Use of the "Non-Sterile" Icon - ISO7000-2609

[Rasmus Lundholt]

New to the cove so apologies for a potential repost/topic thread

I have not been able to arrive at a conclusion regarding if the "non-sterile" icon should be applied to the primary packaging of a Class 1 medical device (multi use, dental application) which is delivered non sterile but requires a sterilization process prior to use.

The instructions for use [IFU] contains specific sterilization instructions however.

The product is sold "world wide".

According to MDD 93/42/EEC:

Section 8.6 address packaging system requirements.

Section 8.7. stipulates that the packaging and/or label must distinguish between identical or similar products sold in both sterile and non-sterile condition - which make perfect sense.

However, given the requirement of prior-use sterilization its seems like a good idea to do... but are the rules i have missed?

I have seen examples of with and with out the symbol on similar competitor products.

Any feedback would be highly appreciated

 

[Pads38]

re: Use of the "Non-Sterile" Icon - ISO7000-2609

From the ISO site for symbol number 2609:

The symbol is also used to indicate that a device that the manufacturer intends to be sterilized has not yet been through the sterilization process.

that would seem to be the one to use.

Welcome to the forums!

 

[Rasmus Lundholt]

Thanks Pads38

Yes, that is the formulation from the ISO7000 regarding symbol 2609 and it does seem like a good idea - but is it required.

Usually my rule of thumb is "not written not required" but my concern is that either i have missed it or there may be a requirenment for certain parts of the world.

Thank you for the reply and the welcome

R

 

[Pads38]

As you have identified that the device must be sterilised by the end-user, that may be thought of as being 'special operating instructions'. That would be information required by MDD Essential requirements 13.3j

I would have thought that using the non-sterile symbol would help you get that information across.

 

[Rasmus Lundholt]

Good point, and perspective.

That actually makes good sense being that it is required and not optional and in addition also connects nicely to 13.3

(k) any warnings and/or precautions to take

Thank you for the answers and the feedback.

R