UNE-EN ISO 8185:2009

Foreword
Section 1. General
Introduction
1.1 Scope
1.2 Normative references
1.3 Definitions
1.4 General requirements
1.5 General requirements for tests
1.6 Classifications
1.7 Identifications, marking and documents
1.8 Power input
Section 2. Environmental conditions
2.1 Basic safety requirements
2.2 Removable protective means
2.3 Environmental conditions
Section 3. Protections 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 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 category AP and category
     APG equipment
6.4 Requirements and tests for category AP equipment,
     parts and components thereof
6.5 Requirements and tests for category APG equipment,
     parts and components thereof
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 error
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 operating 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 Enclosure and covers
10.3 Components and general assembly
10.4 Mains parts, components and layout
10.5 Protective earthing - Terminals and connections
10.6 Construction and layout
Section 11. Additional requirements specific to
            humidifiers
11.1 Humidifier output
11.2 Maximum pressure drop
11.3 Liquid container
11.4 Noise measurement
11.5 Temperature sensors and temperature sensor
     ports
11.6 Humidifier leakage
Annex M (normative) Test of anaesthetic agents for
         non-flammability
Annex N (normative) Temperature display accuracy
Annex O (informative) Specific enthalpy calculations
Annex P (normative) Humidifier output calculations
Annex Q (normative) Temperature sensors and mating
         ports
Annex R (normative) Standard temperature sensor
Annex S (informative) Rationale statement
Annex T (informative) Bibliography
Annex ZA (informative) Clauses of this European
         Standard addressing essential requirements
         or other provisions of EU Directives
Annex ZB (normative) Normative references to
         international publications with their
         relevant European publications
Figures
Tables

Provides requirements for the basic safety and essential performance of humidification systems.