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Biocompatibility Testing for Implantable Medical Devices according to ISO 10993


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  Post Number #1  
Old 12th March 2008, 10:07 AM
Tiffany's Avatar
Tiffany

 
 
Total Posts: 99
Please Help! Biocompatibility Testing for Implantable Medical Devices according to ISO 10993

Hi all,

I have queries on the type of biocompatibility testing according to ISO 10993 series should be carried out for implantable medical devices.(implant > 30 days)

This queries generated where I have different type of biocompatibility testings which recommended by two different testing lab.

Could any experts here to help me up for this queries??

Thanks.

BRegards,
Tiff

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  Post Number #2  
Old 12th March 2008, 11:09 AM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
Total Posts: 2,711
Re: Biocompatibility Testing

If there´s differences between testing labs, how about you contact your notified body (or equivalent)?
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  Post Number #3  
Old 12th March 2008, 12:07 PM
Roland Cooke

 
 
Total Posts: 612
Re: Biocompatibility Testing

IIRC it also makes a difference where in the body the device will be implanted.
  Post Number #4  
Old 12th March 2008, 12:18 PM
EColby's Avatar
EColby

 
 
Total Posts: 4
Re: Biocompatibility Testing

I am unable to submit a link in this response (apparently because I am new to posting). So I suggest going to the FDA website and looking up "Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices" G95-1. Be sure to click on the links for Table 1 and 2. I found those tables helpful.
Thank You to EColby for your informative Post and/or Attachment!
  Post Number #5  
Old 12th March 2008, 09:14 PM
Ajit Basrur's Avatar
Ajit Basrur

 
 
Total Posts: 5,878
Re: Biocompatibility Testing

Quote:
In Reply to Parent Post by EColby View Post

I am unable to submit a link in this response (apparently because I am new to posting). So I suggest going to the FDA website and looking up "Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices" G95-1. Be sure to click on the links for Table 1 and 2. I found those tables helpful.
Welcome to the Cove and thanks for providing valuable link

This is the link that Ecolby referred - Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices May 1, 1995 (G95-1)
Thanks to Ajit Basrur for your informative Post and/or Attachment!
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