YY 0451-2023 Active
YY 0451-2023 Portable infusion devices for single use—Non electrically driven
Abstract
This document specifies the basic requirements and corresponding test methods for non-electrically driven portable infusion pumps (hereinafter referred to as infusion pumps) for single use.
This document is applicable to infusion pumps for continuous (fixed or adjustable) fluid delivery and/or self-controlled fluid delivery for neurological, intravascular, or subcutaneous applications.
Note: The sites of neurological applications include the spine, intrathecal or subarachnoid space, brain ventricles, supra-arachnoid space, extradural space, or interdural space. Neurological applications of anesthetics can be locally injected to affect most parts of the human body (such as limbs) and include plexus blockade (such as brachial plexus blockade or single nerve blockade). The process of neurological applications includes continuous infusion of local anesthetics into the wound.
General Product Information
| Document Type | Industry standards-Medicine |
|---|---|
| Standard Status | Active |
| Standard Code | YY 0451-2023 |
| CCS | Public medical equipment |
| ICS | Integrated disinfection and sterilization |
| Implement Date | 2026-09-15 |