Committees responsible
National foreword
Introduction
Section 1. General
1.1 Scope
1.2 Normative references
1.3 Definitions
1.4 General requirements
1.5 General requirements for tests
1.6 Classification
1.7 Identification, marking and documents
1.8 Power input
Section 2. Environmental conditions
2.1 Basic safety categories
2.2 Removable protective means
2.3 Environmental conditions
2.4 Special measures with respect to safety
2.5 Single fault condition
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 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
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 Infra-red radiation
5.6 Ultraviolet radiation
5.7 Acoustical energy (including ultra-sonics)
5.8 Electromagnetic compatibility
Section 6. Protection against hazards of ignition of
flammable anaesthetic mixtures
6.1 Locations and basic requirements
6.2 Marking and accompanying documents
6.3 Common requirements for category AP and category
APG equipment
6.4 Requirements and tests for category AP equipment,
parts and components
6.5 Requirements and tests for category APG equipment,
and 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
Section 9. Abnormal operation and fault conditions:
environmental 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 - Terminal and connections
10.6 Construction and layout
Section 11. Additional requirements specific to
capnometers
Annex
L (informative) Rationale
National annex
NA (informative) Clarification of clause 60.2.2 'Test
gases'