In vitro biocompatibility testing
in accordance with
DIN EN ISO 10993

Our analyt­ical proce­dures for testing biocompatibility:

In vitro deter­mi­na­tion of cytotoxicity

  • DIN ISO 10993 – 5/USP <87>
  • Read out: XTT/​neutral red/​MTT/​MTS
  • Toxi­city of diffusing substances through agar diffu­sion (USP <87>)
  • Deter­mi­na­tion of photo­tox­i­city (OECD TG 432)

In vitro irri­ta­tion and sensitisation

  • Skin irri­ta­tion on recon­structed human epidermis: ISO 10993 – 10 / 23 (draft) / OECD TG 439
  • ARE-Nrf2 Luciferase test method (Kerati­noSens assay): OECD TG 442d
  • Human cell line acti­va­tion test (h‑CLAT): OECD TG 442e
  • In vitro skin corro­sion: OECD TG 431

In vitro corro­sion and irri­ta­tion on ocular tissue

  • Recon­structed human Cornea-like Epithe­lium Test (RhCe): OECD TG 492
  • Ocular Corro­sives and Severe Irri­tants: OECD TG 460


  • Bacte­rial reverse muta­tion test (AMES test):DIN ISO 10993 – 3/OECD TG 471
  • In vitro mammalian micronu­cleus test: DIN ISO 10993 – 3/OECD TG 487


  • DIN ISO 10993 – 4
  • Static or dynamic process using human whole blood in a closed loop system
  • Integrity of red blood cells: haemol­ysis and deter­mi­na­tion of total and plasma haemoglobin
  • Cellular compo­nents of blood/​blood count
  • Effects on coag­u­la­tion: throm­bo­cyte count, human platelet factor 4 (hPF‑4), prothrombin (PT), fibrinogen (Fib), thrombin time (TT), throm­bin/anti-thrombin complex (TAT)
  • Acti­va­tion of the immune system: comple­ment factors C3a, C5a, Sc5b‑9

Deter­mi­na­tion of bacte­rial endo­toxins and pyrogens

  • Bacte­rial endo­toxin testing (BET): limulus amoe­bo­cyte lysate (LAL) test: Ph. Eur. 2.6.14: veri­fi­ca­tion and testing
  • Deter­mi­na­tion of non-endo­toxin pyro­gens (NEPs): mono­cyte acti­va­tion test (MAT): Ph. Eur. 2.6.30: veri­fi­ca­tion and testing

Bioburden and sterility

  • Deter­mi­na­tion of bioburden: ISO 11737 – 1, Ph. Eur 2.6.12: veri­fi­ca­tion and testing
  • Sterility testing of medical devices as part of a ster­il­i­sa­tion process: ISO 11737 – 2: veri­fi­ca­tion and testing

Gener­a­tion of extracts from and chem­ical char­ac­ter­i­sa­tion of medical devices

  • Gener­a­tion of extracts for biolog­ical and chem­ical char­ac­ter­i­sa­tion (DIN ISO 10993 – 12)
  • Chem­ical char­ac­ter­i­sa­tion of test samples using LC-MS, GC-MS, HS-GC-MS and ICP-MS (DIN ISO 10993−13÷−18)
  • Detec­tion of ethylene oxide residues (DIN ISO 10993 – 7)

In vivo testing

In addi­tion to our in vitro testing plat­form, we offer in vivo testing by qual­i­fied partner laboratories:

  • ISO 10993 – 2 – Animal welfare requirements
  • ISO 10993 – 6 – Tests for local effects after implantation
  • ISO 10993 – 10 – Tests for irri­ta­tion and skin sensitisation
  • ISO 10993 – 11 – Tests for systemic toxicity
  • ISO 10993 – 20 – Prin­ci­ples and methods for immuno­tox­i­cology testing of medical devices
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