GB 9706.224-2021

Active

Medical electrical equipment—Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers

医用电气设备 第2-24部分:输液泵和输液控制器的基本安全和基本性能专用要求

Standard Type
GB
ICS
11.040.20
CCS
C31
Status
Active
Issue Date
2021-12-01
Implementation
2023-05-01
Centralized Committee
国家药监局
Issuing Authority
国家市场监督管理总局、中国国家标准化管理委员会

Application Summary AI generated

This standard specifies the particular safety and performance requirements for infusion pumps and controllers used in medical settings. It applies to devices that deliver fluids into a patient's body at controlled rates, covering aspects like flow rate accuracy, alarm systems, and protection against hazards such as over-infusion or air embolism. The standard is used by manufacturers for product design and testing, and by healthcare facilities for procurement and compliance verification in clinical environments.

Related Standards

Transparency note: The application summary and key sentences on this page were automatically generated by AI from the standard's original text. This content has not been human-verified and should not be used for compliance or regulatory purposes. Always refer to the official standard document from the issuing authority.