SIST EN ISO 10993-23:2021/A1:2025
Biological evaluation of medical devices - Part 23: Tests for irritation - Amendment 1: Additional in vitro reconstructed human epidermis models (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 (ISO 10993-23:2021/Amd 1:2025)
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 15
- Дата публикации:
- 11 сентября 2025 г.
- Издание:
- ISO 10993-23:2021/Amd 1:2025
- ICS:
- 11.100.20
Abstract
Overview
EN ISO 10993-23:2021/A1:2025 is an amendment to ISO 10993-23:2021 - the part of the ISO 10993 series that specifies as part of the biological evaluation of medical devices. Amendment A1 (2025) adds for skin irritation assessment and clarifies the role of RhE tests adapted for . This European adoption (EN ISO) was approved by CEN in January 2025 and is intended to support compliance with Regulation (EU) 2017/745 (EU MDR).
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