Among the modifications of the recognized Standards list, which were published on June 7 by the FDA, the recognition of ANSI / UL 2900-2-1 (section: software, cyber-security) and ISO 18562 (section: anesthesiology , respiratory tract) should be noted.
Demonstration of compliance with the ANSI/UL 2900-2-1 – Standard for Safety, Software Cybersecurity for Network-Connectable Products, Part 2-1: Particular Requirements for Network Connectable Components of Healthcare and Wellness Systems will allow Manufacturers intending to market their Medical Devices in the US to certify the safety of their products that can be connected to the network and related accessories by demonstrating their compliance with this Standard. This demonstration should include data proving manufacturer’s commitment to mitigate the risks and vulnerabilities associated with their products and accessories, thus ensuring their safety.
It is also worth mentioning the ISO 18562 “Biocompatibility evaluation of breathing gas pathways in healthcare applications” as an important new entry in the list of Standards officially recognized by the FDA. Manufacturers of Medical Devices whose products affect the airways, including breathing systems, humidifiers and oxygen storage equipment, can then implement the ISO 18562 tests and the declarations obtained for their pre-market submissions, potentially reducing review timeframes for their applications.
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