SIST-TS CEN/TS 14507-1:2003
(Main)Inhalational nitric oxide systems - Part 1: Delivery systems
- Abstract
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.
(...)
- Status
- Published
- Publication Date
- 31-Aug-2003
- 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 - Medical devices
SIST-TS CEN/TS 14507-1:2003 is the Slovenian adoption of CEN/TS 14507-1:2003 from CEN, for inhalational nitric oxide systems - Part 1: Delivery systems. It specifies particular requirements for inhalational nitric oxide delivery systems and their modules, with a focus on patient gas delivery, monitoring, alarms, leakage control, and safe use in medical environments.
The document is written for delivery systems that may be stand-alone, combined with other equipment, or integrated into devices such as lung ventilators. In practice, it tells manufacturers, test laboratories, and healthcare users what the system has to do, how safety is checked, and what information must accompany the equipment.
What does SIST-TS CEN/TS 14507-1:2003 specify?
SIST-TS CEN/TS 14507-1:2003 gives particular requirements for inhalational nitric oxide delivery systems intended for medical use. It applies the general safety framework of EN 60601-1 and replaces the general scope with a nitric-oxide-specific one.
The document covers systems used in critical care, anaesthesia, and emergency or transport environments. It also addresses monitoring of nitric oxide and oxygen delivery to the patient and the reduction of nitrogen dioxide formation, which matters because those functions affect both treatment accuracy and patient safety.
The document follows the clause structure of the General Standard. Its main body runs through sections on general matters, environmental conditions, electric shock, mechanical hazards, radiation, fire and temperature hazards, accuracy, abnormal operation, and construction, then adds clauses 101 to 103 for nitric oxide/nitrogen mixture supply, materials, and leakage.
| Annex | What it covers |
|---|---|
| Annex AA (informative) | Rationale for the important requirements in this part |
Annexes A to K of EN 60601-1 also apply.
What are the key requirements of SIST-TS CEN/TS 14507-1:2003?
Safety framework and fault assumptions
- Clause 4 adds a fault model that treats short and open circuits that can raise temperatures as relevant safety cases, and treats faults that cannot be found by intrinsic means or periodic inspection as normal conditions. In practice, manufacturers need a clear fault analysis and must show safety by simulating a single fault condition.
- Clause 4.101 allows component type testing to use other methods if they give an equivalent degree of safety. This matters for suppliers and test houses because it permits different test routes, but not weaker safety.
- Clause 43 on fire prevention requires the design to avoid combining ignitable material, ignition temperature, and oxidant under normal or single fault conditions. In practical terms, gas paths, materials, and heat sources must be arranged so that fire risk stays controlled.
Marking, instructions, and user information
- Clause 6 requires packaging and labels to distinguish sterile from non-sterile products made by the same manufacturer, and gas-specific inlets, indicators, and supply points to be marked clearly. This helps users connect the right gas and reduce setup errors.
- The instructions for use must explain alarm testing, correct assembly and connection, pressure-relief characteristics, cleaning or sterilization of reusable parts, sterility on delivery, and the risk of nitric oxide delivery malfunction. For a buyer or clinical user, this is the information needed to install, check, and operate the system safely.
- The instructions must also state preset alarm limits if the manufacturer sets them, the operating range of the delivery device, the expected duration on internal power, and the measures used to reduce toxic degradation products. That means the user can judge whether the device fits the intended therapy and workplace conditions.
Monitoring, alarms, and power failure
- Clause 51.101 requires the delivery control to be one of three forms: flow, concentration, or dose control. Each indicator is calibrated under defined atmospheric and temperature conditions, so the displayed value is tied to a known reference.
- Clauses 51.101.3 to 51.101.5 require monitoring and alarm provisions for nitric oxide, oxygen, and nitrogen dioxide when a hazard could arise from their delivery. If the device does not include those means, the instructions must state that such monitoring and alarming must be added before service.
- Clause 51.102 groups alarms into high, medium, and low priority and requires electrically generated alarms to follow EN 475. High-priority alarms have strict reset and silence limits, which matters because the alarm must warn the clinician without being easy to suppress.
- Clause 49 requires a power failure alarm and, if an internal power supply is present, a way for the operator to determine its state. For users, that means the system has to warn about loss of supply and stay understandable during power interruptions.
Mechanical, environmental, and supply-system requirements
- Clause 21.101 requires delivery systems intended for emergency or transport use to pass vibration and bump tests and continue to function within the manufacturer’s tolerances. This is the practical check that the device can survive movement in ambulances or other transport settings.
- Clause 44 requires splash protection for emergency and transport use and limits spillage so that wetted parts cannot create a hazard. It also requires reusable gas-path components to be sterile, disinfected, sterilizable, or protected by a microbial filter.
- Clause 56 and clause 101 control gas flow paths and connections. The system must limit reverse flow and cross flow between gases, and for nitric oxide/nitrogen mixture supply it must work across the stated inlet pressure range and use the specified hose and regulator interfaces where applicable.
- Clause 103 limits total leakage of nitric oxide/nitrogen mixtures to atmosphere under normal conditions. In practice, this reduces waste and exposure risk and gives manufacturers a measurable performance target.
What terms does SIST-TS CEN/TS 14507-1:2003 define?
- Inhalational nitric oxide delivery device - a device that controls the addition of nitric oxide to the breathing gas, and may control or indicate flow, concentration, or dose.
- Inhalational nitric oxide delivery system - a system made up of delivery device(s) plus monitoring and alarm device(s).
- Inhalational nitric oxide delivery system monitoring device - a device that displays or indicates variables relevant to nitric oxide delivery, such as oxygen, nitric oxide, or nitrogen dioxide.
- General Standard - EN 60601-1:1990 with amendments 1 and 2, which provides the base safety requirements used with this part.
- Nitric oxide/nitrogen mixture(s) - the gas mixture used in the delivery chain and gas-path requirements of this document.
- Patient leakage current - the leakage current measured from applied parts as specified by the electrical safety requirements.
- High priority alarm - an alarm category used for the most urgent conditions in the alarm system.
Who uses SIST-TS CEN/TS 14507-1:2003?
Manufacturers of inhalational nitric oxide delivery systems use SIST-TS CEN/TS 14507-1:2003 to design the device, select components, write instructions, and plan verification tests. Test laboratories use it to check electrical safety, alarms, leakage, vibration, spillage, and EMC behavior.
Hospitals, clinical engineers, buyers, and quality managers use it when specifying or accepting equipment for critical care, anaesthesia, or emergency and transport use. Service teams and users also rely on its marking and instructions requirements for setup, cleaning, maintenance, and safe operation.
Which standards are used with SIST-TS CEN/TS 14507-1:2003?
- EN 60601-1:1990 + A1:1993 + A2:1995 - the general safety base for medical electrical equipment.
- EN 60601-1-2 - EMC requirements and tests.
- EN 61000-4-2 - electrostatic discharge immunity test method used for EMC checking.
- EN 475 - electrically generated alarm signals.
- EN 12598 - requirements for oxygen monitors for patient breathing mixtures.
- EN 738-1 / EN 738-3 - pressure regulators for medical gases.
- EN 739 - low pressure hose assemblies for medical gases.
- EN 13221 - high pressure flexible connections for medical gases.
- EN 60068-2-6, EN 60068-2-64, IEC 60068-2-29 - vibration and bump environmental tests.
- IEC 60079-4 - ignition temperature testing used in fire prevention checks.
- EN ISO 4135 - vocabulary for anaesthetic and respiratory equipment.
- CEN/TS 14507-2 - the companion part covering supply systems.
What does the SIST-TS CEN/TS 14507-1:2003 document contain?
The document contains a clause-by-clause adaptation of the EN 60601-1 safety structure for inhalational nitric oxide delivery systems. It includes detailed requirements for marking, instructions for use, leakage current measurement, transport vibration, splash protection, EMC behavior, alarm priorities, power failure response, and gas-path separation.
It also includes a supply-system section with a typical configuration figure and a cord-retention test with a force table, both of which help manufacturers and test houses verify physical interfaces and mains connection safety. Annex AA provides the reasoning behind selected requirements, which is useful when applying the document to new designs or reviewing why a requirement exists.
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Frequently Asked Questions
SIST-TS CEN/TS 14507-1:2003 is a technical specification published by the Slovenian Institute for Standardization (SIST). Its full title is "Inhalational nitric oxide systems - Part 1: Delivery systems". This standard covers: 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. (...)
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. (...)
SIST-TS CEN/TS 14507-1:2003 is classified under the following ICS (International Classification for Standards) categories: 11.040.10 - Anaesthetic, respiratory and reanimation equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST-TS CEN/TS 14507-1:2003 has the following relationships with other standards: It is inter standard links to SIST EN 60068-2-64:2001, SIST EN 60601-1:2007/A1:2014, SIST EN 60601-1-2:2015, SIST EN IEC 61000-4-2:2025, SIST EN 738-1:2000/A1:2002, SIST EN 739:2000/A1:2002, SIST EN 475:2000, SIST EN 12320:2001, SIST EN ISO 21969:2010, SIST EN ISO 80601-2-55:2018, SIST EN 738-3:2000/A1:2002, SIST-TS CEN/TS 14507-2:2003, SIST EN ISO 4135:2022, SIST EN ISO 8434-1:2018, SIST EN ISO 1179-2:2008. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST-TS CEN/TS 14507-1:2003 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC; Standardization Mandates: M/023. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
SIST-TS CEN/TS 14507-1:2003 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
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
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
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:
´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).
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.
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.
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.
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.
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:
ASD
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