EN 980:2008(E) - Graphical Symbols for Labeling Medical Devices

[MIREGMGR]

Re: EN 980:2008(E)-Graphical symbols for use in the labeling of medical devices

I regard that particular NB-MED document as one of their weaker efforts.

The definition of scope

The ”use-by” time limit relates to the period before the first use of the device. It does not relate to the number or period of subsequent uses (the ”lifetime” of the device).

is both inconsistent with this requirement

The risk analysis and measures taken to manage risk will also identify the period over which the relevant performance or characteristic would be expected to be maintained for safe use, including the shelflife and intended period of use.

and also, by implicitly restricting the use of the hourglass symbol to "period before first use" only, leaves the implementor with no way to communicate the product's lifetime after product is opened.

The company for which I work believes that we better provide for product safety and effectiveness by using the hourglass symbol for both "period before first use" and "lifetime after product is opened", with appropriate, prominent text under the symbol in each case to communicate to the user which concept is intended by that use.

We don't regard that as an ideal solution, but in our view it's better than anything else supported by currently available standardized symbology.

 

[Rolande Hall]

Re: EN 980:2008(E)-Graphical symbols for use in the labeling of medical devices

Before I invest in a copy does anyone know if there is a symbol in the EN980:2008 to show when a product must be disposed of after opening? The jar symbol with the time in months inside the jar is perfect but I believe this is only for cosmetics and may not be used on medical device packaging. I have written to the MHRA and am awaiting a reply, I thought maybe this forum could answer quicker. Many thanks

Save your money.
The "Use By" symbol in EN 980 applies to product in an unopened package.
When drafting EN 1041 it was expected that devices with a "Use by" date would be used immediately after package opening. After this time the product no longer carries the "Use by" label; it will be in the refuse bin with package.
I presume your need applies to a multi-use product which deteriorates with usage. You may choose to use a symbol from another industry provided you explain its significence in the information supplied by the manufacturer with the product.
Perhaps in the long term you can get a new symbol by approaching your National Standards Body, Trade Association or Eucomed with a request that CEN TC 257 consider your proposal.

 

[Woman on a mission]

Re: EN 980:2008(E)-Graphical symbols for use in the labeling of medical devices

Many thanks for your reply. In fact I had a very similar reply from the MHRA. Thank you for the info

Perhaps in the long term you can get a new symbol by approaching your National Standards Body, Trade Association or Eucomed with a request that CEN TC 257 consider your proposal.

again

 

[red66climb]

Re: EN 980:2008(E)-Graphical symbols for use in the labeling of medical devices

Does anyone know if the new standard has the updated symbol for Latex Free?

 

[bio_subbu]

Re: EN 980:2008(E)-Graphical symbols for use in the labeling of medical devices

Does anyone know if the new standard has the updated symbol for Latex Free?

The only symbol available with respect to Latex “CONTAINS OR PRESENCE OF NATURAL RUBBER LATEX” in 6.2 of EN 980:2008

 

[luckidad]

Re: EN 980:2008(E)-Graphical symbols for use in the labeling of medical devices

I need to find a symbol for quantity of units in a box. I've seen an icon of number inside an opened box - even my notified body doesn't know where this comes from, though. I haven't even see anything in the EN 980 summaries I've seen. Anybody have anything? Thanks in advance!

 

[Ajit Basrur]

Re: EN 980:2008(E)-Graphical symbols for use in the labeling of medical devices

I need to find a symbol for quantity of units in a box. I've seen an icon of number inside an opened box - even my notified body doesn't know where this comes from, though. I haven't even see anything in the EN 980 summaries I've seen. Anybody have anything? Thanks in advance!

Any answers for luckidad's question ?

 

[Shamann2]

Re: EN 980:2008(E)-Graphical symbols for use in the labeling of medical devices

I'm looking for the same thing - a symbol for quantity. You'd think this would be commonly needed. I really don't want to translate "quantity" into a gazillion languages. What do people do for this?

In the absence of an internationally recognized symbol, is the "#" sign recognized universally as "number"?

Thanks in advance.

 

[Rolande Hall]

Re: EN 980:2008(E)-Graphical symbols for use in the labeling of medical devices

Hi guys,

I do not understand the desire to preface a number by a symbol for quantity. Why waste space? There is no need for a symbol for quantity.

The accepted approach is to preface the multilanguage description by the quantity.

Example (1): 10 Stainless steel bone drills
(2): 6 Bone screws
(3): Femoral Knee Component
(4): 40g bone cement

If the quantity is unity the singular text avoids the need for a numerical quantity indicator.

 

[Rolande Hall]

Re: EN 980:2008(E)-Graphical symbols for use in the labeling of medical devices

I'm looking for the same thing - a symbol for quantity. You'd think this would be commonly needed. I really don't want to translate "quantity" into a gazillion languages. What do people do for this?

In the absence of an internationally recognized symbol, is the "#" sign recognized universally as "number"?

Thanks in advance.

I forgot to comment about the"#" sign.
This symbol is being increasingly used for number in the context of identification NOT quantity.