I.S. EN ISO 8835-2:2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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INHALATIONAL ANAESTHESIA SYSTEMS - PART 2: ANAESTHETIC BREATHING SYSTEMS
Hardcopy , PDF
29-01-2013
English
01-01-2009
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
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
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