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Embassy Suites Hotel on the Waterfront

IEC 60601-1 Third Edition

Training Seminar

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• Date: Friday, October 28, 2011
• Location:Embassy Suites on the Bay , Burlingame, California USA (near San Francisco International Airport (SFO))

Overview:
 
Without compliance to the 3rd edition the ability to sell in the U.S. and globally will be affected. Most products sold in the EU (new & current production) will need to comply with the new IEC 60601-1 by June 2012! Products should already comply with some of the referenced standards which will be discussed, including usability (IEC 60601-1-6) and alarms (IEC 60601-1-8) in Europe as well. New products must show compliance in Canada by June 2012 and even for new submissions to the FDA by June 2013. Deadlines are rapidly approaching! Now is the time to understand the changes and how they will impact your device including planning and scheduling for new testing or product modifications that may be required. Details of new safety and performance requirements will be presented. The course is appropriate for those new to the standard but will also provide valuable insights and version comparisons for those who are already familiar with it by providing insights from individuals who actually developed the standard and requirements. Included will be a review of a typical isolation diagram and how the new requirements affect it; as well as, a focus on the increased emphasis on risk analysis and how it impacts the standard’s requirements. Christine Ruther and Mike Schmidt will instruct. Mike is the convener of the IEC committee that wrote the 3rd edition of IEC 60601-1 and is currently revising it , he has also served as a technical expert working with the group that developed the IEC Collateral Standard 60601-1-4 (Programmable electrical medical systems), and in the joint ISO/IEC working group that developed and is currently amending ISO 14971 (Risk Management). The IEC 60601-1 3rd edition is being revised! Learn firsthand what changes are proposed and when they will likely take effect. One area of revision will significantly impact how Risk Management is used to meet the requirements of the standard.

What you will learn:

• Understanding of IEC 60601-1 and what has changed in the 3rd edition.
• What additional changes are coming (the first amendment is on it’s way).
• How to meet usability (IEC 60601-1-6) and alarm (IEC 60601-1-8) requirements.
• Clear understanding of new labeling requirements.
• How to design for home use (IEC 60601-1-11).
• Transition periods and planning for compliance.
• Impact of risk management & ISO 14971 in the 3rd edition.
• Upcoming revision details and what to expect, especially changes to how Risk Management is used.

Benefits of Attending:

• Understanding of what has changed or been clarified in the 3^rd edition.
• Clear understanding of new labeling requirements.
• Understanding of new standards required by the 3^rd edition, including ISO 14971, IEC 60601-2, IEC 60601-1-6, -8, -11.
• Opportunity to ask direct questions of the IEC 60601-1 committee co-chairman.
• Ability to plan for a smooth transition to compliance (although time is now short).
• Plan ahead for the coming revisions to the 3rd edition.

Abbreviated Outline:

• A. Transition deadlines- EU, Canada & U.S. FDA, standard & collateral stds.
• B. Understanding the standard & organization- how to find things quickly
• C. Key changes and impact of the 3rd Edition
• D. Understanding details of the new standard revision using an isolation diagram example
• E. Labeling requirements including symbols, changes from previous version
• F. Risk management, inc. ISO 14971; its critical importance in complying with this standard
• G. Revision or Amendment 1 of IEC 6060-1 3rd Ed.: What is changing & When
• H. Collateral Standard IEC 60601-1-6 on Usability
• I. Collateral Standard IEC 60601-1-8 on Alarms
• J. Collateral Standard IEC 60601-1-11 on HomeCare
• K. Q&As
• L. Review and Summary

Speakers: Mike Schmidt, Christine Ruther

Registration & Additional Information : Airfare Discounts, Pricing, Discounts, Continuing Education Units Awarded, Speaker Biographies, Past Participants, Sights to see in the area.

On-line Registration Form Register on-line to reserve your seat now!