Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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032
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Date of Entry 08/06/2013
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FR Recognition Number
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13-60
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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 |
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Scope/Abstract1.1 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. |
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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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Public Law, CFR Citation(s) and Procode(s)*
Any procode which describes a networkable medical device |
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Relevant FDA Guidance and/or Supportive Publications*
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. |
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FDA Technical Contact
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Standards Development Organization
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |