Regulatory Open Forum

Finally, it was published. You can purchase from ISO at https://www.iso.org/standard/77326.html. Attached is a screenshot of the ISO webpage showing today's publication.
If you want to wait til the CEN version is published and European Standards Organizations (ESOs) adopt then purchase from Estonian Standards for much less but not sure when that will be.
Took a long time from FDIS (final draft) til it got published but the committee worked really hard and our efforts paid off TC210/WG3.  We got a nice note from Lena (Convenor of the WG3) today and thx Jeff (past convenor and now project leader) for his hard work & tremendous leadership in the project.  It is a great group to work with and I can't wait to meet some of the members face to face finally.

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

Thanks for sharing this Leonard! We already bought the standard.
Kind Regards,
Claudia

------------------------------
Claudia Solimeo Meneghisse RAC, PhD
Associate Director RA Reagents & Consumables
Männedorf
Switzerland
------------------------------

Original Message:
Sent: 06-Jul-2021 17:03
From: Leonard Eisner
Subject: ISO 15223-1, 4th ed. just published July 6, 2021

Finally, it was published. You can purchase from ISO at https://www.iso.org/standard/77326.html. Attached is a screenshot of the ISO webpage showing today's publication.
If you want to wait til the CEN version is published and European Standards Organizations (ESOs) adopt then purchase from Estonian Standards for much less but not sure when that will be.
Took a long time from FDIS (final draft) til it got published but the committee worked really hard and our efforts paid off TC210/WG3.  We got a nice note from Lena (Convenor of the WG3) today and thx Jeff (past convenor and now project leader) for his hard work & tremendous leadership in the project.  It is a great group to work with and I can't wait to meet some of the members face to face finally.

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

Dear Leonard
Thanks also for sharing. I also bought the standard. I have a couple of questions which I hope you or someone else in this forum may be able to help answer. I am from a large language services provider that translates great volumes of information for medical devices incl. IFUs, user interfaces, labeling, etc. for our MedTech clients.  I see that a new symbol has been added to the standard for translations in case these have been done by another entity than the manufacturer (table 1, ref. 5.7.8). The intention of the symbol, - as described in the standard -, is to disclose the entity that is responsible for the translation activity by name and address. 
Do you know why this new requirement has been introduced and which specific compliance obligations this enforces on the translation provider? I am asking because as a language services provider, we are not a manufacturer that ultimately has the responsibility of the information supplied with the device. I am aware that importers and distributors are required to have a QMS that ensures accuracy of translations if they are responsible for these. We have a QMS as well and I want to update our SOPs with this new requirement.
I just need to be clear on our compliance obligations, given we are not manufacturer, nor involved in any supply chain activities.
I see it as a very positive development that regulators and standards organizations increase their attention to translations. After all, it is the translated version that ends up in the hands of the user. 
Thanks a lot in advance
KR Pia Windelov

------------------------------
Pia Windelov
Director, Product Strategy, Life Sciences
Skovlunde
Denmark
------------------------------

Original Message:
Sent: 06-Jul-2021 17:03
From: Leonard Eisner
Subject: ISO 15223-1, 4th ed. just published July 6, 2021

Finally, it was published. You can purchase from ISO at https://www.iso.org/standard/77326.html. Attached is a screenshot of the ISO webpage showing today's publication.
If you want to wait til the CEN version is published and European Standards Organizations (ESOs) adopt then purchase from Estonian Standards for much less but not sure when that will be.
Took a long time from FDIS (final draft) til it got published but the committee worked really hard and our efforts paid off TC210/WG3.  We got a nice note from Lena (Convenor of the WG3) today and thx Jeff (past convenor and now project leader) for his hard work & tremendous leadership in the project.  It is a great group to work with and I can't wait to meet some of the members face to face finally.

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

Pia, 
The use of the Translation Symbol (5.7.8, ISO 7000-3728) is for entities who are responsible (i.e., distributor, dealer, importer) for the translation activities (i.e., identifying translation house, approving translations, applying translated labels), not the service provider performing the translation - unless of course they are also doing the additional activities listed. This is to identify that the translated information was not provided by the manufacturer, and not a modification of the device. This same rationale also applies to the Repackaging Symbol (5.7.9, ISO 7000-3727).

See MDR 2017/745, article 16, Cases in which obligations of manufacturers apply to importers, distributors or other persons: 

2. For the purposes of point (c) of paragraph 1, the following shall not be considered to be a modification of a device
that could affect its compliance with the applicable requirements:
(a) provision, including translation, of the information supplied by the manufacturer, in accordance with Section 23 of
Annex I, relating to a device already placed on the market and of further information which is necessary in order to
market the device in the relevant Member State.
(b) changes to the outer packaging of a device already placed on the market, including a change of pack size, if the
repackaging is necessary in order to market the device in the relevant Member State and if it is carried out in such
conditions that the original condition of the device cannot be affected by it. In the case of devices placed on the
market in sterile condition, it shall be presumed that the original condition of the device is adversely affected if the
packaging that is necessary for maintaining the sterile condition is opened, damaged or otherwise negatively affected
by the repackaging.

3. A distributor or importer that carries out any of the activities mentioned in points (a) and (b) of paragraph 2 shall
indicate on the device or, where that is impracticable, on its packaging or in a document accompanying the device, the
activity carried out together with its name, registered trade name or registered trade


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

Original Message:
Sent: 15-Jul-2021 02:43
From: Pia Windelov
Subject: ISO 15223-1, 4th ed. just published July 6, 2021

Dear Leonard
Thanks also for sharing. I also bought the standard. I have a couple of questions which I hope you or someone else in this forum may be able to help answer. I am from a large language services provider that translates great volumes of information for medical devices incl. IFUs, user interfaces, labeling, etc. for our MedTech clients.  I see that a new symbol has been added to the standard for translations in case these have been done by another entity than the manufacturer (table 1, ref. 5.7.8). The intention of the symbol, - as described in the standard -, is to disclose the entity that is responsible for the translation activity by name and address.
Do you know why this new requirement has been introduced and which specific compliance obligations this enforces on the translation provider? I am asking because as a language services provider, we are not a manufacturer that ultimately has the responsibility of the information supplied with the device. I am aware that importers and distributors are required to have a QMS that ensures accuracy of translations if they are responsible for these. We have a QMS as well and I want to update our SOPs with this new requirement.
I just need to be clear on our compliance obligations, given we are not manufacturer, nor involved in any supply chain activities.
I see it as a very positive development that regulators and standards organizations increase their attention to translations. After all, it is the translated version that ends up in the hands of the user.
Thanks a lot in advance
KR Pia Windelov

------------------------------
Pia Windelov
Director, Product Strategy, Life Sciences
Skovlunde
Denmark

Original Message:
Sent: 06-Jul-2021 17:03
From: Leonard Eisner
Subject: ISO 15223-1, 4th ed. just published July 6, 2021

Finally, it was published. You can purchase from ISO at https://www.iso.org/standard/77326.html. Attached is a screenshot of the ISO webpage showing today's publication.
If you want to wait til the CEN version is published and European Standards Organizations (ESOs) adopt then purchase from Estonian Standards for much less but not sure when that will be.
Took a long time from FDIS (final draft) til it got published but the committee worked really hard and our efforts paid off TC210/WG3.  We got a nice note from Lena (Convenor of the WG3) today and thx Jeff (past convenor and now project leader) for his hard work & tremendous leadership in the project.  It is a great group to work with and I can't wait to meet some of the members face to face finally.

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

Hi Lena
Thank you very much for your response. Much appreciated and very helpful. Having been in pharma and clinical ops., I always try to make the distinction btw. being accountable and responsible for regulatory compliance (trial sponsor vs. CRO taking on duties on behalf of the Sponsor). Your response confirms my presumptions, thanks. 
I am also familiar with Article 16 but I do have a question on this (copied your message/MDR): "2. For the purposes of point (c) of paragraph 1, the following shall not be considered to be a modification of a device
that could affect its compliance with the applicable requirements:
(a) provision, including translation, of the information supplied by the manufacturer, in accordance with Section 23 of.."

If translations are not considered a modification of a device or subject to compliance, does this exempt the translating entity of any compliance responsibilities? To me, this would invalidate the new ISO symbol introduced on translations and put all compliance obligations in the hands of the manufacturer/EO to do oversight of translation suppliers. Then why introduce this symbol? Logically, this should have a compliance aspect to it. 

Curious to hear more insights on this
Thank you


------------------------------
Pia Windelov
Director, Product Strategy, Life Sciences
Skovlunde
Denmark
------------------------------

Original Message:
Sent: 15-Jul-2021 08:57
From: Lena Cordie-Bancroft
Subject: ISO 15223-1, 4th ed. just published July 6, 2021

Pia,
The use of the Translation Symbol (5.7.8, ISO 7000-3728) is for entities who are responsible (i.e., distributor, dealer, importer) for the translation activities (i.e., identifying translation house, approving translations, applying translated labels), not the service provider performing the translation - unless of course they are also doing the additional activities listed. This is to identify that the translated information was not provided by the manufacturer, and not a modification of the device. This same rationale also applies to the Repackaging Symbol (5.7.9, ISO 7000-3727).

See MDR 2017/745, article 16, Cases in which obligations of manufacturers apply to importers, distributors or other persons: 

2. For the purposes of point (c) of paragraph 1, the following shall not be considered to be a modification of a device
that could affect its compliance with the applicable requirements:
(a) provision, including translation, of the information supplied by the manufacturer, in accordance with Section 23 of
Annex I, relating to a device already placed on the market and of further information which is necessary in order to
market the device in the relevant Member State.
(b) changes to the outer packaging of a device already placed on the market, including a change of pack size, if the
repackaging is necessary in order to market the device in the relevant Member State and if it is carried out in such
conditions that the original condition of the device cannot be affected by it. In the case of devices placed on the
market in sterile condition, it shall be presumed that the original condition of the device is adversely affected if the
packaging that is necessary for maintaining the sterile condition is opened, damaged or otherwise negatively affected
by the repackaging.

3. A distributor or importer that carries out any of the activities mentioned in points (a) and (b) of paragraph 2 shall
indicate on the device or, where that is impracticable, on its packaging or in a document accompanying the device, the
activity carried out together with its name, registered trade name or registered trade


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

Original Message:
Sent: 15-Jul-2021 02:43
From: Pia Windelov
Subject: ISO 15223-1, 4th ed. just published July 6, 2021

Dear Leonard
Thanks also for sharing. I also bought the standard. I have a couple of questions which I hope you or someone else in this forum may be able to help answer. I am from a large language services provider that translates great volumes of information for medical devices incl. IFUs, user interfaces, labeling, etc. for our MedTech clients.  I see that a new symbol has been added to the standard for translations in case these have been done by another entity than the manufacturer (table 1, ref. 5.7.8). The intention of the symbol, - as described in the standard -, is to disclose the entity that is responsible for the translation activity by name and address.
Do you know why this new requirement has been introduced and which specific compliance obligations this enforces on the translation provider? I am asking because as a language services provider, we are not a manufacturer that ultimately has the responsibility of the information supplied with the device. I am aware that importers and distributors are required to have a QMS that ensures accuracy of translations if they are responsible for these. We have a QMS as well and I want to update our SOPs with this new requirement.
I just need to be clear on our compliance obligations, given we are not manufacturer, nor involved in any supply chain activities.
I see it as a very positive development that regulators and standards organizations increase their attention to translations. After all, it is the translated version that ends up in the hands of the user.
Thanks a lot in advance
KR Pia Windelov

------------------------------
Pia Windelov
Director, Product Strategy, Life Sciences
Skovlunde
Denmark

Original Message:
Sent: 06-Jul-2021 17:03
From: Leonard Eisner
Subject: ISO 15223-1, 4th ed. just published July 6, 2021

Finally, it was published. You can purchase from ISO at https://www.iso.org/standard/77326.html. Attached is a screenshot of the ISO webpage showing today's publication.
If you want to wait til the CEN version is published and European Standards Organizations (ESOs) adopt then purchase from Estonian Standards for much less but not sure when that will be.
Took a long time from FDIS (final draft) til it got published but the committee worked really hard and our efforts paid off TC210/WG3.  We got a nice note from Lena (Convenor of the WG3) today and thx Jeff (past convenor and now project leader) for his hard work & tremendous leadership in the project.  It is a great group to work with and I can't wait to meet some of the members face to face finally.

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

I can't speak to why the MDR calls out this specific requirement, but the symbol was introduced to meet the MDR requirement, and to make it clear to the end user that the translated labels were added by someone other than the manufacturer. Translations are not modifying the physical device, but they are a change to the labeling. As service providers, translation entities do have compliance obligations and responsibilities.

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

Original Message:
Sent: 15-Jul-2021 11:37
From: Pia Windelov
Subject: ISO 15223-1, 4th ed. just published July 6, 2021

Hi Lena
Thank you very much for your response. Much appreciated and very helpful. Having been in pharma and clinical ops., I always try to make the distinction btw. being accountable and responsible for regulatory compliance (trial sponsor vs. CRO taking on duties on behalf of the Sponsor). Your response confirms my presumptions, thanks.
I am also familiar with Article 16 but I do have a question on this (copied your message/MDR): "2. For the purposes of point (c) of paragraph 1, the following shall not be considered to be a modification of a device
that could affect its compliance with the applicable requirements:
(a) provision, including translation, of the information supplied by the manufacturer, in accordance with Section 23 of.."

If translations are not considered a modification of a device or subject to compliance, does this exempt the translating entity of any compliance responsibilities? To me, this would invalidate the new ISO symbol introduced on translations and put all compliance obligations in the hands of the manufacturer/EO to do oversight of translation suppliers. Then why introduce this symbol? Logically, this should have a compliance aspect to it.

Curious to hear more insights on this
Thank you


------------------------------
Pia Windelov
Director, Product Strategy, Life Sciences
Skovlunde
Denmark

Original Message:
Sent: 15-Jul-2021 08:57
From: Lena Cordie-Bancroft
Subject: ISO 15223-1, 4th ed. just published July 6, 2021

Pia,
The use of the Translation Symbol (5.7.8, ISO 7000-3728) is for entities who are responsible (i.e., distributor, dealer, importer) for the translation activities (i.e., identifying translation house, approving translations, applying translated labels), not the service provider performing the translation - unless of course they are also doing the additional activities listed. This is to identify that the translated information was not provided by the manufacturer, and not a modification of the device. This same rationale also applies to the Repackaging Symbol (5.7.9, ISO 7000-3727).

See MDR 2017/745, article 16, Cases in which obligations of manufacturers apply to importers, distributors or other persons: 

2. For the purposes of point (c) of paragraph 1, the following shall not be considered to be a modification of a device
that could affect its compliance with the applicable requirements:
(a) provision, including translation, of the information supplied by the manufacturer, in accordance with Section 23 of
Annex I, relating to a device already placed on the market and of further information which is necessary in order to
market the device in the relevant Member State.
(b) changes to the outer packaging of a device already placed on the market, including a change of pack size, if the
repackaging is necessary in order to market the device in the relevant Member State and if it is carried out in such
conditions that the original condition of the device cannot be affected by it. In the case of devices placed on the
market in sterile condition, it shall be presumed that the original condition of the device is adversely affected if the
packaging that is necessary for maintaining the sterile condition is opened, damaged or otherwise negatively affected
by the repackaging.

3. A distributor or importer that carries out any of the activities mentioned in points (a) and (b) of paragraph 2 shall
indicate on the device or, where that is impracticable, on its packaging or in a document accompanying the device, the
activity carried out together with its name, registered trade name or registered trade


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

Original Message:
Sent: 15-Jul-2021 02:43
From: Pia Windelov
Subject: ISO 15223-1, 4th ed. just published July 6, 2021

Dear Leonard
Thanks also for sharing. I also bought the standard. I have a couple of questions which I hope you or someone else in this forum may be able to help answer. I am from a large language services provider that translates great volumes of information for medical devices incl. IFUs, user interfaces, labeling, etc. for our MedTech clients.  I see that a new symbol has been added to the standard for translations in case these have been done by another entity than the manufacturer (table 1, ref. 5.7.8). The intention of the symbol, - as described in the standard -, is to disclose the entity that is responsible for the translation activity by name and address.
Do you know why this new requirement has been introduced and which specific compliance obligations this enforces on the translation provider? I am asking because as a language services provider, we are not a manufacturer that ultimately has the responsibility of the information supplied with the device. I am aware that importers and distributors are required to have a QMS that ensures accuracy of translations if they are responsible for these. We have a QMS as well and I want to update our SOPs with this new requirement.
I just need to be clear on our compliance obligations, given we are not manufacturer, nor involved in any supply chain activities.
I see it as a very positive development that regulators and standards organizations increase their attention to translations. After all, it is the translated version that ends up in the hands of the user.
Thanks a lot in advance
KR Pia Windelov

------------------------------
Pia Windelov
Director, Product Strategy, Life Sciences
Skovlunde
Denmark

Original Message:
Sent: 06-Jul-2021 17:03
From: Leonard Eisner
Subject: ISO 15223-1, 4th ed. just published July 6, 2021

Finally, it was published. You can purchase from ISO at https://www.iso.org/standard/77326.html. Attached is a screenshot of the ISO webpage showing today's publication.
If you want to wait til the CEN version is published and European Standards Organizations (ESOs) adopt then purchase from Estonian Standards for much less but not sure when that will be.
Took a long time from FDIS (final draft) til it got published but the committee worked really hard and our efforts paid off TC210/WG3.  We got a nice note from Lena (Convenor of the WG3) today and thx Jeff (past convenor and now project leader) for his hard work & tremendous leadership in the project.  It is a great group to work with and I can't wait to meet some of the members face to face finally.

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

^{Hello Pia}

That symbol is something the manufacturer could add if wanted.  I don't know this is a legal requirement to use it, is there? Standards are voluntary.

Can someone on the standards committee confirm?


Also, you are absolutely correct that the legal manufacturer is ultimately the one finally responsible for the accuracy of the translations.   But if you are selling a service there is expectation you have some responsibility in this too. 



Ok.- my personal rant is not directed at Pia, it is to the symbols community at large. 

The string of discussions around symbols is always interesting in that the discussion seems to be "let's just apply all these steamer trunk type symbols and labels everywhere and not explain them, and user is smart and will figure them out ".

I hate pictogram labeled Quick Start Guides and the multitude of lazy symbols creeping up.  I would say I saw a fairly recent piece of literature published advocating against symbols, and I have to agree.   It found that even after 20+ years of symbol use, healthcare professionals still only understood  the most common 5 or 6 meant (e.g., sterile, lot, expiry,  CE mark, Rx mark , etc.).   This is a problem.  I really hope more symbols do NOT propagate.  I see no problem as a regulatory and quality profession in this industry and a consumer/ patient of medical technology to see explanations in a table in an IFU. It is one or maybe 2 pages long.  I don't want a HCP making a mistake because of the ever confusing plethora of symbols the committee thinks are "useful", however they "validated" them.






------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com
------------------------------

Original Message:
Sent: 15-Jul-2021 02:43
From: Pia Windelov
Subject: ISO 15223-1, 4th ed. just published July 6, 2021

Dear Leonard
Thanks also for sharing. I also bought the standard. I have a couple of questions which I hope you or someone else in this forum may be able to help answer. I am from a large language services provider that translates great volumes of information for medical devices incl. IFUs, user interfaces, labeling, etc. for our MedTech clients.  I see that a new symbol has been added to the standard for translations in case these have been done by another entity than the manufacturer (table 1, ref. 5.7.8). The intention of the symbol, - as described in the standard -, is to disclose the entity that is responsible for the translation activity by name and address.
Do you know why this new requirement has been introduced and which specific compliance obligations this enforces on the translation provider? I am asking because as a language services provider, we are not a manufacturer that ultimately has the responsibility of the information supplied with the device. I am aware that importers and distributors are required to have a QMS that ensures accuracy of translations if they are responsible for these. We have a QMS as well and I want to update our SOPs with this new requirement.
I just need to be clear on our compliance obligations, given we are not manufacturer, nor involved in any supply chain activities.
I see it as a very positive development that regulators and standards organizations increase their attention to translations. After all, it is the translated version that ends up in the hands of the user.
Thanks a lot in advance
KR Pia Windelov

------------------------------
Pia Windelov
Director, Product Strategy, Life Sciences
Skovlunde
Denmark

Original Message:
Sent: 06-Jul-2021 17:03
From: Leonard Eisner
Subject: ISO 15223-1, 4th ed. just published July 6, 2021

Finally, it was published. You can purchase from ISO at https://www.iso.org/standard/77326.html. Attached is a screenshot of the ISO webpage showing today's publication.
If you want to wait til the CEN version is published and European Standards Organizations (ESOs) adopt then purchase from Estonian Standards for much less but not sure when that will be.
Took a long time from FDIS (final draft) til it got published but the committee worked really hard and our efforts paid off TC210/WG3.  We got a nice note from Lena (Convenor of the WG3) today and thx Jeff (past convenor and now project leader) for his hard work & tremendous leadership in the project.  It is a great group to work with and I can't wait to meet some of the members face to face finally.

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

I want to reply specifically to Ginger's comment about too many symbols and most people / users (from clinicians, nurses, etc to patients say home healthcare device so they may be the operator too) can be very confusing.  I'm on the symbols committee TC 210 WG 3 and happen to agree with this perspective but also don't have a great answer.  So, a table in the IFU that summarizes the explanation of the symbols for what they mean is at least a good starting point.  Does anyone have a better solution we would love to hear about it.  Yes, usability is done on the new symbols that are added to the ISO 15223-1 standard under ISO 15223-2 process but that doesn't mean there are areas of the world or user groups that may not understand those symbols.  Also, it depends how the usability studies are designed how the user groups understand those symbols that are validated under that study.  The more succient you can be with your symbols the better but the more complex the device is the likelihood is there will be more symbols as real estate on a device is limited and regulations have forced more labeling requirements and words needs translation so symbols have been the solution to reduce the translation needed on the device.  The devil is in the details.

Ginger question: Does having the website on the device or UDI or QR code on the device so the user can access the IFU or quick reference guide or the symbols table from the website for those that are tech savvy (I know there are that aren't and that is still a challenge) help with your concern at all?  Just curious on your perspective?

------------------------------
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:
Sent: 16-Jul-2021 08:36
From: Ginger Cantor
Subject: ISO 15223-1, 4th ed. just published July 6, 2021

^{Hello Pia}

That symbol is something the manufacturer could add if wanted.  I don't know this is a legal requirement to use it, is there? Standards are voluntary.

Can someone on the standards committee confirm?


Also, you are absolutely correct that the legal manufacturer is ultimately the one finally responsible for the accuracy of the translations.   But if you are selling a service there is expectation you have some responsibility in this too.



Ok.- my personal rant is not directed at Pia, it is to the symbols community at large.

The string of discussions around symbols is always interesting in that the discussion seems to be "let's just apply all these steamer trunk type symbols and labels everywhere and not explain them, and user is smart and will figure them out ".

I hate pictogram labeled Quick Start Guides and the multitude of lazy symbols creeping up.  I would say I saw a fairly recent piece of literature published advocating against symbols, and I have to agree.   It found that even after 20+ years of symbol use, healthcare professionals still only understood  the most common 5 or 6 meant (e.g., sterile, lot, expiry,  CE mark, Rx mark , etc.).   This is a problem.  I really hope more symbols do NOT propagate.  I see no problem as a regulatory and quality profession in this industry and a consumer/ patient of medical technology to see explanations in a table in an IFU. It is one or maybe 2 pages long.  I don't want a HCP making a mistake because of the ever confusing plethora of symbols the committee thinks are "useful", however they "validated" them.






------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com

Original Message:
Sent: 15-Jul-2021 02:43
From: Pia Windelov
Subject: ISO 15223-1, 4th ed. just published July 6, 2021

Dear Leonard
Thanks also for sharing. I also bought the standard. I have a couple of questions which I hope you or someone else in this forum may be able to help answer. I am from a large language services provider that translates great volumes of information for medical devices incl. IFUs, user interfaces, labeling, etc. for our MedTech clients.  I see that a new symbol has been added to the standard for translations in case these have been done by another entity than the manufacturer (table 1, ref. 5.7.8). The intention of the symbol, - as described in the standard -, is to disclose the entity that is responsible for the translation activity by name and address.
Do you know why this new requirement has been introduced and which specific compliance obligations this enforces on the translation provider? I am asking because as a language services provider, we are not a manufacturer that ultimately has the responsibility of the information supplied with the device. I am aware that importers and distributors are required to have a QMS that ensures accuracy of translations if they are responsible for these. We have a QMS as well and I want to update our SOPs with this new requirement.
I just need to be clear on our compliance obligations, given we are not manufacturer, nor involved in any supply chain activities.
I see it as a very positive development that regulators and standards organizations increase their attention to translations. After all, it is the translated version that ends up in the hands of the user.
Thanks a lot in advance
KR Pia Windelov

------------------------------
Pia Windelov
Director, Product Strategy, Life Sciences
Skovlunde
Denmark

Original Message:
Sent: 06-Jul-2021 17:03
From: Leonard Eisner
Subject: ISO 15223-1, 4th ed. just published July 6, 2021

Finally, it was published. You can purchase from ISO at https://www.iso.org/standard/77326.html. Attached is a screenshot of the ISO webpage showing today's publication.
If you want to wait til the CEN version is published and European Standards Organizations (ESOs) adopt then purchase from Estonian Standards for much less but not sure when that will be.
Took a long time from FDIS (final draft) til it got published but the committee worked really hard and our efforts paid off TC210/WG3.  We got a nice note from Lena (Convenor of the WG3) today and thx Jeff (past convenor and now project leader) for his hard work & tremendous leadership in the project.  It is a great group to work with and I can't wait to meet some of the members face to face finally.

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

Hi Leo

I think I am just clearly an older curmudgeon, but given that the population is aging rapidly, I  am not alone.   I hate having to use my phone to scan a QR code to find more information, even if I am savvy enough to do it.   Yes, it saves companies $ but it  wastes my time.  And what happens if the network is down, link has moved, etc? EU regulation 207:2012 had it right that risks associated with e-IFU and connectivity need to be seriously considered.   

 IMHO adding QR codes is a company efficient, non-user friendly way of providing information companies don't want to deal with in printing. Instead it is a "make the customer work for it attitude".  On a personal note,   I recently bought a Fitbit Inspire 2 just to try it and its associated mobile app.   Device has a sleek little minimal IFU, and a terrible device interface which is impossible to read in bright sun. I will have to scan the QR code and scroll through confusing in-app instructions to figure things out.  Good thing it is JUST a wellness device and not a medical device.  

Maybe the younger generation likes  scanning a QR code, which is just  ANOTHER symbol on a box.   QR is  so much like the official UDI 2-D matrix, that now MDR mandates if there is more than one data carrier you now have to put the UDI symbol in front/near the data carrier that is the actual UDI.  This scenario shows how confusing and overburdened packaging labels are with symbols, just because marketing wanted a cute QR code, and operations wanted the QR code to save $$$.   I am just not sympathetic to use of those at all.

That said, regulators and standards organization participants really need to take a step back and reconsider what is absolutely required and not propagate so many symbols willy nilly from  multiple organizations.   

Not sure what can be done, but the MDR requirement to identify which data carrier is the actual UDI is telling.  Go back to basics such as FDA had -  don't add extra symbols or languages which confuse which ones are the critical ones, make sure your  "white space " doesn't  disappear.  From an operations viewpoint.    Hmmm,  the comment recently about having to rework product because the placement on a label of manufacturing date versus expiry date being switched was interesting.  It  shows confusion even with those who should know the symbols.  To mitigate that risk now manufacturers may want to storyboard the layouts of artwork for their labeling partners

 I have clients that use QR codes for marketing and I hate it.  But that is their decision.  If it is purely for marketing, my advice is just don't.  If it is for additional safety, I am not in favor, and definitely I think it should not  be used for critical safety information if risk of non-connectivity is not minimal or population using it is not tech savvy or has attention issues or issues with on-screen comprehension.

Ok, enough ranting,  clearly I have symbol fatigue, just as HCPs get alarm fatigue.  I think the last straw for me was the statement made at the end of the webinar "Yes, it took five years and we revised ISO 15223-1 but wait! We are just launching a new work program for a new revison".    That statement alone did me in.  

Years ago I was on the Electrosurgical Generators and Accessories Stds Committee as an industry alternate, and also handled feedback to other draft standards when at 3M.  I know these are tough, interesting and collaborative groups that work hard.  But before we propagate new regulations, standards, common specifications, symbols, guidelines, etc. , let's all step back and really question if it is truly needed.

I am actually not someone who believes in total deregulation of the healthcare industry, but enough is enough.  Enforce what is there.  Do not add 3 more layers of complexity. 

Thanks... Ginger


------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com
------------------------------

Original Message:
Sent: 16-Jul-2021 12:06
From: Leonard Eisner
Subject: ISO 15223-1, 4th ed. just published July 6, 2021

I want to reply specifically to Ginger's comment about too many symbols and most people / users (from clinicians, nurses, etc to patients say home healthcare device so they may be the operator too) can be very confusing.  I'm on the symbols committee TC 210 WG 3 and happen to agree with this perspective but also don't have a great answer.  So, a table in the IFU that summarizes the explanation of the symbols for what they mean is at least a good starting point.  Does anyone have a better solution we would love to hear about it.  Yes, usability is done on the new symbols that are added to the ISO 15223-1 standard under ISO 15223-2 process but that doesn't mean there are areas of the world or user groups that may not understand those symbols.  Also, it depends how the usability studies are designed how the user groups understand those symbols that are validated under that study.  The more succient you can be with your symbols the better but the more complex the device is the likelihood is there will be more symbols as real estate on a device is limited and regulations have forced more labeling requirements and words needs translation so symbols have been the solution to reduce the translation needed on the device.  The devil is in the details.

Ginger question: Does having the website on the device or UDI or QR code on the device so the user can access the IFU or quick reference guide or the symbols table from the website for those that are tech savvy (I know there are that aren't and that is still a challenge) help with your concern at all?  Just curious on your perspective?

------------------------------
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:
Sent: 16-Jul-2021 08:36
From: Ginger Cantor
Subject: ISO 15223-1, 4th ed. just published July 6, 2021

^{Hello Pia}

That symbol is something the manufacturer could add if wanted.  I don't know this is a legal requirement to use it, is there? Standards are voluntary.

Can someone on the standards committee confirm?


Also, you are absolutely correct that the legal manufacturer is ultimately the one finally responsible for the accuracy of the translations.   But if you are selling a service there is expectation you have some responsibility in this too.



Ok.- my personal rant is not directed at Pia, it is to the symbols community at large.

The string of discussions around symbols is always interesting in that the discussion seems to be "let's just apply all these steamer trunk type symbols and labels everywhere and not explain them, and user is smart and will figure them out ".

I hate pictogram labeled Quick Start Guides and the multitude of lazy symbols creeping up.  I would say I saw a fairly recent piece of literature published advocating against symbols, and I have to agree.   It found that even after 20+ years of symbol use, healthcare professionals still only understood  the most common 5 or 6 meant (e.g., sterile, lot, expiry,  CE mark, Rx mark , etc.).   This is a problem.  I really hope more symbols do NOT propagate.  I see no problem as a regulatory and quality profession in this industry and a consumer/ patient of medical technology to see explanations in a table in an IFU. It is one or maybe 2 pages long.  I don't want a HCP making a mistake because of the ever confusing plethora of symbols the committee thinks are "useful", however they "validated" them.






------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com

Original Message:
Sent: 15-Jul-2021 02:43
From: Pia Windelov
Subject: ISO 15223-1, 4th ed. just published July 6, 2021

Dear Leonard
Thanks also for sharing. I also bought the standard. I have a couple of questions which I hope you or someone else in this forum may be able to help answer. I am from a large language services provider that translates great volumes of information for medical devices incl. IFUs, user interfaces, labeling, etc. for our MedTech clients.  I see that a new symbol has been added to the standard for translations in case these have been done by another entity than the manufacturer (table 1, ref. 5.7.8). The intention of the symbol, - as described in the standard -, is to disclose the entity that is responsible for the translation activity by name and address.
Do you know why this new requirement has been introduced and which specific compliance obligations this enforces on the translation provider? I am asking because as a language services provider, we are not a manufacturer that ultimately has the responsibility of the information supplied with the device. I am aware that importers and distributors are required to have a QMS that ensures accuracy of translations if they are responsible for these. We have a QMS as well and I want to update our SOPs with this new requirement.
I just need to be clear on our compliance obligations, given we are not manufacturer, nor involved in any supply chain activities.
I see it as a very positive development that regulators and standards organizations increase their attention to translations. After all, it is the translated version that ends up in the hands of the user.
Thanks a lot in advance
KR Pia Windelov

------------------------------
Pia Windelov
Director, Product Strategy, Life Sciences
Skovlunde
Denmark

Original Message:
Sent: 06-Jul-2021 17:03
From: Leonard Eisner
Subject: ISO 15223-1, 4th ed. just published July 6, 2021

Finally, it was published. You can purchase from ISO at https://www.iso.org/standard/77326.html. Attached is a screenshot of the ISO webpage showing today's publication.
If you want to wait til the CEN version is published and European Standards Organizations (ESOs) adopt then purchase from Estonian Standards for much less but not sure when that will be.
Took a long time from FDIS (final draft) til it got published but the committee worked really hard and our efforts paid off TC210/WG3.  We got a nice note from Lena (Convenor of the WG3) today and thx Jeff (past convenor and now project leader) for his hard work & tremendous leadership in the project.  It is a great group to work with and I can't wait to meet some of the members face to face finally.

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

Ginger,

I agree with lots of what you say too.  Labeling / symbols are the lowest level of risk mitigation period bar none as anyone in regulatory should know if they know ISO 14971.  If they don't start reading quickly.  I have always said most users of all sorts ( consumers, clinicians especially, nurses, and anyone that is busy) typically don't read manuals/IFUs, etc.  The only ones that read manuals that I have found are the people that write the standards, are the regulators, or those that put the submissions together as these are the people that pick these apart.  The others aren't interested until the darn thing doesn't work and then they are desperate to figure out that one thing.

I have also noticed that most consumer based user manuals have gone the way of the dodo bird and gotten very thin and pretty worthless and gotten incorporated either into a website or into the device in some way or another and is usually hard to navigate.

Labeling taking up too much real estate is not great as if the user can't understand the symbols which is pretty common even in Europe, which I have found, then what is the value of using it.  But most companies don't really would want to spend the time and money to translate the labeling into 20 different languages either so there is a trade off in this case.

OK back to my real job getting a 60601 training ready for a client now.

Have a great weekend,

------------------------------
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:
Sent: 16-Jul-2021 14:47
From: Ginger Cantor
Subject: ISO 15223-1, 4th ed. just published July 6, 2021

Hi Leo

I think I am just clearly an older curmudgeon, but given that the population is aging rapidly, I  am not alone.   I hate having to use my phone to scan a QR code to find more information, even if I am savvy enough to do it.   Yes, it saves companies $ but it  wastes my time.  And what happens if the network is down, link has moved, etc? EU regulation 207:2012 had it right that risks associated with e-IFU and connectivity need to be seriously considered.

 IMHO adding QR codes is a company efficient, non-user friendly way of providing information companies don't want to deal with in printing. Instead it is a "make the customer work for it attitude".  On a personal note,   I recently bought a Fitbit Inspire 2 just to try it and its associated mobile app.   Device has a sleek little minimal IFU, and a terrible device interface which is impossible to read in bright sun. I will have to scan the QR code and scroll through confusing in-app instructions to figure things out.  Good thing it is JUST a wellness device and not a medical device.

Maybe the younger generation likes  scanning a QR code, which is just  ANOTHER symbol on a box.   QR is  so much like the official UDI 2-D matrix, that now MDR mandates if there is more than one data carrier you now have to put the UDI symbol in front/near the data carrier that is the actual UDI.  This scenario shows how confusing and overburdened packaging labels are with symbols, just because marketing wanted a cute QR code, and operations wanted the QR code to save $$$.   I am just not sympathetic to use of those at all.

That said, regulators and standards organization participants really need to take a step back and reconsider what is absolutely required and not propagate so many symbols willy nilly from  multiple organizations.

Not sure what can be done, but the MDR requirement to identify which data carrier is the actual UDI is telling.  Go back to basics such as FDA had -  don't add extra symbols or languages which confuse which ones are the critical ones, make sure your  "white space " doesn't  disappear.  From an operations viewpoint.    Hmmm,  the comment recently about having to rework product because the placement on a label of manufacturing date versus expiry date being switched was interesting.  It  shows confusion even with those who should know the symbols.  To mitigate that risk now manufacturers may want to storyboard the layouts of artwork for their labeling partners

 I have clients that use QR codes for marketing and I hate it.  But that is their decision.  If it is purely for marketing, my advice is just don't.  If it is for additional safety, I am not in favor, and definitely I think it should not  be used for critical safety information if risk of non-connectivity is not minimal or population using it is not tech savvy or has attention issues or issues with on-screen comprehension.

Ok, enough ranting,  clearly I have symbol fatigue, just as HCPs get alarm fatigue.  I think the last straw for me was the statement made at the end of the webinar "Yes, it took five years and we revised ISO 15223-1 but wait! We are just launching a new work program for a new revison".    That statement alone did me in.

Years ago I was on the Electrosurgical Generators and Accessories Stds Committee as an industry alternate, and also handled feedback to other draft standards when at 3M.  I know these are tough, interesting and collaborative groups that work hard.  But before we propagate new regulations, standards, common specifications, symbols, guidelines, etc. , let's all step back and really question if it is truly needed.

I am actually not someone who believes in total deregulation of the healthcare industry, but enough is enough.  Enforce what is there.  Do not add 3 more layers of complexity.

Thanks... Ginger


------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com

Original Message:
Sent: 16-Jul-2021 12:06
From: Leonard Eisner
Subject: ISO 15223-1, 4th ed. just published July 6, 2021

I want to reply specifically to Ginger's comment about too many symbols and most people / users (from clinicians, nurses, etc to patients say home healthcare device so they may be the operator too) can be very confusing.  I'm on the symbols committee TC 210 WG 3 and happen to agree with this perspective but also don't have a great answer.  So, a table in the IFU that summarizes the explanation of the symbols for what they mean is at least a good starting point.  Does anyone have a better solution we would love to hear about it.  Yes, usability is done on the new symbols that are added to the ISO 15223-1 standard under ISO 15223-2 process but that doesn't mean there are areas of the world or user groups that may not understand those symbols.  Also, it depends how the usability studies are designed how the user groups understand those symbols that are validated under that study.  The more succient you can be with your symbols the better but the more complex the device is the likelihood is there will be more symbols as real estate on a device is limited and regulations have forced more labeling requirements and words needs translation so symbols have been the solution to reduce the translation needed on the device.  The devil is in the details.

Ginger question: Does having the website on the device or UDI or QR code on the device so the user can access the IFU or quick reference guide or the symbols table from the website for those that are tech savvy (I know there are that aren't and that is still a challenge) help with your concern at all?  Just curious on your perspective?

------------------------------
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:
Sent: 16-Jul-2021 08:36
From: Ginger Cantor
Subject: ISO 15223-1, 4th ed. just published July 6, 2021

^{Hello Pia}

That symbol is something the manufacturer could add if wanted.  I don't know this is a legal requirement to use it, is there? Standards are voluntary.

Can someone on the standards committee confirm?


Also, you are absolutely correct that the legal manufacturer is ultimately the one finally responsible for the accuracy of the translations.   But if you are selling a service there is expectation you have some responsibility in this too.



Ok.- my personal rant is not directed at Pia, it is to the symbols community at large.

The string of discussions around symbols is always interesting in that the discussion seems to be "let's just apply all these steamer trunk type symbols and labels everywhere and not explain them, and user is smart and will figure them out ".

I hate pictogram labeled Quick Start Guides and the multitude of lazy symbols creeping up.  I would say I saw a fairly recent piece of literature published advocating against symbols, and I have to agree.   It found that even after 20+ years of symbol use, healthcare professionals still only understood  the most common 5 or 6 meant (e.g., sterile, lot, expiry,  CE mark, Rx mark , etc.).   This is a problem.  I really hope more symbols do NOT propagate.  I see no problem as a regulatory and quality profession in this industry and a consumer/ patient of medical technology to see explanations in a table in an IFU. It is one or maybe 2 pages long.  I don't want a HCP making a mistake because of the ever confusing plethora of symbols the committee thinks are "useful", however they "validated" them.






------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com

Original Message:
Sent: 15-Jul-2021 02:43
From: Pia Windelov
Subject: ISO 15223-1, 4th ed. just published July 6, 2021

Dear Leonard
Thanks also for sharing. I also bought the standard. I have a couple of questions which I hope you or someone else in this forum may be able to help answer. I am from a large language services provider that translates great volumes of information for medical devices incl. IFUs, user interfaces, labeling, etc. for our MedTech clients.  I see that a new symbol has been added to the standard for translations in case these have been done by another entity than the manufacturer (table 1, ref. 5.7.8). The intention of the symbol, - as described in the standard -, is to disclose the entity that is responsible for the translation activity by name and address.
Do you know why this new requirement has been introduced and which specific compliance obligations this enforces on the translation provider? I am asking because as a language services provider, we are not a manufacturer that ultimately has the responsibility of the information supplied with the device. I am aware that importers and distributors are required to have a QMS that ensures accuracy of translations if they are responsible for these. We have a QMS as well and I want to update our SOPs with this new requirement.
I just need to be clear on our compliance obligations, given we are not manufacturer, nor involved in any supply chain activities.
I see it as a very positive development that regulators and standards organizations increase their attention to translations. After all, it is the translated version that ends up in the hands of the user.
Thanks a lot in advance
KR Pia Windelov

------------------------------
Pia Windelov
Director, Product Strategy, Life Sciences
Skovlunde
Denmark

Original Message:
Sent: 06-Jul-2021 17:03
From: Leonard Eisner
Subject: ISO 15223-1, 4th ed. just published July 6, 2021

Finally, it was published. You can purchase from ISO at https://www.iso.org/standard/77326.html. Attached is a screenshot of the ISO webpage showing today's publication.
If you want to wait til the CEN version is published and European Standards Organizations (ESOs) adopt then purchase from Estonian Standards for much less but not sure when that will be.
Took a long time from FDIS (final draft) til it got published but the committee worked really hard and our efforts paid off TC210/WG3.  We got a nice note from Lena (Convenor of the WG3) today and thx Jeff (past convenor and now project leader) for his hard work & tremendous leadership in the project.  It is a great group to work with and I can't wait to meet some of the members face to face finally.

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

You too Leo!

Ginger

------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com
------------------------------

Original Message:
Sent: 16-Jul-2021 17:45
From: Leonard Eisner
Subject: ISO 15223-1, 4th ed. just published July 6, 2021

Ginger,

I agree with lots of what you say too.  Labeling / symbols are the lowest level of risk mitigation period bar none as anyone in regulatory should know if they know ISO 14971.  If they don't start reading quickly.  I have always said most users of all sorts ( consumers, clinicians especially, nurses, and anyone that is busy) typically don't read manuals/IFUs, etc.  The only ones that read manuals that I have found are the people that write the standards, are the regulators, or those that put the submissions together as these are the people that pick these apart.  The others aren't interested until the darn thing doesn't work and then they are desperate to figure out that one thing.

I have also noticed that most consumer based user manuals have gone the way of the dodo bird and gotten very thin and pretty worthless and gotten incorporated either into a website or into the device in some way or another and is usually hard to navigate.

Labeling taking up too much real estate is not great as if the user can't understand the symbols which is pretty common even in Europe, which I have found, then what is the value of using it.  But most companies don't really would want to spend the time and money to translate the labeling into 20 different languages either so there is a trade off in this case.

OK back to my real job getting a 60601 training ready for a client now.

Have a great weekend,

------------------------------
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:
Sent: 16-Jul-2021 14:47
From: Ginger Cantor
Subject: ISO 15223-1, 4th ed. just published July 6, 2021

Hi Leo

I think I am just clearly an older curmudgeon, but given that the population is aging rapidly, I  am not alone.   I hate having to use my phone to scan a QR code to find more information, even if I am savvy enough to do it.   Yes, it saves companies $ but it  wastes my time.  And what happens if the network is down, link has moved, etc? EU regulation 207:2012 had it right that risks associated with e-IFU and connectivity need to be seriously considered.

 IMHO adding QR codes is a company efficient, non-user friendly way of providing information companies don't want to deal with in printing. Instead it is a "make the customer work for it attitude".  On a personal note,   I recently bought a Fitbit Inspire 2 just to try it and its associated mobile app.   Device has a sleek little minimal IFU, and a terrible device interface which is impossible to read in bright sun. I will have to scan the QR code and scroll through confusing in-app instructions to figure things out.  Good thing it is JUST a wellness device and not a medical device.

Maybe the younger generation likes  scanning a QR code, which is just  ANOTHER symbol on a box.   QR is  so much like the official UDI 2-D matrix, that now MDR mandates if there is more than one data carrier you now have to put the UDI symbol in front/near the data carrier that is the actual UDI.  This scenario shows how confusing and overburdened packaging labels are with symbols, just because marketing wanted a cute QR code, and operations wanted the QR code to save $$$.   I am just not sympathetic to use of those at all.

That said, regulators and standards organization participants really need to take a step back and reconsider what is absolutely required and not propagate so many symbols willy nilly from  multiple organizations.

Not sure what can be done, but the MDR requirement to identify which data carrier is the actual UDI is telling.  Go back to basics such as FDA had -  don't add extra symbols or languages which confuse which ones are the critical ones, make sure your  "white space " doesn't  disappear.  From an operations viewpoint.    Hmmm,  the comment recently about having to rework product because the placement on a label of manufacturing date versus expiry date being switched was interesting.  It  shows confusion even with those who should know the symbols.  To mitigate that risk now manufacturers may want to storyboard the layouts of artwork for their labeling partners

 I have clients that use QR codes for marketing and I hate it.  But that is their decision.  If it is purely for marketing, my advice is just don't.  If it is for additional safety, I am not in favor, and definitely I think it should not  be used for critical safety information if risk of non-connectivity is not minimal or population using it is not tech savvy or has attention issues or issues with on-screen comprehension.

Ok, enough ranting,  clearly I have symbol fatigue, just as HCPs get alarm fatigue.  I think the last straw for me was the statement made at the end of the webinar "Yes, it took five years and we revised ISO 15223-1 but wait! We are just launching a new work program for a new revison".    That statement alone did me in.

Years ago I was on the Electrosurgical Generators and Accessories Stds Committee as an industry alternate, and also handled feedback to other draft standards when at 3M.  I know these are tough, interesting and collaborative groups that work hard.  But before we propagate new regulations, standards, common specifications, symbols, guidelines, etc. , let's all step back and really question if it is truly needed.

I am actually not someone who believes in total deregulation of the healthcare industry, but enough is enough.  Enforce what is there.  Do not add 3 more layers of complexity.

Thanks... Ginger


------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com

Original Message:
Sent: 16-Jul-2021 12:06
From: Leonard Eisner
Subject: ISO 15223-1, 4th ed. just published July 6, 2021

I want to reply specifically to Ginger's comment about too many symbols and most people / users (from clinicians, nurses, etc to patients say home healthcare device so they may be the operator too) can be very confusing.  I'm on the symbols committee TC 210 WG 3 and happen to agree with this perspective but also don't have a great answer.  So, a table in the IFU that summarizes the explanation of the symbols for what they mean is at least a good starting point.  Does anyone have a better solution we would love to hear about it.  Yes, usability is done on the new symbols that are added to the ISO 15223-1 standard under ISO 15223-2 process but that doesn't mean there are areas of the world or user groups that may not understand those symbols.  Also, it depends how the usability studies are designed how the user groups understand those symbols that are validated under that study.  The more succient you can be with your symbols the better but the more complex the device is the likelihood is there will be more symbols as real estate on a device is limited and regulations have forced more labeling requirements and words needs translation so symbols have been the solution to reduce the translation needed on the device.  The devil is in the details.

Ginger question: Does having the website on the device or UDI or QR code on the device so the user can access the IFU or quick reference guide or the symbols table from the website for those that are tech savvy (I know there are that aren't and that is still a challenge) help with your concern at all?  Just curious on your perspective?

------------------------------
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:
Sent: 16-Jul-2021 08:36
From: Ginger Cantor
Subject: ISO 15223-1, 4th ed. just published July 6, 2021

^{Hello Pia}

That symbol is something the manufacturer could add if wanted.  I don't know this is a legal requirement to use it, is there? Standards are voluntary.

Can someone on the standards committee confirm?


Also, you are absolutely correct that the legal manufacturer is ultimately the one finally responsible for the accuracy of the translations.   But if you are selling a service there is expectation you have some responsibility in this too.



Ok.- my personal rant is not directed at Pia, it is to the symbols community at large.

The string of discussions around symbols is always interesting in that the discussion seems to be "let's just apply all these steamer trunk type symbols and labels everywhere and not explain them, and user is smart and will figure them out ".

I hate pictogram labeled Quick Start Guides and the multitude of lazy symbols creeping up.  I would say I saw a fairly recent piece of literature published advocating against symbols, and I have to agree.   It found that even after 20+ years of symbol use, healthcare professionals still only understood  the most common 5 or 6 meant (e.g., sterile, lot, expiry,  CE mark, Rx mark , etc.).   This is a problem.  I really hope more symbols do NOT propagate.  I see no problem as a regulatory and quality profession in this industry and a consumer/ patient of medical technology to see explanations in a table in an IFU. It is one or maybe 2 pages long.  I don't want a HCP making a mistake because of the ever confusing plethora of symbols the committee thinks are "useful", however they "validated" them.






------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com

Original Message:
Sent: 15-Jul-2021 02:43
From: Pia Windelov
Subject: ISO 15223-1, 4th ed. just published July 6, 2021

Dear Leonard
Thanks also for sharing. I also bought the standard. I have a couple of questions which I hope you or someone else in this forum may be able to help answer. I am from a large language services provider that translates great volumes of information for medical devices incl. IFUs, user interfaces, labeling, etc. for our MedTech clients.  I see that a new symbol has been added to the standard for translations in case these have been done by another entity than the manufacturer (table 1, ref. 5.7.8). The intention of the symbol, - as described in the standard -, is to disclose the entity that is responsible for the translation activity by name and address.
Do you know why this new requirement has been introduced and which specific compliance obligations this enforces on the translation provider? I am asking because as a language services provider, we are not a manufacturer that ultimately has the responsibility of the information supplied with the device. I am aware that importers and distributors are required to have a QMS that ensures accuracy of translations if they are responsible for these. We have a QMS as well and I want to update our SOPs with this new requirement.
I just need to be clear on our compliance obligations, given we are not manufacturer, nor involved in any supply chain activities.
I see it as a very positive development that regulators and standards organizations increase their attention to translations. After all, it is the translated version that ends up in the hands of the user.
Thanks a lot in advance
KR Pia Windelov

------------------------------
Pia Windelov
Director, Product Strategy, Life Sciences
Skovlunde
Denmark

Original Message:
Sent: 06-Jul-2021 17:03
From: Leonard Eisner
Subject: ISO 15223-1, 4th ed. just published July 6, 2021

Finally, it was published. You can purchase from ISO at https://www.iso.org/standard/77326.html. Attached is a screenshot of the ISO webpage showing today's publication.
If you want to wait til the CEN version is published and European Standards Organizations (ESOs) adopt then purchase from Estonian Standards for much less but not sure when that will be.
Took a long time from FDIS (final draft) til it got published but the committee worked really hard and our efforts paid off TC210/WG3.  We got a nice note from Lena (Convenor of the WG3) today and thx Jeff (past convenor and now project leader) for his hard work & tremendous leadership in the project.  It is a great group to work with and I can't wait to meet some of the members face to face finally.

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

This type of IFU application will be great fodder for plaintiff attorneys in product liability cases in the future. I am involved in a case where IFU is being used to mitigate risk and it is a big point of contention in the case (inadequate information about product use). And this is an old product when paper manuals were provided with lots of detail, unlike today.

Ed Bills
843-810-2157
Sent from my iPhone


Original Message:
Sent: 7/16/2021 9:56:00 PM
From: Ginger Cantor
Subject: RE: ISO 15223-1, 4th ed. just published July 6, 2021

You too Leo!

Ginger

------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com
------------------------------

Original Message:
Sent: 16-Jul-2021 17:45
From: Leonard Eisner
Subject: ISO 15223-1, 4th ed. just published July 6, 2021

Ginger,

I agree with lots of what you say too.  Labeling / symbols are the lowest level of risk mitigation period bar none as anyone in regulatory should know if they know ISO 14971.  If they don't start reading quickly.  I have always said most users of all sorts ( consumers, clinicians especially, nurses, and anyone that is busy) typically don't read manuals/IFUs, etc.  The only ones that read manuals that I have found are the people that write the standards, are the regulators, or those that put the submissions together as these are the people that pick these apart.  The others aren't interested until the darn thing doesn't work and then they are desperate to figure out that one thing.

I have also noticed that most consumer based user manuals have gone the way of the dodo bird and gotten very thin and pretty worthless and gotten incorporated either into a website or into the device in some way or another and is usually hard to navigate.

Labeling taking up too much real estate is not great as if the user can't understand the symbols which is pretty common even in Europe, which I have found, then what is the value of using it.  But most companies don't really would want to spend the time and money to translate the labeling into 20 different languages either so there is a trade off in this case.

OK back to my real job getting a 60601 training ready for a client now.

Have a great weekend,

------------------------------
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:
Sent: 16-Jul-2021 14:47
From: Ginger Cantor
Subject: ISO 15223-1, 4th ed. just published July 6, 2021

Hi Leo

I think I am just clearly an older curmudgeon, but given that the population is aging rapidly, I  am not alone.   I hate having to use my phone to scan a QR code to find more information, even if I am savvy enough to do it.   Yes, it saves companies $ but it  wastes my time.  And what happens if the network is down, link has moved, etc? EU regulation 207:2012 had it right that risks associated with e-IFU and connectivity need to be seriously considered.

 IMHO adding QR codes is a company efficient, non-user friendly way of providing information companies don't want to deal with in printing. Instead it is a "make the customer work for it attitude".  On a personal note,   I recently bought a Fitbit Inspire 2 just to try it and its associated mobile app.   Device has a sleek little minimal IFU, and a terrible device interface which is impossible to read in bright sun. I will have to scan the QR code and scroll through confusing in-app instructions to figure things out.  Good thing it is JUST a wellness device and not a medical device.

Maybe the younger generation likes  scanning a QR code, which is just  ANOTHER symbol on a box.   QR is  so much like the official UDI 2-D matrix, that now MDR mandates if there is more than one data carrier you now have to put the UDI symbol in front/near the data carrier that is the actual UDI.  This scenario shows how confusing and overburdened packaging labels are with symbols, just because marketing wanted a cute QR code, and operations wanted the QR code to save $$$.   I am just not sympathetic to use of those at all.

That said, regulators and standards organization participants really need to take a step back and reconsider what is absolutely required and not propagate so many symbols willy nilly from  multiple organizations.

Not sure what can be done, but the MDR requirement to identify which data carrier is the actual UDI is telling.  Go back to basics such as FDA had -  don't add extra symbols or languages which confuse which ones are the critical ones, make sure your  "white space " doesn't  disappear.  From an operations viewpoint.    Hmmm,  the comment recently about having to rework product because the placement on a label of manufacturing date versus expiry date being switched was interesting.  It  shows confusion even with those who should know the symbols.  To mitigate that risk now manufacturers may want to storyboard the layouts of artwork for their labeling partners

 I have clients that use QR codes for marketing and I hate it.  But that is their decision.  If it is purely for marketing, my advice is just don't.  If it is for additional safety, I am not in favor, and definitely I think it should not  be used for critical safety information if risk of non-connectivity is not minimal or population using it is not tech savvy or has attention issues or issues with on-screen comprehension.

Ok, enough ranting,  clearly I have symbol fatigue, just as HCPs get alarm fatigue.  I think the last straw for me was the statement made at the end of the webinar "Yes, it took five years and we revised ISO 15223-1 but wait! We are just launching a new work program for a new revison".    That statement alone did me in.

Years ago I was on the Electrosurgical Generators and Accessories Stds Committee as an industry alternate, and also handled feedback to other draft standards when at 3M.  I know these are tough, interesting and collaborative groups that work hard.  But before we propagate new regulations, standards, common specifications, symbols, guidelines, etc. , let's all step back and really question if it is truly needed.

I am actually not someone who believes in total deregulation of the healthcare industry, but enough is enough.  Enforce what is there.  Do not add 3 more layers of complexity.

Thanks... Ginger


------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com

Original Message:
Sent: 16-Jul-2021 12:06
From: Leonard Eisner
Subject: ISO 15223-1, 4th ed. just published July 6, 2021

I want to reply specifically to Ginger's comment about too many symbols and most people / users (from clinicians, nurses, etc to patients say home healthcare device so they may be the operator too) can be very confusing.  I'm on the symbols committee TC 210 WG 3 and happen to agree with this perspective but also don't have a great answer.  So, a table in the IFU that summarizes the explanation of the symbols for what they mean is at least a good starting point.  Does anyone have a better solution we would love to hear about it.  Yes, usability is done on the new symbols that are added to the ISO 15223-1 standard under ISO 15223-2 process but that doesn't mean there are areas of the world or user groups that may not understand those symbols.  Also, it depends how the usability studies are designed how the user groups understand those symbols that are validated under that study.  The more succient you can be with your symbols the better but the more complex the device is the likelihood is there will be more symbols as real estate on a device is limited and regulations have forced more labeling requirements and words needs translation so symbols have been the solution to reduce the translation needed on the device.  The devil is in the details.

Ginger question: Does having the website on the device or UDI or QR code on the device so the user can access the IFU or quick reference guide or the symbols table from the website for those that are tech savvy (I know there are that aren't and that is still a challenge) help with your concern at all?  Just curious on your perspective?

------------------------------
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:
Sent: 16-Jul-2021 08:36
From: Ginger Cantor
Subject: ISO 15223-1, 4th ed. just published July 6, 2021

^{Hello Pia}

That symbol is something the manufacturer could add if wanted.  I don't know this is a legal requirement to use it, is there? Standards are voluntary.

Can someone on the standards committee confirm?


Also, you are absolutely correct that the legal manufacturer is ultimately the one finally responsible for the accuracy of the translations.   But if you are selling a service there is expectation you have some responsibility in this too.



Ok.- my personal rant is not directed at Pia, it is to the symbols community at large.

The string of discussions around symbols is always interesting in that the discussion seems to be "let's just apply all these steamer trunk type symbols and labels everywhere and not explain them, and user is smart and will figure them out ".

I hate pictogram labeled Quick Start Guides and the multitude of lazy symbols creeping up.  I would say I saw a fairly recent piece of literature published advocating against symbols, and I have to agree.   It found that even after 20+ years of symbol use, healthcare professionals still only understood  the most common 5 or 6 meant (e.g., sterile, lot, expiry,  CE mark, Rx mark , etc.).   This is a problem.  I really hope more symbols do NOT propagate.  I see no problem as a regulatory and quality profession in this industry and a consumer/ patient of medical technology to see explanations in a table in an IFU. It is one or maybe 2 pages long.  I don't want a HCP making a mistake because of the ever confusing plethora of symbols the committee thinks are "useful", however they "validated" them.






------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com

Original Message:
Sent: 15-Jul-2021 02:43
From: Pia Windelov
Subject: ISO 15223-1, 4th ed. just published July 6, 2021

Dear Leonard
Thanks also for sharing. I also bought the standard. I have a couple of questions which I hope you or someone else in this forum may be able to help answer. I am from a large language services provider that translates great volumes of information for medical devices incl. IFUs, user interfaces, labeling, etc. for our MedTech clients.  I see that a new symbol has been added to the standard for translations in case these have been done by another entity than the manufacturer (table 1, ref. 5.7.8). The intention of the symbol, - as described in the standard -, is to disclose the entity that is responsible for the translation activity by name and address.
Do you know why this new requirement has been introduced and which specific compliance obligations this enforces on the translation provider? I am asking because as a language services provider, we are not a manufacturer that ultimately has the responsibility of the information supplied with the device. I am aware that importers and distributors are required to have a QMS that ensures accuracy of translations if they are responsible for these. We have a QMS as well and I want to update our SOPs with this new requirement.
I just need to be clear on our compliance obligations, given we are not manufacturer, nor involved in any supply chain activities.
I see it as a very positive development that regulators and standards organizations increase their attention to translations. After all, it is the translated version that ends up in the hands of the user.
Thanks a lot in advance
KR Pia Windelov

------------------------------
Pia Windelov
Director, Product Strategy, Life Sciences
Skovlunde
Denmark

Original Message:
Sent: 06-Jul-2021 17:03
From: Leonard Eisner
Subject: ISO 15223-1, 4th ed. just published July 6, 2021

Finally, it was published. You can purchase from ISO at https://www.iso.org/standard/77326.html. Attached is a screenshot of the ISO webpage showing today's publication.
If you want to wait til the CEN version is published and European Standards Organizations (ESOs) adopt then purchase from Estonian Standards for much less but not sure when that will be.
Took a long time from FDIS (final draft) til it got published but the committee worked really hard and our efforts paid off TC210/WG3.  We got a nice note from Lena (Convenor of the WG3) today and thx Jeff (past convenor and now project leader) for his hard work & tremendous leadership in the project.  It is a great group to work with and I can't wait to meet some of the members face to face finally.

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

Yes, standards are voluntary as are the use of symbols. However once ISO 15223-1 is cited in the OJEU, it can be used as a presumption of conformity to the MDR. The translation & repackaging symbols would be used by the manufacturer to indicate the entity that is performing the translation & repackaging activities for them.

Responsibility for effective use and accurate nderstanding of symbols needs to be shared between manufacturers and end-users. As we all know, legal requirements for information that manufacturers need to provide create many challenges, and the intent of symbols is to minimize some of these challenges for both manufacturers and end-users.

Given the amount of work required for design, validation, and approval of symbols, it is not accurate to call them 'lazy symbols'.  Decisions are made through consensus and not at the will of the committee. Everyone - not just the committee members -  has an opportunity to contribute to and participate in the symbol (and standards) development process. There are over 100 members on the ISO committee and many more in each member country's mirror committee.

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

Original Message:
Sent: 16-Jul-2021 08:36
From: Ginger Cantor
Subject: ISO 15223-1, 4th ed. just published July 6, 2021

^{Hello Pia}

That symbol is something the manufacturer could add if wanted.  I don't know this is a legal requirement to use it, is there? Standards are voluntary.

Can someone on the standards committee confirm?


Also, you are absolutely correct that the legal manufacturer is ultimately the one finally responsible for the accuracy of the translations.   But if you are selling a service there is expectation you have some responsibility in this too.



Ok.- my personal rant is not directed at Pia, it is to the symbols community at large.

The string of discussions around symbols is always interesting in that the discussion seems to be "let's just apply all these steamer trunk type symbols and labels everywhere and not explain them, and user is smart and will figure them out ".

I hate pictogram labeled Quick Start Guides and the multitude of lazy symbols creeping up.  I would say I saw a fairly recent piece of literature published advocating against symbols, and I have to agree.   It found that even after 20+ years of symbol use, healthcare professionals still only understood  the most common 5 or 6 meant (e.g., sterile, lot, expiry,  CE mark, Rx mark , etc.).   This is a problem.  I really hope more symbols do NOT propagate.  I see no problem as a regulatory and quality profession in this industry and a consumer/ patient of medical technology to see explanations in a table in an IFU. It is one or maybe 2 pages long.  I don't want a HCP making a mistake because of the ever confusing plethora of symbols the committee thinks are "useful", however they "validated" them.






------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com

Original Message:
Sent: 15-Jul-2021 02:43
From: Pia Windelov
Subject: ISO 15223-1, 4th ed. just published July 6, 2021

Dear Leonard
Thanks also for sharing. I also bought the standard. I have a couple of questions which I hope you or someone else in this forum may be able to help answer. I am from a large language services provider that translates great volumes of information for medical devices incl. IFUs, user interfaces, labeling, etc. for our MedTech clients.  I see that a new symbol has been added to the standard for translations in case these have been done by another entity than the manufacturer (table 1, ref. 5.7.8). The intention of the symbol, - as described in the standard -, is to disclose the entity that is responsible for the translation activity by name and address.
Do you know why this new requirement has been introduced and which specific compliance obligations this enforces on the translation provider? I am asking because as a language services provider, we are not a manufacturer that ultimately has the responsibility of the information supplied with the device. I am aware that importers and distributors are required to have a QMS that ensures accuracy of translations if they are responsible for these. We have a QMS as well and I want to update our SOPs with this new requirement.
I just need to be clear on our compliance obligations, given we are not manufacturer, nor involved in any supply chain activities.
I see it as a very positive development that regulators and standards organizations increase their attention to translations. After all, it is the translated version that ends up in the hands of the user.
Thanks a lot in advance
KR Pia Windelov

------------------------------
Pia Windelov
Director, Product Strategy, Life Sciences
Skovlunde
Denmark

Original Message:
Sent: 06-Jul-2021 17:03
From: Leonard Eisner
Subject: ISO 15223-1, 4th ed. just published July 6, 2021

Finally, it was published. You can purchase from ISO at https://www.iso.org/standard/77326.html. Attached is a screenshot of the ISO webpage showing today's publication.
If you want to wait til the CEN version is published and European Standards Organizations (ESOs) adopt then purchase from Estonian Standards for much less but not sure when that will be.
Took a long time from FDIS (final draft) til it got published but the committee worked really hard and our efforts paid off TC210/WG3.  We got a nice note from Lena (Convenor of the WG3) today and thx Jeff (past convenor and now project leader) for his hard work & tremendous leadership in the project.  It is a great group to work with and I can't wait to meet some of the members face to face finally.

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

This message was posted by a user wishing to remain anonymous

I know that several symbols in ISo 15223-1:2021 are referenced in ISO 7000 database. But there are few ISO 15223-1:2021 symbol that are not listed in ISO 7000 so cannot be brought from ISO Online databse for symbols for example: MD symbol indicating medical device, IVD symbol, UDI symbol.

Does anyone know know where to buy these symbols not listed or referenced in the ISO 7000 database?
Original Message:
Sent: 06-Jul-2021 17:03
From: Leonard Eisner
Subject: ISO 15223-1, 4th ed. just published July 6, 2021

Finally, it was published. You can purchase from ISO at https://www.iso.org/standard/77326.html. Attached is a screenshot of the ISO webpage showing today's publication.
If you want to wait til the CEN version is published and European Standards Organizations (ESOs) adopt then purchase from Estonian Standards for much less but not sure when that will be.
Took a long time from FDIS (final draft) til it got published but the committee worked really hard and our efforts paid off TC210/WG3.  We got a nice note from Lena (Convenor of the WG3) today and thx Jeff (past convenor and now project leader) for his hard work & tremendous leadership in the project.  It is a great group to work with and I can't wait to meet some of the members face to face finally.

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

Symbols can be purchased from the various national standards development organizations such as BSI, AAMI and DIN, but it doesn't look like the SDOs have updated their stores yet. You can also look at the ANSI website. Here are links to three SDOs but NOTE that they only have the 2016 version still.

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:
Sent: 20-Jul-2021 17:50
From: Anonymous Member
Subject: ISO 15223-1, 4th ed. just published July 6, 2021

This message was posted by a user wishing to remain anonymous

I know that several symbols in ISo 15223-1:2021 are referenced in ISO 7000 database. But there are few ISO 15223-1:2021 symbol that are not listed in ISO 7000 so cannot be brought from ISO Online databse for symbols for example: MD symbol indicating medical device, IVD symbol, UDI symbol.

Does anyone know know where to buy these symbols not listed or referenced in the ISO 7000 database?
Original Message:
Sent: 06-Jul-2021 17:03
From: Leonard Eisner
Subject: ISO 15223-1, 4th ed. just published July 6, 2021

Finally, it was published. You can purchase from ISO at https://www.iso.org/standard/77326.html. Attached is a screenshot of the ISO webpage showing today's publication.
If you want to wait til the CEN version is published and European Standards Organizations (ESOs) adopt then purchase from Estonian Standards for much less but not sure when that will be.
Took a long time from FDIS (final draft) til it got published but the committee worked really hard and our efforts paid off TC210/WG3.  We got a nice note from Lena (Convenor of the WG3) today and thx Jeff (past convenor and now project leader) for his hard work & tremendous leadership in the project.  It is a great group to work with and I can't wait to meet some of the members face to face finally.

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

This message was posted by a user wishing to remain anonymous

Thank you, Lena for the information. This was very helpful.
Original Message:
Sent: 21-Jul-2021 09:11
From: Lena Cordie-Bancroft
Subject: ISO 15223-1, 4th ed. just published July 6, 2021

Symbols can be purchased from the various national standards development organizations such as BSI, AAMI and DIN, but it doesn't look like the SDOs have updated their stores yet. You can also look at the ANSI website. Here are links to three SDOs but NOTE that they only have the 2016 version still.

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:
Sent: 20-Jul-2021 17:50
From: Anonymous Member
Subject: ISO 15223-1, 4th ed. just published July 6, 2021

This message was posted by a user wishing to remain anonymous

I know that several symbols in ISo 15223-1:2021 are referenced in ISO 7000 database. But there are few ISO 15223-1:2021 symbol that are not listed in ISO 7000 so cannot be brought from ISO Online databse for symbols for example: MD symbol indicating medical device, IVD symbol, UDI symbol.

Does anyone know know where to buy these symbols not listed or referenced in the ISO 7000 database?
Original Message:
Sent: 06-Jul-2021 17:03
From: Leonard Eisner
Subject: ISO 15223-1, 4th ed. just published July 6, 2021

Finally, it was published. You can purchase from ISO at https://www.iso.org/standard/77326.html. Attached is a screenshot of the ISO webpage showing today's publication.
If you want to wait til the CEN version is published and European Standards Organizations (ESOs) adopt then purchase from Estonian Standards for much less but not sure when that will be.
Took a long time from FDIS (final draft) til it got published but the committee worked really hard and our efforts paid off TC210/WG3.  We got a nice note from Lena (Convenor of the WG3) today and thx Jeff (past convenor and now project leader) for his hard work & tremendous leadership in the project.  It is a great group to work with and I can't wait to meet some of the members face to face finally.

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

Can currently purchase from the the ISO store at https://www.iso.org/standard/77326.html

------------------------------
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:
Sent: 27-Jul-2021 09:50
From: Anonymous Member
Subject: ISO 15223-1, 4th ed. just published July 6, 2021

This message was posted by a user wishing to remain anonymous

Thank you, Lena for the information. This was very helpful.
Original Message:
Sent: 21-Jul-2021 09:11
From: Lena Cordie-Bancroft
Subject: ISO 15223-1, 4th ed. just published July 6, 2021

Symbols can be purchased from the various national standards development organizations such as BSI, AAMI and DIN, but it doesn't look like the SDOs have updated their stores yet. You can also look at the ANSI website. Here are links to three SDOs but NOTE that they only have the 2016 version still.

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:
Sent: 20-Jul-2021 17:50
From: Anonymous Member
Subject: ISO 15223-1, 4th ed. just published July 6, 2021

This message was posted by a user wishing to remain anonymous

I know that several symbols in ISo 15223-1:2021 are referenced in ISO 7000 database. But there are few ISO 15223-1:2021 symbol that are not listed in ISO 7000 so cannot be brought from ISO Online databse for symbols for example: MD symbol indicating medical device, IVD symbol, UDI symbol.

Does anyone know know where to buy these symbols not listed or referenced in the ISO 7000 database?
Original Message:
Sent: 06-Jul-2021 17:03
From: Leonard Eisner
Subject: ISO 15223-1, 4th ed. just published July 6, 2021

Finally, it was published. You can purchase from ISO at https://www.iso.org/standard/77326.html. Attached is a screenshot of the ISO webpage showing today's publication.
If you want to wait til the CEN version is published and European Standards Organizations (ESOs) adopt then purchase from Estonian Standards for much less but not sure when that will be.
Took a long time from FDIS (final draft) til it got published but the committee worked really hard and our efforts paid off TC210/WG3.  We got a nice note from Lena (Convenor of the WG3) today and thx Jeff (past convenor and now project leader) for his hard work & tremendous leadership in the project.  It is a great group to work with and I can't wait to meet some of the members face to face finally.

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