STB PDF

Biological evaluation of medical devices. Toxicokinetic study design for degradation products and leachables. Original standard BS EN ISO 10993-16-2017 (2018) in PDF full version. Additional info + preview on request

Document status: Active

Biological evaluation of medical devices - Establishment of allowable limits for leachable substances. Original standard BS EN ISO 10993-17-2009 in PDF full version. Additional info + preview on request

Document status: Replaced by STB BS EN ISO 10993-17-2023 + A1-2025

Biological evaluation of medical devices - Chemical characterization of materials. Original standard BS EN ISO 10993-18-2009 in PDF full version. Additional info + preview on request

Document status: Replaced by STB BS EN ISO 10993-18-2020 + A1-2023

Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020). Original standard BS EN ISO 10993-18-2020 in PDF full version. Additional info + preview on request

Document status: Active

Biological evaluation of medical devices - Animal welfare requirements. Original standard BS EN ISO 10993-2-2006 in PDF full version. Additional info + preview on request

Document status: Replaced by STB BS EN ISO 10993-2-2022

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017). Original standard BS EN ISO 10993-4-2017 in PDF full version. Additional info + preview on request

Document status: Active