90/385/EEC COUNCIL DIRECTIVE on the approximation of the laws of the Member States relating to active implantable medical devices
93/42/EEC Commission communication in the framework of the implementation of the Council Directive 93/42/EEC concerning medical devices (Text with EEA relevance; Publication of titles and references of harmonised standards under the directive)
ASTM F619-03(2008) Standard Practice for Extraction of Medical Plastics*， 2023-12-23 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 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
BS EN ISO 10993-11:2018 history
0000 BS EN ISO 10993-11:2018(2022)
2018BS EN ISO 10993-11:2018 Biological evaluation of medical devices. Tests for systemic toxicity
2009BS EN ISO 10993-11:2009 Biological evaluation of medical devices - Part 11:Tests for systemic toxicity (ISO 10993-11:2006)