YY/T 0916.6-2022Small-bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications (English PDF)

1 Scope

This part of YY/T 0916 specifies the requirements for small-bore connectors intended for connection in axonal applications. Axonal applications involve the following

Use of several medical devices. anticipated drug delivery to axonal sites, wound infiltration anaesthetic delivery, and other local anaesthetic procedures, or for therapeutic or diagnostic purposes

Monitoring or drainage of cerebrospinal fluid (CSF) for purposes.

Note 1.The site of axonal application includes the spine, intrathecal or subarachnoid space, ventricle, subdural space, epidural space or dural space. Axonal application of anesthesia

Agents can be infused locally to affect large parts of the body (eg, limbs) and include plexus block (eg, branchial nerve block or single nerve block).

Axonal applications include continuous wound infusion of local anesthetics.

Note 2.This section does not consider subcutaneous injection of local anesthesia as axonal application.

Examples. Expected intrathecal chemotherapy, local anesthetics, contrast agents, antibiotics, analgesics.

This section specifies the dimensions of these small-bore connectors intended for use in medical devices, as well as requirements for design and functional characteristics.

This section does not specify requirements for medical devices or accessories using these connectors. These requirements are specified in the standard of the dedicated medical device or accessory.

given in the standard.

Note 3.Even if it is not required in the current special standards related to medical devices, manufacturers are encouraged to apply the small-bore connectors specified in this part to medical devices or accessories.

on the piece. It is expected that the requirements for small bore connectors specified in this section will be included when revising the relevant dedicated medical device standards. In addition, many use

Medical devices for axonal applications still need to develop standards.

Note 4.5.8 of YY/T 0916.1-2014 specifies alternative methods for small aperture connectors that comply with YY/T 0916.1-2014 but do not comply with this part method, these small bore connectors are intended for medical devices or accessories for axonal applications.

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 0916.3-2022 Small bore connectors for medical liquids and gases - Part 3.Connectors for gastrointestinal applications (ISO 80369-3.2016, 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- […]