Japanese rule on EtO residuals in sterilized medical devices?

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M

MIREGMGR

#12
Please clarify in the standard format (i.e. 21 CFR 40, or whatever) the regulation that you're asking about.
 
S

Sammas

#13
generally when we perform EOR test refer to ISO10993-7 but some customers need to comply with US FDA regulation (they said 21 CFR 40) that I don't know this std say? so my question "ISO10993-7:2008(current), this std is harmonized std or not with US regulation?
 
M

MIREGMGR

#14
It appears to me that 21 CFR 40 is not a valid citation for a current US Federal Regulation. Maybe there was a typo or other error in the communication from the customer?

As Doug Tropf pointed out above, ISO10993-7:2008 is not the correct version to use for FDA residuals testing.
 
M

microb7

#15
Hello all,
Happy Friday:D

Additional EO residual Japanese Requirements for medical devices:

1) In addition to meeting the EO residual limits in ISO10993-7:2007, Japan requires that an Ethylene oxide residual certificate –basically a test method description-be attached to the sterilization report.

2) From MHW Notification No. 353-For Japan the requirements are ≤25ppm EO following your sterilization cycle(s).
 
J

JackieT

#16
I can confirm the Japanese requirement of </= 25 ppm from the standpoint that this is what our japanese distributor communicated to us in July of 2009. What they haven't been able to provide is exactly where that has come from, and when. I see the MHW notification citation - but I can't locate it on the JPAL website - can you point me in the right direction?
 
M

MIREGMGR

#17
As long as this thread has come back to life...note that Doug's and my posts from 15 months ago regarding the FDA's Recognized Consensus Standards list including only ISO 10993-7:1995R2001, and not ISO 10993-7:2008, are now obsolete.

The FDA's list currently includes both versions...1995R2001 (standard #14-76) and 2008 (standard #14-279).
 
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