The KUKA LBR Med lightweight robot is the first robotic component worldwide to be certified for integration into a medical product. The LBR Med thus enjoys a unique selling point in medical robotics which is unrivaled.
Certification based on the “ECEE CB Scheme”
The certification is based on the internationally recognized “ECEE CB Scheme” – a procedure for certifying conformity with specific safety and quality standards. Unlike the usual procedure with industrial robots, the Machinery Directive is not applicable to medical products.
To obtain the CB Test Certificate, the LBR iiwa lightweight robot for industrial applications had to be adapted to the needs of the medical sector and pass the tests required by the international standards IEC 60601-1 and IEC 62304. This included comprehensive testing of the hardware and software for the lightweight robot’s two variants for 7 and 14 kg payloads. On the one hand, compliance with the safety requirements for medical electric devices stipulated in the international standards was assessed. On the other, the processes in the life cycle of medical software development were also verified and approved. In both cases, the inspection was carried out by an accredited test body.
Since the certification procedure is internationally recognized, the complexity of the approval process for medical products based on the LBR Med is substantially reduced. Manufacturers of medical products can now develop and obtain approval around the world for products and solutions based on a robotic component much more quickly and easily – a significant competitive advantage. The first deliveries of the LBR Med are scheduled for September 2017.