ISO 80369-7:2021
Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications

Standard No.

ISO 80369-7:2021

Release Date

2021

Published By

International Organization for Standardization (ISO)

Latest

ISO 80369-7:2021

Scope

This document specifies dimensions and requirements for the design and functional performance of small-bore connectors intended to be used for connections in intravascular applications or hypodermic connections in hypodermic applications of medical devices and accessories. EXAMPLES Hypodermic syringes and needles or intravascular (IV) cannulae with male and female Luer slip connectors and Luer lock connectors. NOTE 1 NOTE 2 See Annex A. The Luer connector was originally designed for use at pressures up to 300 kPa. This document does not specify requirements for the medical devices or accessories that use these connectors. Such requirements are given in particular documents for specific medical devices or accessories. This document does not specify requirements for the following small-bore connectors, which are specified in other documents: — haemodialyser, haemodiafilter and haemofilter blood compartment ports (ISO 8637 applicable portion of ISO 8638 [6] referencing blood compartment ports); [5] — haemodialysis, haemodiafiltration and haemofiltration equipment connectors (ISO 8637 [5]); and — infusion system closure piercing connectors (ISO 8536-4 [4]). NOTE 3 Manufacturers are encouraged to incorporate the small-bore connectors specified in this document into medical devices or accessories, even if currently not required by the relevant particular medical device documents. It is expected that when the relevant particular medical device documents are revised, requirements for smallbore connectors, as specified in ISO 80369, will be included. NOTE 4 small-bore connectors intended for use with intravascular applications or hypodermic application medical devices or accessories, which do not conform with this document.

ISO 80369-7:2021 Referenced Document

• IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices
• ISO 14971:2019 Medical devices — Application of risk management to medical devices
• ISO 80369-1:2018 Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements
• ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
• ISO 80369-6:2016 Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications

ISO 80369-7:2021 history

• 2021 ISO 80369-7:2021 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
• 2016 ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications