Use of the Non-Sterile Symbol (EN980/ISO7000/ISO15223-1)

H

HelviReg

Involved In Discussions
Hello everyone,

The EN 980:2008 standard tells us that the symbol for Non-sterile "should only be used to distinguish between identical or similar devices sold in both sterile and non-sterile conditions."

The function of this symbol in the ISO 7000:2012 is: "To indicate that the device that is normally provided sterile in the same or similar packaging has not been sterilized.", which is similar to the previous description.
However, we can find in the latter an additional information saying that "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."

My question is can we use this symbol in order to mean "To be sterilized" (as the "additional information" from ISO 7000 suggests) ? Especially in the case of a device always supplied non-sterile (and then not fulfilling the first conditions of use of the symbol).

Thank you in advance !
 
M

MIREGMGR

OK, that answer was too brief.

The "or similar" condition in 980 and 15223 can be in comparison to devices from other makers that are generally similar to yours, perhaps in a broad categorical sense such as "surgical drapes", but are provided sterile and ready to use rather than your practice of providing devices non-sterile for end user sterilization.

It also can refer to the fact that your device is provided non-sterile, as a reminder to end users that it is not ready for use as provided, but needs to be sterilized first. This of course requires IFU support.

And, less well supported by the standard drafters' word choices but essential for safety in common industry practice, it can refer to the sterility status of a pallet of product, completely manufactured, packaged and labeled as sterile that in fact is not yet sterile because it's on the way to a contract sterilization provider...in this case, the non-sterile symbol appearing at a large size on placards that are affixed to each face of such a pallet to prevent mix-ups between incoming and outgoing goods with opposite sterility statuses at the various facilities involved.

All of these uses are standard industry practice, and are essential to patient safety.

The last-described communication (i.e. placarding of pallets at both ends of the industrial sterilization process to indicate actual status) in fact is mandatory in FDA jurisdiction, although FDA of course currently still requires text...but my employer's experience has been that use of both text and the symbol in question reinforces the message, and no one from FDA has objected to our doing so to date.
 
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H

HelviReg

Involved In Discussions
Hello MIREGMGR,

All your points are totally clear, I got what I was looking for.

Thank you for your thorough answers,
 
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