Differences between the biocompatibility standards ISO 7405 and ISO 10993

Does anyone know the differences between the biocompatibility standards ISO 7405 (dental) and ISO 10993 (medical devices)? I need to determine if I need to purchase ISO 7405; I would really hate to spend money when I am not even sure if I need it. Basically, I need to test a dental bridge, and not sure if compliance to 10993 would be sufficient for FDA or if I need other tests from 7405.
Thanks!

Re: ISO 7405 and ISO 10993

Hello Charlie and welcome to the Cove!

A preview of ISO 7405 can be seen in the following link: http://www.evs.ee/Checkout/tabid/36/screen/freedownload/productid/164923/doclang/en/preview/1/EVS_EN_ISO_7405;2009_en_preview.aspx

From this preview, it seem that it should be used in conjunction with ISO 10993.

Let´s see if other Cove members can help you more.

Charlie70 said:

Does anyone know the differences between the biocompatibility standards ISO 7405 (dental) and ISO 10993 (medical devices)? I need to determine if I need to purchase ISO 7405; I would really hate to spend money when I am not even sure if I need it. Basically, I need to test a dental bridge, and not sure if compliance to 10993 would be sufficient for FDA or if I need other tests from 7405.
Thanks!

Click to expand...

Hi,

I can't really answer directly because I'm not familiar with ISO 7405.

However:

1. Bear in mind that the FDA does not rely on ISO 10993 per-se. It has it's own biocompatibility evaluation scheme (which is based on 10993, but is not identical). Look for memorandum G95-1 and related guidance.

2. As far as I can judge, the FDA does not rely heavily on ISO standards compliance. If compliance with a certain standard is required, or even just beneficial, in the clearance process, it would be in the "recognized standards" list, or more explicitly mentioned under the "special controls" under the specific code regulation. If, in your case, ISO 7405 is in neither, then I assume you don't need it.

Cheers,
Ronen.