Program Description

IEC 60601-1 Ed 3.1 Compliance Program Certificate

Estimated Learning Duration of the Program:
1-2 weeks
Program Description:

This program, developed by world-renowned expert Brian Biersach, provides an in-depth review of the IEC 60601-1 Edition 3.1 requirements and references numerous related standards, including ISO 14971. It includes several examples of specific situations of different types of medical electrical equipment, as well as practical insight for professionals.

This program offers a comprehensive comparison between the previous second edition and current third edition, including Amendment 1.

Learning Objectives:

Upon successfully completing this program, learners will be able to:

  • Apply the IEC standards to different geographic regions
  • Obtain essential information from within different sections of the standards, including collaterals
  • Implement new points from the third edition to the second edition for new and existing devices
  • Execute risk management principles for electrical medical equipment and systems and integrate these principles when performing a risk analysis under the ISO 14971 requirements
  • Employ the classification rules and use appropriate terminology throughout product development
  • Set up a compliant documentation system for medical devices
  • Establish the correct and required markings for equipment, controls, and instruments, and recognize which safety signs are needed
  • Identify the particular requirements and classifications of medical electrical equipment
  • Administer requirements with regard to the applicable mechanical testing
  • Comprehend the design and related testing requirements to ensure protection against thermal and other hazardous material
  • Perform the critical component requirements

Program Pricing

Price1 onlyAs of 5As of 10As of 20As of 50
Price / person €465.00419.00372.00326.00Contact us
Price / person $ (currency fluctuation may apply)623.00561.00498.00436.00Contact us