Overview
EN ISO 7396-2:2007 - Medical gas pipeline systems - Part 2: Anaesthetic gas scavenging disposal systems (ISO 7396-2:2007) sets out requirements for the design, installation, function, performance, documentation, testing and commissioning of anaesthetic gas scavenging disposal systems (AGSS). Its purpose is to ensure patient safety and to minimise occupational exposure to anaesthetic gases and vapours. The standard applies to systems connected via AGSS terminal units compliant with ISO 9170-2 and receiving systems compliant with ISO 8835-3, and also covers extensions, modifications and replacement of power devices.
Key topics and requirements
- System scope and safety goals: Defines objectives such as avoidance of cross-connections, continuity of operation, and use of suitable materials to protect patients and staff.
- Power devices: Requirements and guidance for fans, blowers or dedicated vacuum pumps used as AGSS power devices (see informative Annex A).
- Pipelines and fittings: Specification for pipelines, connecting assemblies and disposal hoses, including non-interchangeability between anaesthetic scavenging components and other medical gas/vacuum systems.
- Performance tests: Methods for verifying pressure and flow characteristics, and means to prevent backflow (pressure/flow test procedures are included).
- Terminal units and interfaces: Compatibility requirements for AGSS terminal units and receiving systems to ensure safe transfer and disposal of waste anaesthetic gases.
- Marking and colour coding: Identification, labelling and durability tests for pipeline components.
- Installation, testing and commissioning: Detailed requirements for site installation, inspection, commissioning procedures and certification (with example procedures in Annex B and sample certification forms in Annex C).
- Documentation and operational information: Manufacturer and installer information requirements, “as-installed” drawings, electrical diagrams, and operational management guidance.
- Risk and rationale: Risk management checklist (Annex D) and rationale for selected requirements (Annex E).
Applications and users
EN ISO 7396-2:2007 is intended for:
- Healthcare facility designers and architects
- Biomedical engineers and maintenance teams
- Medical gas system installers and commissioning agents
- Equipment manufacturers and test laboratories
- Hospital safety officers and regulatory bodies
Typical applications include new hospital theatres, refurbishment or extension of anaesthesia gas scavenging systems, replacement of AGSS power devices, and certification of AGSS installations to ensure compliance and safe operation.
Related standards
- ISO 7396-1 - Pipeline systems for compressed medical gases and vacuum
- ISO 8835-3 - Requirements for AGSS receiving and transfer systems
- ISO 9170-2 - Terminal unit connections for AGSS
- EU Directive 93/42/EEC - Medical devices (relationship detailed in Annex ZA)
Keywords: anaesthetic gas scavenging disposal systems, AGSS, EN ISO 7396-2:2007, medical gas pipeline systems, testing and commissioning, patient safety, medical gas installation.