I.S. 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.