IEC 60601-1 3rd Edition & Certification Requirements
Training On-Site Training Consulting
In-house or On-site Training Seminar
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) now need to comply with the new IEC 60601-1. Products should also 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 and other regions. New products must show compliance in Canada as of June 2012 and must now show compliance for all new submissions to the FDA. 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 be valuable to those familiar with the the standard by providing valuable insights & experiences gained by working with numerous clients, the new version, and various testing houses. 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.
What you will learn:
Benefits of Attending:
Instructor biographies and information will be provided upon request.