| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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049
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Date of Entry 06/07/2018
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FR Recognition Number
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13-104
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| Standard | |
UL ANSI 2900-2-1 First Edition 2017
Standard for Safety, Software Cybersecurity for Network-Connectable Products, Part 2-1: Particular Requirements for Network Connectable Components of Healthcare and Wellness Systems |
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Scope/Abstract1.1 This security evaluation standard applies to the testing of network connected components of healthcare systems. It applies to, but is not limited to, the following key components:
a) Medical devices;
b) Accessories to medical devices;
c) Medical device data systems;
d) In vitro diagnostic devices;
e) Health information technology; and
f) Wellness devices.
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| Extent of Recognition
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Rationale for Recognition
| This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. |
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Relevant FDA Guidance and/or Supportive Publications*
Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions - Guidance for Industry and Food and Drug Administration Staff, issued September 2023.
Postmarket Management of Cybersecurity in Medical Devices: Guidance for Industry and Food and Drug Administration Staff, issued December 2016.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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| FDA Technical Contact
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| Standards Development Organizations
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
