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A study into the use of tolerance analysis in the mechanical design of medical devices

机译：公差分析在医疗设备机械设计中的应用研究

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The medical device industry is fast becoming the most regulated design sector, despite this evidence; the employment of tolerance analysis is scarce. Research conducted into tolerance analysis in the medical device industry and the barriers affecting its use would provide methodology to increase the use of tolerance analysis, consequently improving product quality, reliability, cost-effectiveness and patient care. Telephone interviews and questionnaires were used to collect both qualitative and quantitative research from industry professions. Three industries provided detailed qualitative responses highlighting that complexity and lack guidance were the industry specific factors deterring the use of the tolerance analysis. Research indicated that the primary barrier deterring the wide spread adoption of tolerance analysis was the confusion caused from a lack of guidance. This encouraged the development of a procedure workflow checklist to aid designers through the often misunderstood process of performing a tolerance analysis study.
机译：尽管有这些证据，医疗器械行业正迅速成为管制最严格的设计行业。公差分析的应用很少。对医疗器械行业的公差分析及其影响因素进行的研究将提供增加公差分析使用率的方法论，从而提高产品质量，可靠性，成本效益和患者护理。电话采访和问卷调查被用来收集行业专业人士的定性和定量研究。三个行业提供了详细的定性响应，突显了复杂性和缺乏指导性是阻碍使用公差分析的行业特定因素。研究表明，阻碍公差分析广泛采用的主要障碍是缺乏指导导致的混乱。这鼓励制定程序工作流程清单，以帮助设计人员通过经常被误解的公差分析研究过程。

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