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UNI EN ISO 8835-2 : 2009

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

INHALATIONAL ANAESTHESIA SYSTEMS - PART 2: ANAESTHETIC BREATHING SYSTEMS
Superseded date

05-30-2022

Published date

01-01-2009

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 monitoring
   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
Annex ZA (informative) Relationship between this European
         Standard and the Essential Requirements of EU
         Directive 93/42 EEC
Bibliography

Describes 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. 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.

DocumentType
Standard
PublisherName
Ente Nazionale Italiano di Unificazione (UNI)
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
EN ISO 8835-2:2009 Identical
ISO 8835-2:2007 Identical

IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-6:2010+AMD1:2013 CSV Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
ISO 5356-1:2015 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
ISO/TS 18835:2004 Inhalational anaesthesia systems Draw-over vaporizers and associated equipment
ISO 5356-2:2012 Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors
ISO 5367:2014 Anaesthetic and respiratory equipment — Breathing sets and connectors
IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
ISO 5362:2006 Anaesthetic reservoir bags
ISO 8185:2007 Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems
IEC 60601-2-13:2003+AMD1:2006 CSV Medical electrical equipment - Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems
ISO 2878:2017 Rubber, vulcanized or thermoplastic Antistatic and conductive products Determination of electrical resistance
ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
ISO 594-2:1998 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings

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