Evaluation of Biocompatibility Using In Vitro Methods: Interpretation and Limitations - Tissue Engineering: Cell-Surface Interactions for Tissue Culture - page 120

Table 1 Standards for testing specific responses
Specific response USP ASTM ISO

Cytotoxicity \87[ F813-07 10993-05

F895-84
F1027-06
F1903-98

Sensitization - F720-81 10993-10

F2147-01
F2148-07

Irritation or intracutaneous reactivity; mucous
membrane irritation

\88[ F719-81 10993-10

F749-98

Systemic toxicity (acute toxicity) \88[ F750-87 10993-11

Subchronic toxicity (subacute toxicity) - - 10993-11

Genotoxicity; reproductive or developmental toxicity - E1202-87 10993-3

E1262-88
E1263-97
E1280-97
E1397-91
E1398-91

Blood biocompatibility/complement activation - F2382-04 -

F1984-99
F2065-00

Immune response - F1905-98 10993-20

F1906-98

Hemocompatibility - F 756-08 10993-4

Chronic toxicity - - 10993-11

Carcinogenicity - F 1439-03 10993-3

Biodegradation - F1983-99 10993-9

10993-13
10993-14
10993-15

Implantation short term-long term \88[ F1408-97 10993-6

F763-04
F1904-98
F981-04
F1983-99
Note The listing is based on standards as issued in 2011. Requirements may change and standards
may be withdrawn or new standards issued over time. Therefore, it is important to consult with
the standards organizations on the validity of specific standards

variability within the biological tests. In order to pick -up modifications due to
processing of the raw material (e.g. contamination, chemical disruption), standards
tests are required to evaluate the final product. Process-based contamination is a
cleanliness issue which is not a material property but a process consequence,
and therefore it should not be addressed using biocompatibility approaches
but by chemical and physical analysis as described in ASTM F2847. The bio-
compatibility standards conform regarding material-tissue contact duration, which