Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type - Amendment 2 (ISO 81060-2:2018/Amd 2:2024)

The EN ISO 81060-2:2019/A2:2024 standard, published by the European Committee for Standardization (CEN) on April 3, 2024, and effective from July 31, 2024, is an amendment to the existing EN ISO 81060-2:2019 standard. This amendment specifically addresses the clinical investigation of non-invasive blood pressure monitors of the intermittent automated measurement type, as outlined in ISO 81060-2:2018/Amd 2:2024.

The standard provides detailed requirements and methodologies for the clinical evaluation of these devices, ensuring their accuracy, reliability, and safety in medical settings. It outlines the necessary procedures for validating the performance of non-invasive blood pressure monitors, including the design of clinical studies, data collection, and analysis. The amendment aims to enhance the consistency and quality of clinical investigations, thereby improving the overall trustworthiness of the devices in clinical practice.

By adhering to the guidelines set forth in EN ISO 81060-2:2019/A2:2024, manufacturers and healthcare professionals can ensure that non-invasive blood pressure monitors meet the highest standards of performance and safety. This amendment is crucial for maintaining the integrity of blood pressure measurements, which are vital for diagnosing and managing various cardiovascular conditions.