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Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood — Amendment 1
40.20 DIS ballot initiated: 12 weeks
Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
90.93 Standard confirmed
Biological evaluation of medical devices — Part 6: Tests for local effects after implantation
90.92 Standard to be revised
Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
90.92 Standard to be revised
Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals — Amendment 1: Applicability of allowable limits for neonates and infants
60.60 Standard published
Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals — Technical Corrigendum 1
60.60 Standard published
Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products
60.60 Standard published
Medical products containing viable human cells — Application of risk management and requirements for processing practices
90.93 Standard confirmed
Clinical investigation of medical devices for human subjects — Good clinical practice
90.92 Standard to be revised
Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management
60.60 Standard published
Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling
60.60 Standard published
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
90.93 Standard confirmed
Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables
20.00 New project registered in TC/SC work programme
Biological evaluation of medical devices — Part 2: Animal welfare requirements
20.00 New project registered in TC/SC work programme
Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
20.00 New project registered in TC/SC work programme
Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood — Amendment 1
20.00 New project registered in TC/SC work programme
Clinical evaluation of medical devices
20.00 New project registered in TC/SC work programme
Medical devices utilizing human tissues and their derivatives — Application of risk management
20.00 New project registered in TC/SC work programme