IEC 60601-1 Ed 3.1 - Background and Introduction
Course Description:
This first course in the IEC 60601-1 Edition 3.1 compliance program provides an overview of Edition 3.1 and how its standards are implemented internationally.
It offers a detailed review of how the Edition 3.1 standards, amendment, collaterals, and related standards are structured and executed, and concludes with a comparison between the second and third editions.
Learning Objectives:
Upon successfully completing this course, learners will be able to:
- Apply the standards to different geographic regions
- Find information from different sections of the standards and collaterals
- Execute methods from the third edition to new and existing devices
Who Should Enroll:
Validation, R&D, and quality assurance engineers and notified body auditors are encouraged to enroll in this course.
Prerequisite Knowledge/Requirements:
The following courses are required:
- ISO 14971: 2007 Review (ID 78)
- Preparing Risk Management Files & Which Techniques Apply (ID 83)
- Integrating Risk Management into Your Quality Management System (ID 94)
- Implications of EN ISO 14971: 2012 (ID N189)