ISO 10993-23:2021/Amd 1:2025
Biological evaluation of medical devices — Part 23: Tests for irritation — Amendment 1: Additional in vitro reconstructed human epidermis models
Biological evaluation of medical devices — Part 23: Tests for irritation — Amendment 1: Additional in vitro reconstructed human epidermis models
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 5
- Дата публикации:
- 1 мая 2025 г.
- Издание:
- ISO IS 10993 edition 1 version 1
- ICS:
- 11.100.20
Abstract
Overview
ISO 10993-23:2021/Amd 1:2025 is an important amendment to the international standard for the biological evaluation of medical devices, specifically focusing on Part 23: Tests for irritation. This amendment introduces additional in vitro reconstructed human epidermis (RhE) models for assessing skin irritation potential caused by medical devices. Developed by ISO Technical Committee ISO/TC 194 in collaboration with CEN/TC 206, it reflects the latest advancements in alternative testing methods that reduce reliance on animal testing.
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