Industrial standards for developing medical device software provide requirements that conforming devices must meet. A number of reference software architectures have been proposed to develop such software. The ISO/IEC 25010:2011 family of standards provides a comprehensive software product quality model, including characteristics that are highly desirable in medical devices. Furthermore, frameworks like 4+1 Views provide a robust framework to develop the software architecture or high level design for any software, including for medical devices. However, the alignment between industrial standards and reference architectures for medical device software, on one hand, and ISO/IEC 25010:2011 and 4+1 Views, on the other, is not well understood. This paper aims to explore how ISO/IEC 25010:2011 and 4+1 Views are supported by current standards, namely ISO 13485:2016, ISO 14971:2012, IEC 62304:2006 and IEC 62366:2015, and current reference architectures for medical device software. We classified requirements from medical devices standards into qualities from ISO/IEC 25010:2011 and architectural views from 4+1 Views. A systematic literature review (SLR) method was followed to review current references software architectures and a mapping of their support for the identified ISO/IEC 25010:2011 qualities in the previous step was carried out. Our results show that ISO/IEC 25010:2011 qualities like functional suitability, portability, maintainability, usability, security, reliability and compatibility are highly emphasised in medical device standards. Furthermore, we show that current reference architectures only partially support these qualities. This paper can help medical device developers identify focus areas for developing standards-compliant software. A wider study involving under-development medical devices can help improve the accuracy of our findings in the future.

翻译：开发医疗设备软件的工业标准必须达到符合设备的要求。一些参考软件架构建议开发此类软件。ISO/IEC 25010:2011标准系列提供了全面的软件产品质量模型,其中包括医疗设备非常需要的特征。此外,4+1意见等框架为开发软件架构或高水平设计提供了强有力的框架,包括医疗设备。然而,医疗设备软件的工业标准和参考架构与ISO/IEC 25010:2011年和4+1观点之间的质量标准与标准化组织/IEC 25010:4+1观点之间的统一没有得到很好的理解。本文旨在探索ISO/IEC 25010:2011年标准和4+1观点的准确性如何得到当前标准的支持,包括医疗设备设备非常需要的软件质量。我们将医疗设备标准的要求分为从ISO/IEC 25010:2011年标准质量到4+1观点的品质。 系统文献审评(SLR)当前参考标准是如何得到当前标准支持的,即ISO/I 标准在前一阶段显示我们的安全性结构中的前一阶段,我们的安全性评估显示我们的安全性。