This Standard specifies the terms and definitions, requirements, test methods, marking and manual for administration set use with infusion pump. This Standard applies to administration set use with infusion pump. This Standard does not apply to administration set use with the following special infusion pumps: -- Infusion pump for ambulatory use; -- Volumetric infusion pump whose maximum speed is less than 20 mL/h, and drip-rate infusion pump whose maximum speed is less than 20 drops/min; -- Infusion pump that is specially used for diagnostics or similar purposes; -- Internal infusion pump; -- Extracorporeal circulation infusion pump for blood; -- Implantable device or single-use infusion pump; -- Emergency pump; -- Nutrition pump, flushing pump, etc.
Basic Data
Standard ID
YY/T 1653-2020 (YY/T1653-2020)
Description (Translated English)
Administration set use with infusion pump
Sector / Industry
Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard
C35
Classification of International Standard
11.040.30
Word Count Estimation
11,138
Date of Issue
2020
Date of Implementation
2021-01-01
Issuing agency(ies)
State Drug Administration
Summary
This standard specifies the terms and definitions, requirements, test methods, markings and instructions for pipelines for infusion pumps. This standard applies to infusion pipelines used with infusion pumps. This standard does not apply to the infusion pipeline used with the following special infusion pumps: portable infusion pumps; volumetric infusion pumps with a maximum speed of less than 20mL/h and drip-speed infusion pumps with a maximum speed of less than 20 drops/min; dedicated for diagnostic or Infusion pumps for similar purposes; internal infusion infusion pumps; blood extracorporeal circulation infusion pumps; implantable devices or disposable infusion pumps; emergency pumps; nutrition pumps, irrigation pumps, etc.
