This part of YY 0585 specifies the physical, chemical, and biological requirements for single-use sterile fluid lines for pressure infusion equipment. This part applies to single-use sterile fluid lines for pressure infusion equipment with a maximum pressure of 200 kPa, including.
Basic Data
Standard ID
YY 0585.1-2019 (YY0585.1-2019)
Description (Translated English)
Fluid lines for use with pressure infusion equipment and accessories for single use - Part 1: Fluid lines
Sector / Industry
Medical Device and Pharmaceutical Industry Standard
Classification of Chinese Standard
C31
Classification of International Standard
11.040.20
Word Count Estimation
14,176
Date of Issue
2019
Date of Implementation
2020-12-01
Issuing agency(ies)
State Drug Administration
Summary
This standard specifies the physical, chemical and biological requirements for single-use sterile fluid paths for pressure infusion equipment. This standard applies to single-use sterile liquid circuits for pressure infusion equipment with a maximum pressure of 200kPa, including: syringe pump pipeline (SPL); connecting pipeline (CL); pipeline integrated with the injection cannula (LIC) .
