The Biocompatibility Tests ISO 10993

10993e

Modified from ISO 10993-1:2018 Table A.1-Endpoints to be addressed in a biological risk assessment

Implantation test

  • Guidance

    ISO 10993-6

  • Animals

    Rat, Rabbit

Repeated exposure systemic toxicity Test (sub-acute, sub-chronic, chronic)

  • Guidance

    ISO 10993-11

  • Animals

    Rat

  • Extraction solvent

    Normal Saline/ Cottonseed Oil/ or by implant directly

Acute Systemic Toxicity Study in (Mice, Rats, etc.)

  • Guidance

    ISO 10993-11

  • Animals

    mice

  • Extraction solvent

    Normal Saline、Cottonseed Oil

Rodent Micronucleus Test in Peripheral Blood

  • Guidance

    ISO 10993-3、ISO 10993-33

  • Animals

    ICR mice

  • Extraction solvent

    Normal Saline、Cottonseed Oil

In Vitro Mammalian Chromosomal Aberration test

  • Guidance

    ISO 10993-3、ISO 10993-33

  • Materials

    CHO cell

  • Extraction solvent

    Culture medium without serum、Culture medium with serum