ISO 81060-2:2009 无创伤性血压计 第2部分：自动化测量型的临床确认

标准编号：ISO 81060-2:2009

中文名称：无创伤性血压计 第2部分：自动化测量型的临床确认

英文名称：Non-invasive sphygmomanometers — Part 2: Clinical validation of automated measurement type

发布日期：2009-05

标准范围

ISO 81060-2:2009适用于所有感知或显示脉动、流量或声音的血压计，用于估计、显示或记录血压。这些血压计不需要自动袖带充气。ISO 81060-2:2009涵盖了适用于所有患者群体（如所有年龄和体重范围）的血压计，以及所有使用条件（如动态血压监测、压力测试血压监测和用于家庭医疗环境或自我测量的血压监测）。ISO 81060-2:2009规定了根据本国际标准验证的血压计随附文件的额外披露要求。

ISO 81060-2:2009 is applicable to all sphygmomanometers that sense or display pulsations, flow or sounds for the estimation, display or recording of blood pressure. These sphygmomanometers need not have automatic cuff inflation. ISO 81060-2:2009 covers sphygmomanometers intended for use in all patient populations (e.g. all age and weight ranges), and all conditions of use (e.g. ambulatory blood pressure monitoring, stress testing blood pressure monitoring and blood pressure monitors for the home healthcare environment or self-measurement).ISO 81060-2:2009 specifies additional disclosure requirements for the accompanying documents of sphygmomanometers validated according to this International Standard.

标准预览图