UNI EN ISO 10651-2 : 2009

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements and requirements for tests
5 Classification
6 Identification, marking and documents
    6.1 Marking on the outside of equipment or equipment
           parts
    6.3 Marking of controls and instruments
    6.6 Identification of medical gas cylinders and
           connections
           6.8.2 Instructions for use
           6.8.3 Technical description
    6.101 Test method for legibility
7 Power input
    7.101 Pneumatic power
8 Basic safety categories
9 Removable protective means
10 Environmental conditions
           10.2.1 Environment
           10.2.2 Power supply
    10.101 Pneumatic driving-power supplies
11 Not used
12 Not used
13 General
14 Requirements related to classification
    14.2 Class II Equipment
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
    19.4 Tests
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 Ultraviolet radiation
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
    43.2 Oxygen-enriched atmospheres
    43.101 Compatibility with pressurized oxygen
44 Overflow, spillage, leakage, humidity, ingress of
    liquids, cleaning, sterilization, disinfection and
    compatibility
    44.3 Spillage
    44.7 Cleaning, sterilization and disinfection
    44.8 Compatibility with substances used with the
           equipment
45 Pressure vessels and parts subject to pressure
46 Human errors
47 Electrostatic charges
48 Biocompatibility
49 Interruption of the power supply
    49.101 Internal electrical power source
    49.102 Additional external backup power source
    49.103 Spontaneous breathing during power failure
    49.104 Accidental operation of the on/off-switch
50 Accuracy of operating data
51 Protection against hazardous output
    51.101 Failure of air and oxygen supply systems
    51.102 Adjustable ventilator breathing system pressure
           limitation
    51.103 Maximum ventilator breathing system pressure
           limitation
    51.104 Measurement of airway pressure
    51.105 High-inspiratory pressure alarm condition
    51.106 Expiratory monitoring
    51.107 Hypoventilation alarm condition
    51.108 Continuing pressure alarm condition
    51.109 Respiration-rate alarm condition
52 Abnormal operation and fault conditions
53 Environmental tests
54 General
    54.3 Protection against inadvertent adjustments
55 Enclosures and covers
56 Components and general assembly
    56.3 Connections - General
    56.101 Reservoir bags and breathing tubes
    56.102 Humidifiers and heat and moisture exchangers
    56.103 Pulse oximeters and capnometers
    56.104 Oxygen monitor and alarm condition
    56.105 Integrated monitoring equipment
57 Mains parts, components and layout
    57.3 Power supply cords
58 Protective earthing - Terminals and connections
59 Construction and layout
101 Alarm systems
           201.8.3 Indication and access
    201.12 Alarm condition logging
102 Appendices of IEC 60601-1:1988
Annex AA (informative) Rationale
Annex BB (informative) Reference to the essential principles
Annex ZA (informative) Relationship between this European
         Standard and the Essential Requirements of EU
         Directive 93/42 EEC
Bibliography

Describes requirements for lung ventilators intended for home applications for those patients who are dependent on ventilatory support.