SIST-TS 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

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

La présente partie du CEN/TS 14507 fait référence a l'EN 60601 1:1990 "Appareils électromédicaux - Partie 1 : Regles 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, a 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, a l'exception du paragraphe 1.1, remplacé par le texte suivant :
1.1   La présente partie du CEN/TS 14507 spécifie des exigences particulieres pour les systemes d'administration d'oxyde nitrique inhalé et leurs modules. Elle concerne les dispositifs pouvant équiper des unités combinées, etre intégrés a un autre dispositif médical, tel un ventilateur pulmonaire, ou etre 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'oxygene 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 systemes d'administration d'oxyde nitrique inhalé a 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 etre abordées dans la présente partie du CEN/TS 14507 dans le cadre des aspects spécifiques relatifs aux performances ou de la conception liés a la sécurité. Le développement de telles innovations ne doit pas etre dissuadé. A mesure que la technique et la technologie de ces innovations avancent, il est essentiel que les objectifs en matiere 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: 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 14507-1:2003 - 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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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. 9
Section three — Protection against electrical shock hazards . 9
13 General . 9
14 Requirements related to classification . 9
15 Limitation of voltage and/or energy . 9
16 Enclosures and protective covers. 10
17 Separation. 10
18 Protective earthing, functional earthing and potential equalization. 10
19 Continuous leakage current and patient auxiliary current . 10
20 Dielectric strength. 10
Section four — Protection against mechanical hazards. 10
21 Mechanical strength . 10
22 Moving parts. 11
23 Surfaces, corners, and edges. 11
24 Stability in normal use. 11
25 Expelled parts. 11
26 Vibration and noise. 11
27 Pneumatic and hydraulic power. 11
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28 Suspended masses . 11
Section five — Protection against hazards from unwanted or excessive radiation. 12
29 X-Radiation . 12
30 Alpha, beta, gamma, neutron radiation and other particle radiation . 12
31 Microwave radiation . 12
32 Light radiation (including lasers) . 12
33 Infra-red radiation . 12
34 Ultra-violet radiation. 12
35 Acoustical energy (including ultrasonics) . 12
36 Electromagnetic compatibility. 12
Section six — Protection against hazards of ignition of flammable mixtures . 13
Section seven — Protection against excessive temperatures and other safety hazards. 13
42 Excessive temperatures. 13
43 R) Fire prevention. 13
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and
disinfection. 13
45 Pressure vessels and parts subject to pressure. 14
46 Human errors.14
47 Electrostatic charges.14
48 Biocompatibility.14
49 Interruption of the power supply. 14
Section eight — Accuracy of operation data and protection against incorrect output . 15
50 Accuracy of operating data. 15
51 Protection against hazardous output . 15
Section nine — Abnormal operation and fault conditions — Environmental tests. 17
52 Abnormal operation and fault conditions . 17
53 Environmental tests. 17
Section ten — Constructional requirements. 17
54 General. 17
55 Enclosures and covers. 17
56 Components and general assembly . 17
57 Mains parts, components and layout . 18
58 Protective earthing — Terminals and connections. 19
59 Construction and layout. 19
Annexes . 22
Annex AA (informative)  Rationale. 23
Bibliography . 26
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Foreword
This document (CEN/TS 14507-1:2003) 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 AA of this Part of CEN/TS 14507 is given for information and contains rationale statements for this Part
of CEN/TS 14507. 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.
Section one — General
1 Scope
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:
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´Replacement´ means that the clause or subclause of the General Standard is replaced completely by the text
of this Part of CEN/TS 14507.
´Addition´ means that the text of this Part of CEN/TS 14507 is additional to the requirements of the General
Standard.
´Amendment´ means that the clause or subclause of the General Standard is amended as indicated by the
text of this Part of CEN/TS 14507.
Subclauses or figures which are additional to those of the General Standard are numbered starting from 101.
Additional annexes are lettered AA, BB, etc. and additional items aa), bb), etc.
The term ´this Standard´ is used to make reference to the General Standard and this Part of CEN/TS 14507
taken together.
Where there is no corresponding section, clause or subclause in this Part of CEN/TS 14507, the section,
clause or subclause of the General Standard applies without modification.
Where it is intended that any part of the General Standard, although possibly relevant, is not to be applied, a
statement to that effect is given in this Part of CEN/TS 14507.
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 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).
Appendix L of EN 60601-1:1990 applies with the following additions:
EN 475, Medical devices — Electrically generated alarm signals.
EN 738-1:1997 + A1: 2001, Pressure regulators for use with medical gases — Part 1: Pressure regulators and
pressure regulators with flow metering devices.
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 12598, Oxygen monitors for patient breathing mixtures — Particular requirements.
EN 13221, High pressure flexible connections for use with medical gases.
EN 60068-2-64:1994, Environmental testing — Part 2: Test methods — Test Fh: Vibration, broad-band
random (digital control) and guidance (IEC 60068-2-64: 1993 + Corrigendum 1994.
EN 60601-1:1990 + A1:1993 + A2:1995, Medical electrical equipment — Part 1: General requirements for
safety (IEC 60601-1:1998 + A1:1991 + A2:1995).
EN 60601-1-2, Medical electrical equipment — Part 1: General Requirements for safety 2.Collateral standard:
Electromagnetic compatibility — Requirements and tests (IEC 60601-1-2:1993).
EN 61000-4-2, Electromagnetic compatibility (EMC) — Part 4: Testing and measurement techniques —
Section 2: Electrostatic discharge immunity test — Basic EMC publication (IEC 61000-4-2:1995).
5

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CEN/TS 14507-2, Inhalational nitric oxide systems — Part 2: Supply systems.
EN ISO 4135, Anaesthetic and respiratory equipment — Vocabulary .
IEC 60068-2-6:1995, Environmental testing — Part 2: Tests — Test Fc: Vibration (sinusoidal).
IEC 60068-2-29: 1987, Basic environmental testing procedures — Part 2: Tests — Test Eb and guidance:
Bump.
IEC 60079-4, Electrical apparatus for explosive gas atmospheres — Part 4: Method of test for ignition
temperature.
3 Terms and definitions and terminology
For the purposes of this Technical Specification, clause 2 of the General Standard and EN ISO 4135 apply
together with the following additions:
3.1
1)
inhalational nitric oxide delivery device
device that controls the addition of nitric oxide to the breathing gas
NOTE It can control and indicate flow, concentration or dose.
3.2
2)
inhalational nitric oxide delivery system
system comprising nitric oxide delivery device(s), monitoring and alarm device(s)
3.3
3)
inhalational nitric oxide delivery system monitoring device
device that displays or indicates the values of variables pertinent to the delivery of nitric oxide
NOTE Such variables can be related to e.g. oxygen, nitric oxide and nitrogen dioxide.
4 General requirements and requirements for tests
4.1 Modifications to clause 3 of the General Standard
Clause 3 of the General Standard applies with the following additions:
3.6
Additional items
aa) short and open circuits of components or wiring which can increase temperatures (see section seven);
bb) any fault which is not detected by intrinsic means or by periodic inspection (e. g. an oxidant leak) shall be
regarded as a normal condition and not a single fault condition;

1)
Called “delivery device” within this Part of EN/TS 14507.
2)
Called “delivery system” within this Part of EN/TS 14507.
3)
Called “monitoring device” within this Part of EN/TS 14507.
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Compliance is checked by simulation of a single fault condition.
4.2 Modification to clause 4 of the General Standard
Clause 4 of the General Standard applies with the following addition:
Additional subclause:
4.101 Type testing of components of the delivery system
For type testing components of the delivery system, the requirements of the appropriate section(s) of this Part
of CEN/TS 14507 including the referenced additional standards as stated in the appropriate section apply.
The manufacturer may use type tests different from those detailed within this Part of CEN/TS 14507 if an
equivalent degree of safety is obtained.
5 Classification
Clause 5 of the General Standard applies.
6 Identification, marking and documents
Clause 6 of the General Standard applies together with the following additions:
6.1 Marking on the outside of equipment or equipment parts
Additional items:
aa) Device packaging and/or labelling shall distinguish between identical or similar products in both the sterile
and non-sterile states by the same manufacturer.
bb) Each gas specific inlet shall be durably marked with either the gas-name or chemical symbol in
accordance with EN 739:1997 + A1:2001 for a nitric oxide/nitrogen mixture. This marking shall be legible.
cc) If colour coding is used in addition for nitric oxide/nitrogen mixtures, it shall be bright green and black in
accordance with EN 739:1997 + A1:2001 for a nitric oxide/nitrogen mixture.
dd) The delivery device shall be durably marked with the rated supply pressure(s) to which the device can be
connected. These markings shall be legible.
ee) The name or chemical symbol in accordance with EN 739:1997 + A1:2001 for the gas shall be legibly
marked on or adjacent to the delivery indicator. If colour coding is used, it shall be in conformance with
EN 739:1997 + A1:2001.
6.8 Accompanying documents
6.8.2 Instructions for use
Additional items:
aa) The instructions for use shall describe methods of testing the alarm functions specified in this Part of
CEN/TS 14507.
bb) Instructions for use shall include testing for correct assembly and connection of each device included in
the delivery system.
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cc) The instructions for use shall include the operating characteristics of any means of pressure relief
provided with the delivery system.
dd) The instructions for use shall describe any medical devices that are recommended for use with the
delivery system, together with any restrictions e. g. use with flammable anaesthetic agents.
ee) The instructions for use shall include information about cleaning, disinfection and/or sterilization of
reusable parts.
ff) The instructions for use shall include information about the cleanliness and sterility of respiratory gas
conducting parts upon delivery.
gg) The instructions for use shall include information about the risk arising from a malfunction in nitric oxide
delivery and a recommendation to the effect that an alternative means of nitric oxide delivery be available
whenever the delivery system is in use.
hh) If alarm limits are preset by the manufacturer, the limits shall be disclosed in the instructions for use.
ii) The manufacturer shall disclose the operating range(s) of the delivery device.
jj) R The instructions for use shall include a description of the functioning of the delivery system after an
unintended interruption of the normal power supply.
kk) The manufacturer shall disclose the procedures recommended to minimize the formation of toxic
degradation products of nitric oxide, e.g. by arranging for all gas pathways containing nitric oxide to be kept
separate from all oxygen-containing pathways until they reach the breathing system or as close to it as it is
practicable and by purging with nitrogen or the nitric oxide/nitrogen mixture .
ll) The instructions for use shall include a warning advising users to ensure that local requirements
concerning the occupational safety limits for nitric oxide and nitrogen dioxide should not be exceeded during
use.
mm) If an internal power supply is provided, the instructions for use shall contain an estimation of the
duration of operation of the device when using its internal power supply and the conditions under which this
estimate was determined.
nn) The manufacturer shall disclose the range of inlet pressures over which the delivery device meets the
requirements of this Part of CEN/TS 14507.
oo) If 51.101.3, 51.101.4 and 51.101.5 apply and the delivery device is not provided with means to monitor
the amount of nitric oxide, oxygen and/or nitrogen dioxide delivered to the patient and to initiate an alarm(s),
the instructions for use shall include a statement that the delivery device shall be provided with such means
before being put in service
6.8.3 Technical description
Additional items:
aa) Disclosure of accuracies (including bias and precision), display resolutions and range of each calibrated
control for each monitored variable that is displayed and the rise time for any monitor provided;
bb) Disclosure of interdependence of controls, if applicable;
cc) Disclosure of all information necessary to check that a delivery system and/or its devices is/are installed
correctly and in correct working order, and on the nature and frequency of maintenance operations necessary
to ensure continuing correct operation.
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dd) Each delivery system shall be provided with a checklist(s) of the procedures recommended by the
manufacturer to be performed prior to each use of the system.
NOTE These procedures can be performed automatically, in whole or in part, or by the operator. Attention is drawn to
additional checklists established by regional or national medical associations, or government agencies. The use of
electronic displays integral to, or provided with, the delivery system is permitted to provide such a checklist.
7 Power Input
Clause 7 of the General Standard applies.
Section two — Environmental conditions
8 Basic safety categories
Not used.
9 Removable protective means
Not used.
10 Environmental conditions
Clause 10 of the General Standard applies:
11 Not used
12 Not used
Section three — Protection against electrical shock hazards
13 General
Clause 13 of the General Standard applies.
14 Requirements related to classification
Clause 14 of the General Standard applies.
15 Limitation of voltage and/or energy
Clause 15 of the General Standard applies.
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16 Enclosures and protective covers
Clause 16 of the General Standard applies.
17 Separation
Clause 17 of the General Standard applies.
18 Protective earthing, functional earthing and potential equalization
Clause 18 of the General Standard applies.
19 Continuous leakage current and patient auxiliary current
Clause 19 of the General Standard applies with the following additions:
19.4 h) R Measurement of the patient leakage current.
Addition:
12) The patient leakage current shall be measured from all applied parts classified as the same type (see 14.6
of the General Standard). These parts shall be connected together electrically. Parts connected to the
protective earth terminal shall be tested separately.
20 Dielectric strength
Clause 20 of the General Standard applies.
Section four — Protection against mechanical hazards
21 Mechanical strength
Clause 21 of the General Standard applies with the following addition:
Additional subclause:
21.101 If the delivery system is intended to be used in an emergency and/or transport environment it shall be
submitted to the following tests:
 Vibration (sinusoidal) according to IEC 60068-2-6, Test Fc, using the following parameters:
 Frequency range: 10 Hz to 1 000 Hz
-2

Amplitude/acceleration: 0,35 mm/49 ms
 Sweep rate: 1 octave/min
 Number of sweep cycles: 4 in each axis
 Broad-band random vibration according to EN 60068-2-64, Test Fh, using the following parameters:
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2
 ASD (Acceleration Spectral Density) 10 Hz to 200 Hz: 0,01 g /Hz
2
 ASD 200 Hz to 500 Hz: 0,003 g /Hz
Total rms acceleration: 1,7 g
 ms
 Duration/axis/mounting: 30 min
 Bump according to IEC 60068-2-29, Test Eb, using the following parameters:
 Peak acceleration: 15 g
 Pulse duration: 6 ms
 Number of bumps: 4 000
 Direction: Vertical, with the delivery system in its normal operating positions(s)
During and after the tests, the delivery system shall continue to function within the tolerances
...