Home › Standard
EN ISO 10993-1
2 current listing(s) — 1 EU harmonised, 1 UK designated.
Current listings
| Edition | List | Title | Presumption from | Withdrawal / cessation | |
|---|---|---|---|---|---|
| EN ISO 10993-1:2009 | UK UK Medical Devices (designated) | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009) | 01/01/2021 | source | |
| EN ISO 10993-1:2025 | EU Medical Devices Regulation | Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk | source |
Timeline
- 2026-06-17listed in Medical Devices Regulation
EN ISO 10993-1:2025