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I.S. EN ISO 8835-3:2009

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 3: TRANSFER AND RECEIVING SYSTEMS OF ACTIVE ANAESTHETIC GAS SCAVENGING SYSTEMS
Available format(s)

Hardcopy , PDF

Superseded date

01-29-2013

Language(s)

English

Published date

01-01-2010

Preview

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.

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements and alternative test methods
   4.1 Materials
   4.2 Means of pressure relief
   4.3 Alternative test methods
5 Patient and environmental protection
   5.1 Normal operating conditions
   5.2 Single fault conditions
6 Connectors
7 Transfer systems
   7.1 Inlet of transfer systems
   7.2 Outlet of transfer systems
8 Receiving systems
   8.1 General
   8.2 Inlet of receiving systems
   8.3 Outlet of receiving systems
   8.4 Visual indicator
   8.5 Particle filter
   8.6 Receiving hoses
9 Extract flow resistance
   9.1 Low-flow transfer and receiving systems
   9.2 High-flow transfer and receiving systems
10 Electrical requirements
11 Information to be supplied by the manufacturer
12 Marking
13 Colour coding
Annex A (informative) Typical test arrangement and method
        for pressure measurement at inlet to AGSS
Annex B (informative) Typical test arrangement and method
        for sub-atmospheric pressure limitation
Annex C (informative) Typical test arrangement and method for
        testing of induced flow
Annex D (informative) Typical test arrangement and method for
        resistance to extract flow
Annex E (informative) Typical test arrangement and method for
        spillage
Annex F (informative) Rationale
Annex G (informative) Environmental aspects
Annex ZA (informative) Relationship between this European
         Standard and the Essential Requirements of EU
         Directive 93/42/EEC
Bibliography

Describes requirements for transfer and receiving systems of active anaesthetic gas scavenging systems (active AGSSs) intended to reduce exposure of healthcare personnel to anaesthetic gases and vapours while providing patient protection (e.g. against excessive flow and pressure).

DevelopmentNote
Together with I.S. EN ISO 8835-2, I.S. EN ISO 8835-4 and I.S. EN ISO 8835-5 supersedes I.S. EN 740. (09/2007)
DocumentType
Standard
Pages
49
PublisherName
National Standards Authority of Ireland
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
EN ISO 8835-3:2009/A1:2010 Identical
ISO 8835-3:2007 Identical

IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
ISO 5356-1:2015 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
ISO 9170-2:2008 Terminal units for medical gas pipeline systems — Part 2: Terminal units for anaesthetic gas scavenging systems
ISO 7396-2:2007 Medical gas pipeline systems Part 2: Anaesthetic gas scavenging disposal systems
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 21647:2004 Medical electrical equipment Particular requirements for the basic safety and essential performance of respiratory gas monitors
ISO 5359:2014 Anaesthetic and respiratory equipment Low-pressure hose assemblies for use with medical gases
IEC 60079-11:2011 Explosive atmospheres - Part 11: Equipment protection by intrinsic safety "i"
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 9170-1:2017 Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with compressed medical gases and vacuum
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
ISO 8835-2:2007 Inhalational anaesthesia systems Part 2: Anaesthetic breathing systems
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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