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NAMSA eLearning ISO 10993 Series 1

About

Course Dates

Open-ended

Enrollment Dates

Enroll Anytime

Who Can Enroll

Anyone

Course Language

English

Price

$1,625.00

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.

Course Structure

Part 1
ISO 10993 - Evaluation and testing in the risk management process
00:50:00

Evaluation and testing in the risk management process

50:00 mins

eLearn Questions - Part 1

Part 3
ISO 10993 - Tests for genotoxicity, carcinogenicity and reproductive toxicity
00:00:00

Tests for genotoxicity, carcinogenicity and reproductive toxicity

eLearn Questions - Part 3

Part 5
ISO 10993 - Tests for In Vitro Cytotoxicity
00:00:00

Tests for In Vitro Cytotoxicity

eLearn Questions - Part 5

Part 7
ISO 10993 - Ethylene oxide sterilization residuals
00:00:00

Ethylene oxide sterilization residuals

eLearn Questions - Part 7

Part 10
ISO 10993 - Tests for irritation and delayed-type hypersensitivity
00:00:00

Tests for irritation and delayed-type hypersensitivity

eLearn Questions - Part 10

Part 11
ISO 10993 - Tests for systemic toxicity
00:00:00

Tests for systemic toxicity

eLearn Questions - Part 11

Part 12
ISO 10993 - Sample preparation and reference materials
00:00:00

Sample preparation and reference materials

eLearn Questions - Part 12

Part 17
ISO 10993 - Establishment of allowable limits for leachable substances
00:00:00

Establishment of allowable limits for leachable substances

eLearn Questions - Part 17

Part 18
ISO 10993 - Chemical characterization of materials
00:00:00

Chemical characterization of materials

eLearn Questions - Part 18