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

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

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1   Scope

This part of ISO 80369 specifies general requirements for small-boreconnectors, which convey liquids or gases in healthcare applications. These small-boreconnectors are used in medicaldevices or accessories intended for use with a patient.
This International Standard also specifies the healthcare fields in which these small-boreconnectors are intended to be used.
These healthcare fields of use include, but are not limited to, applications for:
  • — breathingsystems and driving gases,
  • — enteral and gastric,
  • — urethral and urinary,
  • — limb cuff inflation,
  • — neuraxial devices, and
  • — intravascular or hypodermic.
Small-boreconnectors 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-boreconnectors based on their inherent design and dimensions in order to reduce the risk of misconnections between medicaldevices or between accessories for different applications and to reduce the risk of misconnections between medicaldevices 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 medicaldevices or accessories that use thesesmall-boreconnectors. Such requirements are given in particular International Standards for specific medicaldevices or accessories.

NOTE 1 It is intended that new designs of small-boreconnectors 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-boreconnectors specified in this series of standards into medicaldevices, medical systems or accessories, even if currently not required by the relevant particular medicaldevice standards. It is expected that when the relevant particular medicaldevice standards are revised, requirements for small-boreconnectors as specified in the series of standards will be included.

NOTE 3 Manufacturers and responsibleorganizations are encouraged to report their experience with the small-boreconnectors 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.