ISO 9170-2:2008

Overview

ISO 9170-2:2008 - "Terminal units for medical gas pipeline systems - Part 2: Terminal units for anaesthetic gas scavenging systems" specifies requirements and dimensions for terminal units used in anaesthetic gas scavenging systems (AGSS) in accordance with ISO 7396-2. The standard covers two terminal unit types based on whether the power device is upstream or downstream of the terminal unit and defines the mating counterpart (probe) for type-specific connection points. ISO 9170-2:2008 focuses on safety, type specificity, cleanliness, testing, identification and information to be supplied by the manufacturer.

Key topics and technical requirements

• Scope and types
  • Defines two AGSS terminal unit types (Type 1 and Type 2) depending on the position of the power device relative to the terminal unit.
  • Clarifies that operating pressure ranges are given in ISO 7396-2.
• Type specificity and dimensions
  • Requires type-specific connection points and probes to prevent incorrect connections between AGSS components.
  • Specifies dimensional requirements for sockets, probes and interfaces (mating counterparts).
• Materials and construction
  • Emphasizes suitability of materials, cleanliness, and construction to meet safety objectives.
• Safety and risk management
  • Requires design and documentation consistent with ISO 14971 risk management principles to reduce hazards in normal and single-fault conditions.
• Testing and performance
  • Includes test methods for: endurance, pressure drop, connection/disconnection force, mechanical strength, leakage, and type specificity.
  • Requires tests for effective connection of probes and durability of markings and colour coding.
• Identification and information
  • Specifies marking, colour coding, packaging and manufacturer-supplied information required for installation and testing.
• Interfacing
  • Aligns with related standards for transfer/receiving systems (ISO 8835-3) and medical gas pipeline systems (ISO 7396-2).

Applications and who uses this standard

ISO 9170-2:2008 is directly applicable to:

• Medical device and terminal unit manufacturers designing AGSS terminal units, probes and sockets
• Hospital biomedical engineers and facilities teams installing and maintaining medical gas pipeline and anaesthetic gas scavenging systems
• Contractors and installers performing pipeline pressure testing and commissioning under ISO 7396-2
• Regulatory bodies and procurement teams assessing compliance and safety of AGSS components
• Clinical engineers and risk managers applying ISO 14971 for safe system integration

Practical benefits include preventing hazardous cross-connections, ensuring reliable probe/socket mating, simplifying maintenance/testing, and improving patient and staff safety during anaesthetic gas disposal.

Related standards

• ISO 7396-2 - Medical gas pipeline systems: Anaesthetic gas scavenging disposal systems
• ISO 8835-3 - Transfer and receiving systems for active AGSS
• ISO 14971 - Risk management for medical devices
• ISO 15001 - Compatibility with oxygen
• ISO 9170-1 - Terminal units for compressed medical gases and vacuum

Keywords: ISO 9170-2:2008, anaesthetic gas scavenging systems, AGSS terminal units, terminal unit probes, type-specific connection, medical gas pipeline systems, ISO 7396-2, testing and marking.