- This event has passed.
ISO 10993-1: 2018 Just Released! Here’s what to know
November 29, 2018 @ 11:00 am - 12:00 pm
ISO 10993-1: 2018 released in August and there are a lot of new concepts included as well as the reinforcement of previous ones. Many of these changes may change the course of your evaluation process and submission. Included will be a review of changes including:
Revision of the assessment requirements in the Biocompatibility Evaluation Endpoints chart – Hello physical/chemical characterization!
Conduct of biological and risk evaluations
Evaluation of non- and transitory-contacting medical devices, nanomaterials and absorbable materials
Reusable medical device end of life evaluation
Other clarification edits made throughout the document