ISO 10993-18 vs ISO 18562-4

lahol

Registered
#1
Hi all,

Our anaesthetic filter range requires leachables in condensate testing for MDR requirements.

Finding a lab to do testing as per ISO 18562-4 has proven challenging and is otherwise very costly. One of the labs I requested a quote from said that regulatory bodies accept either ISO 10993-18 or ISO 18562-4 in regards to leachables.

Does anyone know if this is the case? I'm currently awaiting an answer on the topic from our notified body but in the meantime thought I would ask here.

Thanks
 
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planB

Super Moderator
#2
The vertical ISO 18562 series has been developed in order to account for the special situation of breathing gas pathways in healthcare application, that have been recognised to not be adequately and fully covered by the horizontal ISO 10993 series. Thus, ISO 18562-4 would be your preferred primary source to seek guidance for testing gas-pathway devices, unless you have a scientifically valid rationale why you would expect an equally representative leaching profile when resorting to ISO 10993-18. Cross-checking and agreeing with your NB is definitely a good idea.

HTH,
 

lahol

Registered
#3
The vertical ISO 18562 series has been developed in order to account for the special situation of breathing gas pathways in healthcare application, that have been recognised to not be adequately and fully covered by the horizontal ISO 10993 series. Thus, ISO 18562-4 would be your preferred primary source to seek guidance for testing gas-pathway devices, unless you have a scientifically valid rationale why you would expect an equally representative leaching profile when resorting to ISO 10993-18. Cross-checking and agreeing with your NB is definitely a good idea.

HTH,
I figured this was the case which is why the lab saying either standard was acceptable for NB didn't really make sense to me.

Nevertheless, I'll wait to receive confirmation from my NB.

Thank you for your reply.
 

Ronen E

Problem Solver
Moderator
#4
Technically speaking, both standards are not yet harmonized under the MDR, so from a formal perspective they are equally "relevant". If the lab provides a written rationale why 10993-18 is relevant in this case (subject matter wise), and the lab itself if accredited for these standards under 17025, I think there should be no material reason for the NB to object.
 

lahol

Registered
#5
Technically speaking, both standards are not yet harmonized under the MDR, so from a formal perspective they are equally "relevant". If the lab provides a written rationale why 10993-18 is relevant in this case (subject matter wise), and the lab itself if accredited for these standards under 17025, I think there should be no material reason for the NB to object.
Just as an update - our NB was happy for us to skip 18562-4 testing provided we consider Leachables in condensate within our risk analysis as well as sufficient material characterisation and justification with PMS data.
 
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