TUV Rheinland Introduces Custom Certification Process for Compliance to IEC 60601-1 3rd Edition
In response to requests from power supply manufacturers, TÜV Rheinland North America has developed a custom certification process for compliance to IEC 60601-1 3rd Edition for power supplies being sold into the medical market.
Currently, most worldwide markets require certification to IEC 60601-1 2nd Edition, but the 3rd Edition, introduced in 2005, is expected to become the standard for Europe and Canada by June of 2012 and for the FDA in the United States by June of 2013. While there are a number of differences between the second and third editions, one of the more significant changes has to do with risk management.
To address the various risk management approaches of power supply manufacturers, TÜV Rheinland has developed a custom certification process for compliance to IEC 60601-1 3rd Edition. This process is designed to simplify conformance to the standard, eliminate confusion, and increase efficiencies in the testing and documentation review required. The process does not put any unnecessary demands on the manufacturer and allows the maximum flexibility in achieving a level of compliance that provides value to their customers.
The TÜV process offers power supply manufacturers three options: testing for evaluation to IEC 60950 or other non-medical standard; evaluation to IEC 60601-1:2005, 3rd Edition with no risk management process and no risk management review; and evaluation to IEC 60601-1:2005, 3rd Edition with a review of all applicable risk management processes.
For all three options, the application limits of the power supply will be noted so that OEMs will be fully aware of the power supply’s intended use. For example, a power supply might provide one Means of Operator Protection for 300V from main to secondary. This rating would be clearly included in the product report to give purchasers and designers full information. Where the manufacturer does not perform a risk management analysis, the test certificates shall have the risk management process exclusion clearly stated: "The risk management requirements of the standard were not addressed."
These three options are in alignment with the recent recommendations of the IECEE Medical Electrical Equipment Task Force, which is responsible for developing guidelines for the application of risk management processes to medical equipment. "The task force recognized the difficulties power supply manufacturers face when selling into the medical device market, because some manufacturers may not be sure how and where their products will ultimately be used, and others might have little or no experience with the risk management standard ISO 14971," said Dale Hallerberg, Medical Test Technical Manager for TÜV Rheinland North America and a member of the task force. "However, other manufacturers want do everything they can, including risk analysis, to make the use of their product easier for medical equipment manufacturers to accept. Accordingly, we developed these options to give power supply manufacturers more flexibility and control over their path to conformity.
"It is important for manufacturers to be aware of the third edition and how it impacts them, as the 2012 adoption for Europe and Canada is not that far away," said Hallerberg. "Testing firms such as TÜV Rheinland already test to both the 2nd and 3rd editions, and this certification path will help power supply manufacturers meet Third Edition requirements."
