Taxonomy‐based testing and validation of a new defect classification for health software

Abstract

Defect‐based testing is a powerful tool for finding errors in software. Many software manufacturers avoid this method because it requires a detailed defect taxonomy that is expensive to construct and difficult to validate. The Association for the Advancement of Medical Instrumentation is developing SW91, a defect taxonomy to be published as a standard for health software. This paper details three methods to validate SW91 for its comprehensiveness. The initial validations of SW91 were conducted via mapping vulnerabilities from the common weakness enumeration and a dataset from a medical device software development company in Ireland. Taxonomy‐based testing is another validation method proposed in this research, and its applicability was investigated using empirical data from a medical device software development company in Ireland. Finally, the paper details future plans to implement taxonomy‐based testing to improve software quality in medical device software and to validate SW91. This validation will focus on the efficiency, reliability, and ability to perform useful analyses and defect coverage of SW91.

A Framework for Taxonomy Based Testing Using Classification of Defects in Health Software-SW91

“…Participants can go through Annex F to get an overall picture of the defect categories and then they can go through the SW91 document to see defect category definitions. Further details on SW91 were explained in our previous paper [9].…”

“…process's validation step. How taxonomy based testing fits with the V model development process from Annex C.4 of IEC 62304:2006+A1:2015 was explained in our previous papers [9,11]. This section has discussed the interconnection between the MDS development processes from IEC 62304:2006+A1:2015 and taxonomy based testing using SW91 defect categories.…”

“…It includes defect categories from the requirements gathering to the maintenance phase of software development. This research has contributed to the development of SW91 via validating its defect coverage [9,11].…”

“…Adopting generic defect classifications into safety critical software domains is not straightforward [8]. Since MDS is often safety critical, a domain specific defect classification scheme was needed [9]. To address this, the Association for the Advancement of Medical Instrumentation (AAMI) has developed and published a standard, a new defect classification scheme called classification of defects in health software-SW91 in cooperation with the US Food and Drug Administration (FDA).…”

“…This study has helped to assess the applicability and the benefits of taxonomy based testing. The process followed in this study and benefits including defect reporting at the testing phase, defect minimisation and risk minimisation were explained in our previous publications [9,11].…”