ISO 5359:2014/Amd 1:2017

Overview

ISO 5359:2014/Amd 1:2017 is an important amendment to the international standard for anaesthetic and respiratory equipment, specifically addressing low-pressure hose assemblies for use with medical gases. Published by ISO (International Organization for Standardization), this amendment reflects updates essential for the continued safety and effectiveness of medical gas delivery systems in healthcare settings. The standard aligns with the evolving definitions and classifications of medical gases, notably replacing “oxygen-enriched air” with the newly defined term “oxygen 93”.

This update ensures clarity and consistency across the medical device industry, facilitating safer practices in anaesthesia and respiratory care by specifying technical requirements for flexible hose assemblies used with medical gases.

Key Topics

• Terminology Update:

  • The amendment replaces the term “oxygen-enriched air” with “oxygen 93,” reflecting changes in ISO 7396-1:2016.
  • “Oxygen 93” is defined as gas produced by an oxygen concentrator unit with a concentration within relevant pharmacopoeial limits.

• Scope and Application:

  • Applies specifically to low-pressure hose assemblies used to connect medical gas systems, including anaesthetic and respiratory equipment.
  • Ensures compatibility and safety of hoses used with various medical gases, now including oxygen 93.

• Technical Revisions:

  • Amendment modifies Table 1 (connecting medical gases to color coding and symbols) to replace “oxygen-enriched air” with “oxygen 93.”
  • Footnotes clarifying color coding are updated to reflect national authority requirements, removing references to symbol definitions.

• Standardization Process:

  • Prepared by ISO Technical Committee ISO/TC 121, Subcommittee SC 1 (Anaesthetic and respiratory equipment).
  • Reflects collaboration with international organizations and aligns with the ISO/IEC directives.

Applications

ISO 5359:2014/Amd 1:2017 is critical for manufacturers, healthcare providers, and safety regulators involved in the design, production, and use of medical gas hose assemblies. Practical applications include:

• Medical Gas Supply Systems: Ensures hoses used in oxygen delivery, anaesthesia machines, and respiratory devices meet updated safety and performance standards.

• Hospital and Clinical Settings: Helps hospital procurement departments specify compliant low-pressure hose assemblies, minimizing risk in oxygen therapy and anaesthetic procedures.

• Device Manufacturing and Quality Control: Guides manufacturers in labeling and color coding to maintain consistency with national and international safety standards.

• Regulatory Compliance: Supports compliance with global medical device regulations by ensuring that medical gas hoses conform to the latest international standards on performance and safety.

Related Standards

• ISO 7396-1:2016 – Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum
  This standard directly relates to the amendment’s redefinition of “oxygen 93” and governs oxygen supply systems critical for medical gas management.

• ISO 11146 Series – Anaesthetic and respiratory equipment standards
  Complements ISO 5359 by covering other components in breathing attachments and anaesthetic machines.

• ISO/IEC Directives Part 1 and Part 2 – Guidelines for ISO standard development and editorial rules
  Ensures standardized document preparation and maintenance.

• National Color Coding Standards
  The amendment refers to national authorities for colour coding of medical gas hoses, maintaining local regulatory consistency.

By adopting ISO 5359:2014/Amd 1:2017, healthcare equipment manufacturers and users ensure adherence to the latest recognized safety parameters for low-pressure hose assemblies, particularly addressing modern oxygen supply requirements. This standard enhances patient safety, device interoperability, and regulatory compliance across global medical gas applications.