Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process (ISO 10993-1:2025)

Standard published on 1.4.2026

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

Standard published on 1.3.2015

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

Standard published on 1.11.2009

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

Change published on 1.6.2025

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

Standard published on 1.7.2017

Biologické hodnotenie zdravotníckych pomôcok. Časť 6: Skúšky lokálnych účinkov po implantácii (ISO 10993-6: 2026) (Norma na priame používanie ako STN).

Standard published on 1.9.2026

Biologické hodnotenie zdravotníckych pomôcok. Časť 7: Zvyšky po sterilizácii etylénoxidom (ISO 10993-7: 2026) (Norma na priame používanie ako STN).

Standard published on 1.9.2026

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019)

Standard published on 1.1.2022

Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)

Standard published on 1.5.2023

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)

Standard published on 1.11.2018