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CEN/TS 14507-1:2003

Inhalational nitric oxide systems - Part 1: Delivery systems

Edition date: 2006-11-07
In Force
Summary: This Part of CEN/TS 14507 refers to EN 60601 1:1990 "Medical electrical equipment - Part 1: General requirements for safety", as amended by its amendments 1 (1991) and 2 (1995). For brevity Part 1 is referred to in this Part of CEN/TS 14507 either as the General Standard or as the General requirements. The scope given in clause 1 of the General Standard applies except that 1.1 is replaced by the following: 1.1 This Part of CEN/TS 14507 specifies particular requirements for inhalational nitric oxide delivery systems and their modules. It covers devices which can be supplied in combined units, integrated into another medical device, for example a lung ventilator, or as individual devices. This Part of CEN/TS 14507 addresses the monitoring of nitric oxide and oxygen delivery to the patient and minimization of the production of nitrogen dioxide. This Part of CEN/TS 14507 covers the requirements for inhalational nitric oxide delivery systems intended for medical use, for example, in critical care, anaesthesia, and emergency/transport environments. NOTE It is recognized that from time to time innovations and designs will appear that offer advantages and yet are not covered by specific safety-related design or performance aspects of this Part of CEN/TS 14507; such innovations are not to be discouraged. As the techniques and technologies in these innovations advance, it is essential that the safety objectives of this Part of CEN/TS 14507 are considered as minimum requirements. The requirements of clause 1.3 of the General Standard apply with the following additions: The numbering of clauses and subclauses of this Part of CEN/TS 14507 corresponds to that of the General Standard. The changes to the text of the General Standard are specified by the use of the following words: ´Replacement´ means that the clause or subclause of the General Standard is replaced completely by the text of this Part of CEN/TS 14507. (...)

La présente partie du CEN/TS 14507 fait référence à l'EN 60601 1:1990 "Appareils électromédicaux - Partie 1 : Règles générales de sécurité", modifiée par les amendements 1 (1991) et 2 (1995). Pour des raisons de simplicité, il est fait référence, dans la présente partie du CEN/TS 14507, à la partie 1 par l'expression Norme générale ou Exigences générales. Le domaine d'application présenté dans l'article 1 de la Norme générale s'applique, à l'exception du paragraphe 1.1, remplacé par le texte suivant : 1.1 La présente partie du CEN/TS 14507 spécifie des exigences particulières pour les systèmes d'administration d'oxyde nitrique inhalé et leurs modules. Elle concerne les dispositifs pouvant équiper des unités combinées, être intégrés à un autre dispositif médical, tel un ventilateur pulmonaire, ou être considérés en tant que dispositifs individuels. La présente partie du CEN/TS 14507 porte sur le monitorage de l'administration de l'oxyde nitrique et de l'oxygène au patient et sur la minimisation de la production de dioxyde d'azote. La présente partie du CEN/TS 14507 concerne les exigences requises pour les systèmes d'administration d'oxyde nitrique inhalé à usage médical, par exemple en soins intensifs, lors d'une anesthésie, dans les cas d'urgence ou au cours de transports. NOTE Il est admis que, de temps en temps, des innovations et des conceptions nouvelles constitueront des avantages sans pour autant être abordées dans la présente partie du CEN/TS 14507 dans le cadre des aspects spécifiques relatifs aux performances ou de la conception liés à la sécurité. Le développement de telles innovations ne doit pas être dissuadé. A mesure que la technique et la technologie de ces innovations avancent, il est essentiel que les objectifs en matière de sécurité stipulés dans la présente partie du CEN/TS 14507 soient considérés comme des exigences minimales. Les exigences de l'article 1.3 de la Norme générale s'appliquent, avec les ajouts suivants : La numérotation des
ICS: 11.040.10-Anaesthetic, respiratory and reanimation equipment
CTN: CEN/TC 215 - 6196

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