IEC 60601-1 Ed 3.1 - Risk Management and General Requirements
Course Description:
This second course in the IEC 60601-1 Edition 3.1 compliance program offers an in-depth review of risk management’s function covered by this standard. It also examines the relationship between IEC 60601-1 Edition 3.1 and the ISO 14971 risk management standard for medical devices.
The latter part of this course reviews the general requirements needed to move onto the next courses (which cover more practical aspects of the standard).
The following general requirements are covered:
- Philosophy of the standard
- Classifications
- Basic terminology
- Markings on the inside and outside of the equipment
- Markings of controls and instruments
- Safety signs
- Indicator lights
- Accompanying documents
Learning Objectives:
Upon successfully completing this course, learners will be able to :
- Apply the risk management principles to electrical medical equipment and systems
- Integrate the aforementioned principles when performing risk analyses under ISO 14971 requirements
- Utilize classifications and terminology to further study the requirements of the IEC 60601-1 Edition 3.1 standard and related collaterals
- Employ the required markings for equipment, controls, and instruments
- Understand which safety signs are needed on which types of equipment
Who Should Enroll:
Validation, R&D, and quality assurance engineers and notified body auditors are all 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)