ISO Approves Korean Animal Alternative Skin Irritation Test for Medical Devices
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By Invented Reporter | SEOUL – 2025/05/25 08:28:54
The International Standardization Association (ISO) has officially recognized the medical Device Skin irritation Testing Act, which utilizes Keraskintm, an animal alternative test developed by the KFDA, as an international standard, effective May 14.
Developed by the Korea Animal Alternative Testing Act (KOCVAM) starting in 2019, under the guidance of the Food and Drug Governance (Director Kang Seok -yeon) and the Ministry of Food and Drug Safety (Director Oh Yu -kyung), this testing method assesses skin irritation caused by medical devices using the domestically developed ‘Keraskintm’. This marks the frist instance of an animal replacement test developed in Korea achieving ISO international standard status.
the ISO listing is anticipated to boost the domestic biohealth sector, reducing both the time and costs associated with skin irritation testing for medical devices conducted by entities such as non-clinical testing agencies.
The Korea Food and Drug Administration has stated its commitment to ongoing collaboration with the OECD and ISO to harmonize domestic animal alternative testing regulations, enhance regulatory consolidation, and actively promote the adoption of animal alternative testing methods.
Benefits of the New ISO Standard
The adoption of the ‘Keraskintm’ based Medical Device Skin irritation Testing Act as an ISO standard brings several advantages to the biohealth industry and regulatory landscape.
“This marks the first instance of an animal replacement test developed in Korea achieving ISO international standard status.”
This standardization not only streamlines the testing process but also aligns South Korea with global best practices in ethical and efficient medical device assessment.
Understanding Animal Alternative Testing
Frequently Asked Questions
- What is animal alternative testing?
- Animal alternative testing refers to methods that replace or reduce the use of animals in scientific and regulatory testing, frequently enough involving cell-based assays and computer modeling.
- What is ‘Keraskintm’?
- ‘Keraskintm’ is a domestically developed testing method used to assess skin irritation caused by medical devices, and it is an animal alternative test.
- Why is the ISO listing important?
- The ISO listing streamlines the testing process, aligns South Korea with global best practices, and reduces time and costs associated with skin irritation testing.
