Design Realization/Detailed Design - Medical Device Design: Innovation from Concept to Market - page 171

Table 8.4: A Selection of ISO Biocompatibility Standards and FDA Recognized Consensus
Standards

Standard Title

BS EN ISO 10993 family Biological evaluation of medical devices.

BS EN ISO 10993-1:2009 Biological evaluation of medical devices. Evaluation and testing within a

risk management process.

FDA Recognition
Number 2-156

Biological evaluation of medical devices. Evaluation and testing within a
risk management process (biocompatibility).

BS EN ISO 7405:2008 Evaluation of biocompatibility of medical devices used in dentistry.

FDA Recognition
Number 4-179

ISO 7405 - Evaluation of biocompatibility of medical devices used in
dentistry.

BS EN ISO 11979-5:2006 Ophthalmic implants. Intraocular lenses. Biocompatibility.

FDA Recognition
Number 10-48

Ophthalmic implants. Intraocular lenses. Biocompatibility.

Therefore if you are intending to use a material that communicates with a body then it has
to be proven to behave in the way it is supposed to behave, and that it does not cause any
deleterious effects. Note these effects can be local or systemic: this means the material could
simply produce a skin rash at the point of application; or it could bring on an asthma attack
even though the lungs have not been touched. Also, the effects may present themselves many
years later. This is a serious issue for the introduction of novel materials: How do you identify
age-related effects?

It should be no surprise that there are numerous guidelines and standards associated with this
topic. A good rule of thumb is to use what has been used before unless there is a very good
reason not to do so.

Table 8.4 is very brief. ISO 10993 has 16 parts, all having slightly different nuances on
biocompatibility. They are revised all of the time as new evidence of effects comes to light.
Even now Part 3 (genotoxicity, carcinogenicity, and reproductive toxicity) is under revision
and is open for public comment. Clearly you should have a copy of Part 1 at hand.

You will also note that there are specific tests for particular disciplines. If, for example, you
were in dentistry you must also meet the relevant standards for that discipline too. Make
sure that you do this search for your own discipline and for the state or country in which you
intend to sell, be that the USA, the EU, or wherever.

8.6 Computer-Aided Design
The rise of the personal computer (be that PC or Mac) has been relentless. But a few
years ago companies had darkened rooms containing two or three very expensive