Verify GB/T 16886 is the same as ISO 10993

B

bbrown579

#1
I have submitted a 510k for a medical device manufactured in China. Bio testing was done under GB/T 16886 and FDA tells me they only recognize ISO 10993. Can anyone direct me to documentation that verifies the correlation of the two?
 
Elsmar Forum Sponsor
#3
The foreword in GB/T 16886-1 clearly stated that GB/T 16886 is equivalent to ISO 10993. I have attached the Chinese version here for your reference.

I believe if the lab you conducted the GB/T 16886 test is competent and qualified, then you may claim the report/test being equivalent. However, I think the ultimate decision of acceptance is still with FDA.

I hope this helps.
 

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B

bbrown579

#4
Thank your for your reply. This is pretty much where we're at. Getting a translation of the forward and try to convince FDA it's the same.
 
H

hxy8899

#5
Be very careful when using ISO standards assuming they are equivalence of the GB/T standards. GB/T sometimes make minor changes to their standards and they use older versions of ISO, which result in huge difference in test requirements.
 
M

MIREGMGR

#6
If the lab agrees that the test process they applied was fully consistent with the necessary levels and versions of ISO 10993, get them to re-issue their report set in English, specifically re-written to say that they tested not to GB/T standards, but to ISO 10993 standards.

What matters is whether the test process they performed met the requirements of the corresponding ISO 10993 level/version. If it did, they should be willing to say so.
 
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