BS EN ISO 80369-1:2018

BS EN ISO 80369-1:2018

Small-bore connectors for liquids and gases in healthcare applications. General requirements

Status : Current   Published : November 2018



What is this standard about?

This document specifies general requirements for small-bore connectors, which convey liquids or gases in healthcare applications. These small-bore connectors are used in medical devices or accessories intended for use with a patient. This document also specifies the healthcare fields in which these small-bore connectors are intended to be used. These healthcare fields include, but are not limited to:

— breathing systems and driving gases;

— enteral;

— limb cuff inflation;

— neuraxial;

— intravascular or hypodermic.

This document provides the methodology to assess non-interconnectable characteristics of small-bore connectors based on their inherent design and dimensions in order to reduce the risk of misconnections between medical devices or between accessories for different applications as specified in this document as well as those that will be developed under future parts of the ISO 80369 series.

This document does not specify requirements for the medical devices or accessories that use these small-bore connectors. Such requirements are given in particular International Standards for specific medical devices or accessories.

NOTE 1 A clause in the document allows for additional designs of small-bore connectors for new applications for inclusion in the ISO 80369 series.

NOTE 2 Manufacturers are encouraged to incorporate the small-bore connectors specified in the ISO 80369 series into medical devices, medical systems or accessories, even if currently not required by the relevant particular medical device standards. It is expected that when the relevant particular medical device standards are revised, the risks associated with changing to the new small-bore connectors as specified in the ISO 80369 series of standards will be considered.

NOTE 3 The connectors specified in the ISO 80369 series are intended for use only in their specified application. Use of these connectors for other applications increases risk that a hazardous misconnection could occur.

NOTE 4 Manufacturers and responsible organizations are encouraged to report their experience with the small-bore connectors specified in the ISO 80369 series to the Secretariat of ISO/TC 210 so that this feedback can be considered during the revision of the relevant part of the ISO 80369 series.

Standard NumberBS EN ISO 80369-1:2018
TitleSmall-bore connectors for liquids and gases in healthcare applications. General requirements
Publication Date26 November 2018
Normative References(Required to achieve compliance to this standard)ISO 14971, ISO 80369-6, ISO 80369-7, ISO 80369-3, IEC 62366-1, IEC 80369-5
Informative References(Provided for Information)ASTM STP 1369-EB, CEN/CR 13825, ISO 5356-1, ISO 80601-2-74, IEC 60601-1, ISO 6892-1, ISO 527-2, ISO 178, ISO 7886-1, ASTM D790 - 17, ISO 7010:2011, ASTM D638 - 14, ISO 16142-1:2016, ISO 15223-1:2016, EN 13544-2:2002+A1:2009
ReplacesBS EN ISO 80369-1:2010
International RelationshipsEN ISO 80369-1:2018,ISO 80369-1:2018
Draft Superseded By15/30287229 DC
DescriptorsConical fittings (syringes), Medical breathing apparatus, Blood transfusion equipment, Pipe connections, Risk assessment, Medical equipment, Small, Safety measures, Drug administration, Liquids, Parenteral infusion equipment, Gases, Catheters, Fluids handling equipment (medical)
Title in FrenchRaccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé Exigences générales
Title in GermanVerbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in medizinischen Anwendungen Allgemeine Anforderungen
ISBN978 0 580 83780 7
File Size1.399 MB

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