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

Norma vydaná dňa 30.12.2022

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

Norma vydaná dňa 26.11.2021

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

Norma vydaná dňa 29.8.2025

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

Norma vydaná dňa 30.12.2022

Biological evaluation of medical devices—Part 19:Physico-chemical,morphological and topographical characterization of materials

Norma vydaná dňa 30.12.2022

Biological evaluation of medical devices - Part 2: Animal welfare requirements

Norma vydaná dňa 30.12.2011

Biological evaluation of medical devices—Part 2: Animal welfare requirements
K dispozici od: únor 2027

Norma vydaná dňa 28.1.2026

Biological evaluation of medical devices—Part 20:Principles and methods for immunotoxicology testing of medical devices

Norma vydaná dňa 10.12.2015

Biological evaluation of medical devices—Part 22:Guidance on nanomaterials

Norma vydaná dňa 30.12.2022

Biological evaluation of medical devices—Part 23:Tests for irritation

Norma vydaná dňa 27.11.2023