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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 032 Date of Entry 08/06/2013 
FR Recognition Number 13-60
Standard
IEC  TS 62443-1-1 Edition 1.0 2009-07
Industrial communication networks - Network and system security - Part 1-1: Terminology, concepts and models
Scope/Abstract
1.1 General
This part of the IEC 62443 series is a technical specification which defines the terminology, concepts and models for Industrial Automation and Control Systems (IACS) security. It establishes the basis for the remaining standards in the IEC 62443 series.
To fully articulate the systems and components the IEC 62443 series address, the range of coverage may be defined and understood from several perspectives, including the following:
a) range of included functionality;
b) specific systems and interfaces;
c) criteria for selecting included activities;
d) criteria for selecting included assets.
Extent of Recognition
Complete standard
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.

NOTE: Conformance to this standard may not satisfy all the cybersecurity requirements outlined in Section 524B of FD&C Act or the recommendations in the (1) listed below (Relevant FDA Guidance). Manufacturers should consider the information contained within these resources in their assessment of cybersecurity for their device.
Public Law, CFR Citation(s) and Procode(s)*
Any procode which describes a networkable medical device
Relevant FDA Guidance and/or Supportive Publications*
1. Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions, Guidance for Industry and Food and Drug Administration Staff, issued February 2026.

2. Postmarket Management of Cybersecurity in Medical Devices, Guidance for Industry and Food and Drug Administration Staff, issued December 2016.

3. Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices, Guidance for Industry and Food and Drug Administration Staff, issued September 2017.

4. NIST Special Publication 800-82, Guide to Industrial Control Systems (ICS) Security, June 2011

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 CDRH Division of Medical Device Cybersecurity
  FDA/OC/CDRH/OST/ORR/
  --
  CyberMed@fda.hhs.gov
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
Software/Informatics
*These are provided as examples and others may be applicable.
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