CEN/TS 14507-2:2003

Inhalational nitric oxide systems - Part 2: Supply systems

Specifies safety and performance requirements for mobile equipment used to supply nitric oxide/nitrogen mixtures to patients, with particular reference to continuity of therapy.

Inhalationssysteme für Stickstoffmonoxid - Teil 2: Versogungssysteme

Systèmes d'oxyde nitrique inhalé - Partie 2: Systèmes d'alimentation

1.1   La présente partie du CEN/TS 14507 s'applique aux systèmes d'alimentation en mélanges d'oxyde nitrique/d'azote vers un système de monitorage et d'administration conforme au CEN/TS 14507-1 pour le traitement d'un patient à la fois, dans une unité médicale.
1.2   La présente partie du CEN/TS 14507 s'applique aux systèmes d'alimentation équipés de bouteilles d'une pression de remplissage de 20 000 kPa maximum et à des concentrations de 1 000 µl/l maximum d'oxyde nitrique dans de l'azote.
1.3   R La présente partie du CEN/TS 14507 ne s'applique pas aux :
"   systèmes de distribution pour alimenter en mélanges d'oxyde nitrique/d'azote plus d'un patient à la fois ;
"   systèmes d'alimentation en mélanges d'oxyde nitrique/d'azote pour les soins à domicile, dans les cas d'urgence ou au cours de transports.

Inhalacijski sistemi z dušikovim oksidom – 2. del: Napajalni 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 14507-2:2003 - Inhalational nitric oxide systems - Part 2: Supply systems

Standards Content (Sample)

SLOVENSKI STANDARD
SIST-TS CEN/TS 14507-2:2003
01-september-2003
Inhalacijski sistemi z dušikovim oksidom – 2. del: Napajalni sistemi
Inhalational nitric oxide systems - Part 2: Supply systems
Inhalationssysteme für Stickstoffmonoxid - Teil 2: Versogungssysteme
Systemes d'oxyde nitrique inhalé - Partie 2: Systemes d'alimentation
Ta slovenski standard je istoveten z: CEN/TS 14507-2:2003
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST-TS CEN/TS 14507-2:2003 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST-TS CEN/TS 14507-2:2003

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SIST-TS CEN/TS 14507-2:2003
TECHNICAL SPECIFICATION
CEN/TS 14507-2
SPÉCIFICATION TECHNIQUE
TECHNISCHE SPEZIFIKATION
March 2003
ICS 11.040.10
English version
Inhalational nitric oxide systems – Part 2: Supply systems
Inhalationssysteme für Stickstoffmonoxid - Teil 2:
Versorgungssysteme
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 14507-2:2003 E
worldwide for CEN national Members.

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SIST-TS CEN/TS 14507-2:2003
CEN/TS 14507-2:2003 (E)
Contents Page
Foreword. 3
INTRODUCTION. 3
1 Scope. 4
2 Normative references . 4
3 Terms and definitions. 5
4 Terminology. 5
5 General requirements . 5
5.1 R Safety. 5
5.2 R Alternative construction . 5
5.3 Materials. 5
6 Design requirements . 6
6.1 Components of the supply systems for nitric oxide . 6
6.2 Cylinders. 6
6.3 R Cylinder valves . 7
6.4 R Pressure regulators. 7
6.5 Pressure gauges . 7
6.6 R High-pressure flexible connections .
...