SIST EN ISO 5359:2015/A1:2018
(Amendment)Anaesthetic and respiratory equipment - Low-pressure hose assemblies for use with medical gases - Amendment 1 (ISO 5359:2014/Amd 1:2017)
Anaesthetic and respiratory equipment - Low-pressure hose assemblies for use with medical gases - Amendment 1 (ISO 5359:2014/Amd 1:2017)
2017-08-31 - BTC 110/2017 - BT approve publication of EN ISO with modified Annex ZA & Foreword
2017-08-08 - Cannot allocate for publication due to negative assessment from Consultant.
CEN/BT C082/2011: DOW = DAV + 36 months
Anästhesie- und Beatmungsgeräte - Niederdruck-Schlauchleitungssysteme zur Verwendung mit medizinischen Gasen (ISO 5359:2014/Amd 1:2017)
Matériel d'anésthésie et de réanimation respiratoire - Flexibles de raccordement à basse pression pour utilisation avec les gaz médicaux (ISO 5359:2014/Amd 1:2017)
Anestezijska in dihalna oprema - Nizkotlačne povezovalne cevi za delo z medicinskimi plini - Dopolnilo A1 (ISO 5359:2014/Amd 1:2017)
General Information
- Status
- Published
- Public Enquiry End Date
- 14-Sep-2015
- Publication Date
- 08-Jan-2018
- Technical Committee
- VAZ - Healthcare
- Current Stage
- 6060 - National Implementation/Publication (Adopted Project)
- Start Date
- 08-Dec-2017
- Due Date
- 12-Feb-2018
- Completion Date
- 09-Jan-2018
- Directive
- Not Harmonized93/42/EEC - Medical devices
Relations
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 01-Feb-2018
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.
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Frequently Asked Questions
SIST EN ISO 5359:2015/A1:2018 is a amendment published by the Slovenian Institute for Standardization (SIST). Its full title is "Anaesthetic and respiratory equipment - Low-pressure hose assemblies for use with medical gases - Amendment 1 (ISO 5359:2014/Amd 1:2017)". This standard covers: 2017-08-31 - BTC 110/2017 - BT approve publication of EN ISO with modified Annex ZA & Foreword 2017-08-08 - Cannot allocate for publication due to negative assessment from Consultant. CEN/BT C082/2011: DOW = DAV + 36 months
2017-08-31 - BTC 110/2017 - BT approve publication of EN ISO with modified Annex ZA & Foreword 2017-08-08 - Cannot allocate for publication due to negative assessment from Consultant. CEN/BT C082/2011: DOW = DAV + 36 months
SIST EN ISO 5359:2015/A1:2018 is classified under the following ICS (International Classification for Standards) categories: 11.040.10 - Anaesthetic, respiratory and reanimation equipment; 83.140.40 - Hoses. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN ISO 5359:2015/A1:2018 has the following relationships with other standards: It is inter standard links to SIST EN 1789:2020+A1:2024, SIST EN 1789:2020, SIST EN 13718-2:2015+A1:2020, SIST EN 13718-1:2015+A1:2020, SIST EN ISO 5359:2015. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN ISO 5359:2015/A1:2018 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC; Standardization Mandates: M/023. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
SIST EN ISO 5359:2015/A1:2018 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
01-februar-2018
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Anaesthetic and respiratory equipment - Low-pressure hose assemblies for use with
medical gases - Amendment 1 (ISO 5359:2014/Amd 1:2017)
Anästhesie- und Beatmungsgeräte - Niederdruck-Schlauchleitungssysteme zur
Verwendung mit medizinischen Gasen (ISO 5359:2014/Amd 1:2017)
Matériel d'anésthésie et de réanimation respiratoire - Flexibles de raccordement à basse
pression pour utilisation avec les gaz médicaux (ISO 5359:2014/Amd 1:2017)
Ta slovenski standard je istoveten z: EN ISO 5359:2014/A1:2017
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
83.140.40 Gumene cevi Hoses
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 5359:2014/A1
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2017
EUROPÄISCHE NORM
ICS 83.140.40; 11.040.10
English Version
Anaesthetic and respiratory equipment - Low-pressure
hose assemblies for use with medical gases - Amendment
1 (ISO 5359:2014/Amd 1:2017)
Matériel d'anesthésie et de réanimation respiratoire - Anästhesie- und Beatmungsgeräte - Niederdruck-
Flexibles de raccordement à basse pression pour Schlauchleitungssysteme zur Verwendung mit
utilisation avec les gaz médicaux - Amendement 1 (ISO medizinischen Gasen - Änderung 1 (ISO
5359:2014/Amd 1:2017) 5359:2014/Amd 1:2017)
This amendment A1 modifies the European Standard EN ISO 5359:2014; it was approved by CEN on 16 August 2017.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This amendment exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 5359:2014/A1:2017 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered . 5
European foreword
The text of this Amendment EN ISO 5359:2014/A1:2017 to the EN ISO 5359:2014 from Technical
Committee ISO/TC 121 “Anaesthetic and respiratory equipment” of the International Organization for
Standardization (ISO) has been taken over as an amendment to the European Standard by Technical
Committee CEN/TC 215 “Respiratory and anaesthetic equipment” the secretariat of which is held by
BSI.
This Amendment to the European Standard EN ISO 5359:2014 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by May 2018, and
conflicting national standards shall be withdrawn at the latest by November 2020.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive.
For relationship with EU Directive, see informative Annex ZA, which is an integral part of this
document.
The following referenced documents are indispensable for the application of this document. For
undated references, the latest edition of the referenced document (including any amendments) applies.
For dated references, only the edition cited applies. However, for any use of this standard ‘within the
meaning of Annex ZA, the user should always check that any referenced document has not been
superseded and that its relevant contents can still be considered the generally acknowledged state-of-
art.
When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a
normative reference to the corresponding EN standard, if available, and otherwise to the dated version
of the ISO or IEC standard, as listed below.
NOTE The way in which these referenced documents are cited in normative requirements determines the
extent (in whole or in part) to which they apply.
Table — Correlation between normative references and dated EN and ISO standards
Normative
Equivalent dated standard
references
EN ISO
as listed in Clause 2 of the
ISO standard
ISO 1307:2006 EN ISO 1307:2008 ISO 1307:2006
ISO 1402:2009 EN ISO 1402:2009 ISO 1402:2009
ISO 8033:2006 EN ISO 8033:2006 ISO 8033:2006
ISO 9170-1:2008 EN ISO 9170-1:2008 ISO 9170-1:2008
ISO 14155:2011 EN ISO 14155:2011 ISO 14155:2011
ISO 14971:2007 EN ISO 14971:2012 ISO 14971:2007
ISO 15001:2010 EN ISO 15001:2011 ISO 15001:2010
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 5359:2014/Amd 1:2017 has been approved by CEN as EN ISO 5359:2014/A1:2017
without any modification.
Annex ZA
(informative)
Relationship between this European Standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered
This European Standard has been prepared under a Commission’s standardization request [M/023
concerning the development of European Standards related to medical devices] to provide one
voluntary means of conforming to essential requirements of Council Directive 93/42/EEC of 14 June
1993 concerning medical devices [OJ L 169].
Once this standard is cited in the Official Journal of the European Union under
...