ISO 10993 Biological evaluation of medical devices:

ISO 10993-1: Evaluation and testing

ISO 10993-2: Animal welfare requirements

ISO 10993-12: Sample preparartion and reference materials

Tests for irritation and skin sensitization (ISO 10993-10)

Acute systemic toxicity test (ISO 10993-11)

Pyrogen test (ISO 10993-11, European Pharmacopoeia-7th edition)

Tests for in vitro cytotoxicity (ISO 10993-5)

Tests for local effects after implantation (ISO 10993-6)

Biological absorption assay (surgical polyglactin suture) (TS 7342)

Genocytotoxicity (OECD-471)

Determination of aqueous extractable proteins (medical gloves for single use) (EN 455-3)

Hemolytical effect (ISO 10993-4/A1, ASTM F756-08)