IEC 62304 Ed. 2: Software Life Cycle Standard for Health Software

Alpo Värri, Patty Kranz-Zuppan, Richard de la Cruz

Research output: Chapter in Book/Report/Conference proceedingConference contributionScientificpeer-review

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The quality of software is high in medical devices due to the strict regulatory requirements and their implementation in the software development processes through the use of the IEC 62304 standard. The goal of this standard revision project was to extend the scope of the standard to all health software and also to bring the requirements of the 12 year old standard back to the state-of-the-art including provisions for cybersecurity. The joint IEC/SC62A and ISO/TC215 project team revised the standard and adapted its risk management, usability, and security requirements to serve both the medical device industry and the overall health software industry. The resulting second version of the standard has gone through a multistage global voting process to achieve a consensus of the requirements to serve both these communities. The resulting standard has potential to have a major impact on the quality of software used in health care globally
Original languageEnglish
Title of host publicationMedinfo 2019
Subtitle of host publicationProceedings of the 17th World Congress on Medical and Health Informatics
EditorsLucila Ohno-Machado, Brigitte Séroussi
PublisherIOP Press
Number of pages5
ISBN (Electronic)978-1-64368-003-3
ISBN (Print)978-1-64368-002-6
Publication statusPublished - 23 Aug 2019
Publication typeA4 Article in conference proceedings
EventWorld Congress on Medical and Health Informatics: HEALTH AND WELLBEING E-NETWORKS FOR ALL - Convention Centre, Lyon, France
Duration: 25 Aug 201930 Aug 2019

Publication series

NameStudies in Health Technology and Informatics
PublisherIOS Press
ISSN (Print)0926-9630
ISSN (Electronic)1879-8365


ConferenceWorld Congress on Medical and Health Informatics
Abbreviated titleMedinfo 2019
Internet address


  • Standards
  • Software Engineering
  • Health Care Technology

Publication forum classification

  • Publication forum level 1

ASJC Scopus subject areas

  • Computer Science(all)


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