B. Braun’s Space Infusion Pump Systems earn UL 2900-2-1 certification 

December 1, 2022 – B. Braun Medical Inc. (B. Braun), a leader in infusion therapy and pain management, today announced that the wireless devices of the Space Infusion Pump System earned certification to UL 2900-2-1 through UL Cybersecurity Assurance Program (UL CAP). The UL 2900-2-1 standard is published as a U.S. national consensus standard by the American National Standards Institute (ANSI) and a recognized consensus standard by the U.S. Food and Drug Administration (FDA) supporting their pre- and post-market cybersecurity guidance. 

Based on the UL 2900 series of Standards created with input from cybersecurity experts in government, academia and industry, UL Solutions rigorously tests and evaluates connected devices and software. Specifically, the CAP program tests products and evaluates software development activities and the internal operational processes that enable organizations to address cybersecurity challenges and mitigate security risks. 

The technical experts at UL Solutions explored all facets of the UL 2900-2-1 Standard requirements in their evaluation of the Space Infusion Pump Systems for CAP certification. This included establishing the strength of encryption used, analyzing the source code in each of the devices and applications and conducting penetration and fuzz testing to identify any vulnerabilities.  

As part of the evaluation, UL Solutions’ technical experts reviewed all of B. Braun’s software development processes according to the requirements of UL 2900-2-1 to assess whether they reflect cybersecurity best practices and a security-minded approach. Notably, UL Solutions also evaluated B. Braun’s internal processes and its ability to quickly inform customers of any cybersecurity issues, mitigate them and provide software updates. 

In addition to receiving certification to the UL 2900-2-1 Standard, Perfusor® Syringe Pump, within B. Braun’s Space Infusion Pump Systems platform, is the first in the industry with medical ground and/or air transport in the FDA cleared indications for use. B. Braun also received a 2021 Best in KLAS Award for Infusomat® Space® Large Volume Pump based on numerous features including the ability to integrate with EMR system, real-time location systems and alarm management technologies. 

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