Section 1 General
1.1 Scope
1.2 Normative references
1.3 Definitions
1.4 General requirements and general requirements for
tests
1.5 Classification
1.6 Identification, marking and documents
1.7 Power input
Section 2 Environmental conditions
2.1 Basic safety categories
2.2 Removable protective means
2.3 Environmental conditions
Section 3 Protection against electric shock hazards
3.1 General
3.2 Requirements related to classification
3.3 Limitation of voltage and/or energy
3.4 Enclosures and protective covers
3.5 Separation
3.6 Protective earthing, functional earthing and
potential equalization
3.7 Continuous leakage current and patient auxiliary
currents
3.8 Dielectric strength
Section 4 Protection against mechanical hazards
4.1 Mechanical strength
4.2 Moving parts
4.3 Surface, corners and edges
4.4 Stability in normal use
4.5 Expelled parts
4.6 Vibration and noise
4.7 Pneumatic and hydraulic power
4.8 Suspended masses
Section 5 Protection against hazards from unwanted or
excessive radiation
5.1 X-radiation
5.2 Alpha, beta, gamma, neutron radiation and other
particle radiation
5.3 Microwave radiation
5.4 Light radiation (including lasers)
5.5 Infrared radiation
5.6 Ultraviolet radiation
5.7 Acoustical energy (including ultrasonics)
5.8 Electromagnetic compatibility
Section 6 Protection against hazards of ignition of
flammable anaesthetic mixtures
6.1 Locations and basic requirements
6.2 Marking, accompanying documents
6.3 Common requirements for categories AP and APG
equipment
6.4 Requirements and tests for category AP equipment,
parts and components
6.5 Requirements and tests for category APG equipment,
parts and components
Section 7 Protection against excessive temperatures
and other safety hazards
7.1 Excessive temperatures
7.2 Fire prevention
7.3 Overflow, spillage, leakage, humidity, ingress of
liquids, cleaning, sterilization and disinfection
7.4 Pressure vessels and parts subject to pressure
7.5 Human errors
7.6 Electrostatic charges
7.7 Materials in applied parts in contact with body of
patient
7.8 Interruption of power supply
Section 8 Accuracy of operating data and protection
against hazardous output
8.1 Accuracy of operating data
8.2 Protection against hazardous output
Section 9 Abnormal operation and fault conditions,
environment tests
9.1 Abnormal operation and fault conditions
9.2 Environmental tests
Section 10 Constructional requirements
10.1 General
10.2 Enclosures and covers
10.3 Components and general assembly
10.4 Main parts, components and layout
10.5 Protective earthing - Terminals and connections
10.6 Construction and layout
Section 11 Additional requirements specific to
anaesthetic gas monitors
11.1 Interfering gas and vapour effects (other than
water vapour)
11.2 Obstruction of sampling tube
11.3 Breathing system connections
11.4 Contamination of breathing systems
Annexes
A to L
M Test of anaesthetic agents for non-flammability
N Rationale
P Bibliography