Biomedical Engineering Reference
In-Depth Information
Part 10: Tests for irritation and sensitization
Part 11: Tests for systemic toxicity
Part 12: Sample preparation and reference materials
Part 13: Identifi cation and quantifi cation of degradation products from
polymers
Part 14: Identifi cation and quantifi cation of degradation products from
ceramics
Part 15: Identifi cation and quantifi cation of degradation products from
metals and alloys
Part 16: Toxicokinetic study design for degradation products and
leachables
Part 17: Establishment of allowable limits for leachable substances
Part 18: Chemical characterization of materials
Part 19: Physico-chemical, mechanical and morphological charact-
erization
Part 20: Principles and methods for immunotoxicology testing of med-
ical devices.
It should be noted that there is also ISO guidance for device risk assess-
ment (based primarily on data from the above standards - EN 14971).
Only recently (2008-09) have the requirements of parts 13-16 begun to be
addressed. The result for devices is that studies must be conducted to iden-
tify and quantitate chemical substances that can be extracted from a device
over a period of time after the device would be prolonged (or introduced)
into internal patient contact. These fall into three categories: volatiles, met-
als and organic extractable. Such substances must be identifi ed and quanti-
fi ed. In addition, the potential biological risks to patients must be assessed
and allowable limits of exposure established. Tables 9.1 and 9.2 present the
basic ISO test requirements schemes for device non-clinical biocompatibility
evaluation (as presented in ISO 10993-1).
9.4 United States Food and Drug Administration
(FDA) regulation and guidance
FDA regulation of medical devices rests primarily on fi ve statutes:
1. Food Drug and Cosmetic Act (FDCA) of 1938
2. Medical Device Amendments (to the FDCA) of 1976
3. Safe Medical Devices Act of 1990
4. Medical Device Amendments (to the FDCA) of 1992
5. Medical Device User Fee and Modernization Act of 2002.
While the FDA generally adheres to (and accepts as suffi cient testing done
in accordance with the) ISO 10993 standards, it does have its own guidance,
