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YY 0451-2010

Chinese standards (related to): 'YY 0451-2010'
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)See DetailStatusGoogle Book
YY 0451-2010English145 Add to Cart 0--10 minutes. Auto immediate delivery. Portable infusion devices for single use - Non electrically driven YY 0451-2010 Valid YY 0451-2010
YY 0451-2003English679 Add to Cart Days<=5 Single-use injectors for continuous ambulatory administration of medicinal products by parenteral route YY 0451-2003 Obsolete YY 0451-2003


   
BASIC DATA
Standard ID YY 0451-2010 (YY0451-2010)
Description (Translated English) Portable infusion devices for single use - Non electrically driven
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C46
Classification of International Standard 11.120.30
Word Count Estimation 14,176
Date of Issue 2010-12-27
Date of Implementation 2012-06-01
Older Standard (superseded by this standard) YY 0451-2003
Quoted Standard GB/T 1962.1; GB/T 1962.2; GB 8368; GB/T 14233.1; GB/T 14233.2; GB/T 16886.1; GB/T 16886.2; GB/T 16886.3; GB/T 16886.4; GB/T 16886.5; GB/T 16886.6; GB/T 16886.7; GB/T 16886.9; GB/T 16886.10; GB/T 16886.11; GB/T 16886.12; GB/T 16886.13; GB/T 16886.14; GB/T 16886.15; GB/T 16886.16; GB/T 16886.17; GB/T 6682; YY/T 0466.1
Drafting Organization Shandong Province Quality Inspection Center of Medical Devices
Administrative Organization National Standardization Technical Committee of infusion
Regulation (derived from) State Food and Drug Administration Notice 2010 No. 97
Proposing organization National Standardization Technical Committee infusion set (SAC/TC 106)
Issuing agency(ies) China Food and Drug Administration
Summary This standard specifies the use of non- electrically driven portable infusion pump disposable basic requirements and the corresponding test methods. For sustainable solution to (fixed or adjustable), and (or) controlled infusion pump for liquid. This standard does not apply to: IEC 60601-2-24 included electric drive or electric controlled infusion pump, implantable devices, intestinal supplies pumps, liquid transdermal device, infusion powered power than the device itself, but by patients with active intervention to gain momentum (eg: rely on gravity as a power device).