Cytotoxicity testing to ISO 10993-5 results - Is 1/ mild a pass or fail?

D

Dosumi

#1
I sent a foam hand grip for cytotoxicity testing to ISO 10993-5.
After receiving the results reactivity graded as 1,1,1 noted as mild 50%?
I posed the question to the test house if 1/ mild is a pass or fail.

Their answer was “There is no specification for pass/fail per ISO-10993-5. We can only report the cytotoxicity score and the interpretation.
However, the USP requirement for a pass is that the "test sample does not induce a greater than "2" cytotoxicity score," which is equivalent to a mild reaction”


As I will need to justify my acceptance of this test to use this item on our CE marked products.
How would I do that, are the USP standards a pass/fail type test? Is the test similar enough to reference the ISO to the USP?
Or is their an ISO document or MDD I can use to compare the results.

Thanks
Don
 
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M

mknight

#2
Hi Don,

We had to set our own internal pass/fail specifications based on the performance of our previoulsy validated cleaning process. I know of no specs on this and have been equally frustrated. In our specs less than 50% of cells showing a cytopathic response (2 out of 4 or less score) is a pass. Keep in mind this is only a pass if other tests for particulate count and TOC are passed concurrently. Again, this is based on old internal company data and not any external stadard. I am sorry I can't be of more help.
 

Michael Malis

Quite Involved in Discussions
#3
I sent a foam hand grip for cytotoxicity testing to ISO 10993-5.
After receiving the results reactivity graded as 1,1,1 noted as mild 50%?
I posed the question to the test house if 1/ mild is a pass or fail.

Their answer was “There is no specification for pass/fail per ISO-10993-5. We can only report the cytotoxicity score and the interpretation.
However, the USP requirement for a pass is that the "test sample does not induce a greater than "2" cytotoxicity score," which is equivalent to a mild reaction”


As I will need to justify my acceptance of this test to use this item on our CE marked products.
How would I do that, are the USP standards a pass/fail type test? Is the test similar enough to reference the ISO to the USP?
Or is their an ISO document or MDD I can use to compare the results.

Thanks
Don
It depends...what is the use of your device or Clasification?

Is is a handle bar for the bike or part of the implantable device?
If this is Class 1 device, 1 is acceptable. However, if this is Class III it could be another story...
 
D

Dosumi

#5
Thank you for the replies.

Item is for a class 1 medical device / wheelchair hand grip
How would I go about showing acceptance of the product?
If I purchased the USP standard, does that have a pass/fail reactivity grading system, I could use to compare the ISO test results and use that as my basis for acceptance?


Don
 
M

MIREGMGR

#6
Under present FDA regulations, USP standards are wholly irrelevant to medical devices, and are only applicable to pharma and related packaging and pharma-regulated dispensing systems.
 

Michael Malis

Quite Involved in Discussions
#7
Thank you for the replies.

Item is for a class 1 medical device / wheelchair hand grip
How would I go about showing acceptance of the product?
If I purchased the USP standard, does that have a pass/fail reactivity grading system, I could use to compare the ISO test results and use that as my basis for acceptance?


Don
Just attached the results of ISO 10993 to your Technical File with conclusion of acceptance!
 
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