YY/T 1986-2025 Sterile and single-use catheters and accessories for neuraxial application

Scope

This document specifies the expected performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging, and manufacturer-provided information requirements for neural catheters and accessories, and describes the corresponding test methods.
For therapeutic or diagnostic purposes, neural catheters are intended to deliver drugs directly to neural sites, provide wound infiltration analgesia and other local anesthesia, or are intended for monitoring or removing fluid from neural sites.
Note 1: Neural application sites include the spine, intrathecal or subarachnoid space, and epidural space (these sites are merely examples and not all inclusive). In neural applications, anesthetics/analgesics can be administered to most localized areas of the body, such as limbs, and include nerve blockade (e.g., brachial plexus blockade or single nerve blockade). Neural applications include continuous infusion of local anesthetics into wounds.
Note 2: Local anesthetic/analgesic injections subcutaneously and systemic injections of anesthetics are not considered neural applications.
This document applies to the following types of devices: — Spinal/epidural catheters and accessories; — Spinal/epidural port catheters and accessories; — Peripheral nerve blockade catheters and accessories; — Wound infusion catheters and accessories (also known as continuous postoperative analgesia catheters and accessories).
This document does not apply to: — Pumps and other devices intended to deliver drugs through catheters and accessories; — Drug delivery catheters (such as trocars) that do not directly act on the nervous system but have an indirect effect on it; — Other drainage catheters outside of neural applications.

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