In the ISO 81060-2 standard developed by the International Standards Organization (ISO), the features and test methods of non-invasive, intermittent automatic blood pressure gauges are described. This standard has been published in our country by the Turkish Standards Institute (TSE) with the following title: TS EN ISO 81060-2 Non-invasive blood pressure meters - Part 2: Clinical investigation of the intermittent automatic measurement type.
The said standard describes requirements and provides test methods for clinical research of equipment used for intermittent non-invasive automatic estimation of arterial blood pressure. This standard applies to all sphygmomanometers that detect or display vibrations, flow or sounds to predict, display or record blood pressure. These devices do not require automatic cuff inflation.
This standard covers sphygmomanometers intended for use in all age and weight ranges and all patient groups, and all their conditions of use, such as ambulatory blood pressure monitoring, stress test blood pressure monitoring and home blood pressure monitors for self-measurement. It also includes the devices used in a professional healthcare facility. For example, automatic sphygmomanometers subject to the IEC 80601-2-30 standard are also subject to this standard.
However, this standard does not apply to clinical trials of non-automatic sphygmomanometers covered by the ISO 81060-1 standard or invasive blood pressure monitoring equipment covered by the IEC 60601-2-34 standard.
Accurate diagnosis is essential for treating high blood pressure . This requires having the necessary equipment to determine blood pressure and taking accurate measurements. Standard sphygmomanometers (blood pressure monitors) that meet standard criteria are used to measure blood pressure.
Within the scope of laboratory services, our organization also provides ISO 81060-2 non-invasive, intermittent automatic blood pressure testing services.
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