Orthopaedic Implant & Biocompatibity

D

DRDDO

#1
As we know, material for Orthopaedic implant is controlled such as by ISO 5832_1, in this biocompetablity is still required or not?
if someone has experiaence please advise
:frust::thanx:
DRDDO
 
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Marcelo

Inactive Registered Visitor
#2
Re: Orthopaedic implant & Biocompetability

This series of standard only deals with the material composition and some physical tests. They do not address biocompatibity.

Also, what exactly do you mean with "biocompatibility is still required or not?"

Required by whom, where?

For example, if you´re trying to comply with the essential requirements of CE marking, you need to comply with biological safety, of which biocompatibility is only one aspect. The other one general relates to chemical interactions between the materials which compose the devices.

Standard such as ISO 5832 COULD be used to comply with this latter aspect because they deal with the material. I´m not sure if they can, though. It might more study on the subject (and the series of standards :))
 
A

achorste

#3
Re: Orthopaedic implant & Biocompetability

As I remember it the equivalent ASTM standards have a statement in their material specs for implant materials along the lines of 'we don't guarantee they are bio-compatible but they've been used a lot'. I can't remember off the top of my head if the ISO standard make any similar claims / disclaimers.

However, biocompatibility testing will still be required as during the manufacturing process the components will come into contact with all manner of substances & you will still need to prove they are either removed and / or do not pose a problem with biocompatibility.

Also, as mentioned before, biocompatibilty is only one aspect of biological safety, there are many other factors to consider / test / validate.
 
J

Juan Dude

#4
Re: Orthopaedic implant & Biocompetability

Applicability of biocompatibility tests depends if there are any materials on the device that come into contact with the end user, if there are any then depending on your specific procedures biocompatibility tests may be required.
 
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