NAMSA eLearning ISO 10993 Series 1
About
Please note that the e-learning part 4 & 6 are currently being updated, we are looking forward to share with you the new videos according to the new standards.
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 11 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.
If you have questions about the e-learning , please reach out to communications@namsa.com
Course Structure
Part 1
ISO 10993 - Evaluation and testing in the risk management process
00:00:00Evaluation and testing in the risk management process
eLearn Questions - Part 1
Part 3
ISO 10993 - Tests for genotoxicity, carcinogenicity and reproductive toxicity
00:00:00Tests for genotoxicity, carcinogenicity and reproductive toxicity
eLearn Questions - Part 3
Part 4
ISO 10993 - Selection of tests for interactions with blood (not current to 2017 version, currently being updated)
00:00:00Selection of tests for interactions with blood (not current to 2017 version, currently being updated)
eLearn Questions - Part 4
Part 5
ISO 10993 - Tests for In Vitro Cytotoxicity
00:00:00Tests for In Vitro Cytotoxicity
eLearn Questions - Part 5
Part 7
ISO 10993 - Ethylene oxide sterilization residuals
00:00:00Ethylene oxide sterilization residuals
eLearn Questions - Part 7
Part 10
ISO 10993 - Tests for irritation and delayed-type hypersensitivity
00:00:00Tests for irritation and delayed-type hypersensitivity
eLearn Questions - Part 10
Part 11
ISO 10993 - Tests for systemic toxicity
00:00:00Tests for systemic toxicity
eLearn Questions - Part 11
Part 12
ISO 10993 - Sample preparation and reference materials
00:00:00Sample preparation and reference materials
eLearn Questions - Part 12
Part 17
ISO 10993 - Establishment of allowable limits for leachable substances
00:00:00Establishment of allowable limits for leachable substances
eLearn Questions - Part 17
Part 18
ISO 10993 - Chemical characterization of materials
00:00:00Chemical characterization of materials
eLearn Questions - Part 18