DIN EN ISO 10993-18:2021
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020); German version EN ISO 10993-18:2020
- Standard No.
- DIN EN ISO 10993-18:2021
- Release Date
- 2021
- Published By
- German Institute for Standardization
- Status
- Replace By
- DIN EN ISO 10993-18:2009
- DIN EN ISO 10993-18:2018
- DIN EN ISO 10993-18:2021-03
- Latest
- DIN EN ISO 10993-18:2009
- DIN EN ISO 10993-18:2018
- DIN EN ISO 10993-18:2021-03
- Scope
- This document specifies a framework for the identification of biological hazards and the estimation and control of biological risks from material constituents, using a stepwise approach to the characterization of a medical device through: - the identification of its materials of
DIN EN ISO 10993-18:2021 history
- 2021 DIN EN ISO 10993-18:2021 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020); German version EN ISO 10993-18:2020
- 1970 DIN EN ISO 10993-18 E:2018-09 Biological evaluation of medical devices Part 18: Chemical characterization of medical device materials during risk management (draft)
- 2018 DIN EN ISO 10993-18 E:2018 Draft Document - Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO/DIS 10993-18:2018); German and English version prEN ISO 10993-18:2018
- 2009 DIN EN ISO 10993-18:2009 Biological assessment of medical devices
- 2005 DIN EN ISO 10993-18:2005 Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005); German version EN ISO 10993-18:2005
