NF EN ISO 11990
Optics and optical instruments - Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shafts
ISO 11990:2003 specifies a method of testing the continuous wave (cw) laser resistance of the shaft of a tracheal tube. Other components of the system, such as the inflation system and cuff, are outside the scope of ISO 11990:2003. The specified test method shall be used to measure and describe the properties of materials, products or assemblies in response to heat and flame under controlled laboratory conditions and shall not be used to describe or appraise the fire hazard or fire risk of materials, products, or assemblies under actual fire conditions. However, results of this test may be used as elements of a fire risk assessment which takes into account all the factors which are pertinent to an assessment of the hazard of a particular end use. Caution should be observed in interpreting these results, since the direct applicability of the result of this test method to the clinical situation has not been fully established.
ISO 11990:2003 specifies a method of testing the continuous wave (cw) laser resistance of the shaft of a tracheal tube. Other components of the system, such as the inflation system and cuff, are outside the scope of ISO 11990:2003.
The specified test method shall be used to measure and describe the properties of materials, products or assemblies in response to heat and flame under controlled laboratory conditions and shall not be used to describe or appraise the fire hazard or fire risk of materials, products, or assemblies under actual fire conditions. However, results of this test may be used as elements of a fire risk assessment which takes into account all the factors which are pertinent to an assessment of the hazard of a particular end use. Caution should be observed in interpreting these results, since the direct applicability of the result of this test method to the clinical situation has not been fully established.
La présente Norme internationale spécifie une méthode d'essai de la résistance au laser du tube proprement dit d'un tube trachéal. Les autres éléments du système, comme le système de gonflage et le ballonnet, n'entrent pas dans le domaine d'application de la présente Norme internationale. Il convient d'utiliser la méthode d'essai spécifiée pour mesurer et décrire les propriétés des matériaux, produits ou assemblages par rapport à la chaleur et à la flamme, en conditions de laboratoire contrôlées, et non pour décrire ou évaluer le danger ou le risque de feu pour les matériaux, produits ou assemblages en conditions réelles de feu. Cependant, les résultats de cet essai peuvent constituer des éléments d'évaluation du risque de feu prenant en compte tous les facteurs pertinents pour l'évaluation du danger dans le cadre d'un usage particulier.NOTE 1: Il convient d'interpréter ces résultats avec prudence, car l'applicabilité directe du résultat de cette méthode d'essai à la situation clinique n'a pas été complètement établie.NOTE 2: Cette méthode d'essai peut impliquer des matériaux, des fonctionnements et des équipements dangereux. La présente Norme internationale ne prétend pas traiter tous les problèmes de sécurité associés à son utilisation. Il incombe à l'utilisateur de cette méthode d'essai d'établir des pratiques appropriées en matière d'hygiène et de sécurité, et de déterminer l'applicabilité des limites réglementaires avant utilisation.
ISO 11990-1:2011 specifies a method of testing the continuous wave (cw) resistance of the shaft of a tracheal tube designed to resist ignition by a laser. It is not applicable to other components of the system, such as the inflation system and cuff, which are defined in ISO 11990-2:2010. ISO 11990-1:2011 can be used to measure and describe the properties of materials, products or assemblies in response to heat and flame under controlled laboratory conditions. It does not describe or appraise the fire hazard or fire risk of materials, products, or assemblies under actual clinical use conditions. However, the results of this test can be used as one element of a fire risk assessment which takes into account all factors pertinent to an assessment of the hazard of a particular end use.
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1Domaine d'application 1
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2Références normatives 1
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3Termes et définitions 1
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4Principe 2
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5Portée et utilisation de l'essai 2
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6Appareillage 3
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7Réactifs et matériaux 6
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8Préparation des échantillons pour essai 6
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9Préparation de l'appareillage 6
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10Mode opératoire 7
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11Interprétation des résultats 8
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12Rapport d'essai 8
- Bibliographie10
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