Space Infusion Pump Wireless Devices Earn Cybersecurity Certification

B. Braun Medical’s Space Infusion Pump System wireless devices have earned Underwriter Laboratory (UL) 2900-2-1 Cybersecurity Assurance Program (CAP) certification, a standard supported by the FDA.

The UL CAP certification followed testing for known vulnerabilities and malware by establishing the strength of encryption used, analyzing the source code in each device and application, and conducting penetration and “fuzz testing” — introducing invalid, malformed, or unexpected inputs — to identify vulnerabilities, the company said.

The UL 2900-2-1 standard provides a way for manufacturers and developers to assess the cybersecurity risk of network connectable devices. The test methods and risk assessment requirements in the standard apply to all medical devices and accessories, medical device data systems, in-vitro diagnostic devices and health information technology.