IEC - International Electrotechnical Commission - ISO 80369-1:2010
Small-bore connectors for liquids and gases in healthcare applications -- Part 1: General requirements
|Organization:||IEC - International Electrotechnical Commission|
|Publication Date:||15 December 2010|
|ICS Code (Anaesthetic, respiratory and reanimation equipment):||11.040.10|
|ICS Code (Transfusion, infusion and injection equipment):||11.040.20|
ISO 80369-1:2010 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... View More
ISO 80369-1:2010 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.
ISO 80369-1:2010 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 ISO 80369-1:2010 are non-interconnectable
- 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.
ISO 80369-1:2010 provides the methodology to assess non-interconnectable
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.