Standards ČSN - Czech national standards - Page 7688

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products

Standard published on 1.2.2022

Biological evaluation of medical devices - Part 10: Tests for skin sensitization

Standard published on 1.9.2023

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity

Standard published on 1.9.2018

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials

Standard published on 1.2.2022

Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices

Standard published on 1.11.2010

Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics

Standard published on 1.11.2009

Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys

Standard published on 1.12.2023

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables

Standard published on 1.4.2018

Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents

Standard published on 1.6.2024

Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process

Standard published on 1.10.2021