Standards UNE - Spanish national standards - Page 126

Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process - Amendment 1: Determination of the uncertainty factor (ISO 10993-18:2020/Amd 1:2022)

Change published on 22.5.2024

Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022)

Standard published on 12.7.2023

Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)

Standard published on 13.10.2021

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)

Change published on 6.5.2026

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)

Standard published on 6.5.2015

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)

Standard published on 24.1.2018

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - Amendment 1 (ISO 10993-4:2017/Amd 1:2025, Corrected version 2025-04)

Change published on 22.10.2025

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)

Standard published on 9.12.2009

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

Change published on 22.10.2025

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)

Standard published on 25.10.2017