YY/T 0916.7-2024 Active

This document specifies the dimensions of small-bore connectors, as well as the requirements for their design and functional characteristics, which are intended for use in medical devices and accessories for intravascular applications or subcutaneous injection connections in medical devices and accessories.
Example: Subcutaneous syringes and injection needles or intravascular (IV) catheters with male and female luer non-locking (sliding) connectors and luer locking connectors.
Note 1: See Appendix A.
Note 2: Luer connectors were originally designed for pressures not exceeding 300 kPa.
This document does not specify the requirements for medical devices or accessories that use these connectors. These requirements are given in the dedicated documents for specific medical devices or accessories.
This document does not specify the requirements for small-bore connectors specified in the following other documents:
—— Blood dialyzers, blood dialysis filters, and blood filter blood chamber interfaces (applicable parts of ISO 8637 and ISO 8638 related to blood chamber interfaces);
—— Connectors for blood dialysis, blood dialysis filtration, and blood filtration equipment (ISO 8637);
—— Bottle cap penetration connectors for infusion systems (ISO 85364).
Note 3: Even if the current dedicated documents related to medical devices do not make requirements, manufacturers are encouraged to apply small-bore connectors that comply with this document to medical devices or accessories. It is expected that when the relevant dedicated medical device documents are revised, the requirements for small-bore connectors specified in YY/T 0916 will be included therein.
Note 4: Chapter 7 of YY/T 0916.1—2021 specifies alternative methods for small-bore connectors that comply with YY/T 0916.1—2021 but do not comply with this document, which are intended for use in medical devices or accessories for intravascular applications or subcutaneou