a 2022

In vitro cytotoxicity evaluation of selected materials for wound dressing application

KAUEROVÁ, Tereza, Peter KOLLÁR and Pavel SUCHÝ

Basic information

Original name

In vitro cytotoxicity evaluation of selected materials for wound dressing application

Name in Czech

In vitro hodnocení cytotoxicity vybraných krycích materiálu pro hojení ran

Authors

KAUEROVÁ, Tereza (203 Czech Republic, belonging to the institution), Peter KOLLÁR (203 Czech Republic, belonging to the institution) and Pavel SUCHÝ (203 Czech Republic, belonging to the institution)

Edition

27th Interdisciplinary Toxicology Conference TOXCON 2022, 2022

Other information

Language

English

Type of outcome

Konferenční abstrakt

Field of Study

30108 Toxicology

Country of publisher

Czech Republic

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

RIV identification code

RIV/00216224:14160/22:00134443

Organization unit

Faculty of Pharmacy

ISSN

Keywords in English

medical devices; wound dressings; cytotoxicity

Tags

Změněno: 29/5/2023 13:52, JUDr. Sabina Krejčiříková

Abstract

V originále

Every medical device that is in contact with human body must be subjected to series of biological tests during the risk assessment process. Cytotoxicity testing belongs to the group of endpoints for biological evaluation of medical devices and its whole process is defined in ISO 10993-5 “Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity”. In a short time, it provides an initial information about toxicity, which serves as a good indicator of general toxic properties and thus it can reduce the number of in vivo models required for subsequent toxicity analyzes. There are different approaches to cytotoxicity testing, either direct contact toxicity evaluation or elution methods. In our study, we focused on the latter approach, namely on optimizing the preparation of the material extracts in accordance with recommendations from ISO 10993-12 “Biological evaluation of medical devices – Part 12: Sample preparation and reference materials”. Based on the specific properties of tested materials, we selected volume of solvent used per surface area of test samples. Material samples were extracted in appropriate cell culture medium supplemented with serum. The materials were extracted at 37 °C for 24 hours with continuous circulation of sterile material immersed in the extraction medium in sealed tubes. In addition, we further extended the analyzes to dose ranging cytotoxicity evaluation to determine the level at which cytotoxicity no longer occurs.

Links

TH04020540, research and development project
Name: Nová bioaktivní hemostatika a krytí ran na bázi kolagenu a celulózy
Investor: Technology Agency of the Czech Republic