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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 054 Date of Entry 07/06/2020 
FR Recognition Number 13-115
Standard
ISO IEC IEEE  29119-1 First edition 2013-09-01
Software and systems engineering - Software testing - Part 1: Concepts and definitions
Scope/Abstract
This part of ISO/IEC/IEEE 29119 specifies definitions and concepts in software testing. It provides definitions of testing terms and discussion of concepts key to the understanding of the ISO/IEC/IEEE 29119 series of software testing international standards.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard provides definitions of certain vocabulary, concepts and methods used in software testing, an essential part of a secure software development lifecycle. It therefore supports an improved common semantic framework between FDA, subject matter experts and device sponsors. This should lead to improved communication leading to improvement in safety, effectiveness and secure interoperability.

This standard is relevant to all medical devices which contain, or are, software or which claim interoperability with other networked entities through software based protocols and is being recognized on its scientific and technical merit because it supports existing regulatory policies.
Relevant FDA Guidance and/or Supportive Publications*
1. Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2017.

2. Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued May 2005.

3. Off-The-Shelf Software Use in Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2019

4. Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2019.

5. Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued October 2014

6. Guidance for Industry - Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software, issued January 2005

7. Postmarket Management of Cybersecurity in Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued December 2016

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
 Matthew Diamond
  FDA/OC/CDRH/OSPTI/DDH/
  301-796-5386
  matthew.diamond@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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