Use of EN 980 and ISO 15223 Symbols for Non Medical Mevices

RA Guy

Involved In Discussions
#1
Does anyone have a learned opinion on whether the use of these symbols on a non-medical device (e.g., laboratory or agricultural product) is appropriate?

Obvioulsy the product should not otherwise be represented as a medical device, but I am thinking more about symbols for storage temperature, manufacturer, etc. Some symbols would be unusable solely due to their meaning (for example IVD, or EC Rep).
 
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MIREGMGR

#2
Re: use of 980/15223 symbols for non medical devices

Standards-wise, the symbols in question are defined for their use with medical devices. Are they also used and defined in some other standard pertaining to agricultural or laboratory products? If not, since your product would not be a medical device, how will you define the symbols' meanings? What are the regulatory requirements for labeling of the products you are interested in?
 

Marcelo

Inactive Registered Visitor
#3
Re: Use of 980/15223 symbols for non medical devices

All symbols in EN 980 and ISO 15223 are symbols for everything - it´s a little difficult to explain, but ISO and IEC have symbols databases and every symbol is included in these - when a symbol is proposed to ISO and IEC, it has to be proposed to be added to the symbol database, not to a standard. The symbols from these databases can be used, for example, in sector standards, but they are only done this way to group them and make it easy to a sector to find, and also because this way they can be used for example by regulations.

The more generic symbols, as the cited temperature, manufacturer, etc, are the same for all areas (otherwise there would be caos :))
 
R

Reiko Shiratori

#4
Re: Use of 980/15223 symbols for non medical devices

How about ISO780, Packaging - Pictorial marking for handling of goods?
This standard is not limited for medical devices.

As mmantunes mentioned above, you see some same symbols as EN980/ISO15223, in ISO780.

I hope this helps you.

Reiko:bigwave:
 

RA Guy

Involved In Discussions
#5
Re: Use of 980/15223 symbols for non medical devices

Thanks for the help mmantunes and Reiko. I've been working exclusively in medical devices for many years but recently moved to a small biotech company that makes IVDs and research products.
 

RA Guy

Involved In Discussions
#7
Dear MIREGMGR

That's a very good question. The animal products have a relatively low level of regulation. FDA, for example, has little formal regulations for vetrinary medical devices as oposed to vetrinary food or drugs. They request that manufacturers send copies of labels for review and do not prescribe content or format of the labels.

Japanese Ministry of Agriculture seems to regulate animal diagnostics similar to human diagnostics.

Laboratory/research products (human use) are generally exempt from product specific regulations by virtue of the fact that they can disclaim usage for patient diagnostics as prescribed in 21CFR or the IVD Directive.
Other regulations related to consumer protection, chemical hazards, electrical hazards could apply depending on the product.

My question was not asked to fullfil regulatory requirements for the animal and research products per se, but more to ensure that use of some symbols would not create the potential for a user to mistake an RUO device for an IVD device. Regulators tend to frown on any labeling that could imply innapproriate use of a "non-regulated product".

The reality is that there is no need to use symbols to achieve regulatory compliance. The symbols are generally used as an option to meet requirements in an efficient way when dealing with multiple languages or very little label/packaging/devide real estate on which to include information.

As far as defining the symbols, best practice is to include a symbol legend for each translation of the user guide.

Best
RA Guy
 
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