This document specifies the basic requirements and corresponding test methods for single-use portable infusion pumps - non-electrically driven (hereinafter referred to as infusion pumps). This document applies to infusion pumps for continuous (fixed or adjustable) and/or self-controlled delivery of fluids for neurological, intravascular or subcutaneous applications. This document does not apply to: electric or electronically controlled infusion pumps covered by GB 9706.224; devices for single patient use for delivering discrete (bolus) medicinal liquids covered by the YY/T 1768 series; implantable devices; intestinal Feeding pump; transcutaneous infusion device; device in which infusion power is not provided by the device itself or obtained by active intervention of the patient (for example, a device powered only by gravity).
YY 0451-2023 history
2023YY 0451-2023 Single use portable infusion pump non-electrically driven
2010YY 0451-2010 Portable infusion devices for single use.Non electrically driven
2003YY 0451-2003 Single-use injectors for continuous ambulatory administration of medicinal products by parenteral route