该文从通用软件质量评估模型出发，以医疗器械软件中信息的传输形式为基础，探索建立了医疗器械软件模型。应用此模型，初步建立了医疗器械软件测评规范原则，并在两种不同存在形式的医疗器械软件上进行了验证。%Based on common software quality evaluation model, this paper explores medical device softwares model established in the basis of the information transmission form. Applying this model, a medical device software evaluation principle has been established, and two different existing forms of medical device software are verified.
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