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

1 Scope

This part of YY/T 0916 specifies the dimensions, design and functional characteristics requirements.

Note 1 to entry. Gastrointestinal medical devices include gastrointestinal feeder systems, gastrointestinal drain systems, gastrointestinal syringes, and patient-entry devices with input ports.

instrument.

This section does not specify the dimensions and requirements of medical devices or accessories using these connectors. These requirements are specified in dedicated medical devices or attached given in the standard for the piece.

This standard does not specify requirements for small bore connectors for.

--- Medical devices for gastric suction only;

--- Medical devices for oral use only;

Example. Oral terminal syringes that are not intended to be connected to other medical devices and are intended to be used directly for patient oral administration.

--- Pressurized or pressure-relieved fixation mechanisms (such as balloons) used to fix medical devices inserted into the gastrointestinal tract in the correct position;

--- Gastrointestinal endoscopy equipment;

--- Medical devices for performing gastrostomy on the skin.

Note 2.Even if the current special standards related to medical devices do not require it, manufacturers are encouraged to apply small-bore connectors that meet the requirements of this part to gastrointestinal medical devices.

on the device or accessory. When it is expected to revise the relevant special medical device standards, the requirements for small aperture connectors specified in YY/T 0916 will be included in the in.

2 Normative references

The following documents are essential for the application of this document. For dated references, only the dated version applies to this article pieces. For undated references, the latest edition (including all amendments) applies to this document.

YY/T 0316-2016 Application of Medical Device Risk Management to Medical Devices (ISO 14971.2007 Corrected Edition, IDT)

YY/T 0916.1-2014 Small bore connectors for medical liquids and gases - Part 1.General requirements (ISO 80369-1.

2010, IDT)

YY/T 0916.6-2022 Small bore connectors for medical liquids and gases - Part 6.Connectors for shaft applications (ISO 80369-

6.2016, IDT)

YY/T 0916.20-2019 Small aperture connectors for medical liquids and gases-Part 20.General test methods (ISO 80369-

20.2015, IDT)

ISO 80369-7.2016 Small bore connectors for medical liquids and gases - Part 7.Connectors for intravascular or subcutaneous applications tics)

ASTM D790 Standard Test Method for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials (Standardtestmeth- […]