June 19, 2009 - IEC 60601-1 3rd Edition: Major Changes! Prepare Now!

FDA & International Consulting and Training Services

IEC 60601-1 Third Edition

Training SeminarDownload brochure

• • Date: Friday, June19, 2009

    Location: Paradise Pier Hotel, Disneyland Resort; Anaheim, California USA

• • • Which requirements are unaffected by the 3^rd edition.
    • Which requirements have been clarified in the 3^rd edition.
    • New requirements imposed by the 3^rd edition.
    • An overview of the new standards required by the 3^rd edition.
    • The transition periods for compliance.
    • What you need to do to comply with the 3^rd edition.
    • Understanding of what has changed or been clarified in the 3^rd edition.
    • Clear understanding of new labeling requirements.
    • Overview of new standards required by the 3^rd edition.
    • Opportunity to ask direct questions of the IEC committee co-chair.
    • Planning for a smooth transition to compliance.
    • A. New table of contents - how to find things
    • B. Overview of the key changes and impact of the 3rd Edition
    • C. Overview of the basics using an isolation diagram
    • D. Labeling changes
    • E. Review emphasis on risk management
    • F. Overview of key points of IEC 60601-1-6 on Usability
    • G. Overview of key points of IEC 60601-1-8 on Alarms
    • H. Transition planning for compliance
    • I. Q&As
    • J. Review and Summary

  Overview:
  IEC 60601-1 3^rd edition, “Medical electrical equipment - Part 1: General requirements for basic safety and essential performance”, has been released. Without compliance to the 3^rd edition modifications, clearance to continue to sell product could be affected and should be investigated. Now is the time to understand the changes and how they will impact your medical device. Now is the time to plan for new testing or product modification that will be required. This course will compare the previous and current versions of the standard and includes a review of a typical medical device isolation diagram while walking carefully through the impacts of the 3^rd edition to medical device product design and exploring the impact of the increased emphasis on risk analysis. Related international standards including IEC 60601-1-6 for Usability and IEC 60601-1-8 for Alarms, the new standards required by the 3^rd edition, will be introduced. Information on the transition periods for European compliance to the 3^rd edition as well as for test marks issued by UL and CSA will be provided to allow for focused planning for compliance and to ensure a smooth transition to the new 3^rd edition of IEC 60601-1 that is also recognized as a FDA consensus standard. This seminar will provide details for an understanding of medical electrical equipment safety and performance requirements for regulatory affairs, quality assurance, engineering, electrical design engineers, and quality engineers to allow for not only continued compliance to the standard but also continued sales internationally and within the United States .

  What you will learn:

  Benefits of Attending:

  Abbreviated Outline:

  Speakers: Christine Ruther