DIN EN ISO 81060-1:2012-08
Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007); German version EN ISO 81060-1:2012 / Note: DIN EN 1060-1 (2010-03) and DIN EN 1060-2 (2010-03) remain valid alongside this standard until 2015-05-01.
| Fecha edición: |
2012-08-01
En Vigor
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| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | This part of ISO 81060 specifies requirements for non-automated sphygmomanometers and their accessories, which, by means of an inflatable cuff, are used for the non-invasive blood pressure measurement by operator observation. This document specifies requirements for the safety, essential performance, effectiveness, and labelling for non-automated sphygmomanometers and their accessories, including test methods to determine the accuracy of their measurements. The document covers non-invasive blood pressure measurement devices with a pressure sensing element and display used in conjunction with means to determine blood flow (e. g., a stethoscope for detecting Korotkoff sounds, Doppler ultrasound, or other manual methods). |
| Keywords: | Blood pressure|Blood pressure meter|CE marking|Clinical investigations|Cuffs|Defects|Definitions|Diagnostic equipment|Electrical safety|Equipment safety|Error limits|Fine mechanics|Fitness for purpose|Head losses|Identification|Instructions for use|Legibility|Letterings|Manipulation|Marking|Measured value|Measurement|Measuring accuracy|Measuring instruments|Measuring techniques|Mechanic|Medical devices|Medical equipment|Medical products|Medical sciences|Medical technology|Mercury|Non-automatic|Pneumatics|Precision|Pressure gauges|Pressure measurement (fluids)|Pressure reading|Routine tests|Safety|Safety of products|Scales|Specification (approval)|Sphygmomanometers|Strength of materials|Technical documents|Testing |
| ICS: | 11.040.55 - Equipo de diagnóstico |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN ISO 81060-1:2012 Idéntica ISO 81060-1:2007 |
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Reemplazo Normas |
Reemplaza a DIN EN 1060-1:2010-03 Reemplaza a DIN EN 1060-2:2010-03 Reemplaza a DIN EN ISO 81060-1:2011-11 |
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