The 3rd Edition of IEC 60601-1 represents a shift in philosophy from the 2nd Edition, including a greater emphasis on risk management and essential performance. As with any other standard change, a failure to implement these new requirements in a timely manner could cause costly delays in getting your device to market. Because the 2nd Edition of IEC 60601-1 is so deeply ingrained in the electrical medical equipment industry, acclimating to the changes in the 3rd Edition will be a challenge that requires designers, manufacturers and testing companies to work in a close, partnering relationship.
Intertek will partner with you to meet the Risk Management requirements in the 3rd Edition, providing an interactive approach addressing your concerns via device design reviews; assessments of your Risk Analysis; and overall development of your Risk Management File, and its suitability to the 3rd Edition series of standards.
As a leading testing and certification body, Intertek is well-qualified to help you navigate through the new approach and requirements. Starting with the development of your Risk Management File through the final stages of testing and certification, Intertek's experienced 3rd Edition engineering team will partner with you to help your company achieve the greatest advantages from the new philosophy of the 3rd Edition.
In this article, we will review the "new philosophy" of the 3rd Edition, and outline the specific changes from the 2nd Edition. We will also provide you with an update on the acceptance of the 3rd Edition in the world's largest markets for medical devices. With this insight and knowledge, you can complete the transition quickly and painlessly.
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