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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

Access Recording


November 29, 2018
11:00 am - 12:00 pm
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