YY 0585.3-2018: Fluid lines for use with pressure infusion equipment and accessories for single use. Part 3: Filters

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Scope

This Part of YY 0585 specifies the design, materials, physical, chemical and biological,
packaging, labeling, and disposal requirements for filters for use with pressure infusion
equipment, but does not include the effectiveness of filters in removing particles or
bacteria.
This Part applies to fluid lines for infusion equipment with pressures not exceeding 200
kPa and to sterile infusion filters for single use with infusion sets as specified in YY
0286.4.

Basic Data

Standard ID	YY 0585.3-2018 (YY0585.3-2018)
Description (Translated English)	Fluid lines for use with pressure infusion equipment and accessories for single use. Part 3: Filters
Sector / Industry	Medical Device and Pharmaceutical Industry Standard
Classification of Chinese Standard	C31
Classification of International Standard	11.040.20
Word Count Estimation	10,196
Date of Issue	2018-11-07
Date of Implementation	2020-05-01
Older Standard (superseded by this standard)	YY 0585.3-2005
Quoted Standard	GB/T 1962.2; GB 8368; YY/T 0466.1
Adopted Standard	ISO 8536-11-2015, MOD
Regulation (derived from)	Announcement No. 87 of 2018 by the State Drug Administration
Issuing agency(ies)	State Drug Administration
Summary	This standard specifies the design, materials, physics, chemistry and biology, packaging, labeling, disposal and other requirements of filters for pressure infusion equipment, excluding the effectiveness of filters to filter out particles or bacteria. This standard applies to liquid infusion equipment for pressures up to 200 kPa and disposable infusion filters for infusion sets specified in YY 0286.4.