Sterile barrier system with outer protective packaging Symbol

#1
The updated standard of ISO 15223-1:2021 introduces new symbols for a sterile barrier system with inner/outer protective packaging.
Like a lot of other products on the market, we pack our product in a Tyvek pouch, which is kept in a package (so the pouch is the sterile barrier and the package is the protective packaging). Currently, we are using exactly the same labels on the pouch and on the box (duplication - each label is printed twice).

There are no clear instructions on how to use these symbols - does it mean that we should have a different label for the sterile pouch (one Oval shape with a continuous line) and a different label for carton packaging (inner oval and Outer ellipse with dashed line)?
 
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#2
Hello MayaLe,

We package in a similar configuration. We have the oval shape with continuous line on our Tyvek pouch and no oval shape on our secondary / box label. Our secondary / box label is significantly different from our primary label. Unfortunately, I don't have any specific details on why we use the symbols in that way.
 

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#3
The updated standard of ISO 15223-1:2021 introduces new symbols for a sterile barrier system with inner/outer protective packaging.
Like a lot of other products on the market, we pack our product in a Tyvek pouch, which is kept in a package (so the pouch is the sterile barrier and the package is the protective packaging). Currently, we are using exactly the same labels on the pouch and on the box (duplication - each label is printed twice).

There are no clear instructions on how to use these symbols - does it mean that we should have a different label for the sterile pouch (one Oval shape with a continuous line) and a different label for carton packaging (inner oval and Outer ellipse with dashed line)?
I've been wondering about this too, I'm interested to see what others have done. We have a Tyvek pouch for each product, then pack 10 of those pouched products into a larger box.
 

Zero_yield

"You can observe a lot by just watching."
#4
I've been wondering about this too, I'm interested to see what others have done. We have a Tyvek pouch for each product, then pack 10 of those pouched products into a larger box.
Amusingly, we also have another product produced at this plant that's 10 Tyvek pouches in a larger box. I checked a primary (Tyvek) and secondary (box) label for each one, and it's the same. The Tyvek pouch has the oval shape with the continuous line, and the box label has none.
 
#5
Our company is also experiencing a big debate interpreting the SBS symbol requirement.

At what point does a Class I medical device (say a HSE dressing or sterile plasters) become a SBS rather than just a sterile product, with a standard STERILE|R or STERILE|EO symbol? If a product such as these are sold as individually wrapped items (not in outer packaging), does the standard sterile symbol not suffice or does the sterile & oval need to be used in this instance too?

We've got hundreds of first aid product lines where the symbols would need to be updated on packaging. Naturally we want to get this right. If anybody can advise it would be greatly appreciated.
 
#6
The Sterile Barrier association have some good resources on this particular issue, in addition to an example diagram of a packaged product
sterilebarrier.org/document/
They were involved in the consulation process for the development of the new symbols.
I have found this very helpful for doing a labelling review/gap analysis.
 

Zero_yield

"You can observe a lot by just watching."
#7
The Sterile Barrier association have some good resources on this particular issue, in addition to an example diagram of a packaged product
sterilebarrier.org/document/
They were involved in the consulation process for the development of the new symbols.
I have found this very helpful for doing a labelling review/gap analysis.
This is an excellent resource. Thank you, CreatureofCompliance!

I understand why our labeling looks the way it does. This description fits our products perfectly:

Aseptic presentation technique requires opening by an assistant nurse. (Sterile) Scrub nurses or surgeons must not touch the outer surface of the packaging. Pack must not be placed on sterile surfaces.
 
#8
Thanks, guys. I'm still experiencing mixed messages internally, and from colleagues having been through an ISO 13485 audit (this month) in terms of the application of the symbols on labelling. The SBA links kindly sent by Creatureofcompliance clearly show and mention the combination of the ovals around the sterile symbol, however an auditor gave a non conformity because the oval should have been adjacent to the symbol, not around it.

Does anybody else have experience of this? Or was this simply an over zealous auditor wanting to pull something?

I'm wanting to clarify before I proceed with an instruction from our QARA team to update artwork labels on 100+ designs.
 

Zero_yield

"You can observe a lot by just watching."
#9
We do ovals around the symbol. We've never received a nonconformity from this. My vote is for an overzealous or misinformed auditor.
 
#10
Thanks, guys. I'm still experiencing mixed messages internally, and from colleagues having been through an ISO 13485 audit (this month) in terms of the application of the symbols on labelling. The SBA links kindly sent by Creatureofcompliance clearly show and mention the combination of the ovals around the sterile symbol, however an auditor gave a non conformity because the oval should have been adjacent to the symbol, not around it.

Does anybody else have experience of this? Or was this simply an over zealous auditor wanting to pull something?

I'm wanting to clarify before I proceed with an instruction from our QARA team to update artwork labels on 100+ designs.
That is strange.... BS EN ISO 15223-1:2021 specifically gives examples of how to use the SBS symbols at A.22 in Annex A <(informative) Guidance and examples of symbol use, including multiple symbols>
 
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