DIN EN ISO 10993-11:2009
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006); English version of DIN ENISO 10993-11:2009-08
- Standard No.
- DIN EN ISO 10993-11:2009
- Release Date
- 2009
- Published By
- German Institute for Standardization
- Status
- Replace By
- DIN EN ISO 10993-11 E:2015
- Latest
- DIN EN ISO 10993-11:2018-09
- Replace
- DIN EN ISO 10993-11/A1:2009
- Scope
- This part of ISO 10993 specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.
DIN EN ISO 10993-11:2009 Referenced Document
- ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process*， 2018-08-01 Update
- ISO 10993-2 Biological evaluation of medical devices — Part 2: Animal welfare requirements*， 2022-11-03 Update
DIN EN ISO 10993-11:2009 history
- 2018 DIN EN ISO 10993-11:2018-09 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017); German version EN ISO 10993-11:2018
- 2018 DIN EN ISO 10993-11:2018 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)
- 1970 DIN EN ISO 10993-11 E:2015-12 Biological Evaluation of Medical Devices Part 11: Systemic Toxicity Testing (Draft)
- 2015 DIN EN ISO 10993-11 E:2015 Draft Document - Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO/DIS 10993-11:2015); German and English version prEN ISO 10993-11:2015
- 2009 DIN EN ISO 10993-11:2009 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006); English version of DIN ENISO 10993-11:2009-08
- 2006 DIN EN ISO 10993-11:2006 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006); German version EN ISO 10993-11:2006
