YY/T 0916.1-2021 Active Industry standards-Medicine

YY/T 0916.1-2021 Small-bore connectors for liquids and gases in healthcare applications—Part 1:General requirements

Publish Date: 2021-09-06 Implement Date: 2022-09-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: YY/T 0916.1-2021

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Anesthesia, respiration, and resuscitation equipment

Publish Date: 2021-09-06

Implement Date: 2022-09-01

Pages: 30 pages

Scope

This part of YY/T 0916 specifies the general requirements for small-bore connectors used to deliver liquids or gases in the field of medical applications. These small-bore connectors are used in medical devices or accessories intended for use on patients.
This part also specifies the medical fields in which these small-bore connectors are intended to be applied.
These medical fields include (but are not limited to):
——Respiratory system and drive gas;
——Gastrointestinal tract;
——Urinary tract;
——Inflation of limb airbags;
——Axial nerves; and
——Intravascular or subcutaneous applications.
This part provides a methodology for evaluating the non-interconnectivity characteristics of small-bore connectors based on their inherent design and dimensions, to ensure that the risk of erroneous connections between different medical devices or accessories in the applications specified in this part and those to be developed in future parts of the ISO 80369 series standard is reduced.
This part does not specify the requirements for medical devices or accessories using these small-bore connectors. These requirements are given in the relevant standards for specific medical devices or accessories.
Note 1: Chapter 7 allows the inclusion of designs for small-bore connectors for other new applications in the ISO 80369 series standard.
Note 2: Although the current relevant standards for specific medical devices do not yet require it, manufacturers are encouraged to introduce small-bore connectors specified in this series standard into medical devices, medical systems, or accessories. It is expected that when the relevant standards for specific medical devices are revised in the future, the risk of switching to small-bore connectors specified in the ISO 80369 series standard will be considered.
Note 3: The connectors specified in the ISO 80369 series standard are intended to be used only in their specified applic