Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

My company manufactures single use disposable devices and is currently assessing ISO 20417: 2021. Our risk file currently lists a handful of risks that are only mitigated through labeling, such as product sizing and compatibility with other medical devices. ISO 20417, 6.1.5 states:  


In previous lives, when working with electrical medical equipment, the dreaded "blue man" symbol was a known requirement for labeling. The symbol was almost always included and always blue.

Now working in non-electrical, disposable devices, I am left questioning how needed the symbol is and the burden that it would pose on the labeling process (current labeling is in black and white). Is the use of this symbol expanding beyond electrical medical equipment and we just need to incorporate it now? Management is asking if we have to incorporate, can it replace other symbols such as the booklet or the caution symbol and can it include eIFU information (such as the website), and from what I've researched it looks like this isn't possible. 

I'm looking for a couple of things:
1. Am I being too literal when reading ISO 20417? Does this symbol apply to non-active medical devices?
2. Would it replace ISO 15223-1 symbol 5.4.3? If so, can it be accompanied by the web address for eIFU (the ISO database doesn't include that information in the information)? 

Thank you in advance!!!

Hello Anon,

Indeed this is an interesting question when going through different product development over the years, always wondered myself about using some of the symbols from ISO 7010 as compared to using those symbols in ISO 15223-1.  There can be a number of interpretations as to how these would be applied, but generally a product specific standard would "rank higher" than a general type of standard.  The argument could be made the "read instructions" symbol in ISO 15223-1  is used specific to all medical devices.  When I found the blue-man symbol needing to be used was for active devices where our electrical safety laboratory was not too familiar with ISO 15223-1, more familiar with ISO 7010, and so required us to include the blue-man symbol.  Plus traditionally, I think if you look at 99% of non-active medical device labelling, you will either find the triangle symbol with exclamation, the book with the 'i', or both.  I also found the ISO 7010 symbols to be used in more general use such as any type of electrical equipment, manufacturing environments, any safety instances, and non-medical device industry use.  I have used the blue-man symbol directly on the device itself, an electrical reusable device, which were placed in different environments such as large hospitals where they were use to seeing the blue-man symbol and not the triangle or book symbol.

So to answer your questions: 1) I would not think it needs to be used, but should refresh on the scope of ISO 7010 just to confirm or maybe include rationale in your technical documentation why certain symbols are used (I would do that anyway). 2) No, the refer to instructions symbol would be the one I would use and yes include the web address for eIFU if you do this.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 27-Aug-2021 10:39
From: Anonymous Member
Subject: Labeling Question from ISO 20417 and the use of ISO 7010 M002 Symbol

This message was posted by a user wishing to remain anonymous

My company manufactures single use disposable devices and is currently assessing ISO 20417: 2021. Our risk file currently lists a handful of risks that are only mitigated through labeling, such as product sizing and compatibility with other medical devices. ISO 20417, 6.1.5 states:

When the manufacturer uses consulting the accompanying information as a primary risk control measure for a specific risk, (e.g., the instructions for use contain information for safety), the medical device or accessory shall be labelled with:
1) The mandatory action safety sign ISO 7010-M002; or

2) a text string to the effect that it is a mandatory action to read the instructions for use.

In previous lives, when working with electrical medical equipment, the dreaded "blue man" symbol was a known requirement for labeling. The symbol was almost always included and always blue.

Now working in non-electrical, disposable devices, I am left questioning how needed the symbol is and the burden that it would pose on the labeling process (current labeling is in black and white). Is the use of this symbol expanding beyond electrical medical equipment and we just need to incorporate it now? Management is asking if we have to incorporate, can it replace other symbols such as the booklet or the caution symbol and can it include eIFU information (such as the website), and from what I've researched it looks like this isn't possible.

I'm looking for a couple of things:
1. Am I being too literal when reading ISO 20417? Does this symbol apply to non-active medical devices?
2. Would it replace ISO 15223-1 symbol 5.4.3? If so, can it be accompanied by the web address for eIFU (the ISO database doesn't include that information in the information)?

Thank you in advance!!!

Hello Anon, I agree with Richard that 15223 book symbol is more general and you may want to consider what is needed specifically for your product label and users. You can add the website next to the book symbol on your labels and DFU symbol glossary . However, wanted to point out that the latest revision of 15223-1 (2021) disallows use of Caution symbol to persuade user to refer to IFU. The Caution symbol which is a safety caution may have been incorrectly used in the past with IFU symbol.

------------------------------
Vidya
USA
------------------------------

Original Message:
Sent: 27-Aug-2021 10:39
From: Anonymous Member
Subject: Labeling Question from ISO 20417 and the use of ISO 7010 M002 Symbol

This message was posted by a user wishing to remain anonymous

My company manufactures single use disposable devices and is currently assessing ISO 20417: 2021. Our risk file currently lists a handful of risks that are only mitigated through labeling, such as product sizing and compatibility with other medical devices. ISO 20417, 6.1.5 states:

When the manufacturer uses consulting the accompanying information as a primary risk control measure for a specific risk, (e.g., the instructions for use contain information for safety), the medical device or accessory shall be labelled with:
1) The mandatory action safety sign ISO 7010-M002; or

2) a text string to the effect that it is a mandatory action to read the instructions for use.

In previous lives, when working with electrical medical equipment, the dreaded "blue man" symbol was a known requirement for labeling. The symbol was almost always included and always blue.

Now working in non-electrical, disposable devices, I am left questioning how needed the symbol is and the burden that it would pose on the labeling process (current labeling is in black and white). Is the use of this symbol expanding beyond electrical medical equipment and we just need to incorporate it now? Management is asking if we have to incorporate, can it replace other symbols such as the booklet or the caution symbol and can it include eIFU information (such as the website), and from what I've researched it looks like this isn't possible.

I'm looking for a couple of things:
1. Am I being too literal when reading ISO 20417? Does this symbol apply to non-active medical devices?
2. Would it replace ISO 15223-1 symbol 5.4.3? If so, can it be accompanied by the web address for eIFU (the ISO database doesn't include that information in the information)?

Thank you in advance!!!

This message was posted by a user wishing to remain anonymous

Hi Anon,

I agree with the previous posters.

Also, don't forget to read Annex A of ISO 20417 for a little extra guidance and insight on this issue.
Original Message:
Sent: 27-Aug-2021 10:39
From: Anonymous Member
Subject: Labeling Question from ISO 20417 and the use of ISO 7010 M002 Symbol

This message was posted by a user wishing to remain anonymous

My company manufactures single use disposable devices and is currently assessing ISO 20417: 2021. Our risk file currently lists a handful of risks that are only mitigated through labeling, such as product sizing and compatibility with other medical devices. ISO 20417, 6.1.5 states:

When the manufacturer uses consulting the accompanying information as a primary risk control measure for a specific risk, (e.g., the instructions for use contain information for safety), the medical device or accessory shall be labelled with:
1) The mandatory action safety sign ISO 7010-M002; or

2) a text string to the effect that it is a mandatory action to read the instructions for use.

In previous lives, when working with electrical medical equipment, the dreaded "blue man" symbol was a known requirement for labeling. The symbol was almost always included and always blue.

Now working in non-electrical, disposable devices, I am left questioning how needed the symbol is and the burden that it would pose on the labeling process (current labeling is in black and white). Is the use of this symbol expanding beyond electrical medical equipment and we just need to incorporate it now? Management is asking if we have to incorporate, can it replace other symbols such as the booklet or the caution symbol and can it include eIFU information (such as the website), and from what I've researched it looks like this isn't possible.

I'm looking for a couple of things:
1. Am I being too literal when reading ISO 20417? Does this symbol apply to non-active medical devices?
2. Would it replace ISO 15223-1 symbol 5.4.3? If so, can it be accompanied by the web address for eIFU (the ISO database doesn't include that information in the information)?

Thank you in advance!!!

Previous posts are correct! The 'blue man' has it's own purpose and is different from the IFU symbol. So don't use it if you don't have to! ISO 20417 is a high-level, general requirements standard that pulls in labeling requirements from across the medical device spectrum. AND as all standards are, the use of it is voluntary.

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

Original Message:
Sent: 27-Aug-2021 10:39
From: Anonymous Member
Subject: Labeling Question from ISO 20417 and the use of ISO 7010 M002 Symbol

This message was posted by a user wishing to remain anonymous

My company manufactures single use disposable devices and is currently assessing ISO 20417: 2021. Our risk file currently lists a handful of risks that are only mitigated through labeling, such as product sizing and compatibility with other medical devices. ISO 20417, 6.1.5 states:

When the manufacturer uses consulting the accompanying information as a primary risk control measure for a specific risk, (e.g., the instructions for use contain information for safety), the medical device or accessory shall be labelled with:
1) The mandatory action safety sign ISO 7010-M002; or

2) a text string to the effect that it is a mandatory action to read the instructions for use.

In previous lives, when working with electrical medical equipment, the dreaded "blue man" symbol was a known requirement for labeling. The symbol was almost always included and always blue.

Now working in non-electrical, disposable devices, I am left questioning how needed the symbol is and the burden that it would pose on the labeling process (current labeling is in black and white). Is the use of this symbol expanding beyond electrical medical equipment and we just need to incorporate it now? Management is asking if we have to incorporate, can it replace other symbols such as the booklet or the caution symbol and can it include eIFU information (such as the website), and from what I've researched it looks like this isn't possible.

I'm looking for a couple of things:
1. Am I being too literal when reading ISO 20417? Does this symbol apply to non-active medical devices?
2. Would it replace ISO 15223-1 symbol 5.4.3? If so, can it be accompanied by the web address for eIFU (the ISO database doesn't include that information in the information)?

Thank you in advance!!!

Good Day Lena,

I attended a webinar provided by Greenlight Guru in July on the new ISO 15223-1 standard and during that webinar, the speaker stated that the "blue man" must now be used if your IFU mitigates risk associated with your device.  He said that you can no longer use 5.4.3 for risk mitigation.  A question was posed at the end and again, the speaker said the blue man must now be used for risk mitigation.

Do you have documentation that supports your comment that it does not?  I am curious as no one else can seem to debate what was stated in the webinar.  They have either not seen this change or they agree that you can no longer use 5.4.3 if mitigating risk.

I'm very interested in your response.

Many thanks!!!

------------------------------
D Michelle Williams
VP - Operations
United States
------------------------------

Original Message:
Sent: 01-Sep-2021 10:09
From: Lena Cordie-Bancroft
Subject: Labeling Question from ISO 20417 and the use of ISO 7010 M002 Symbol

Previous posts are correct! The 'blue man' has it's own purpose and is different from the IFU symbol. So don't use it if you don't have to! ISO 20417 is a high-level, general requirements standard that pulls in labeling requirements from across the medical device spectrum. AND as all standards are, the use of it is voluntary.

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

Original Message:
Sent: 27-Aug-2021 10:39
From: Anonymous Member
Subject: Labeling Question from ISO 20417 and the use of ISO 7010 M002 Symbol

This message was posted by a user wishing to remain anonymous

My company manufactures single use disposable devices and is currently assessing ISO 20417: 2021. Our risk file currently lists a handful of risks that are only mitigated through labeling, such as product sizing and compatibility with other medical devices. ISO 20417, 6.1.5 states:

When the manufacturer uses consulting the accompanying information as a primary risk control measure for a specific risk, (e.g., the instructions for use contain information for safety), the medical device or accessory shall be labelled with:
1) The mandatory action safety sign ISO 7010-M002; or

2) a text string to the effect that it is a mandatory action to read the instructions for use.

In previous lives, when working with electrical medical equipment, the dreaded "blue man" symbol was a known requirement for labeling. The symbol was almost always included and always blue.

Now working in non-electrical, disposable devices, I am left questioning how needed the symbol is and the burden that it would pose on the labeling process (current labeling is in black and white). Is the use of this symbol expanding beyond electrical medical equipment and we just need to incorporate it now? Management is asking if we have to incorporate, can it replace other symbols such as the booklet or the caution symbol and can it include eIFU information (such as the website), and from what I've researched it looks like this isn't possible.

I'm looking for a couple of things:
1. Am I being too literal when reading ISO 20417? Does this symbol apply to non-active medical devices?
2. Would it replace ISO 15223-1 symbol 5.4.3? If so, can it be accompanied by the web address for eIFU (the ISO database doesn't include that information in the information)?

Thank you in advance!!!

There seems to be some confusion from what was said during the presentation.  I was the presenter and it is quite confusing.  The "blue man" symbol is really only for medical electrical equipment per the IEC 60601-1 standard that it is a requirement and the requirement has changed from ed. 3.0/3.1 to the most recent 3.2 where the clarification has been placed.  Also, in ISO 20417:2021 similar but slightly different requirements have been included for the situation.

The most recent versions of IEC 60601-1 (3rd ed. + Amendment 2) and 1st edition of ISO 20417:2021 are written only that the safety sign (blue man symbol) should be used for primary risk control measure or otherwiser the ISO 15223-1 symbol 5.4.3 (i in a booklet) may be used. But in the past both were used because the "blue man"safety sign ISO 7010-M002 was forced to be used by most test labs from a misunderstanding of the requirement in IEC 60601-1 not being written well. The problem is that most medical electrical device manufacturers were also using the consult instructions for use symbol (5.4.3) as well causing some confusion. Note, that the blue man symbol really should only be used for medical electrical equipment and only when used only as a primary risk control measure for your IFU and not using as a design or other forms of primary risk mitigation. You would not want to use this symbol for non actrive medical devices.

------------------------------
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: 03-Sep-2021 08:35
From: D Michelle Williams
Subject: Labeling Question from ISO 20417 and the use of ISO 7010 M002 Symbol

Good Day Lena,

I attended a webinar provided by Greenlight Guru in July on the new ISO 15223-1 standard and during that webinar, the speaker stated that the "blue man" must now be used if your IFU mitigates risk associated with your device.  He said that you can no longer use 5.4.3 for risk mitigation.  A question was posed at the end and again, the speaker said the blue man must now be used for risk mitigation.

Do you have documentation that supports your comment that it does not?  I am curious as no one else can seem to debate what was stated in the webinar.  They have either not seen this change or they agree that you can no longer use 5.4.3 if mitigating risk.

I'm very interested in your response.

Many thanks!!!

------------------------------
D Michelle Williams
VP - Operations
United States

Original Message:
Sent: 01-Sep-2021 10:09
From: Lena Cordie-Bancroft
Subject: Labeling Question from ISO 20417 and the use of ISO 7010 M002 Symbol

Previous posts are correct! The 'blue man' has it's own purpose and is different from the IFU symbol. So don't use it if you don't have to! ISO 20417 is a high-level, general requirements standard that pulls in labeling requirements from across the medical device spectrum. AND as all standards are, the use of it is voluntary.

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

Original Message:
Sent: 27-Aug-2021 10:39
From: Anonymous Member
Subject: Labeling Question from ISO 20417 and the use of ISO 7010 M002 Symbol

This message was posted by a user wishing to remain anonymous

My company manufactures single use disposable devices and is currently assessing ISO 20417: 2021. Our risk file currently lists a handful of risks that are only mitigated through labeling, such as product sizing and compatibility with other medical devices. ISO 20417, 6.1.5 states:

When the manufacturer uses consulting the accompanying information as a primary risk control measure for a specific risk, (e.g., the instructions for use contain information for safety), the medical device or accessory shall be labelled with:
1) The mandatory action safety sign ISO 7010-M002; or

2) a text string to the effect that it is a mandatory action to read the instructions for use.

In previous lives, when working with electrical medical equipment, the dreaded "blue man" symbol was a known requirement for labeling. The symbol was almost always included and always blue.

Now working in non-electrical, disposable devices, I am left questioning how needed the symbol is and the burden that it would pose on the labeling process (current labeling is in black and white). Is the use of this symbol expanding beyond electrical medical equipment and we just need to incorporate it now? Management is asking if we have to incorporate, can it replace other symbols such as the booklet or the caution symbol and can it include eIFU information (such as the website), and from what I've researched it looks like this isn't possible.

I'm looking for a couple of things:
1. Am I being too literal when reading ISO 20417? Does this symbol apply to non-active medical devices?
2. Would it replace ISO 15223-1 symbol 5.4.3? If so, can it be accompanied by the web address for eIFU (the ISO database doesn't include that information in the information)?

Thank you in advance!!!

Hello Leonard 

My company manufactures EM equipment so we were already using the ISO 7010-M002 (Blue Man symbol) and  it will not change with IEC 60601-1 (Ed. 3.2) or the first edition of ISO 20417:2021 since consulting IFUs will remain a primary risk control measures.

Could we consider that the use of ISO 7010-M002 makes the use of the ISO 15223-1 symbol 5.4.4 (Caution) unnecessary because it encompasses the meaning of the Caution symbol (5.4.4).?


 

------------------------------
Maxime TIROUVANZIAM
Somerset NJ
United States
------------------------------

Original Message:
Sent: 04-Sep-2021 01:17
From: Leonard Eisner
Subject: Labeling Question from ISO 20417 and the use of ISO 7010 M002 Symbol

There seems to be some confusion from what was said during the presentation.  I was the presenter and it is quite confusing.  The "blue man" symbol is really only for medical electrical equipment per the IEC 60601-1 standard that it is a requirement and the requirement has changed from ed. 3.0/3.1 to the most recent 3.2 where the clarification has been placed.  Also, in ISO 20417:2021 similar but slightly different requirements have been included for the situation.

The most recent versions of IEC 60601-1 (3rd ed. + Amendment 2) and 1st edition of ISO 20417:2021 are written only that the safety sign (blue man symbol) should be used for primary risk control measure or otherwiser the ISO 15223-1 symbol 5.4.3 (i in a booklet) may be used. But in the past both were used because the "blue man"safety sign ISO 7010-M002 was forced to be used by most test labs from a misunderstanding of the requirement in IEC 60601-1 not being written well. The problem is that most medical electrical device manufacturers were also using the consult instructions for use symbol (5.4.3) as well causing some confusion. Note, that the blue man symbol really should only be used for medical electrical equipment and only when used only as a primary risk control measure for your IFU and not using as a design or other forms of primary risk mitigation. You would not want to use this symbol for non actrive medical devices.

------------------------------
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: 03-Sep-2021 08:35
From: D Michelle Williams
Subject: Labeling Question from ISO 20417 and the use of ISO 7010 M002 Symbol

Good Day Lena,

I attended a webinar provided by Greenlight Guru in July on the new ISO 15223-1 standard and during that webinar, the speaker stated that the "blue man" must now be used if your IFU mitigates risk associated with your device.  He said that you can no longer use 5.4.3 for risk mitigation.  A question was posed at the end and again, the speaker said the blue man must now be used for risk mitigation.

Do you have documentation that supports your comment that it does not?  I am curious as no one else can seem to debate what was stated in the webinar.  They have either not seen this change or they agree that you can no longer use 5.4.3 if mitigating risk.

I'm very interested in your response.

Many thanks!!!

------------------------------
D Michelle Williams
VP - Operations
United States

Original Message:
Sent: 01-Sep-2021 10:09
From: Lena Cordie-Bancroft
Subject: Labeling Question from ISO 20417 and the use of ISO 7010 M002 Symbol

Previous posts are correct! The 'blue man' has it's own purpose and is different from the IFU symbol. So don't use it if you don't have to! ISO 20417 is a high-level, general requirements standard that pulls in labeling requirements from across the medical device spectrum. AND as all standards are, the use of it is voluntary.

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

Original Message:
Sent: 27-Aug-2021 10:39
From: Anonymous Member
Subject: Labeling Question from ISO 20417 and the use of ISO 7010 M002 Symbol

This message was posted by a user wishing to remain anonymous

My company manufactures single use disposable devices and is currently assessing ISO 20417: 2021. Our risk file currently lists a handful of risks that are only mitigated through labeling, such as product sizing and compatibility with other medical devices. ISO 20417, 6.1.5 states:

When the manufacturer uses consulting the accompanying information as a primary risk control measure for a specific risk, (e.g., the instructions for use contain information for safety), the medical device or accessory shall be labelled with:
1) The mandatory action safety sign ISO 7010-M002; or

2) a text string to the effect that it is a mandatory action to read the instructions for use.

In previous lives, when working with electrical medical equipment, the dreaded "blue man" symbol was a known requirement for labeling. The symbol was almost always included and always blue.

Now working in non-electrical, disposable devices, I am left questioning how needed the symbol is and the burden that it would pose on the labeling process (current labeling is in black and white). Is the use of this symbol expanding beyond electrical medical equipment and we just need to incorporate it now? Management is asking if we have to incorporate, can it replace other symbols such as the booklet or the caution symbol and can it include eIFU information (such as the website), and from what I've researched it looks like this isn't possible.

I'm looking for a couple of things:
1. Am I being too literal when reading ISO 20417? Does this symbol apply to non-active medical devices?
2. Would it replace ISO 15223-1 symbol 5.4.3? If so, can it be accompanied by the web address for eIFU (the ISO database doesn't include that information in the information)?

Thank you in advance!!!

From the ISO Online Browsing Platform the definition of the Caution symbol ISO 700-0434A (5.4.4 of ISO 15223-1) is "To indicate that caution is necessary when operating the device or control close to where the symbol is placed. To indicate that the current situation needs operator awareness or operator action in order to avoid undesirable consequences. On the health app quality label: to indicate that the health app requires approval from a health professional for use." The 155223-1 definition is very similar but doesn't include the health app reference which is "Indicates that caution is necessary when operating the device or control close to where the symbol is placed,  or that the current situation needs operator awareness or operator action in order to avoid undesirable consequences."

This is not the same as the ISO 7010-M002 (Blue Man symbol) intent and so you will need to be very clear in your intent and risk analysis to show how this would be equivalent.  I would not agree that the two symbols could be combined into one and use just the ISO 7010-M002 (Blue Man symbol) based on risk analysis.

You could try to justify these two symbols to be equivalent to the ISO 7010-M002 (Blue Man symbol) in the application as but does that work for the application, the overall situation and scenario and your risk analysis would definitely need to clearly make a case to explain why you are not using the second symbol if a standard is calling it out?  There may be a case to reduce confusion in usability sense but would require a lot of justification and may not be worth the hassle of arguing with the safety test lab or an emc test lab and you may have as much trouble with the regulators/notified bodies, as well.

------------------------------
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: 18-Feb-2022 10:53
From: Maxime TIROUVANZIAM
Subject: Labeling Question from ISO 20417 and the use of ISO 7010 M002 Symbol

Hello Leonard

My company manufactures EM equipment so we were already using the ISO 7010-M002 (Blue Man symbol) and  it will not change with IEC 60601-1 (Ed. 3.2) or the first edition of ISO 20417:2021 since consulting IFUs will remain a primary risk control measures.

Could we consider that the use of ISO 7010-M002 makes the use of the ISO 15223-1 symbol 5.4.4 (Caution) unnecessary because it encompasses the meaning of the Caution symbol (5.4.4).?


 

------------------------------
Maxime TIROUVANZIAM
Somerset NJ
United States

Original Message:
Sent: 04-Sep-2021 01:17
From: Leonard Eisner
Subject: Labeling Question from ISO 20417 and the use of ISO 7010 M002 Symbol

There seems to be some confusion from what was said during the presentation.  I was the presenter and it is quite confusing.  The "blue man" symbol is really only for medical electrical equipment per the IEC 60601-1 standard that it is a requirement and the requirement has changed from ed. 3.0/3.1 to the most recent 3.2 where the clarification has been placed.  Also, in ISO 20417:2021 similar but slightly different requirements have been included for the situation.

The most recent versions of IEC 60601-1 (3rd ed. + Amendment 2) and 1st edition of ISO 20417:2021 are written only that the safety sign (blue man symbol) should be used for primary risk control measure or otherwiser the ISO 15223-1 symbol 5.4.3 (i in a booklet) may be used. But in the past both were used because the "blue man"safety sign ISO 7010-M002 was forced to be used by most test labs from a misunderstanding of the requirement in IEC 60601-1 not being written well. The problem is that most medical electrical device manufacturers were also using the consult instructions for use symbol (5.4.3) as well causing some confusion. Note, that the blue man symbol really should only be used for medical electrical equipment and only when used only as a primary risk control measure for your IFU and not using as a design or other forms of primary risk mitigation. You would not want to use this symbol for non actrive medical devices.

------------------------------
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: 03-Sep-2021 08:35
From: D Michelle Williams
Subject: Labeling Question from ISO 20417 and the use of ISO 7010 M002 Symbol

Good Day Lena,

I attended a webinar provided by Greenlight Guru in July on the new ISO 15223-1 standard and during that webinar, the speaker stated that the "blue man" must now be used if your IFU mitigates risk associated with your device.  He said that you can no longer use 5.4.3 for risk mitigation.  A question was posed at the end and again, the speaker said the blue man must now be used for risk mitigation.

Do you have documentation that supports your comment that it does not?  I am curious as no one else can seem to debate what was stated in the webinar.  They have either not seen this change or they agree that you can no longer use 5.4.3 if mitigating risk.

I'm very interested in your response.

Many thanks!!!

------------------------------
D Michelle Williams
VP - Operations
United States

Original Message:
Sent: 01-Sep-2021 10:09
From: Lena Cordie-Bancroft
Subject: Labeling Question from ISO 20417 and the use of ISO 7010 M002 Symbol

Previous posts are correct! The 'blue man' has it's own purpose and is different from the IFU symbol. So don't use it if you don't have to! ISO 20417 is a high-level, general requirements standard that pulls in labeling requirements from across the medical device spectrum. AND as all standards are, the use of it is voluntary.

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

Original Message:
Sent: 27-Aug-2021 10:39
From: Anonymous Member
Subject: Labeling Question from ISO 20417 and the use of ISO 7010 M002 Symbol

This message was posted by a user wishing to remain anonymous

My company manufactures single use disposable devices and is currently assessing ISO 20417: 2021. Our risk file currently lists a handful of risks that are only mitigated through labeling, such as product sizing and compatibility with other medical devices. ISO 20417, 6.1.5 states:

When the manufacturer uses consulting the accompanying information as a primary risk control measure for a specific risk, (e.g., the instructions for use contain information for safety), the medical device or accessory shall be labelled with:
1) The mandatory action safety sign ISO 7010-M002; or

2) a text string to the effect that it is a mandatory action to read the instructions for use.

In previous lives, when working with electrical medical equipment, the dreaded "blue man" symbol was a known requirement for labeling. The symbol was almost always included and always blue.

Now working in non-electrical, disposable devices, I am left questioning how needed the symbol is and the burden that it would pose on the labeling process (current labeling is in black and white). Is the use of this symbol expanding beyond electrical medical equipment and we just need to incorporate it now? Management is asking if we have to incorporate, can it replace other symbols such as the booklet or the caution symbol and can it include eIFU information (such as the website), and from what I've researched it looks like this isn't possible.

I'm looking for a couple of things:
1. Am I being too literal when reading ISO 20417? Does this symbol apply to non-active medical devices?
2. Would it replace ISO 15223-1 symbol 5.4.3? If so, can it be accompanied by the web address for eIFU (the ISO database doesn't include that information in the information)?

Thank you in advance!!!

PS - In IEC 60601-1, ed. 3.2 in clauses 8.11.1 I) The use of ISO 700-0434A is a caution next to "any part within the ENCLOSURE of ME EQUIPMENT with a circuit voltage exceeding 42,4 V peak a.c. or 60 V d.c. that cannot be disconnected from its supply by an external switch or a plug device that is accessible at all times shall be protected against being touched even after opening of the ENCLOSURE by an additional covering or, in the case of a spatially separated arrangement, shall be marked clearly as exceeding the permitted voltage for parts that can be touched."  This is a different requirement then when the ISO 7010-M002 (Blue Man symbol) requirement comes up in the standard.

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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: 21-Feb-2022 16:18
From: Leonard Eisner
Subject: Labeling Question from ISO 20417 and the use of ISO 7010 M002 Symbol

From the ISO Online Browsing Platform the definition of the Caution symbol ISO 700-0434A (5.4.4 of ISO 15223-1) is "To indicate that caution is necessary when operating the device or control close to where the symbol is placed. To indicate that the current situation needs operator awareness or operator action in order to avoid undesirable consequences. On the health app quality label: to indicate that the health app requires approval from a health professional for use." The 155223-1 definition is very similar but doesn't include the health app reference which is "Indicates that caution is necessary when operating the device or control close to where the symbol is placed,  or that the current situation needs operator awareness or operator action in order to avoid undesirable consequences."

This is not the same as the ISO 7010-M002 (Blue Man symbol) intent and so you will need to be very clear in your intent and risk analysis to show how this would be equivalent.  I would not agree that the two symbols could be combined into one and use just the ISO 7010-M002 (Blue Man symbol) based on risk analysis.

You could try to justify these two symbols to be equivalent to the ISO 7010-M002 (Blue Man symbol) in the application as but does that work for the application, the overall situation and scenario and your risk analysis would definitely need to clearly make a case to explain why you are not using the second symbol if a standard is calling it out?  There may be a case to reduce confusion in usability sense but would require a lot of justification and may not be worth the hassle of arguing with the safety test lab or an emc test lab and you may have as much trouble with the regulators/notified bodies, as well.

------------------------------
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: 18-Feb-2022 10:53
From: Maxime TIROUVANZIAM
Subject: Labeling Question from ISO 20417 and the use of ISO 7010 M002 Symbol

Hello Leonard

My company manufactures EM equipment so we were already using the ISO 7010-M002 (Blue Man symbol) and  it will not change with IEC 60601-1 (Ed. 3.2) or the first edition of ISO 20417:2021 since consulting IFUs will remain a primary risk control measures.

Could we consider that the use of ISO 7010-M002 makes the use of the ISO 15223-1 symbol 5.4.4 (Caution) unnecessary because it encompasses the meaning of the Caution symbol (5.4.4).?


 

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Maxime TIROUVANZIAM
Somerset NJ
United States

Original Message:
Sent: 04-Sep-2021 01:17
From: Leonard Eisner
Subject: Labeling Question from ISO 20417 and the use of ISO 7010 M002 Symbol

There seems to be some confusion from what was said during the presentation.  I was the presenter and it is quite confusing.  The "blue man" symbol is really only for medical electrical equipment per the IEC 60601-1 standard that it is a requirement and the requirement has changed from ed. 3.0/3.1 to the most recent 3.2 where the clarification has been placed.  Also, in ISO 20417:2021 similar but slightly different requirements have been included for the situation.

The most recent versions of IEC 60601-1 (3rd ed. + Amendment 2) and 1st edition of ISO 20417:2021 are written only that the safety sign (blue man symbol) should be used for primary risk control measure or otherwiser the ISO 15223-1 symbol 5.4.3 (i in a booklet) may be used. But in the past both were used because the "blue man"safety sign ISO 7010-M002 was forced to be used by most test labs from a misunderstanding of the requirement in IEC 60601-1 not being written well. The problem is that most medical electrical device manufacturers were also using the consult instructions for use symbol (5.4.3) as well causing some confusion. Note, that the blue man symbol really should only be used for medical electrical equipment and only when used only as a primary risk control measure for your IFU and not using as a design or other forms of primary risk mitigation. You would not want to use this symbol for non actrive medical devices.

------------------------------
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: 03-Sep-2021 08:35
From: D Michelle Williams
Subject: Labeling Question from ISO 20417 and the use of ISO 7010 M002 Symbol

Good Day Lena,

I attended a webinar provided by Greenlight Guru in July on the new ISO 15223-1 standard and during that webinar, the speaker stated that the "blue man" must now be used if your IFU mitigates risk associated with your device.  He said that you can no longer use 5.4.3 for risk mitigation.  A question was posed at the end and again, the speaker said the blue man must now be used for risk mitigation.

Do you have documentation that supports your comment that it does not?  I am curious as no one else can seem to debate what was stated in the webinar.  They have either not seen this change or they agree that you can no longer use 5.4.3 if mitigating risk.

I'm very interested in your response.

Many thanks!!!

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D Michelle Williams
VP - Operations
United States

Original Message:
Sent: 01-Sep-2021 10:09
From: Lena Cordie-Bancroft
Subject: Labeling Question from ISO 20417 and the use of ISO 7010 M002 Symbol

Previous posts are correct! The 'blue man' has it's own purpose and is different from the IFU symbol. So don't use it if you don't have to! ISO 20417 is a high-level, general requirements standard that pulls in labeling requirements from across the medical device spectrum. AND as all standards are, the use of it is voluntary.

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Lena Cordie-Bancroft
Victoria MN
United States

Original Message:
Sent: 27-Aug-2021 10:39
From: Anonymous Member
Subject: Labeling Question from ISO 20417 and the use of ISO 7010 M002 Symbol

This message was posted by a user wishing to remain anonymous

My company manufactures single use disposable devices and is currently assessing ISO 20417: 2021. Our risk file currently lists a handful of risks that are only mitigated through labeling, such as product sizing and compatibility with other medical devices. ISO 20417, 6.1.5 states:

When the manufacturer uses consulting the accompanying information as a primary risk control measure for a specific risk, (e.g., the instructions for use contain information for safety), the medical device or accessory shall be labelled with:
1) The mandatory action safety sign ISO 7010-M002; or

2) a text string to the effect that it is a mandatory action to read the instructions for use.

In previous lives, when working with electrical medical equipment, the dreaded "blue man" symbol was a known requirement for labeling. The symbol was almost always included and always blue.

Now working in non-electrical, disposable devices, I am left questioning how needed the symbol is and the burden that it would pose on the labeling process (current labeling is in black and white). Is the use of this symbol expanding beyond electrical medical equipment and we just need to incorporate it now? Management is asking if we have to incorporate, can it replace other symbols such as the booklet or the caution symbol and can it include eIFU information (such as the website), and from what I've researched it looks like this isn't possible.

I'm looking for a couple of things:
1. Am I being too literal when reading ISO 20417? Does this symbol apply to non-active medical devices?
2. Would it replace ISO 15223-1 symbol 5.4.3? If so, can it be accompanied by the web address for eIFU (the ISO database doesn't include that information in the information)?

Thank you in advance!!!