The utmost degree of experience, expertise and safety are required for human body applications in medical technology. Medical technology demands various types of certification to guarantee these, thereby ensuring that the product used on or inside the human body fulfills additional safety requirements. These requirements also apply to mobile applications which have a battery-operated energy source. Particular caution is required in this respect:
Pros and cons of lithium technology
More and more manufacturers of battery – operated products are focusing on energy sources with lithium ion technology. The advantages speak for themselves: Lithium has a significantly higher power density and voltage than material used prior to this. It can be operated for a much longer period or with more power. The batteries are considerably smaller than previous models with comparable performance data. The higher number of charge cycles and the long durability of the battery argue in favour of this technology.
However, the use of lithium ion batteries also carries an increased risk because of their higher energy density. This risk concerns not only the manufacturing and transportation of the batteries but also the final product including the battery and its use.
Certification requirements for batteries in medical technology
IEC62133-4 is a certification procedure of the International Electrotechnical Commission (IEC), a standardisation body for electrotechnology. Here, similar to UL1642, detailed battery tests, exceeding the requirements of the UN tests, are conducted which should guarantee the safety of the battery used in medical technology.
Exchange of information right from the start
For this reason, it is important even during the design-in phase of the final product, to work closely together with a battery assembler, who knows the opportunities and risks and can keep track of the medical technology manufacturer`s project from a battery perspective. This entails not only advising the manufacturer with regard to safety and battery performance but also regarding legal requirements, transportation of the finished product and the particular requirements of certain industries such as the above mentioned IEC62133-4- certification.
Jauch Quartz`s battery experts can answer all these questions, support and also advise the manufacturer throughout the whole project phase. The technical know-how of the experts, their comprehensive knowledge of the certification process, as well as Jauch`s qualified certification partners, enables them to provide maximum safety in processing, transportation and the final use of the lithium ion battery.