YY/T 0916.7-2024: Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications

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Scope

This document specifies the dimensions and requirements for the design and functional
characteristics of small-bore connectors, which are intended for use in connections for
intravascular applications or hypodermic injection applications involving medical
devices and accessories.
Examples. Hypodermic syringes and needles or intravascular (hereinafter referred to as IV)
cannulae with male and female Luer non-locking (slip) connectors and Luer-lock connectors.
Note 1.See Appendix A.
Note 2.Luer connectors were originally designed for pressures not exceeding 300 kPa.
This document does not specify requirements for medical devices or accessories that
use these connectors. Such requirements are provided in specific documents for
particular medical devices or accessories.
This document does not specify requirements for small-bore connectors specified in the
following other documents.
- Blood compartment ports of hemodialyzers, hemodiafilters, hemofilters (relevant
parts of ISO 8637 and ISO 8638 regarding blood compartment ports);
- Connectors for hemodialysis, hemodiafiltration, hemofiltration equipment (ISO
8637);
- Spike connectors for infusion systems (ISO 8536-4).
Note 3.Manufacturers are encouraged to incorporate small-bore connectors complying with
this document into medical devices or accessories, even if current specific documents for those
medical devices do not require it. It is anticipated that when relevant specific medical device
documents are revised, the requirements for small-bore connectors specified in YY/T 0916 will
be included.
Note 4.Chapter 7 of YY/T 0916.1-2021 specifies alternative methods for small-bore connectors
intended for use with medical devices or accessories for intravascular or hypodermic
applications; these connectors comply with YY/T 0916.1-2021 but do not comply with this
document.

Basic Data

Standard ID	YY/T 0916.7-2024 (YY/T0916.7-2024)
Description (Translated English)	Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C30
Classification of International Standard	040.25
Word Count Estimation	50,590
Date of Issue	2024-07-08
Date of Implementation	2026-07-20
Issuing agency(ies)	State Drug Administration