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

Scope

This part of YY/T 0916 specifies the requirements for small-bore connectors intended for use in neural axonal applications. Neural axonal applications involve the use of the following medical devices: administration of drugs to neural axonal sites, infiltration anesthesia for wound treatment, and other local anesthesia procedures, or monitoring or drainage of cerebrospinal fluid (CSF) for therapeutic or diagnostic purposes.
Note 1: The sites of neural axonal applications include the spine, intrathecal or subarachnoid space, brain ventricles, subdural space, extradural space, or interdural space. Neural axonal anesthetics can be locally infused to affect most parts of the human body (such as limbs) and include nerve plexus blockade (such as phrenic nerve blockade or single nerve blockade). Neural axonal applications include continuous infusion of local anesthetics into wounds.
Note 2: This part does not consider subcutaneous local anesthesia injection as a neural axonal application.
Example: Administration of chemotherapy drugs intrathecally, local injection of anesthetics, contrast agents, antibiotics, and analgesics.
This part specifies the dimensions and design and functional characteristics requirements for these small-bore connectors intended for medical devices.
This part does not specify the requirements for medical devices or accessories using these connectors. These requirements are given in the standards for dedicated medical devices or accessories.
Note 3: Even if the current dedicated standards for medical devices do not require it, manufacturers are encouraged to apply the small-bore connectors specified in this part to medical devices or accessories. It is expected that the requirements for small-bore connectors specified in this part will be included when the relevant dedicated medical device standards are revised. In addition, many medical devices used for neural axonal applications still need to be standardized.

Development Information

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Referenced Standards

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