Standards UNE - Spanish national standards - Page 125

Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)

Standard published on 9.9.2009

Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019)

Standard published on 17.1.2024

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)

Standard published on 16.5.2018

Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023)

Standard published on 22.5.2024

Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)

Standard published on 20.1.2021

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 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