EN ISO 11196 : 1997

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:
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 - 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

Defines requirements for anaesthetic gas monitors to be used in determination of the anaesthetic vapour and/or gas level(s) in breathing gas mixtures. Covers both diverting and non-diverting gas monitors, whichever measuring technology is used. Includes anaesthetic gas mixtures identifying monitors, and monitoring of patient breathing mixtures, output of anaesthesia workstations, output of vaporizers in addition to anaesthesia ventilators and breathing systems. Does not cover anaesthetic gas monitors for laboratory research, non-human use or for calibrating anaesthetic agent vaporizers.