AAMI 80369-1

Description / Abstract: 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.

NOTE 1 It is intended that new designs of SMALL-BORE CONNECTORS will be included in this series of standards after they have been assessed according to the PROCEDURE given in Clause 6.

NOTE 2 MANUFACTURERS are encouraged to incorporate the SMALL-BORE CONNECTORS specified in this series of standards 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, requirements for SMALL-BORE CONNECTORS as specified in the series of standards will be included.

NOTE 3 MANUFACTURERS and RESPONSIBLE ORGANIZATIONS are encouraged to report their experience with the SMALL-BORE CONNECTORS specified in this series of standards to the Secretariat of ISO/TC 210 to consider this feedback during the revision of the relevant part of this series of standards.