GSO ISO 81060-2:2022

Non-invasive sphygmomanometers — Part 2: Clinical investigation of intermittent automated measurement type

GSO ISO 81060-2:2022 发布历史

GSO ISO 81060-2:2022由GSO 发布于 2022-05-12。

GSO ISO 81060-2:2022在国际标准分类中归属于: 11.040.10 麻醉、呼吸和复苏设备。

GSO ISO 81060-2:2022 的最新版本是哪一版？

最新版本是 GSO ISO 81060-2:2022 。

GSO ISO 81060-2:2022的历代版本如下：

• 2022年 GSO ISO 81060-2:2022

This document specifies the requirements and methods for the clinical investigation of me equipment used for the intermittent non-invasive automated estimation of the arterial blood pressure by utilizing a cuff. This document 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. This document 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 for self-measurement as well as use in a professional healthcare facility). EXAMPLE Automated sphygmomanometer as given in IEC 80601-2-30 undergoing clinical investigation according to this document. This document specifies additional disclosure requirements for the accompanying documents of sphygmomanometers that have passed a clinical investigation according to this document. This document is not applicable to clinical investigations of non-automated sphygmomanometers as given in ISO 81060-1 or invasive blood pressure monitoring equipment as given in IEC 60601-2-34.

标准号

GSO ISO 81060-2:2022

发布

2022年

发布单位

GSO

当前最新

GSO ISO 81060-2:2022

 

 

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