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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
90.93 Standard confirmed
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
60.60 Standard published
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
90.20 Standard under periodical review