Free white paper discusses new philosophy on Risk Management and Essential Performance
Boxborough, MA, August 16, 2010 — Intertek, a global leader in testing and certification for medical devices, is offering a free white paper, IEC 60601-1: The New Philosophy of the 3rd Edition, educating medical device manufacturers on the new approach to risk management and essential performance in the third edition of IEC 60601-1.
The mandatory adoption date for the third edition of IEC 60601-1 in Europe and Canada is June 2012. As with any other standard change, a failure to implement these new requirements in a timely manner could cause costly delays in getting devices 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.
This white paper reviews the “new philosophy” of the 3rd Edition, and outlines the specific changes from the 2nd Edition. It includes updates on the acceptance of the 3rd Edition in the world’s largest markets for medical devices. With this insight and knowledge, manufacturers can complete the transition quickly and painlessly.
The acceptance of the 3rd Edition is becoming mature, as more regulatory bodies decide to accept it. Of particular concern has been manufacturer’s preparedness to meet the Risk Management requirements in the 3rd Edition. Learn how an interactive approach addresses 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.
Download the white paper, IEC 60601-1: The New Philosophy of the 3rd Edition at http://www.intertek.com/medical/electrical-safety-testing/iec-60601-1/3rd-ed-paper/
For more information on Intertek’s testing services for IEC 60601-1, visit www.intertek.com/medical, email icenter@intertek.com, or call us at 1-800-WORLDLAB (1-800-967-5352).
Media Inquiries, please contact:
Roy Strunin
Senior Marketing Manager
Telephone: +1-978-263-2662
Roy.Strunin@intertek.com
About Intertek
Intertek is the leading provider of quality and safety solutions serving a wide range of industries around the world. From auditing and inspection to testing, quality assurance and certification, Intertek people are dedicated to adding value to customers’ products and processes, supporting their success in the global marketplace. Intertek has the expertise, resources and global reach to support its customers through its network of more than 1,000 laboratories and offices and over 26,000 people in more than 100 countries around the world. For more information, call 1-800-WORLDLAB or email icenter@intertek.com
