BS EN ISO 80369-1:2010
Small bore connectors for liquids and gases in healthcare applications. General requirements

Standard No.

BS EN ISO 80369-1:2010

Release Date

2011

Published By

British Standards Institution (BSI)

Status

Be replaced

Replace By

BS EN ISO 80369-1:2018

Latest

BS EN ISO 80369-1:2018

Replace

BS EN 15546-1:2008

Scope

This part of ISO 80369 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 International Standard also specifies the healthcare fields in which these SMALL-BORE CONNECTORS are intended to be used. These healthcare fields of use include, but are not limited to, APPLICATIONS for: - BREATHING SYSTEMS and driving gases, - enteral and gastric, - urethral and urinary, - limb cuff inflation, - neuraxial devices, and - intravascular or hypodermic. SMALL-BORE CONNECTORS as specified in this International Standard are NON-INTERCONNECTABLE with: - the cones and sockets of ISO 5356-1:2004 and ISO 5356-2:2006; - the temperature sensor CONNECTOR and mating ports specified in Annex DD of ISO 8185:2007; and - the nipples of EN 13544-2:2002. This International Standard 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 and to reduce the RISK of misconnections between MEDICAL DEVICES with 6 % Luer CONNECTORS, and all other non-Luer CONNECTORS that will be developed under future parts of this series of standards. It 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.

BS EN ISO 80369-1:2010 Referenced Document

• EN 13544-2:2002 Respiratory therapy equipment - Part 2: Tubing and connectors (Incorporates Amendment A1: 2009)*， 2024-04-19 Update
• IEC 62366:2007 Medical devices - Application of usability engineering to medical devices
• ISO 14971:2007 Medical devices - Application of risk management to medical devices
• ISO 5356-1:2004 Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets
• ISO 5356-2:2006 Anaesthetic and respiratory equipment - Conical connectors - Part 2: Screw-threaded weight-bearing connectors

BS EN ISO 80369-1:2010 history

• 2020 BS EN ISO 80369-1:2018 Small - bore connectors for liquids and gases in healthcare applications Part 1 : General requirements
• 2011 BS EN ISO 80369-1:2010 Small bore connectors for liquids and gases in healthcare applications. General requirements
• 2008 BS EN 15546-1:2008 Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements

BS EN ISO 80369-1:2010 Small bore connectors for liquids and gases in healthcare applications. General requirements has been changed from BS EN 15546-1:2008 Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements.