EO Residual for Sterilization of Implantable Products

akyt

Registered
#1
Hello everyone!

We need to define ethylene oxide residual limits after sterilization for implantable medical-dental products, and I'm not sure about the correct criteria.
The standard ISO 10993-7:2008 offers the following limits:

"Permanent contact devices
[...] The maximum EO dose shall not exceed:
- 4 mg in the first 24 h;
- 60 mg in the first 30 d;
- 2,5 g in a lifetime."

Which of these values should I consider to release my product after the aeration process? 4 mg (in the first 24 h) or 2,5 g (lifetime)?

Thanks!
 
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akyt

Registered
#3
In our case, our product only applies to the adult population. So the amendment would not apply.
According to the standard, the EO TCL shall not exceed 10 µg/cm² for implants. How can I apply this value to calculate the threshold?

In item G.8.5, the following calculation is given:
mdev, BSC = TCL × A

Our product is very small, approximately 1 cm². Then:
mdev, BSC = 10 x 1 = 10 mg/product

Would it be this? Could I consider this value (10 mg/product) as the for EO residual limit?

PS.: After defining the EO limits, I will apply the rationale for the ECH.
 

planB

Super Moderator
#4
caution: your calculated mass limit based on a device surface of 1 cm² would be 10 _micro_ gram, not 10 _milli_ gram.
 

akyt

Registered
#5
Sorry, thanks! So it would be 10 µg/ product... :eek:
Instead of using TCL, could I not define it as 4 mg/product, which the standard sets as a maximum for the first 24 hours (initial contact)?
 

planB

Super Moderator
#6
For permanent implants you have to comply to all these limits _simultaneously_ (except for the TCL, where you also have the option to demonstrate your device being non-irritating as part of your activities in the framework of ISO 10993-1 in case you exceed the defined TCL).
 
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