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)
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
ISO 10993-3 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
ISO 10993-4 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood*， 2017-04-01 Update
ISO 10993-5 Biological evaluation of medical devices — Part 5: Tests for cytotoxicity: in vitro methods
ISO 10993-6 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation*， 2016-12-01 Update
ISO 10993-7 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals; Technical Corrigendum 1
ISO 10993-9 Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products*， 2019-11-26 Update
ISO 14971 Medical devices — Application of risk management to medical devices — Amendment 1: Rationale for requirements*， 2019-12-10 Update
ISO 22442-2 Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling*， 2020-09-15 Update
ISO 22442-3 Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
BS EN ISO 22442-1:2015 history
2020BS EN ISO 22442-1:2020 Medical devices utilizing animal tissues and their derivatives. Application of risk management
2015BS EN ISO 22442-1:2015 Medical devices utilizing animal tissues and their derivatives. Application of risk management
2008BS EN ISO 22442-1:2008 Medical devices utilizing animal tissues and their derivatives - Application of risk management