Fraunhofer Institute for Manufacturing Engineering and Automation IPA
Biological testing of medical devices
Cytotoxicity tests*
- Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (Activity of metabolism after contact with extracts or direct contact (MTS-test)) according to DIN EN ISO 10993-5, Status 2009-10 and Standard Operation Procedure IVT 01-0
*test services in the accredited area without flexible accreditation
Irritation tests *
- Biological evaluation of medical devices - Part 23: Tests of irritation (In vitro tests for irritation -reconstructed human epidermis. Activity of metabolism after contact with extracts or direct contact (MTT-test)) according to DIN EN ISO 10993-23, Status 2021-10 and Standard Operation Procedure IVT 02-0
- Optional with cytokine-determination (IL-1 alpha) according to Standard Operation Procedure IVT 02-1
*test services in the accredited area without flexible accreditation
Test for bacterial endotoxins*
- Test for bacterial endotoxins, chromogenic kinetic method, according to European Pharmacopoeia, 2.6.14, Status 2018-01 corrected 11.0 and Standard Operation Procedure IVT 05-0
applicable: Ph. Eur. 5.1.10, USP <85>
*test services in the accredited area without flexible accreditation