Operating extremely close to people, applications in medical technology require the highest levels of experience, expertise, and safety. To ensure the safety of medical technology products for use on or in human beings, there are global regulations and standards that must be followed. This also applies to mobile applications and devices powered by batteries. The battery is one of the components that must be tested and certified for use in the medical field.
Lithium batteries for medical technology
More and more manufacturers of battery-powered products for medical technology rely on energy sources based on lithium-ion technology. The advantages speak for themselves: compared to other electrochemical battery systems, lithium provides much higher voltage and volumic energy. As a result, applications can be operated for a considerably longer time or at higher power. Lithium-ion batteries are significantly smaller than other batteries with the similar performance. The high number of charging cycles and the long battery life are also points in favor of this technology.
However, in matters of product suppliers, quality, and supply security, the market is unclear. This, as well as the classification of lithium batteries as dangerous goods in transportation law, means that the selection of suppliers, the design-in, and ultimately the certification require more of an investment. In addition, high and still rising demand and rising material costs have created a market shortage. At the very least, increased delivery times must be expected.
National and international certification requirements
Worldwide, there are a variety of national and international regulations, standards, and certification requirements for medical technology products and their components. Keeping track of them is by no means easy and requires a lot of know-how and experience in this area. The battery experts at Jauch Quartz know the regulations intimately and offer reliable support to their customers when it comes to certifications. “Our customers often involve us at very early stages of their project. This allows us not only to provide customers with the best battery solution for their applications, but also to support them in certification questions,” says Sönke Zacher, a sales manager at Jauch.
The most important international certification standards for batteries used in the medical field are the IEC62133 for rechargeable cells and batteries and the IEC60086-4 for non-rechargeable cells and batteries. However, these certifications alone do not suffice in every country. In addition to the international certification standard, some countries have individual requirements that also apply to the accreditation of a battery.
Facilitated market access through the CB procedure
To make the accreditation process for batteries in many different countries less complex and time-consuming, the IECEE (International Electrotechnical Commission for Electrical Equipment) has created the CB procedure. Sönke Zacher emphasizes the advantages of this process: “The more than 60 countries that have joined the CB process so far accept CB test reports from recognized testing centers in other countries. This eliminates individual certification procedures for individual countries and allows batteries to be easily licensed in multiple global markets.”
For the North American market, the national standards of the USA and Canada must also be taken into account. The standard for rechargeable lithium batteries is UL2054. The UL62133 standard is new, and in large part it harmonizes with IEC62133. A simultaneous certification according to both of these two standards obviously offers certain advantages. It remains to be seen to what extent this new standard is being implemented.
In addition, the UN38.3 transportation test is always obligatory for lithium batteries.
Cooperation from the beginning
To avoid problems with the accreditation of a product, it must be ensured that all certification criteria are observed from the outset. Therefore, it is important to work with an experienced and competent battery assembler, such as Jauch Quartz, during the design-in phase of a project. Jauch’s specialists know all the opportunities and risks in battery development and keep track of the battery-related aspects of a customer’s project. This means that Jauch not only develops an optimal battery solution focused on safety and battery performance, but also provides support for questions about legal specifications, transportation of the end product, and required certifications.