  RE: ISO 15223-1:2021

    Posted 12-Jul-2021 11:27
    With MDR just going into effect any feedback from regulators on timing for harmonization?

    ------------------------------
    Edward Panek
    VP, QA/RA
    Med Device
    USN Veteran
    Research into Neural Nets - https://www.twitch.tv/edosani
    ------------------------------

    Original Message


  • 23.  RE: ISO 15223-1:2021

    Posted 12-Jul-2021 12:02
    ISO 15223-1 is included in the EU Commission's Standardization Request (M/575) and will become a harmonized standard to the MDR and used as a presumption of conformity to the GSPRs. This is where the EN version is necessary as it contains the Annexes ZA & ZB that show how the MDR requirements are covered. We are waiting for publication of the EN version from CEN.

    There are three steps to harmonization:
    1. Standard needs to be included in a standardization request - DONE 14 April 2021 but waiting formal implementation by approval of CEN/CENELEC and the EU Commission as an implementing decision
    2. Standard must include European Foreword and Annexes ZA & ZB, and be reviewed & approved by HAS Consultants - DONE 
    3. Must be published in the Official Journal of the European Union (OJEU) - OPEN ITEM

    So in short, all critical steps for harmonization are in place and waiting for the finalization of the formal steps. 

    ------------------------------
    Lena Cordie-Bancroft
    Victoria MN
    United States
    ------------------------------

    Original Message


  • 24.  RE: ISO 15223-1:2021

    Posted 12-Jul-2021 13:25
    Harmonised Standards | Internal Market, Industry, Entrepreneurship and SMEs (europa.eu)

    Arent several other standards also in line for this last step?

    ------------------------------
    Edward Panek
    VP, QA/RA
    Med Device
    USN Veteran
    Research into Neural Nets - https://www.twitch.tv/edosani
    ------------------------------

    Original Message


  • 25.  RE: ISO 15223-1:2021

    Posted 12-Jul-2021 15:27
    Yes, there are over 200 standards included in the Standardization Request (M/575) https://ec.europa.eu/growth/tools-databases/mandates/index.cfm?fuseaction=search.detail&id=599#

    However the draft Annexes to the Commission's initial Implementing Decisions include only five standards for the MDR and four for the IVDR. It is unclear when the OJEU citation will occur to create the first wave of harmonized standards, but it is anticipated it will happen soon and that additional standards will follow quarterly.

    DISCLAIMER: None of this is set in stone, but just what I have heard rumblings about.

    ------------------------------
    Lena Cordie-Bancroft
    Victoria MN
    United States
    ------------------------------

    Original Message


  • 26.  RE: ISO 15223-1:2021

    Posted 09-Aug-2021 00:33
    Lena,

    What about the Symbols in IOS 15223-1 like MD & IVD that don't have ISO symbol numbers assigned.  I'm a little confused by your post 21 from27 days ago that if I'm reading right says that ISO TC 145 after their review and approval or rejection you say "are still approved ISO symbols in ISO 15223-1."  But if the table in ISO 15223-1:201 says there is no ISO or IEC symbol identifier this conflicts with that statement.  So, I am just looking for clarification to make sure I understand clearly what the process is for validation of these symbols that are text based that don't fall in the criteria for TC145 requirements but are accepted for TC210 WG3 for ISO 15223-1 as we have agreed to place these symbols in the standard.

    Thx much,

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


  • 27.  RE: ISO 15223-1:2021

    This message was posted by a user wishing to remain anonymous
    Posted 12-Jul-2021 15:30
    This message was posted by a user wishing to remain anonymous

    Hi Lena,

    Very useful information. Thank you for sharing the information. If symbol from ISo 15223-1:2021 i not available for purchase via OBP, how should one purchse new symbols listed in 2021 versions e.g. MD, UDI, etc.

    Thank you!
    Original Message


  • 28.  RE: ISO 15223-1:2021

    Posted 12-Jul-2021 15:42
    Symbols can be purchased from the various national standards development organizations such as BSI, AAMI and DIN, but it doesn't look like all SDOs have updated their stores yet. You can also look at the ANSI website.

    AAMI: https://store.aami.org/s/store#/store/browse/detail/a152E000006jKtWQAU
    BSI: https://shop.bsigroup.com/ProductDetail?pid=000000000030351180
    DIN: https://www.beuth.de/en/standard/din-en-iso-15223-1/251855161

    ------------------------------
    Lena Cordie-Bancroft
    Victoria MN
    United States
    ------------------------------

    Original Message


  • 29.  RE: ISO 15223-1:2021

    Posted 12-Jul-2021 17:07
    The two links for BSI & DIN are to the older version of the standard (3rd ed) as they are not published as EN standards yet.  I double checked your links.  I also double checked the BSI and DIN sites and they only have the draft version of the standard but those are different links which I don't know if there are changes to the final publication so I didn't want to provide the links (Lena your comment).  If you view the CEN website there is only a Date of Ratification (DOR) but not a Date of Availability yet when the "the definitive text in the official language versions of an approved CEN publication is distributed by the Central Secretariat of CEN to the ESOs for publication.  Not sure when that will be.

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


  • 30.  RE: ISO 15223-1:2021

    Posted 13-Jul-2021 05:23
    Correct. I included the links as location references once the revised standard & symbols are available on the websites. As a Vienna Agreement standard, the ISO and CEN versions are to be published 'in parallel' so we do expect the EN version to be available soon.

    ------------------------------
    Lena Cordie-Bancroft
    Victoria MN
    United States
    ------------------------------

    Original Message


  • 31.  RE: ISO 15223-1:2021

    This message was posted by a user wishing to remain anonymous
    Posted 21-Jul-2021 08:46
    This message was posted by a user wishing to remain anonymous

    Thank you, Lena for the information.  I guess we will have to wait until these websites are updated to reflect new version of this standard.
    Original Message


  • 32.  RE: ISO 15223-1:2021

    This message was posted by a user wishing to remain anonymous
    Posted 21-Jul-2021 08:46
    This message was posted by a user wishing to remain anonymous

    Thank you, Leo for the information.
    Original Message


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