Review on the in vitro cytotoxicity assessment in accordance to the International Organization for Standardization (ISO)
Cytotoxicity is a predominant biological evaluation applied to search for a suitable and non-toxic bioactive compound and to determine the biocompatibility of medical devices-related human body. The broad usage of cytotoxicity tests leads to a robust establishment of cytotoxicity assays with high se...
| Main Authors: | , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Faculty of Medicine and Health Sciences, Universiti Putra Malaysia
2021
|
| Online Access: | http://psasir.upm.edu.my/id/eprint/90357/ http://psasir.upm.edu.my/id/eprint/90357/1/2021040613505636_MJMHS_0637.pdf |
| _version_ | 1848861044706902016 |
|---|---|
| author | Mohd Shafiee, Muhammad Aminuddin Muhamad Asri, Mohd Ashraf Syed Alwi, Sharifah Sakinah |
| author_facet | Mohd Shafiee, Muhammad Aminuddin Muhamad Asri, Mohd Ashraf Syed Alwi, Sharifah Sakinah |
| author_sort | Mohd Shafiee, Muhammad Aminuddin |
| building | UPM Institutional Repository |
| collection | Online Access |
| description | Cytotoxicity is a predominant biological evaluation applied to search for a suitable and non-toxic bioactive compound and to determine the biocompatibility of medical devices-related human body. The broad usage of cytotoxicity tests leads to a robust establishment of cytotoxicity assays with high sensitivity and prompt results. In vitro assays are always prioritized over in vivo due to the reproducible data, reduce numbers of animal used and easily accessible material. Compounds concentration that execute 50% of cell population is determined by calculating the IC50. According to ISO10993, cytotoxicity tests must be performed to determine the biocompatibility of medical devices that has contact with human body. This is crucial to ensure the safety of research and its clinical use. Under the recommendation of ISO10995-Part 5, three categories of tests have been documented; extract elution, direct contact and indirect contact test. Each category plays significant role depending on the nature of experiment and sample used. |
| first_indexed | 2025-11-15T12:54:52Z |
| format | Article |
| id | upm-90357 |
| institution | Universiti Putra Malaysia |
| institution_category | Local University |
| language | English |
| last_indexed | 2025-11-15T12:54:52Z |
| publishDate | 2021 |
| publisher | Faculty of Medicine and Health Sciences, Universiti Putra Malaysia |
| recordtype | eprints |
| repository_type | Digital Repository |
| spelling | upm-903572021-09-10T01:00:21Z http://psasir.upm.edu.my/id/eprint/90357/ Review on the in vitro cytotoxicity assessment in accordance to the International Organization for Standardization (ISO) Mohd Shafiee, Muhammad Aminuddin Muhamad Asri, Mohd Ashraf Syed Alwi, Sharifah Sakinah Cytotoxicity is a predominant biological evaluation applied to search for a suitable and non-toxic bioactive compound and to determine the biocompatibility of medical devices-related human body. The broad usage of cytotoxicity tests leads to a robust establishment of cytotoxicity assays with high sensitivity and prompt results. In vitro assays are always prioritized over in vivo due to the reproducible data, reduce numbers of animal used and easily accessible material. Compounds concentration that execute 50% of cell population is determined by calculating the IC50. According to ISO10993, cytotoxicity tests must be performed to determine the biocompatibility of medical devices that has contact with human body. This is crucial to ensure the safety of research and its clinical use. Under the recommendation of ISO10995-Part 5, three categories of tests have been documented; extract elution, direct contact and indirect contact test. Each category plays significant role depending on the nature of experiment and sample used. Faculty of Medicine and Health Sciences, Universiti Putra Malaysia 2021-04 Article PeerReviewed text en http://psasir.upm.edu.my/id/eprint/90357/1/2021040613505636_MJMHS_0637.pdf Mohd Shafiee, Muhammad Aminuddin and Muhamad Asri, Mohd Ashraf and Syed Alwi, Sharifah Sakinah (2021) Review on the in vitro cytotoxicity assessment in accordance to the International Organization for Standardization (ISO). Malaysian Journal of Medicine and Health Sciences, 17 (2). pp. 261-269. ISSN 1675-8544; ESSN: 2636-9346 https://medic.upm.edu.my/upload/dokumen/2021040613505636_MJMHS_0637.pdf |
| spellingShingle | Mohd Shafiee, Muhammad Aminuddin Muhamad Asri, Mohd Ashraf Syed Alwi, Sharifah Sakinah Review on the in vitro cytotoxicity assessment in accordance to the International Organization for Standardization (ISO) |
| title | Review on the in vitro cytotoxicity assessment in accordance to the International Organization for Standardization (ISO) |
| title_full | Review on the in vitro cytotoxicity assessment in accordance to the International Organization for Standardization (ISO) |
| title_fullStr | Review on the in vitro cytotoxicity assessment in accordance to the International Organization for Standardization (ISO) |
| title_full_unstemmed | Review on the in vitro cytotoxicity assessment in accordance to the International Organization for Standardization (ISO) |
| title_short | Review on the in vitro cytotoxicity assessment in accordance to the International Organization for Standardization (ISO) |
| title_sort | review on the in vitro cytotoxicity assessment in accordance to the international organization for standardization (iso) |
| url | http://psasir.upm.edu.my/id/eprint/90357/ http://psasir.upm.edu.my/id/eprint/90357/ http://psasir.upm.edu.my/id/eprint/90357/1/2021040613505636_MJMHS_0637.pdf |