MDR 2017/745 sterile and non-sterile labeling

#1
Hi,
I'm reaching out to better understand the following definition in the MDR requirement:
"The labelling of the device shall distinguish between identical or similar devices placed on the market in both a sterile and a non-sterile condition additional to the symbol used to indicate that devices are sterile." [Annex I Chapter II paragraph 11.8 pg.98]
What I'm confused about is the pat of the definition saying: "additional to the symbol used to indicate that devices are sterile" - what does it means? do I put two contradicting symbols in one label? It make no sense.
 
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chris1price

Trusted Information Resource
#2
Hi, I think this is just poor wording. ISO 15223 has symbols for both sterile and non-sterile. I would use the appropriate one. However where there is a possibility confusing sterile and non-sterile products, there should be an additional method to distinguish between them. I presume this could be colour coding, additional text etc.
 

Marcelo

Inactive Registered Visitor
#3
This requires that you use the symbol AND another solution (probably because some people may not understand the symbol). I know it's counter intuitive, but this seems the basis for that
 

shimonv

Trusted Information Resource
#4
Hi Maya,
It's an odd requirement that comes right after a requirement that deals with a medical device intended for reprocessing... so they just want to make a very clear distinction between identical devices that are supplied in a sterile /non-sterile packaging. It's a rare situation.
Since the risk relates to the unsterile device, I would think that something like a watermark "unsterilized" on the immediate container should suffice.

Shimon
 

craiglab

Involved In Discussions
#5
It is not so rare with orthopaedic implants. I believe that "...additional to the symbol used to indicate that devices are sterile" can be the symbol used to indicate the non-sterile device.
 

Chrisx

Involved In Discussions
#6
Annex I 23.3 of the MDR (text below) would seem to indicate a separate indication is needed to indicate the sterile package. This appears to be a separate clause from indicating sterility. Am I understanding this correctly? Is there a proposed symbol for sterile package?

Information on the packaging which maintains the sterile condition of a device (‘sterile packaging’) The following particulars shall appear on the sterile packaging:
(a) an indication permitting the sterile packaging to be recognised as such,
(b) a declaration that the device is in a sterile condition,
 

craiglab

Involved In Discussions
#7
New symbols were proposed in 2017 by SBA and are included in ISO 11607-1:2019 Annex E (informative) with the purpose "...to inform the reader of the status of efforts underway, at the time of the publication of this document, to address ways to differentiate a sterile barrier system from protective packaging." Also "When symbols for these meanings are standardized in ISO 7000 this annex will be withdrawn."

Some additional info here: Key Medical Packaging Standard, ISO 11607-1/2 Published; More Regulatory Support on the Way
 
#8
Does anybody know if there are any vector formats or high quality images available for the symbols that are currently proposed in the ISO 15223 /ISO 11607 standards?
 
#10
Thanks craigslab, however I was specifically referring to the new proposed symbols, eg the sterile barrier symbols. Those are I believe not yet available via ISO, at least I have not been able to find them.
 
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