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

Geno­tox­i­city

  • 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

Haemo­com­pat­i­bility

  • 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
We Value Your Privacy
We use cookies on our website. Some of them are essential, while others help us to improve this website and your experience.
We Value Your Privacy
Statistics
We use these technologies to analyze how this website is being used.
Name Google Analytics, Google Tag Manager
Provider Google Ireland Limited, Gordon House, Barrow Street, Dublin 4, Ireland
Purpose Cookie by Google used for website analytics. Generates statistical data on how the visitor uses the website.
Privacy Policy https://policies.google.com/privacy
Cookie Name _ga, _gat, _gid
Cookie Expiry 2 years
Customer Interaction
These technologies will allow you to contact us through our website, i.e. use the chat widget.
Name LiveChat
Provider LiveChat Software S.A., ul. Zwycięska 47, 53-033 Wroclaw, Poland
Purpose Communication with clients via online chat using the API of the chat service LiveChat.
Privacy Policy https://www.livechat.com/legal/privacy-policy/
Cookie Name __lc_cid, __lc_cst
Cookie Expiry 2 years
Essential
Technologies required to enable the core functionality of this website.
Name Cookie Consent
Provider Owner of this website, Imprint
Purpose Saves the visitors preferences selected in the cookie banner.
Cookie Name ws_cookie_consent
Cookie Expiry 1 year