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