Medical Device Labels - Use Symbols Not Words

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M

MPiska

#13
Hi All, bringing back a thread from the crypt...

We are looking to move further towards using symbols for various pieces of information in our labelling.

Where the relevant standards to the products do not provide a harmonised/standard symbol - are there rules/requirements if creating your own symbols?

for example labels that say "Max Voltage" or "Frequency"?

Are the symbols from ISO 7001 relevant and usable in any situation (as long as they are still defined within the IFU as per their definition in the standard)

What is the usual practise?

Thanks

MP
 
M

MIREGMGR

#14
You don't specify what regulatory systems apply to your labeling.

As is posted in this thread, US FDA does not accept symbols on labels (or more precisely, ignores them in its determination of label adequacy), except for a limited set of symbols and only on certain IVD labels.
 
M

MPiska

#15
We have specific labeling for the USA, thank you for asking

We are working to the relevant product specific standards and country regulatory requirements.

However some of the statements we are looking at moving to symbols for in various territories where possible - as per my examples.



Sent from my Nexus 4 using Tapatalk
 

Michael Malis

Quite Involved in Discussions
#16
MPiska,

If you have an appropriate (and approved) labeling for US, why not try to adapt CE labeling standards?

There is a number of approved symbol standards for general and specific use, such as electrical. To me, this is a better solution vs. creation of country-specific labels. My preference would be to create 1 universal label and not different labels for different county use.

Regards,
Michael
 
M

MPiska

#17
Hi Michael,

"My preference would be to create 1 universal label and not different labels for different county use."

This is exactly what we are trying to do, except for the USA where symbols are frowned upon...

Where we are following harmonised product standards, there are many requirements for product markings - a very quick example:

[FONT=CenturySchoolbook,Bold]BS EN ISO 15002:2008[/FONT]

In addition, flow-metering devices shall be clearly and durably marked with the following:


the name and/or the trademark of the manufacturer or distributor;


means to ensure traceability, such as type, batch or serial number and year of manufacture;


the rated inlet pressure, p1;


the direction for increasing the flow;
point on the indicator for reading the flow on a flowmeter with a tube;


the inlet pressure or range of inlet pressures for which the flow-metering device is calibrated;


“USE NO OIL” or the symbol shown in Figure 1.


The standard gives a specific symbol to use for "Use no Oil" but not for the other markings required.
Some are standard requirements and have their symbols in relevant standards/regulations, however some are specific.

This has resulted in the label having text such as "Inlet Pressure: ### kPa" and "Read flow at center of ball".

As labelling must be translated throughout europe (~23 languages, more or less) this means we need to translate this free text.
As such we don't have the "one universal label".

My question was based on symbols to represent these fixed pieces of text, referencing these within the IFU where required and what is appropriate to use and current practices.

Thank you.

MP.
 
#18
There is a standard database of symbols - ISO 7000, not limited to medical devices.

You can search it on-line (free!) at

https://www.iso.org/obp/ui/#search

And then from the bibliography section of EN980:

ISO 15223-1: 2007, Medical devices ? Symbols to be used with medical device labels, labelling and information to be supplied ? Part 1: General requirements
IEC 60417-DB, Graphical symbols for use on equipment

EN 80416-1, Basic principles for graphical symbols for use on equipment ? Part 1: Creation of symbol originals
EN 80416-2, Basic principles for graphical symbols for use on equipment ? Part 2: Form and use of arrows (ISO 80416-2:2001)
EN 80416-3, Basic principles for graphical symbols for use on equipment ? Part 3: Guidelines for the application of graphical symbols (IEC 80416-3:2002)
ISO 80416-4, Basic principles for graphical symbols for use on equipment ? Part 4: Guidelines for the adaptation of graphical symbols for use on screens and displays (icons)
ISO 3864-1:2002, Graphical symbols ? Safety colours and safety signs ? Part 1: Design principles for safety signs in workplaces and public areas
ISO 7000: 2004, Graphical symbols for use on equipment - Index and synopsis.
 

Sam Lazzara

Trusted Information Resource
#19
FDA is making a move towards not requiring English subtext next to each label symbol.
I wonder what the current status is.

http : //www .fda. gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM350760.pdf - DEAD LINK UNLINKED (404)

http ://www .fda. gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM352039.pdf - DEAD LINK UNLINKED (404)

http ://www. raps. org/focus-online/news/news-article-view/article/3206/new-regulation-proposes-allowing-device-manufacturers-to-use-validated-symbols.aspx - DEAD LINK UNLINKED (404)

"Under our proposed rule revising parts 660, 801, and 809, FDA seeks to harmonize US regulatory requirements with those of the European Commission by allowing stand-alone standardized symbols recognized by FDA to be used in medical device labeling when a symbols glossary contemporaneously accompanies the medical device," FDA explained.
 
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