Risk mitigation always has been a salient requirement for the design, development and manufacture of medical devices that are safe and effective for their intended use. The tools employed in the pursuit of effective risk management however, have varied significantly. EN ISO 14971:2012 Medical Devices. Application of risk to medical devices is categorized as a concensus standard by the U.S. Food and Drug Administration (FDA). Since July 31, 2012, it's also been considered a harmonized standard in Europe. With the advent of EN ISO 14971:2012, the device industry now has well-defined guidelines to assist in its pursuit of effective risk management. Although the application of risk management tools will vary depending on organizational structure, the underlying purpose for applying risk management is patient and user safety, driven by medical devices that are safe and effective for their intended use.
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机译：对于设计，开发和制造对于其预期用途安全有效的医疗设备，降低风险一直是其显着的要求。但是，在追求有效的风险管理中使用的工具差异很大。 EN ISO 14971：2012医疗设备。美国食品和药物管理局（FDA）将风险应用于医疗设备归类为共识标准。自2012年7月31日起，它在欧洲也被视为统一标准。随着EN ISO 14971：2012的到来，设备行业现在有了定义明确的准则，以协助其追求有效的风险管理。尽管风险管理工具的应用会根据组织结构的不同而有所不同，但应用风险管理的基本目的是患者和用户的安全，这是由安全，有效的医疗设备驱动的。
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