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EN ISO 7396-2:2007

Current

Current

The latest, up-to-date edition.

Medical gas pipeline systems - Part 2: Anaesthetic gas scavenging disposal systems (ISO 7396-2:2007)

Published date

04-01-2007

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
   4.1 Safety
   4.2 Alternative construction
   4.3 Materials
   4.4 Continuity of operation
5 Power device
6 Indicating systems
7 Pipelines, connecting assemblies and disposal hoses
8 Disposal system characteristics and test methods for
   pressure and flow
   8.1 Requirements
   8.2 Test methods for pressure and flow
   8.3 Means to prevent backflow
9 Terminal units
10 Marking and colour coding
   10.1 Marking
   10.2 Colour coding
   10.3 Test for durability
11 Pipeline installation
12 Testing, commissioning and certification
   12.1 General
   12.2 General requirements for tests
   12.3 Tests, inspections and checks
   12.4 Requirements for tests, inspections and checks
        listed in 12.3
   12.5 Certification of the system
   12.6 Extensions or modifications
13 Information to be supplied by the manufacturer
   13.1 General
   13.2 Instructions for use
   13.3 Operational management information
   13.4 "As-installed" drawings
   13.5 Electrical diagrams
Annex A (informative) Guidelines for power devices consisting
        of fans, blowers or dedicated vacuum pumps
Annex B (informative) Example of procedure for testing and
        commissioning
Annex C (informative) Typical forms for certification of
        AGS disposal systems
Annex D (informative) Risk management checklist
Annex E (informative) Rationale
Annex ZA (informative) Relationship between this International
         Standard and the Essential Requirements of EU
         Directive 93/42/EC on Medical devices
Bibliography

ISO 7396-2:2007 specifies requirements for the design, installation, function, performance, documentation, testing and commissioning of anaesthetic gas scavenging disposal systems, to ensure patient safety and to minimize exposure of the operator and other persons to anaesthetic gases and vapours. It includes requirements for the power device, pipeline system, performance, non-interchangeability between key components and avoidance of cross connections between anaesthetic gas scavenging (AGS) disposal systems and medical gas and vacuum pipeline systems.ISO 7396-2:2007 is applicable only to those disposal systems intended to be connected via AGSS terminal units compliant with ISO 9170-2 to AGSS receiving systems compliant with ISO 8835-3.ISO 7396-2:2007 also applies to:extensions of existing AGSS disposal systems;modifications of existing AGSS disposal systems;modifications or replacement of power devices.

Committee
CEN/TC 215
DevelopmentNote
Supersedes EN 737-2. (06/2007)
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Current
Supersedes

12/30266576 DC : 0 BS EN 13718-2 - MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS OF AIR AMBULANCES
BS EN 13976-1:2011 Rescue systems. Transportation of incubators Interface conditions
BS EN 13718-1:2014 Medical vehicles and their equipment. Air ambulances Requirements for medical devices used in air ambulances
EN 13718-2:2015 Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances
BS EN 13348:2016 Copper and copper alloys. Seamless, round copper tubes for medical gases or vacuum
EN 13348:2016 Copper and copper alloys - Seamless, round copper tubes for medical gases or vacuum
13/30276231 DC : 0 BS EN 13718-1 - MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES
EN 13976-1:2011 Rescue systems - Transportation of incubators - Part 1: Interface conditions
I.S. EN 13348:2016 COPPER AND COPPER ALLOYS - SEAMLESS, ROUND COPPER TUBES FOR MEDICAL GASES OR VACUUM
UNI EN 13718-1 : 2014 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES
DIN EN 1789:2014-12 MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES
UNE-EN 13976-1:2011 Rescue systems - Transportation of incubators - Part 1: Interface conditions
DIN EN 13718-2:2015-05 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES
DIN EN 13718-1:2014-12 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES
I.S. EN 1789:2007 MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES
EN 1789:2007+A2:2014 Medical vehicles and their equipment - Road ambulances
UNI EN 13348 : 2008 COPPER AND COPPER ALLOYS - SEAMLESS, ROUND COPPER TUBES FOR MEDICAL GASES OR VACUUM
16/30333928 DC : 0 BS EN 13976-1 - RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 1: INTERFACE CONDITIONS
UNI EN 13976-1 : 2011 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 1: INTERFACE CONDITIONS
UNE-EN 13718-2:2015 Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances
EN 13718-1:2014 Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
BS EN 1789 : 2007 MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES
I.S. EN 13718-1:2014 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES
UNE-EN 1789:2007 Medical vehicles and their equipment - Road ambulances
BS EN 13718-2:2015 Medical vehicles and their equipment. Air ambulances Operational and technical requirements for air ambulances
I.S. EN 13718-2:2015 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES
UNE-EN 13348:2016 Copper and copper alloys - Seamless, round copper tubes for medical gases or vacuum
I.S. EN 13718-2:2015+A1:2020 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES
DIN EN 13976-1 E : 2011 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 1: INTERFACE CONDITIONS
DIN EN 13976-1:2016-03 (Draft) RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 1: INTERFACE CONDITIONS
I.S. EN 13976-1:2011 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 1: INTERFACE CONDITIONS
DIN EN 13976-1:2011-08 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 1: INTERFACE CONDITIONS
UNI EN 1789 : 2014 MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES

ISO 8835-3:2007 Inhalational anaesthesia systems Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems
EN 740:1998/A1:2004 ANAESTHETIC WORKSTATIONS AND THEIR MODULES - PARTICULAR REQUIREMENTS
ISO 15001:2010 Anaesthetic and respiratory equipment Compatibility with oxygen
ISO 9170-2:2008 Terminal units for medical gas pipeline systems — Part 2: Terminal units for anaesthetic gas scavenging systems
ISO 5359:2014 Anaesthetic and respiratory equipment Low-pressure hose assemblies for use with medical gases
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
NFPA 99 : 2018 HEALTH CARE FACILITIES CODE
ISO 14971:2007 Medical devices Application of risk management to medical devices
EN 13348:2016 Copper and copper alloys - Seamless, round copper tubes for medical gases or vacuum
ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
ISO 7396-1:2016 Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum

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