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

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

Standard

IEC 62304 Ed. 2: Software Life Cycle Standard for Health Software. / Värri, Alpo; Kranz-Zuppan, Patty; de la Cruz, Richard.

Medinfo 2019: Proceedings of the 17th World Congress on Medical and Health Informatics. ed. / Lucila Ohno-Machado; Brigitte Séroussi. IOP Press, 2019. p. 868-872 (Studies in Health Technology and Informatics; Vol. 264).

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

Harvard

Värri, A, Kranz-Zuppan, P & de la Cruz, R 2019, IEC 62304 Ed. 2: Software Life Cycle Standard for Health Software. in L Ohno-Machado & B Séroussi (eds), Medinfo 2019: Proceedings of the 17th World Congress on Medical and Health Informatics. Studies in Health Technology and Informatics, vol. 264, IOP Press, pp. 868-872, World Congress on Medical and Health Informatics, Lyon, France, 25/08/19. https://doi.org/10.3233/SHTI190347

APA

Värri, A., Kranz-Zuppan, P., & de la Cruz, R. (2019). IEC 62304 Ed. 2: Software Life Cycle Standard for Health Software. In L. Ohno-Machado, & B. Séroussi (Eds.), Medinfo 2019: Proceedings of the 17th World Congress on Medical and Health Informatics (pp. 868-872). (Studies in Health Technology and Informatics; Vol. 264). IOP Press. https://doi.org/10.3233/SHTI190347

Vancouver

Värri A, Kranz-Zuppan P, de la Cruz R. IEC 62304 Ed. 2: Software Life Cycle Standard for Health Software. In Ohno-Machado L, Séroussi B, editors, Medinfo 2019: Proceedings of the 17th World Congress on Medical and Health Informatics. IOP Press. 2019. p. 868-872. (Studies in Health Technology and Informatics). https://doi.org/10.3233/SHTI190347

Author

Värri, Alpo ; Kranz-Zuppan, Patty ; de la Cruz, Richard. / IEC 62304 Ed. 2: Software Life Cycle Standard for Health Software. Medinfo 2019: Proceedings of the 17th World Congress on Medical and Health Informatics. editor / Lucila Ohno-Machado ; Brigitte Séroussi. IOP Press, 2019. pp. 868-872 (Studies in Health Technology and Informatics).

Bibtex - Download

@inproceedings{ec332ed8094845d79306d7fd1e62de47,
title = "IEC 62304 Ed. 2: Software Life Cycle Standard for Health Software",
abstract = "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",
keywords = "Standards, Software Engineering, Health Care Technology",
author = "Alpo V{\"a}rri and Patty Kranz-Zuppan and {de la Cruz}, Richard",
year = "2019",
month = "8",
day = "23",
doi = "10.3233/SHTI190347",
language = "English",
isbn = "978-1-64368-002-6",
series = "Studies in Health Technology and Informatics",
publisher = "IOP Press",
pages = "868--872",
editor = "Lucila Ohno-Machado and Brigitte S{\'e}roussi",
booktitle = "Medinfo 2019",

}

RIS (suitable for import to EndNote) - Download

TY - GEN

T1 - IEC 62304 Ed. 2: Software Life Cycle Standard for Health Software

AU - Värri, Alpo

AU - Kranz-Zuppan, Patty

AU - de la Cruz, Richard

PY - 2019/8/23

Y1 - 2019/8/23

N2 - 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

AB - 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

KW - Standards

KW - Software Engineering

KW - Health Care Technology

U2 - 10.3233/SHTI190347

DO - 10.3233/SHTI190347

M3 - Conference contribution

SN - 978-1-64368-002-6

T3 - Studies in Health Technology and Informatics

SP - 868

EP - 872

BT - Medinfo 2019

A2 - Ohno-Machado, Lucila

A2 - Séroussi, Brigitte

PB - IOP Press

ER -