NEN EN 13544-1 : 2007 + A1 2009

Foreword
Introduction
Section one - General
1 R) Scope
2 Normative references
3 Terms and definitions
4 General requirements and general requirements for test
5 Classification
6 Identification, marking and documents
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 electric 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 R) Continuous leakage currents and patient auxiliary currents
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 hazards 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 ultra-sonics)
36 Electromagnetic compatibility
Section six - Protection against hazards of ignition of flammable
              anaesthetic mixtures
37 R) Locations and basic requirements
38 R) Marking, accompanying documents
39 R) Common requirements for category AP and category APG
      equipment
40 R) Requirements and tests for Category AP equipment,
      parts and components thereof
41 R) Requirements and test for Category APG equipment,
      parts and components thereof
Section seven - Protection against excessive temperatures and
                others safety hazards
42 Excessive temperatures
43 R) 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 operating data and protection against
                hazardous 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 R) 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
Annex A A (informative) Rationale
Annex B B (informative) Diameters of the particles depositable
                        fraction
Annex C C (normative) Test methods for the aerosol output rate,
                        the aerosol output and for particle sizing
Annex D D (deleted)
Annex E E (informative) Mass balance checks on cascade impactor tests
Annex ZA (informative) Clauses of this European Standard addressing
                        Essential Requirements or other provisions
                        of EU Directives
Bibliography

Defines requirements for nebulizing systems used for the delivery of drugs in an aerosol form to humans through the respiratory system.