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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 032 Date of Recognition 08/06/2013 
FR Recognition Number 13-59
Standard
IEC ISO 15026-4 First edition 2012-10-01
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
There is no relevant guidance developed at this time.
FDA Technical Contact
 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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