YY/T 0916.3-2022 Small-bore connectors for liquids and gases in healthcare applications—Part 3:Connectors for enteral applications

Scope

This part of YY/T 0916 specifies the dimensions of small-bore connectors intended for use in gastrointestinal medical devices and accessories, as well as requirements for their design and functional characteristics.
Note 1: Gastrointestinal medical devices include gastrointestinal feeding systems, gastrointestinal drainage systems, gastrointestinal injectors, and devices that enter the patient's body with an input interface.
This part does not specify the dimensions and requirements of medical devices or accessories that use these connectors. These requirements are given in the standards for dedicated medical devices or accessories.
This part does not specify requirements for small-bore connectors used in the following:
——Medical devices used solely for gastric aspiration;
——Medical devices used solely for the oral cavity;
Example: An oral terminal injector intended not to be connected to other medical devices and intended to be used directly for administering fluids to the patient's oral cavity.
——Pressurizing or decompression fixing mechanisms (such as balloons) used to fix medical devices inserted into the gastrointestinal tract in the correct position;
——Gastrointestinal endoscopic examination instruments;
——Medical devices used for performing gastrostomy on the skin.
Note 2: Even if the current dedicated standards for medical devices do not make such requirements, manufacturers are encouraged to apply small-bore connectors that comply with the provisions of this part to gastrointestinal medical devices or accessories. It is expected that when the relevant dedicated medical device standards are revised, the requirements for small-bore connectors specified in YY/T 0916 will be included therein.

Development Information

Same series standard

Referenced Standards

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