From that date on all medical devices can only be sold in the EU if they are designed, validated and verified according to this specific standard.

The main differences in comparison to the 2nd edition are the new philosophy of safety and a risk management according to the DIN EN ISO 14971 which are valid for the whole lifecycle of a product. This has to be determined, documented and maintained in a continuous process. The procedure itself contains the elements of risk analysis, risk assessment, risk control as well as information from the manufacturing process. Furthermore the manufacturer has to prove that all risks are on an acceptable level and that the remaining ones are really minimized.

Additionally there are further requirements regarding electrical safety, isolation concepts (MOPP and MOOP), software validation & verification as well as the consideration of other combinations with non-medical devices.

RRC power solutions, as a certified medical device manufacturer, already has experience in new developments according to the IEC 60601-1 3^rd edition since 2008. Please feel free to contact us, if you want to benefit from our experience.

Press release from RRC

For that reason the “Japan Electronics and Information Technology Industries Association” (JEITA) and the “Battery Association of Japan” (BAJ) published a guideline to enhance the safety of Lithium-ion batteries. The “Guide for the Safe Use of Secondary Lithium-ion Batteries in Notebook-type Personal Computers” not only applies to portable computers, but also aims in general on advanced safety and ideal charging methods for all Lithium-ion batteries.

In today’s battery designs, RRC power solutions works according to these guidelines to ensure the maximum safety for the end user and the application. The combination of quality brand name cells and state-of-the-art battery management systems guarantee top performance on all battery designs. Furthermore, extensive safety test requirements to JEITA/BAJ begin at the cell level and continue to the complete assembled battery!