Biomedical Engineering Reference
In-Depth Information
23. Biocompatibility testing is a very complex issue. It is a materi-
al's lack of interaction with living tissue or a living system by not
being toxic, injurious, or physiologically reactive, and not causing
an immunological rejection. This testing is required, and two com-
mon test regimens are commonly used to measure biocompatibility:
USP 88, Biological Reactivity Testing (USP Class VI), and ISO 10993,
Biological Evaluation of Medical Devices, which has replaced the
USP Class VI test.
24. The ISO 10993 has 20 parts and provides testing requirements in
great detail. These parts include
a. Evaluation and testing (see Appendix I)
b. Animal welfare requirements
c. Tests for genotoxicity, carcinogenicity, and reproductive toxicity
d. Selection of tests for interactions with blood
e. Tests for in vitro cytotoxicity
f. Tests for local effects after implantation
g. Ethylene oxide sterilization residuals
h. Clinical investigation of medical devices
i. Framework for identification and quantification of potential deg-
radation products
j. Tests for irritation and delayed-type hypersensitivity
k. Tests for systemic toxicity
l. Sample preparation and reference materials
m. Identification and quantification of degradation products from
polymeric medical devices
n. Identification and quantification of degradation products
from ceramics
o. Identification and quantification of degradation products from
metals and alloys
p. Toxicokinetic study design for degradation products and
leachables
q. Establishment of allowable limits for leachable substances
r. Chemical characterization of materials
s. Physicochemical, morphological, and topographical character-
ization of materials
t. Principles and methods for immunotoxicology testing of medi-
cal devices
25. The USP 88 protocols are used to classify plastics in Classes I-VI,
based on end use, type, and time of exposure of human tissue to
