Table 1 Parameters and options of elution test stated in ISO 10993.

From: Test conditions can significantly affect the results of in vitro cytotoxicity testing of degradable metallic biomaterials

Parameter

Options

Citation

Extraction volume

125 mm2 · ml−1

Or 0.2 g · ml−1

ISO 10993-12

The velocity of orbital shaking during extraction

Shaking required, but velocity not specified

ISO 10993-12

FBS concentration in extraction medium

5%, 10% or without FBS

ISO 10993-5 Annex A

Cultivation medium composition (type)

According to the cell type

ISO 10993-5

Time of extraction

24 ha

ISO 10993-5

Cell type

e.g. L929 cells

ISO 10993-5 Annex C

Mode of exposition

Cell layer or freshly suspended cells

ISO 10993-5

Incubation time

At least 24 h

ISO 10993-5

  1. aWhen cultivation medium with serum is used.