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Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
00.00 Proposal for new project received
Mathematical models for the evaluation of toxicokinetics
00.00 Proposal for new project received
Biological evaluation of medical devices — Part 22: Guidance on nanomaterials
00.00 Proposal for new project received
Ensuring quality of analytical chemistry in support of biological evaluation
00.00 Proposal for new project received
Preparation of medical device extracts for chemical analysis to support toxicological risk assessment
00.00 Proposal for new project received
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
Cardiovascular biological evaluation of medical devices — Guidance for absorbable implants
60.60 Standard published
Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and topographical characterization of materials
90.20 Standard under periodical review
Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices
90.93 Standard confirmed
Biological evaluation of medical devices — Requirements for interlaboratory studies to demonstrate the applicability of validated in vitro methods to assess the skin sensitization of medical devices
60.00 Standard under publication
Biological evaluation of medical devices — Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
90.93 Standard confirmed
Biological evaluation of absorbable medical devices — Part 1: General requirements
60.60 Standard published
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
20.20 Working draft (WD) study initiated