| Title |
Proposal for Improving Software Classification method in the 2nd Edition Revised Works of IEC 62304 |
| Authors |
최승연(Seung Yeon Choi) ; 김영모(Young Mo Kim) |
| DOI |
https://doi.org/10.5573/ieie.2021.58.5.47 |
| Keywords |
IEC 62304 2nd edition; health software; wellness software; medical device software; safety class |
| Abstract |
IEC 62304, which is an international standard for 'Life Cycle Process of Medical Device Software', is published in ed.1.1 and is being revised for new ed.2. A noticeable difference from the existing ed.1.1 is that it seeks to extend a scope from medical devices software to health software. As a result of many national committees making different opinions in many ways, including the extension of scope, that resemble opposing parties with focus on Netherlands(NL) statement about CDV(Committee Draft for Vote) in 2019, the CDV:2019(=62A/1349/CDV) was disapproved, the JWG 7 executive committee for the IEC 62304 ed.2 presented ATTACHMENTs that suggested various solutions as a countermeasure, and a new CDV, which has chosen one of the various ideas, was recently released in 2021. However, the CDVs for IEC 62304 ed.2, which are released until March 2021, remain unresolved in the NL statemnt's items. This study aims to analyze the NL statement’s two items(No.1, 5) on the software safety classification, which are key items from past ed.1.1 to the draft for ed.2, to examine the unresolved parts by ATTACHMENT and the CDV:2021(=62A/1422/CDV) resulting in executive's action, and to propose a better solution to two items. Items 1 and 5 are analyzed and identified as evaluation items, and as a result of evaluating the 2 existing classification tables and 2 proposals according to the risk assessment method for each evaluation item, all proposals had a significantly lower risk than before and the 2nd offer scored the lowest risk. Further research on this study and other NL’s items will assist in the revision of standards. |