Foreword
1 General
1.1 R Scope and object
1.2 Normative references
1.3 Definitions and terminology
1.4 General requirements and requirements for test
1.5 Classification
1.6 Identification, marking and documents
1.7 Power input
2 Environmental conditions
2.1 Basic safety categories
2.2 Removable protective means
2.3 R Environmental conditions
2.4 Clause 11 of the general standard does not apply
2.5 Clause 12 of the general standard does not apply
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 R Separation
3.6 Protective earthing, functional earthing and
potential equalization
3.7 R Continuous leakage currents and patient auxiliary
currents
3.8 Dielectric strength
4 Protection against mechanical hazards
4.1 Mechanical strength
4.2 Moving parts
4.3 Surfaces, 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
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
6 Protection against hazards of ignition of flammable
anaesthetic mixtures
6.1 Locations and basic requirements
6.2 Marking, accompanying documents
6.3 R Common requirements for category AP and category
APG equipment
6.4 Requirements and tests for category AP equipment,
parts and components thereof
7 Protection against excessive temperatures and other
safety hazards
7.1 Excessive temperatures
7.2 R 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 Biocompatibility
7.8 Interruption of the power supply
8 Accuracy of operating data and protection against
hazardous output
8.1 Accuracy of operating data
8.2 Protection against hazardous output
9 Fault conditions causing overheating and/or mechanical
damage; environmental tests
9.1 Abnormal operation and fault conditions
9.2 Environmental tests
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
11 Additional requirements
11.1 R Interfering gas and vapour effects
11.2 Contamination of breathing systems
11.3 R Gas leakage and sampling loss
11.4 Connections
11.5 Rise time
Annex AA (informative) Rationale
Annex BB (informative) Bibliography
Annex CC (normative) Test method for anaesthetic agents
for non-flammability
Annex ZA (informative) Clauses of this European Standard
addressing essential requirements or other provisions of
EU Directives