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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 046 Date of Entry 12/23/2016 
FR Recognition Number 13-87
Standard
ISO IEC  15026-2 First edition 2011-02-15
Systems and software engineering - Systems and software assurance - Part 2: Assurance case
Scope/Abstract
This part of ISO/IEC 15026 specifies minimum requirements for the structure and contents of an assurance case. An assurance case includes a top-level claim for a property of a system or product (or set of claims), systematic argumentation regarding this claim, and the evidence and explicit assumptions that underlie this argumentation. Arguing through multiple levels of subordinate claims, this structured argumentation connects the top-level claim to the evidence and assumptions.

This part of ISO/IEC 15026 does not place requirements on the quality of the contents of an assurance case. Rather, it places requirements on the existence of the contents and structure of an assurance case. While several notations and slightly varying terminologies are currently used in practice, this part of ISO/IEC 15026 does not require the use of a particular terminology or graphical representation. Likewise, it places no requirements on the means of physical implementation of the data, including no requirements for redundancy or co-location.
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.
Relevant FDA Guidance and/or Supportive Publications*
Infusion Pumps Total Product Life Cycle - Guidance for Industry and FDA Staff, issued on December 4, 2014.

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
 Aneesh Deoras
  CDRH/OPEQ/OHTII/DHTIIA
  240-402-4263
  aneesh.deoras@fda.hhs.gov
Standards Development Organizations
ISO International Organization for Standardization https://www.iso.org/
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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