EN ISO 8835-2:2009

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General
   4.1 Materials
   4.2 Anaesthetic breathing system component
        packaging
   4.3 Electrical requirements
   4.4 Alternative test methods
5 Connection ports
   5.1 Patient connection port
   5.2 Y-Piece
   5.3 Exhaust connection port
   5.4 Interchangeable non-rebreathing exhaust valves
   5.5 Reservoir bag connection port
   5.6 Anaesthetic ventilator connection port
   5.7 Connection ports of interchangeable anaesthetic
        breathing system components
   5.8 Inspiratory and expiratory connection ports of an
        interchangeable circle absorber assembly
   5.9 Other connection ports
6 Reservoir bag/anaesthetic ventilator selector
   switch
7 Complete anaesthetic breathing system either
   supplied assembled or assembled in accordance
   with the manufacturer's instructions
   7.1 Leakage
   7.2 Inspiratory and expiratory pressure/flow
        characteristics
8 Interchangeable anaesthetic breathing system
   components - Exhaust valves
   8.1 Direction of movement of controls
   8.2 Pressure/flow characteristics
   8.3 Opening pressure
   8.4 Leakage
9 Circle absorber assemblies
   9.1 Construction
   9.2 Absorbent bypass mechanism
   9.3 Pressure/flow characteristics
   9.4 Inspiratory and expiratory valves
10 Pressure monitoring and limitation
   10.1 Pressure monitor
   10.2 Pressure-limiting device
11 Location of components in an anaesthetic breathing
   system containing a circle absorber assembly
   (as defined in 3.3)
   11.1 Exhaust valve
   11.2 Reservoir bag connection port
   11.3 Fresh gas inlet
   11.4 Inspiratory and expiratory valves
12 Marking
   12.1 Marking of complete anaesthetic breathing
        systems and anaesthetic breathing system
        components
   12.2 Marking of packages
13 Information to be provided by the manufacturer or
   supplier
   13.1 General
   13.2 For anaesthetic breathing systems supplied
        complete
   13.3 For anaesthetic breathing system components
Annex A (normative) - Typical test arrangements and
        methods
Annex B (informative) - Rationale
Annex C (informative) - Environmental aspects
Annex D (normative) - Antistatic requirements
Bibliography
Annex ZA (informative) - Relationship between this
         Standard and the Essential Requirements of
         EU Directive 93/42/EEC

ISO 8835-2:2007 specifies requirements for anaesthetic breathing systems that are supplied either assembled by the manufacturer or for assembly by the user in accordance with the manufacturer's instructions.ISO 8835-2:2007 also covers circle absorber assemblies, exhaust valves, inspiratory and expiratory valves and, in some designs, those parts of an anaesthetic breathing system that are incorporated within an inhalation anaesthetic system, including the expiratory gas pathway of an anaesthetic ventilator.