DD CEN/TS 14507-1:2003

Foreword
Section one - General
1 Scope
2 Normative references
3 Terms and definitions and terminology
4 General requirements and requirements for tests
   4.1 Modifications to clause 3 of the General Standard
   4.2 Modification to clause 4 of the General Standard
5 Classification
6 Identification, marking and documents
   6.1 Marking on the outside of equipment or equipment
       parts
7 Power Input
Section two - Environmental conditions
8 Basic safety categories
9 Removable protective means
10 Environmental conditions
11 Not used
12 Not used
Section three - Protection against electrical shock
                hazards
13 General
14 Requirements related to classification
15 Limitation of voltage and/or energy
16 Enclosures and protective covers
17 Separation
18 Protective earthing, functional earthing and potential
   equalization
19 Continuous leakage current and patient auxiliary
   current
20 Dielectric strength
Section four - Protection against mechanical hazards
21 Mechanical strength
22 Moving parts
23 Surfaces, corners, and edges
24 Stability in normal use
25 Expelled parts
26 Vibration and noise
27 Pneumatic and hydraulic power
28 Suspended masses
Section five - Protection against from unwanted or
               excessive radiation
29 X-Radiation
30 Alpha, beta, gamma, neutron radiation and other particle
   radiation
31 Microwave radiation
32 Light radiation (including lasers)
33 Infra-red radiation
34 Ultra-violet radiation
35 Acoustical energy (including ultrasonics)
36 Electromagnetic compatibility
Section six - Protection against hazards of ignition of
              flammable mixtures
Section seven - Protection against excessive temperatures
                and other safety hazards
42 Excessive temperatures
43 Fire prevention
44 Overflow, spillage, leakage, humidity, ingress of
   liquids, cleaning, sterilization and disinfection
45 Pressure vessels and parts subject to pressure
46 Human errors
47 Electrostatic charges
48 Biocompatibility
49 Interruption of the power supply
Section eight - Accuracy of operation data and protection
                against incorrect output
50 Accuracy of operating data
51 Protection against hazardous output
Section nine - Abnormal operation and fault conditions -
               Environmental tests
52 Abnormal operation and fault conditions
53 Environmental tests
Section ten - Constructional requirements
54 General
55 Enclosures and covers
56 Components and general assembly
57 Mains parts, components and layout
58 Protective earthing - Terminals and connections
59 Construction and layout
Annexes
Annex AA (informative) Rationale
Bibliography

Provides particular requirements for inhalational nitric oxide delivery systems and their modules.

This Part of CEN/TS14507 refers to EN60601‑1:1990 \'Medical electrical equipment — Part1: General requirements for safety\', as amended by its amendments 1 (1991) and 2 (1995). For brevity Part1 is referred to in this Part of CEN/TS14507 either as the General Standard or as the General requirements.

The scope given in clause1 of the General Standard applies except that 1.1 is replaced by the following:

1.1 This Part of CEN/TS14507 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 examplea lung ventilator, or as individual devices.

This Part of CEN/TS14507 addresses the monitoring of nitric oxide and oxygen delivery to the patient and minimization of the production of nitrogen dioxide.

This Part of CEN/TS14507 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/TS14507; 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/TS14507 are considered as minimum requirements.

The requirements of clause1.3 of the General Standard apply with the following additions:

The numbering of clauses and subclauses of this Part of CEN/TS14507 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/TS14507.

´Addition´ means that the text of this Part of CEN/TS14507 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/TS14507.

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/TS14507 taken together.

Where there is no corresponding section, clause or subclause in this Part of CEN/TS14507, 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/TS14507.