I.S. EN ISO 8835-3:2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
INHALATIONAL ANAESTHESIA SYSTEMS - PART 3: TRANSFER AND RECEIVING SYSTEMS OF ACTIVE ANAESTHETIC GAS SCAVENGING SYSTEMS
Hardcopy , PDF
29-01-2013
English
01-01-2010
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 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)
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| DocumentType |
Standard
|
| Pages |
49
|
| PublisherName |
National Standards Authority of Ireland
|
| 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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