EN ISO 10651-6:2009

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
    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
    6.101 Test method for legibility
7 Power input
    7.101 Pneumatic power
8 Basic safety categories
9 Removable protective means
10 Environmental conditions
    10.101 Pneumatic driving power supplies
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 Ultra-violet 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 Spontaneous breathing during power failure
    49.103 Accidental operation of the on/off-switch
50 Accuracy of operating data
51 Protection against hazardous output
    51.101 Maximum ventilator breathing system
           pressure limitation
    51.102 Measurement of airway pressure
    51.103 High-inspiratory pressure alarm condition
    51.104 Expiratory monitoring
    51.105 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
57 Mains parts, components and layout
    57.3 Power supply cords
58 Protective earthing - Terminals and connections
59 Construction and layout
101 Alarm systems
102 Appendices of IEC 60601-1:1988
Annex AA (informative) - Rationale
Annex BB (informative) - Reference to the Essential
         Principles
Bibliography
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of EU
         Directive 93/42 EEC

ISO 10651-6:2004 specifies the basic safety and essential performance requirements for home-care ventilatory support devices, intended mainly for use in home care but which could be used elsewhere (e.g. in hospitals) for appropriate patients for whom the use of a home-care ventilator complying with ISO 10651-2 is not required. It is intended to be used in conjunction with the General Standard IEC 60601-1:1988.The requirements of ISO 10651-6:2004 which replace or modify the requirements of IEC 60601-1:1988 and its Amendments 1 (1991) and 2 (1995) are intended to take precedence over the corresponding general requirements.