DIN EN ISO 11990:2018-12
Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shaft and tracheal cuffs (ISO 11990:2018); German version EN ISO 11990:2018 / Note: To be replaced by DIN EN ISO 11990 (2025-07).
| Fecha edición: |
2018-12-01
En Vigor
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| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | This document specifies a method of testing the continuous wave (cw) laser resistance of the shaft of a tracheal tube and the cuff regions including the inflation system of tracheal tubes designed to resist ignition by a laser. NOTE 1 When interpreting these results, the attention of the user is drawn to the fact that the direct applicability of the results of this test method to the clinical situation has not been fully established. NOTE 2 The attention of the users of products tested by this method is drawn to the fact that the laser will be wavelength sensitive and tested at the wavelength for which it is intended to be used. If tested using other wavelengths, explicitly state the power settings and modes of delivery. CAUTION: This test method can involve hazardous materials, operations and equipment. This document provides advice on minimizing some of the risks associated with its use but does not purport to address all such risks. It is the responsibility of the user of this document to establish appropriate safety and health practices and to determine the applicability of regulatory limitations prior to use. |
| Keywords: | Accident prevention|Apparatus|Breathing equipment|CE marking|Continuous wave laser|Cuffs|Definitions|Designations|Determination|Effect of heating|Electrical engineering|Endotracheal tubes|Fire conditions|Fire safety|Heat|Hospitals|Ignition|Instructions|Laboratory tests|Laser beams|Laser engineering|Laser equipment|Laser radiation|Laser-related equipment|Lasers|Materials specification|Medical breathing apparatus|Medical devices|Medical equipment|Medical products|Medical sciences|Medical technology|Optical equipment|Optical instruments|Optical tests|Optics|Oxygen lance process|Radiation|Radiation measurement|Resistance|Safety measures|Safety requirements|Shafts|Specification (approval)|Specifications|Surfaces|Surgery|Surgical instruments|Testing|Top blowing|Tracheal tubes|Tubing (medical)|Tubus|Wavelengths |
| ICS: | 11.040.10 - Equipo de respiración, anestesia y reanimación, 31.260 - Optoelectrónica. Equipos láser |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN ISO 11990:2018 Idéntica ISO 11990:2018 |
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Reemplazo Normas |
Reemplaza a DIN EN ISO 11990:2017-05 Reemplaza a DIN EN ISO 11990-1:2016-02 Reemplaza a DIN EN ISO 11990-2:2016-02 |
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