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SGS and WMDO are proud to present this newly released online compliance program for IEC 60601 edition 3.1 that offers medical device engineers as well as auditors the most up to date knowledge and expert insight for a truly effective and practical learning experience.

Program description

Developed by world renowned expert Brian Biersach, this comprehensive five course program provides you with an in-depth review of the IEC 60601 edition 3.1 requirements, offering reference to numerous collateral and other related standards, including ISO 14971.

Throughout the program a comprehensive comparison is provided between the previous 2nd edition up through the current 3rd edition, including amendment 1.

The extensive information contained in this program offers learners several examples and specific situations for different types of medical electrical equipment as well as practical insight for professionals.

A certificate of completion will be delivered to participants having successfully passed this program.

Course program

The online IEC 60601 ed 3.1 Compliance program includes the following five courses:

  • IEC 60601-1 Ed 3.1 - Background and Introduction
  • IEC 60601-1 Ed 3.1 - Risk Management and General Requirements
  • IEC 60601-1 Ed 3.1 - Protection Against Electrical Shock, and verifying Electrical Insulation
  • IEC 60601-1 Ed 3.1 - Medical Electrical Systems and Protection Against Mechanical Hazards
  • IEC 60601-1 Ed 3.1 - Protection Against Thermal and Other Hazards and Components

Learning objectives

Upon successful completion of this program, learners will be able to successfully:

  • Apply the standards within the different geographic regions.
  • Obtain essential information from within the different sections of the standards, and collaterals
  • Apply new points of the third edition compared to second edition for existing and new devices
  • Implement risk management principles for electrical medical equipment and systems as well as integrate these principles when performing a risk analysis under the ISO 14971 requirements
  • Employ classification and terminology to further study the requirements of the IEC 60601-1 ed 3.1 standard and related collaterals
  • Establish the correct and required markings for equipment, controls and instruments as well as recognize which safety signs are needed
  • Identify the particular requirements and classification of medical electrical equipment
  • Apply the requirements with regards to the applicable mechanical testing
  • Comprehend the changes with regards to mechanical testing since revision 2 of the standard and apply updates to existing devices where needed
  • Comprehend the design and related testing requirements to ensure protection against thermal and other hazards
  • Apply the critical component requirements

Target functions

This compliance program was specifically developed for validation engineers, R&D engineers, notified body auditors and quality assurance engineers.

Register for the program here

Further Information

For more information on SGS Medical Devices Services visit www.sgs.com/medicaldevices or contact us.

About SGS

SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognised as the global benchmark for quality and integrity. With more than 80,000 employees, SGS operates a network of over 1,650 offices and laboratories around the world.