Overview
EN ISO 5359:2014/A1:2017 (CEN adoption) is Amendment 1 to ISO 5359:2014 covering low-pressure hose assemblies for use with medical gases. Approved by CEN in August 2017, this amendment is incorporated into the European Standard without modification and supports conformity with EU medical device requirements (see Annex ZA and Directive 93/42/EEC). The amendment primarily clarifies gas designation and terminology and updates table footnotes and colour-coding language.
Key Topics
- Scope and status: Amendment A1 modifies EN ISO 5359:2014 and was approved by CEN on 16 August 2017. National implementation deadlines and withdrawal of conflicting standards are specified in the European foreword.
- 'Oxygen 93' designation: The amendment replaces the term "oxygen-enriched air" with "oxygen 93" throughout the document. The definition adopted from ISO 7396-1:2016 states that oxygen 93 is the gas produced by an oxygen concentrator unit whose concentration is within the limits specified in the relevant pharmacopoeial monograph.
- Table and footnote changes: Table 1 is updated to reflect the new designation O2 (O 93) in table entries and footnotes. The amendment refines wording in footnotes, replacing "Symbol and colour coding to be defined by national authorities." with "Colour coding to be defined by national authorities."
- Regulatory alignment: Annex ZA maps the standard to essential requirements of Directive 93/42/EEC. Compliance with the normative clauses provides a presumption of conformity within the scope of the standard.
Applications
This amendment and the underlying standard are relevant to:
- Manufacturers and suppliers of low-pressure hose assemblies and breathing system components who need to ensure product labelling, gas designation and colour coding meet current European practice.
- Procurement and clinical engineering teams specifying hoses and connectors for anaesthesia and respiratory equipment in hospitals and clinics.
- Regulatory and quality teams preparing technical documentation and demonstrating conformity with EU medical device requirements.
Practical benefits include clearer gas terminology (reducing ambiguity around oxygen supply from concentrators), consistent national colour-coding expectations, and a documented path to demonstrate compliance with EU directives.
Related Standards
- ISO 5359:2014 (base standard) - Low-pressure hose assemblies for medical gases
- ISO 7396-1:2016 - Source of the "oxygen 93" definition
- ISO 15001 and ISO 14971 - referenced in Annex ZA for risk management and material considerations
For implementation, users should consult the full EN ISO 5359:2014/A1:2017 text and related normative references. National standards bodies provide the official language versions and details on national implementation and any additional national requirements.
