The ISO 81060-1 standard, developed by the International Organization for Standardization (ISO), describes the performance characteristics and test methods of blood pressure monitors used in non-surgical procedures . This standard has also been published in Turkey by the Turkish Standards Institute (TSE) under the title: TS EN ISO 81060-1 Non-invasive blood pressure monitors - Part 1: General characteristics.
This standard describes the requirements for non-automatic sphygmomanometers and accessories used for non-invasive blood pressure measurement under operator supervision, by means of inflatable cuffs. This standard includes basic safety and performance requirements, including efficacy and labeling for non-automatic sphygmomanometers and their accessories, as well as test methods for determining the accuracy of noninvasive blood pressure measurement.
The ISO 81060-1 standard covers non-invasive blood pressure measuring devices with a pressure sensing element and display, used with blood flow sensing tools.
It is recognized that the lowest safety requirements specified in this standard provide a practical level of safety in the operation of non-automatic sphygmomanometers (sphygmomanometers). The requirements in the standard follow the specifications of the relevant test methods.
Requirements for non-invasive blood pressure devices with screens used with electrically powered pressure sensing equipment or other automatic methods of determining blood pressure are contained in the IEC 60601-2-30 standard. The requirements for invasive blood pressure measuring equipment that directly measure blood pressure are included in the IEC 60601-2-34 standard.
The standards that are referred to as normative in the application of this standard and indispensable for its implementation are: ISO 594-1, ISO 594-2, ISO 7010, ISO 10993-1, ISO 14937, ISO 15223-1 and IEC 60601-1.
Performance testing services of ISO 81060-1 non-invasive blood pressure devices are also provided by our organization within the scope of laboratory services.
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