EN 13544-1:2007+A1:2009

Foreword
Introduction
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
8 Basic safety categories
9 Removable protective means
10 Environmental conditions
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 currents and patient auxiliary
   currents
20 Dielectric strength
21 Mechanical strength
22 Moving parts
23 Surfaces, corners and edges
24 Stability in normal use
25 Expelled parts
26 Vibration and no
27 Pneumatic and hydraulic power
28 Suspended masses
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
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 tests for Category APG equipment,
   parts and components thereof
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
50 Accuracy of operating data
51 Protection against hazardous output
52 Abnormal operation and fault conditions
53 Environmental tests
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
Annex BB (informative) - Diameters of the particles depositable
                         fraction
Annex CC (normative) - Test methods for the aerosol output
                       rate, the aerosol output and for
                       particle sizing
Annex DD (normative) - Mass balance checks on cascade impactor
                       tests
Annex EE (informative) - Environmental aspects
Annex ZA (informative) - Relationship between this European
                         Standard and the Essential Requirements
                         of EU Directive 93/42 EEC on medical
                         devices
Bibliography

The scope given in Clause 1 of EN 60601-1:1990 applies except that 1.1 is replaced by the following:1.1This European Standard specifies requirements for nebulizing systems used for the delivery of drugs in an aerosol form to humans through the respiratory system.This European Standard includes gas-powered nebulizers which may be derived from e.g. compressors, pipeline systems, cylinders etc., or electrically-powered nebulizers (e.g. ultrasonic and membrane devices) or manually-powered nebulizers.NOTERequirements for nebulizers having also a humidification function are specified in EN ISO 8185:1997 + AC: 2002 "Humidifiers" (see 56.102).This European Standard does not apply to nebulizers precharged with a specific medicinal product (e.g. MDI, DPI).