CEN/TS 14507-1:2003
(Main)Inhalational nitric oxide systems - Part 1: Delivery systems
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
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
...
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