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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 13-59
Standard
ISO IEC IEEE  15026-4 First edition 2021-10-01
Systems and software engineering - Systems and software assurance - Part 4: Assurance in the life cycle
Scope/Abstract
This part of ISO/IEC 15026 gives guidance and recommendations for conducting selected processes, activities and tasks for systems and software products requiring assurance claims for properties selected for special attention, called critical properties. This part of ISO/IEC 15026 specifies a property-independent list of processes, activities and tasks to achieve the claim and show the achievement of the claim. This part of ISO/IEC 15026 establishes the processes, activities, tasks, guidance and recommendations in the context of a defined life cycle model and set of life cycle processes for system and/or software life cycle management.

NOTE The stakeholders determine which of the system or software properties are selected for special attention and require assurance claims. This part of ISO/IEC 15026 uses the term "critical" to distinguish those properties from other requirements.
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*
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
 Brian Fitzgerald
  FDA/OC/CDRH/OSPTI/DAHRSSP/
  301-796-2579
  Brian.Fitzgerald@fda.hhs.gov
Standards Development Organizations
ISO International Organization for Standardization https://www.iso.org/
IEC International Electrotechnical Commission http://www.iec.ch/
IEEE Institute of Electrical and Electronic Engineers https://www.ieee.org/
FDA Specialty Task Group (STG)
Software/Informatics
*These are provided as examples and others may be applicable.
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