eLearning ISO 10993 Series 1

Published:

Content Type:

No category assigned
Please log in to access your purchased courses.

The ISO 10993 series of standards are used by medical device manufacturers for the evaluation of biological safety, more commonly referred to as biocompatibility.

In the 22 parts of this standard, various biological safety endpoints are described and prescribed for evaluation based on a medical device contact type and duration. An evaluation strategy is developed specific to material, device contact, and contact duration; allowing manufacturers to produce devices that are safe for patient contact or implant.

In this multi-part eLearning module, NAMSA experts will guide you through the process outlined in the standards, discuss the most common sections, tests, strategies, as well as share personal experiences with the evaluation strategy and how to plan project timelines with chemical characterization testing, biological risk assessment, and biological effects and tests. This module addresses 11 of the 22 parts of ISO 10993. Each section contains a narrated video, and an education evaluation quiz. Upon successful completion of each section of this module, attendees receive a completion certificate in their grade book, suitable for printing for human resource training requirements.

Part 1: Evaluation and testing in the risk management process Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity Part 4: Selection of tests for interactions with blood Part 5: Tests for In Vitro Cytotoxicity Part 6: Tests for Local Effects After Implantation Part 7: Ethylene oxide sterilization residuals Part 10: Tests for irritation and delayed-type hypersensitivity Part 11: Tests for systemic toxicity Part 12: Sample preparation and reference materials Part 17: Establishment of allowable limits for leachable substances Part 18: Chemical characterization of materials