BS EN ISO 7396-2:2007

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.