ISO 10993-11:2017
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
- Standard No.
- ISO 10993-11:2017
- Release Date
- 2017
- Published By
- International Organization for Standardization (ISO)
- Latest
- ISO 10993-11:2017
- Scope
- This document 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.
ISO 10993-11:2017 Referenced Document
- ASTM F619-03 Standard Practice for Extraction of Medical Plastics*， 2024-04-20 Update
- ISO 10993 Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products*， 2019-11-26 Update
- ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- ISO 10993-2:2006 Biological evaluation of medical devices - Part 2: Animal welfare requirements
ISO 10993-11:2017 history
- 2017 ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
- 2006 ISO 10993-11:2006 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
- 1993 ISO 10993-11:1993 Biological evaluation of medical devices; part 11: tests for systemic toxicity
