Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements and general requirements for tests
5 Classification
6 Identification, marking and documents
7 Power input
8 Basic safety categories
9 Removable protective means
10 Environmental conditions
11 Not used
12 Not used
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 Surface, corners and edges
24 Stability in normal use
25 Expelled parts
26 Vibration and noise
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 Ultraviolet energy
35 Acoustical energy (including ultrasonics)
36 Electromagnetic compatibility
37 Locations and basic requirements
38 Marking, accompanying documents
39 Common requirements for category AP and category
APG equipment
40 Requirements and tests for category AP equipment,
parts and components thereof
41 Requirements and tests for category APG equipment,
parts and components thereof
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 error
47 Electrostatic charges
48 Biocompatibility
49 Interruption of power supply
50 Accuracy of operating data
51 Protection against hazardous output
52 Abnormal operation and fault conditions
53 Environmental tests
54 General
55 Enclosure and covers
56 Components and general assembly
57 Mains parts, components and layout
58 Protective earthing - Terminals and connections
59 Construction and layout
101 Humidification system output
102 Liquid container
103 Alarm systems
Annex AA (informative) Rationale
Annex BB (normative) Determination of the accuracy of
the displayed temperature
Annex CC (informative) Specific enthalpy calculations
Annex DD (normative) Temperature sensors and mating ports
Annex EE (normative) Determination of humidification system
output
Annex FF (normative) Standard temperature sensor
Annex GG (informative) Environmental aspects
Annex HH (informative) Reference to the essential principals
of safety and performance
Annex II (informative) Terminology - Index of defined terms
Bibliography
Annex ZA (Informative) Relationship between this European
Standard and the Essential Requirements of EU
Directive 93/42/EEC 56
National Annex NA (informative) Bibliography