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YY 0451-2010

Search Result of Chinese Standard: 'YY 0451-2010'
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Detail Information of 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: 14,178
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Older Standard (superseded by this standard): YY 0451-2003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).

YY 0451-2010
Portable infusion devices for single use - Non electrically driven
ICS 11.120.30
C46
People's Republic of China pharmaceutical industry standards
Replacing YY 0451-2003
Disposable non-electrically driven portable infusion pump
Portableinfusiondevicesforsingleuse-Nonelectricalydriven
Issued on: 2010-12-27
2012-06-01 implementation
State Food and Drug Administration issued
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
This standard replaces YY 0451-2003 "disposable infusion pumps."
The technical contents of this standard reference ISO /DIS28620:2009 "Non-electrically driven portable infusion pump."
The main technical standards and YY 0451-2003 content differences are as follows:
--- Modify the nominal capacity, the definition of nominal capacity, increasing the definition of residues, canceled the definition of an effective amount of infusion;
--- Modify the requirements and test methods for traffic;
--- Modify the requirements and test methods for automatic control of liquid volume;
--- Modify the design and testing requirements and characteristics;
--- Modify the requirements and test methods for chemical properties.
The infusion set standard by the National Standardization Technical Committee (SAC/TC106) and focal points.
This standard was drafted: Shandong Medical Devices Product Quality Inspection Center, Shanghai Yue new medical equipment limited liability company.
Drafters of this standard: Wu Ping, Yaoxiu Jun, SHEN Yong, Jia Yu fly, Like Fang.
Disposable non-electrically driven portable infusion pump
1 Scope
This standard specifies a one-time non-electrically driven portable infusion pump (hereinafter referred to as an infusion pump) basic requirements and corresponding test methods.
Suitable for a sustainable solution to the (fixed or adjustable) and (or) to the liquid-controlled infusion pump.
This standard does not apply to:
--- IEC 606
Related standard:   YY/T 0490-2017  YY/T 0506.2-2016
   
 
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