EN ISO 17510-1:2009

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Classification and designation
6 Marking, labelling and packaging
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 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 Ultra-violet radiation
35 Acoustical energy (including ultra-sonics)
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
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 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
Annex AA (informative) - Rationale
Annex BB (normative) - Pressure accuracy in normal use
         test methods
Annex CC (normative) - Maximum flowrate test method
Annex DD (informative) - Environmental aspects
Annex EE (informative) - Reference to the essential
         principles
Annex FF (informative) - Terminology - Alphabetized
         index of defined terms
Bibliography
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of EU
         Directive 93/42/EEC

ISO 17510-1:2007 specifies requirements for equipment intended for sleep apnoea breathing therapy for domiciliary use, ships, aircraft and other transport vehicles and for use in healthcare institutions.ISO 17510-1:2007 applies to equipment intended for use with adults and children, and excludes equipment intended for use with neonates.Jet and very high frequency ventilation and oscillation are not considered in ISO 17510-1:2007.