Cytotoxicity testing

DIN EN ISO 10993-5:2009

This test is used for medical devices which have contact to human skin to assess cytotoxicity. L929 Fibroblasts are exposed to different concentrations (e.g. 10 %, 30 %, 50 %, 70 % and 100 %) of an extract of a medical device for 24 hours. After exposure fibroblast morphology is evaluated (Prediction 1) and vitality is assessed by MTT-test (colorimetric assay). If remaining vitality is >70% the medical device is not cytotoxic (Prediction 2).

Prediction Model 1

Morphology Reactivity Grading
discrete intracytoplasmic granule; no cellular dissolution; no inhibition of growth none 0
not more than 20% of cells are round, loosely attached and without any intracytoplasmic granule or show changes in morphology; a few dissolved cells are present, only slight growth inhibition is noticeable slight 1
not more than 50% of cells are round; free of intracytoplasmic granule; no extensive cell dissolution is detected; not more than 50% growth inhibition noticeable mild 2
not more than 70% of cell layers contain round or dissolute cells; layers are not completely destroyed, but more than 50% growth inhibition is noticeable moderate 3
almost complete or complete destruction of cell layers severe 4

Prediction Model 2

Percentage of cell viability Prediction
100 – 70 % Not cytotoxic
70 – 50 % Weak cytotoxic
50 – 30 % Moderate cytotoxic
30 – 0 % Severe cytotoxic

If viability is reduced to < 70 % of the blank, the test item has cytotoxic potential.

Schnellkontakt

Rufen Sie uns unter 0251 481637-0 an oder senden Sie eine Nachricht. Wir melden uns umgehend bei Ihnen.
Welche Daten im Einzelnen gespeichert werden und wer Zugriff auf diese hat, erfahren Sie in unserer Datenschutzerklärung.

Ich stimme der Speicherung und Nutzung meiner Daten laut Datenschutzerklärung zu und bin mit der Verarbeitung meiner Daten innerhalb der Dermatest GmbH für die Beantwortung meiner Kontakt- oder Informationsanfrage einverstanden.

Meine Einwilligungen kann ich jederzeit für die Zukunft widerrufen.

Quick request

Call us on 0251 481637-0 or send an email. We will get back to you straight away.
You can find details about what personal data we store and who has access to it in our data protection policy.

I consent to my personal data being stored and processed in line with the data protection policy and I consent my personal data being processed by Dermatest GmbH in order to answer my contact or information request.

I can withdraw my consent at any time with immediate effect.