YY/T 0916.1-2021: (Small-aperture connectors for medical drugs and gases - Part 1: General requirements)

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Scope

This Part of YY/T 0916 specifies general requirements for small-bore connectors used
for conveying liquids or gases in medical applications. These small-bore connectors are
intended for use in medical devices or accessories intended for patients.
This Part also specifies the medical fields of intended use for these small-bore
connectors.
These medical areas include (but are not limited to).
- respiratory systems and drive gases;
- gastrointestinal tract;
- urinary tract;
- limb cuff inflation;
- axonal; and
- intravascular or subcutaneous.
Based on the inherent design and dimensions of small-bore connectors, this Part
provides a methodology for assessing their non-interconnectable characteristics, so as
to minimize the risk of misconnections between medical devices or accessories
intended for different applications - whether specified in this Part or in future parts of
the ISO 80369 series.
This Part does not specify requirements for medical devices or accessories using these
small-bore connectors. Such requirements are provided in the relevant standards for
specific medical devices or accessories.
NOTE 1.Chapter 7 allows for the design of small-bore connectors for other new applications to be
included in the ISO 80369 series of standards.
NOTE 2.Although not yet required by current device-specific standards, manufacturers are
encouraged to incorporate the small-bore connectors specified in this series of standards into
medical devices, medical systems, or accessories. It is anticipated that future revisions of relevant
device-specific standards shall consider the risks associated with transitioning to the small-bore

Basic Data

Standard ID	YY/T 0916.1-2021 (YY/T0916.1-2021)
Description (Translated English)	(Small-aperture connectors for medical drugs and gases - Part 1: General requirements)
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C30
Word Count Estimation	31,380
Issuing agency(ies)	State Drug Administration