Overview
SIST EN ISO 5359:2015/A1:2018 is an amendment to the standard governing anaesthetic and respiratory equipment, specifically focusing on low-pressure hose assemblies used with medical gases. Approved in February 2018, this amendment aligns with international practices and brings terminology and definitions in line with other related standards, most notably by replacing "oxygen-enriched air" with "oxygen 93". This update enhances safety and clarity for medical gas systems, supporting regulatory compliance across European healthcare environments.
This amendment is based on the European implementation of ISO 5359:2014/Amd 1:2017 and forms an integral part of the harmonized medical devices regulatory landscape in Europe, supporting essential requirements under EU medical device directives.
Key Topics
- Medical Gases Terminology: Introduction of "oxygen 93" in place of "oxygen-enriched air", aligning with ISO 7396-1:2016. This change ensures clear identification and specification of oxygen produced by concentrator units, enhancing safety and regulatory compliance.
- Hose Assemblies: Low-pressure hoses are critical in the delivery of medical gases. This standard amendment clarifies the designation and colour coding of hoses for oxygen 93, with national authorities defining specific codes where necessary.
- Regulatory Alignment: The amendment supports essential requirements from EU Directive 93/42/EEC for medical devices. Adherence to this standard confers a presumption of conformity regarding safety, labelling, and performance.
- Safety and Maintenance: The document addresses risk management and the importance of using appropriate materials, maintenance, and labelling for hose assemblies to ensure the continuous, safe supply of medical gases in clinical settings.
Applications
The amendment to ISO 5359 is highly relevant for:
- Hospitals and Clinics: Ensuring that all anaesthetic and respiratory hoses are clearly labelled and suitable for their intended medical gases, especially the newly clarified "oxygen 93".
- Medical Device Manufacturers: Updating product labelling, design documentation, and risk management processes to reflect the new definitions and requirements.
- Maintenance and Service Providers: Following the updated guidance for inspection, maintenance, and calibration of hose assemblies to maintain compliance and operational safety.
- Regulatory Compliance Departments: Demonstrating conformity with EU medical device regulations during audits and market access processes.
These applications support the uninterrupted and correct supply of medical gases, reduce risk associated with misidentification, and establish uniform requirements for products used across the European healthcare system.
Related Standards
Organizations implementing SIST EN ISO 5359:2015/A1:2018 should also be aware of several closely related standards:
- ISO 7396-1: Medical gas pipeline systems - Essential for contextual understanding of oxygen 93 and requirements for pipeline distribution.
- ISO 15001: Oxygen compatibility of materials - Relevant for design and selection of hose assemblies.
- ISO 1402, ISO 1307, ISO 8033: Standards covering hoses and their general requirements.
- ISO 9170-1: Terminal units for medical gas pipeline systems - Integration with hose assemblies.
- ISO 14155, ISO 14971: Application in clinical investigations and risk management, respectively.
Ensuring compatibility and adherence to these standards supports comprehensive safety for anaesthetic and respiratory equipment used with medical gases in healthcare settings.
Keywords: Anaesthetic equipment, respiratory equipment, low-pressure hose assemblies, medical gases, oxygen 93, medical device compliance, healthcare safety, ISO 5359, European Standard, medical gas hoses.
