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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
Clinical laboratory testing and in vitro medical devices — Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
60.60 Standard published
Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices — Part 1: Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases
90.20 Standard under periodical review
Clinical laboratory testing and in vitro diagnostic test systems — Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices — Part 2: Evaluation of performance of antimicrobial susceptibility test devices against reference broth micro-dilution
60.60 Standard published
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 1: Requirements and general principles for the evaluation of biological safety within a risk management process
40.00 DIS registered
Biological evaluation of medical devices — Part 6: Tests for local effects after implantation
40.00 DIS registered
Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
40.00 DIS registered
Clinical investigation of medical devices for human subjects — Good clinical practice
40.00 DIS registered
Biological evaluation of medical devices — Part 22: Guidance on nanomaterials
60.60 Standard published
Biological evaluation of medical devices — Part 33: Guidance on tests to evaluate genotoxicity — Supplement to ISO 10993-3
60.60 Standard published
Biological evaluation of medical devices — Part 55: Interlaboratory study on cytotoxicity
60.60 Standard published
Pyrogenicity — Principles and methods for pyrogen testing of medical devices
60.60 Standard published
Medical devices utilizing animal tissues and their derivatives — Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes
90.93 Standard confirmed
Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and topographical characterization of materials
90.93 Standard confirmed