SIST-TS 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

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

1.1   La présente partie du CEN/TS 14507 s'applique aux systemes d'alimentation en mélanges d'oxyde nitrique/d'azote vers un systeme de monitorage et d'administration conforme au CEN/TS 14507-1 pour le traitement d'un patient a la fois, dans une unité médicale.
1.2   La présente partie du CEN/TS 14507 s'applique aux systemes d'alimentation équipés de bouteilles d'une pression de remplissage de 20 000 kPa maximum et a 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 :
"   systemes de distribution pour alimenter en mélanges d'oxyde nitrique/d'azote plus d'un patient a la fois ;
"   systemes d'alimentation en mélanges d'oxyde nitrique/d'azote pour les soins a 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: 31-Aug-2003
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 01-Sep-2003
• Due Date: 01-Sep-2003
• Completion Date: 01-Sep-2003
• 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: 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 . 7
6.7 R Low-pressure hose assemblies . 8
6.8 Outlet connector of the supply system . 8
6.9 Quick-connectors. 8
6.10 Outlet pressure. 8
6.11 Alarms . 8
6.12 Flow . 8
6.13 Leakage. 9
6.14 R Change-over. 9
6.15 R Purging . 9
6.16 R Supporting structure. 9
6.17 R Stability. 9
6.18 R Rail system. 9
6.19 R Electrical components . 9
6.20 Back-up power supply. 10
7 Constructional requirements. 10
7.1 R Cleaning. 10
7.2 R Lubricants . 10
8 Test methods. 10
8.1 Ambient conditions. 10
8.2 Type tests of components. 10
8.3 Production tests of the supply system. 10
9 Marking and packaging . 11
9.1 Marking. 11
9.2 Packaging . 11
10 Information to be supplied by the manufacturer . 11
Annex A Rationale (Informative). 14
Bibliography . 15
2

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SIST-TS CEN/TS 14507-2:2003
CEN/TS 14507-2:2003 (E)
Foreword
This document (CEN/TS 14507-2:2003) has been prepared by Technical Committee CEN/TC 215
“Respiratory and anaesthetic equipment”, the secretariat of which is held by BSI.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
CEN/TS 14507 consists of the following Parts under the general title "Inhalational nitric oxide systems"
Part 1 - Delivery systems
Part 2 - Supply systems
Attention is drawn to the rationales and guidance on equipment for use with nitric oxide given in CR 13903
Annex A of this European Technical Specification is given for information and contains rationale statements
for this European Technical Specification. The clauses which have corresponding rationale statements are
marked with R) after their number.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to anounce this European Standard: Austria, Belgium, Czech Republic, Denmark,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands,
Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and the United Kingdom.
INTRODUCTION
Supply systems for nitric oxide/nitrogen mixtures are used to provide a continuous flow of gas to delivery and
monitoring systems which comply with CEN/TS 14507-2. The components of the system can either be
attached to a mobile trolley or fixed to a permanent structure such as a wall. Since nitric oxide reacts
spontaneously with ambient oxygen to form toxic products, it is important to prevent the ingress of air into the
supply system and also to provide a means of purging the supply system before use. Leakage to atmosphere
should also be kept to a minimum. Continuity of supply can be obtained by the provision of two cylinders with
an alarm for low cylinder pressure and a means of change-over from one cylinder to another. In order to
ensure traceability of the gas supply, only one cylinder should be in use at the same time. It is essential that
regular inspection and maintenance are undertaken to ensure that the supply systems continue to meet the
requirements of this Part of CEN/TS 14507.
This Part of CEN/TS 14507 pays particular attention to:
• Continuity of supply
• Suitability of materials and components
• Safety (mechanical strength, release of excess pressure, leakage and stability)
• Gas-specificity
• Cleanliness
• Testing
• Identification
• Information supplied (including procedures for purging and replacement of cylinders)
3

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SIST-TS CEN/TS 14507-2:2003
CEN/TS 14507-2:2003 (E)
1 Scope
1.1 This Part of CEN/TS 14507 applies to systems for the supply of nitric oxide/nitrogen mixtures to a
delivery and monitoring system complying with CEN/TS 14507-1 for treatment of one patient at a time, in a
healthcare facility.
1.2 This Part of CEN/TS 14507 applies to supply systems with cylinders at a filling pressure up to 20 000
kPa and concentrations up to 1000 μl/l of nitric oxide in nitrogen.
1.3 R This Part of CEN/TS 14507 does not apply to:
• pipeline systems for delivery of nitric oxide/nitrogen mixtures to more than one patient at a time;
• supply systems for nitric oxide/nitrogen mixtures intended for use in home care, emergency and transport.
2 Normative references
This Technical Specification incorporates, by dated or undated reference, provisions from other publications.
These normative references are cited at the appropriate places in the text and the publications are listed
hereafter. For dated references, subsequent amendments to or revision of any of these publications apply to
this Technical Specification only when incorporated in it by amendment or revision. For undated references
the latest edition of the publication referred to applies (including amendments).
EN 738-1:1997 + A1:2001, Pressure regulators for use with medical gases -Part 1: Pressure regulators and
pressure regulators with flowmetering devices (including Amendment 1:2001)
EN 738-3:1998 + A1:2001, Pressure regulators for use with medical gases - Part 3: Pressure regulators
integrated with cylinder valves
EN 739:1998 + A1:2001, Low-pressure hose assemblies for use with medical gases
EN 837-1, Pressure gauges - Part 1: Bourdon tube pressure gauges - Dimensions, metrology, requirements
and testing
EN 962, Gas cylinders - Valve protection caps and valve guards for industrial and medical gas cylinders
-Design, construction and tests
EN 1441, Medical devices - Risk analysis
EN 12218, Rail systems for supporting medical equipment
EN 13221:2000, High pressure flexible connections for use with medical gases
EN 60601-1:1990, Medical electrical equipment - Part 1: General requirements for safety (IEC 60601-2:1988)
EN 60601-1-2, Medical electrical equipment - Part 1: General requirements for safety – Electromagnetic
compatibility (IEC 60601-1-2:2001)
prEN ISO 407:2001, Small medical gas cylinders - Yoke-type valve connections (ISO/DIS 407:2001)
prEN ISO 10297:2002, Transportable gas cylinders - Cylinder valves -Specification and type testing (ISO/DIS
10297:2002)
ISO/DIS 5145:2001, Cylinder valve outlets for gases and mixtures -Selection and dimensioning
4

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SIST-TS CEN/TS 14507-2:2003
CEN/TS 14507-2:2003 (E)
3 Terms and definitions
For the purposes of this Technical Specification the following terms and definitions apply:
3.1
low-pressure hose assembly
assembly which consists of a flexible hose with permanent attached gas-specific inlet and outlet connectors
which is designed to conduct a medical gas at pressures between 300 kPa and 1400 kPa and for use with
vacuum service at pressures above 10 kPa absolute pressure
3.2
quick-connector
pair of non-threaded gas-specific components which can be easily and rapidly joined together by a single
action of one or both hands without the use of tools
3.3
single fault condition
condition in which a single means for protection against a safety hazard in equipment is defective or a single
external abnormal condition is present
4 Terminology
A typical example of a nitric oxide supply system with examples of terminology is given in Figure 1.
5 General requirements
5.1 R Safety
Supply systems for nitric oxide/nitrogen mixtures shall, when transported, stored, installed, operated in normal
use and maintained according to the instructions of the manufacturer, cause no safety hazard which could be
foreseen using risk analysis procedures in accordance with EN 1441 and which is connected with their
intended application, in normal condition and in single fault condition.
In particular the risk analysis shall address the possible consequences of a catastrophic release of the entire
contents of a cylinder of nitric oxide/nitrogen mixture.
Evidence shall be provided by the manufacturer.
5.2 R Alternative construction
Supply systems for nitric oxide/nitrogen mixtures and components or parts thereof, using materials or having
forms of construction different from those detailed in clauses 5 and 6 of this Part of CEN/TS 14507 shall be
accepted if it can be demonstrated that an equivalent degree of safety is obtained.
Such evidence shall be provided by the manufacturer.
5.3 Materials
5.3.1 The materials in contact with the gas shall be corrosion-resistant and compatible with nitric
oxide/nitrogen mixtures (up to a concentration of 1000 μl/l of nitric oxide in nitrogen) in the temperature range
specified in 5.3.2.
NOTE 1 Corrosion resistance includes resistance against
...