DIN EN ISO 10993-1:2021
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10); German version EN ISO 10993-1:2020
- Standard No.
- DIN EN ISO 10993-1:2021
- Release Date
- 2021
- Published By
- German Institute for Standardization
- Status
- 2017-04
- Replace By
- DIN EN ISO 10993-1:2010
- DIN EN ISO 10993-1:2017
- DIN EN ISO 10993-1:2021-05
- Latest
- DIN EN ISO 10993-1:2021
- DIN EN ISO 10993-1:2017
- DIN EN ISO 10993-1:2021-05
- Scope
- The role of this part of ISO 10993 is to serve as a framework in which to plan a biological evaluation which, as scientific knowledge advances our understanding of the basic mechanisms of tissue responses, minimizes the number and exposure of test animals by giving preference to
DIN EN ISO 10993-1:2021 history
- 2021 DIN EN ISO 10993-1:2021 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10); German version EN ISO 10993-1:2020
- 2017 DIN EN ISO 10993-1:2017 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO/DIS 10993-1:2017); German and English version prEN ISO 10993-1:2017
- 2010 DIN EN ISO 10993-1:2010 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system (ISO 10993-1:2009); German version EN ISO 10993-1:2009
