The Biocompatibility Tests ISO 10993

10993e

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

Oral Mucosa Irritation Study in Hamsters
  • Guidance

    ISO 10993-23

  • Animals

    Hamsters

  • Extraction solvent

    Normal Saline、Cottonseed Oil

Vaginal irritation test in white Rabbits
  • Guidance

    ISO 10993-10

  • Animals

    New Zealand white rabbits

  • Extraction solvent

    Normal Saline、Cottonseed Oil

Skin Sensitization Study in Guinea Pigs (Maximization Test)
  • Guidance

    ISO 10993-10

  • Animals

    Guinea Pigs

  • Extraction solvent

    Normal Saline、Cottonseed Oil

Hemolysis test
  • Guidance

    ISO 10993-4

    ASTM F619

  • Materials

    Blood of New Zealand white rabbits

Pyrogen Test in White Rabbits
  • Guidance

    ISO 10993-11

    USP 151

  • Animals

    New Zealand white rabbits

  • Extraction solvent

    Pyrogen free normal saline

Salmonella Reverse Mutation Test
  • Guidance

    ISO 10993-3、ISO 10993-33

  • Materials

    Salmonella typhimurium

  • Extraction solvent

    Sterile water、DMSO or Ethanol

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

Rodent Micronucleus Test in Peripheral Blood
  • Guidance

    ISO 10993-3、ISO 10993-33

  • Animals

    ICR mice

  • Extraction solvent

    Normal Saline、Cottonseed Oil

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

    ISO 10993-11

  • Animals

    mice

  • Extraction solvent

    Normal Saline、Cottonseed Oil

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

Implantation test
  • Guidance

    ISO 10993-6

  • Animals

    Rat, Rabbit