CEN/TS 14507-1:2003

Inhalational nitric oxide systems - Part 1: Delivery systems

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.
(...)

Inhalationssysteme für Stickstoffmonoxid - Teil 1: Abgabesysteme

Systèmes d'oxyde nitrique inhalé - Partie 1: Systèmes d'administration

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

Inhalacijski sistemi z dušikovim oksidom – 1. del: Dovodni sistemi

General Information

• Status: Published
• Publication Date: 25-Mar-2003
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Drafting Committee: CEN/TC 215/WG 3 - Medical gas supply systems
• Current Stage: 9093 - Decision to confirm - Review Enquiry
• Start Date: 07-Nov-2006
• Completion Date: 07-Nov-2006
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST-TS CEN/TS 14507-1:2003 - Inhalational nitric oxide systems - Part 1: Delivery systems

Standards Content (Sample)

SLOVENSKI STANDARD
SIST-TS CEN/TS 14507-1:2003
01-september-2003
Inhalacijski sistemi z dušikovim oksidom – 1. del: Dovodni sistemi
Inhalational nitric oxide systems - Part 1: Delivery systems
Inhalationssysteme für Stickstoffmonoxid - Teil 1: Abgabesysteme
Systemes d'oxyde nitrique inhalé - Partie 1: Systemes d'administration
Ta slovenski standard je istoveten z: CEN/TS 14507-1:2003
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST-TS CEN/TS 14507-1:2003 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST-TS CEN/TS 14507-1:2003

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SIST-TS CEN/TS 14507-1:2003
TECHNICAL SPECIFICATION
CEN/TS 14507-1
SPÉCIFICATION TECHNIQUE
TECHNISCHE SPEZIFIKATION
March 2003
ICS 11.040.10
English version
Inhalational nitric oxide systems – Part 1: Delivery systems
Inhalationssysteme für Stickstoffmonoxid - Teil 1:
Abgabesysteme
This Technical Specification (CEN/TS) was approved by CEN on 02 November 2002 for provisional application.
The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to submit their
comments, particularly on the question whether the CEN/TS can be converted into a European Standard.
CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS available. It
is permissible to keep conflicting national standards in force (in parallel to the CEN/TS) until the final decision about the possible
conversion of the CEN/TS into an EN is reached.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2003 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TS 14507-1:2003 E
worldwide for CEN national Members.

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SIST-TS CEN/TS 14507-1:2003
CEN/TS 14507-1:2003 (E)
Contents Page
Foreword. 4
Section one — General. 4
1 Scope. 4
2 Normative references . 5
3 Terms and definitions and terminology. 6
4 General requirements and requirements for tests . 6
4.1 Modifications to clause 3 of the General Standard . 6
4.2 Modification to clause 4 of the General Standard .7
5 Classification. 7
6 Identification, marking and documents . 7
6.1 Marking on the outside of equipment or equipment parts . 7
7 Power Input. 9
Section two — Environmental conditions . 9
8 Basic safety categories . 9
9 Removable protective means . 9
10 Environmental conditions . 9
11 Not used. 9
12 Not used.
...