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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 046 Date of Recognition 12/23/2016 
FR Recognition Number 13-86
Standard
IEC ISO 15026-1 First edition 2013-11-01
Systems and software engineering - Systems and software assurance - Part 1: Concepts and vocabulary
Scope/Abstract
This part of ISO/IEC 15026 defines assurance-related terms and establishes an organized set of concepts and relationships to establish a basis for shared understanding across user communities for assurance. It provides information to users of the other parts of ISO/IEC 15026 including the combined use of multiple parts. The essential concept introduced by ISO/IEC 15026 is the statement of claims in an assurance case and the support of those claims through argumentation and evidence. These claims are in the context of assurance for properties of systems and software within life cycle processes for the system or software product.

Assurance for a service being operated and managed on an ongoing basis is not covered in ISO/IEC 15026.

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.
FDA Technical Contacts
 Alan Stevens
  FDA/OMPT/CDRH/ODE/DAGID/GHDB/
  301-796-6294
  alan.stevens@fda.hhs.gov
 Brian Fitzgerald
  FDA/OMPT/CDRH/OSEL/
  301-796-2579
  brian.fitzgerald@fda.hhs.gov
Standards Development Organizations
IEC International Electrotechnical Commission http://www.iec.ch/
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Software/Informatics
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