Detailed Information on Publication Record
2022
In vitro cytotoxicity evaluation of selected materials for wound dressing application
KAUEROVÁ, Tereza, Peter KOLLÁR and Pavel SUCHÝBasic 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
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 |
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