无创血压计.第3部分:连续自动测量型的临床研究

[中文适用范围]： 本文件规定了用于测量患者血压的连续自动无创血压计（C-A-NIBP）临床调查的要求和方法。本文件不涵盖数据展示或输出的形式和方式等方面的易用性方面。本文件未规定输出时间间隔的最小数值。输出间隔显著大于30秒的连续自动无创血压计通常不被视为连续自动无创血压计。 本文件涵盖了趋势连续自动无创血压计和绝对精度连续自动无创血压计，并且仅关注临床调查的要求。本文件未涵盖输出表示。 [外文原描述]： This document specifies the requirements and methods for the clinical investigation of continuous automated non-invasive sphygmomanometers used for the measurement of the blood pressure of a patient. This document does not cover usability aspects such as the form and manner of the data display or output. This document does not specify a numerical threshold on the minimum output period . A continuous automated non-invasive sphygmomanometer providing blood pressure parameters (e.g., systolic blood pressure , diastolic blood pressure or mean arterial pressure ) with an output period considerably larger than 30 s is not typically considered a continuous automated non-invasive sphygmomanometer . This document covers both trending continuous automated non-invasive sphygmomanometers and absolute accuracy continuous automated non-invasive sphygmomanometers and focuses solely on requirements for the clinical investigation . Representation of output is not covered by this document. NOTE 1 IEC 62366 - 1 provides requirements on the application of usability engineering to medical devices. The usability engineering process can be used to clarify for the intended user whether the displayed data concerns absolute accurate values or trending values. The requirements and methods for the clinical investigation of continuous automated non-invasive sphygmomanometers provided in this document are applicable to any subject population, and any condition of use of the continuous automated non-invasive sphygmomanometers . NOTE 2 Subject populations can, for example, be represented by age or weight ranges. NOTE 3 This document does not provide a method to assess the effect of artefacts during the clinical investigation (e.g. motion artefacts induced by the movement of the subject or the movement of the platform supporting the subject). This document specifies additional disclosure requirements for the accompanying documents of continuous automated non-invasive sphygmomanometers that have undergone clinical investigation according to this document. This document is not applicable to: — the clinical investigation of a non-automated sphygmomanometer as given in ISO 81060 - 1 , — the clinical investigation of an intermittent automated non-invasive sphygmomanometer as given in ISO 81060 - 2 , — an automated non-invasive sphygmomanometer as given in IEC 80601 - 2-30 , or — invasive blood pressure monitoring equipment as given in IEC 60601 ‑ 2‑ 34 .