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UNI EN ISO 8835-3 : 2010

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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INHALATIONAL ANAESTHESIA SYSTEMS - PART 3: TRANSFER AND RECEIVING SYSTEMS OF ACTIVE ANAESTHETIC GAS SCAVENGING SYSTEMS

Superseded date

21-02-2013

Published date

01-01-2010

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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements and alternative test methods
5 Patient and environmental protection
6 Connectors
7 Transfer systems
8 Receiving systems
9 Extract flow resistance
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). Also describes requirements for transfer and receiving systems of active anaesthetic gas scavenging systems in which the power device is integral with the transfer and receiving system.

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Superseded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

Standards Relationship
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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