Biomedical Engineering Reference
In-Depth Information
Table 9.10
Intracutaneous reactivity test procedures required by ISO 10993-10
guidelines
ISO 10993-10
Number of test animals:
Three rabbits for 1 to 2 extracts.
Number of test/control injections per extract:
Five test and fi ve control injections.
Evaluation of responses:
Quantitative comparison of responses of test and control responses.
Table 9.11
Eye irritation testing procedures outlined in ISO 1093-10
ISO 10993-10
Time of exposure:
1 second
Grading scale:
Classifi cation system for grading ocular lesions.
Table 9.12
Cytotoxicity test procedures specifi ed by ISO 10993-5 and USP
ISO 10993-10
Number of cells per dish:
0.5-1 million cells
Extraction ratio:
60 cm
2
per 20 mL if thickness 80.5 mm
120 cm
2
per 20 mL if thickness 70.5 mm
or 4 g per 20 mL
Exposure period:
Typically 24-72 h
(2 h for fi lter diffusion test)
Toxicity determination:
Visual grading and/or quantitative assessments
Positive controls:
Materials providing a reproducible cytotoxic response
(e.g. organo-tin-impregnated polyvinyl chloride)
Hematocompatibility
: This evaluates any effects of blood contacting mate-
rials on hemolysis, thrombosis, plasma proteins, enzymes, and the formed
elements using an animal model. Traditionally, hemolysis, which determines
the degree of red blood cell lysis and the separation of hemoglobin caused
by test materials and/or extracts from the materials
in vitro
, has been 'the'
representative test employed. A broader range of primary tests (adding
