This Standard specifies the basic requirements and appropriate test methods for non electrically driven portable infusion devices (hereinafter referred to as "infusion device"). It is applicable to sustainable infusion device (fixed or adjustable) and (or) automatic bolus infusion device. This Standard is not applicable to. - Electrically driven or electrically controlled infusion devices included by IEC 60601-2-24; - Implantable devices; - Enteral supply pump; - Transdermal infusion device; - Device of which the infusion power is not provided by the device but by the active intervention of patient (e.g. the device which only takes gravity as power).
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 and Pharmaceutical Industry Standard
State Food and Drug Administration Notice 2010 No. 97
Issuing agency(ies)
State 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).
