Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

046

Date of Entry 12/23/2016

FR Recognition Number

13-86

Standard

ISO IEC 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.

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 Contacts

Alan Stevens

FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIC/

301-796-6294

Alan.Stevens@fda.hhs.gov

Brian Fitzgerald

FDA/OC/CDRH/OSPTI/DAHRSSP/

301-796-2579

Brian.Fitzgerald@fda.hhs.gov

Standards Development Organizations