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BS EN ISO 7396-2:2007

Current
Current

The latest, up-to-date edition.

Medical gas pipeline systems Anaesthetic gas scavenging disposal systems
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

07-31-2007

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

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.

This part of ISO7396 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.

NOTE In this part of ISO7396, the term “pipeline?? refers exclusively to pipelines that are part of a dedicated anaesthetic gas scavenging system (AGSS).

This part of ISO7396 is applicable only to those disposal systems intended to be connected via AGSS terminal units conforming to ISO9170-2 and to AGSS receiving systems conforming to ISO8835-3.

This part of ISO7396 also applies to:

  • extensions of existing AGSS disposal systems;

  • modifications of existing AGSS disposal systems;

  • modifications or replacement of power devices.

Committee
CH/121/6
DevelopmentNote
Supersedes 05/30128373 DC. (05/2007) Supersedes BS EN 737-2. (07/2007)
DocumentType
Standard
Pages
58
PublisherName
British Standards Institution
Status
Current
Supersedes

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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