Belarus standards PDF

Biological evaluation of medical devices Part 15- Identification and quantification of degradation products from metals and alloys (ISO 10993-15-2000). Original standard UNE-EN ISO 10993-15-2009 in PDF full version. Additional info + preview on request

Document status: Replaced by STB UNE-EN ISO 10993-15-2024

Biological evaluation of medical devices Part 17- Establishment of allowable limits for leachable substances (ISO 10993-17-2002). Original standard UNE-EN ISO 10993-17-2009 in PDF full version. Additional info + preview on request

Document status: Replaced by STB UNE-EN ISO 10993-17-2024

Biological evaluation of medical devices - Part 18- Chemical characterization of medical device materials within a risk management process (ISO 10993-18-2020). Original standard UNE-EN ISO 10993-18-2021 in PDF full version. Additional info + preview on request

Document status: Active

Biological evaluation of medical devices Part 3- Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3-2014). Original standard UNE-EN ISO 10993-3-2015 in PDF full version. Additional info + preview on request

Document status: Active

Biological evaluation of medical devices - Part 4- Selection of tests for interactions with blood (ISO 10993-4-2017). Original standard UNE-EN ISO 10993-4-2018 in PDF full version. Additional info + preview on request

Document status: Active

Biological evaluation of medical devices - Part 7- Ethylene oxide sterilization residuals (ISO 10993-7-2008). Original standard UNE-EN ISO 10993-7-2009 in PDF full version. Additional info + preview on request

Document status: Active