YY/T 1469-2016: Electrical infusion pump for ambulatory use

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Scope

This Standard specifies the definition, basic requirements and corresponding
test methods of electrical infusion pump for ambulatory use (hereinafter referred
to as infusion pump for ambulatory use).
This Standard applies to electrical infusion pump for ambulatory use which are
used in medical monitoring environments; the intended use of this product is for
intravenous or epidural analgesic administration.
The infusion pump for ambulatory use is mainly composed of a drive unit, a
restoration set and an infusion line; the restoration set and the infusion line are
single-use components.
This Standard does not apply to the following equipment.
-- equipment which is specially used for diagnostics or similar purposes (such
as high-pressure injectors);
-- gastrointestinal feeding pump;
-- equipment for extracorporeal blood circulation;
-- insulin pump and pumps for similar clinical applications;
-- infusion pump for ambulatory use that has special requirements for
infusion accuracy.

Basic Data

Standard ID	YY/T 1469-2016 (YY/T1469-2016)
Description (Translated English)	Electrical infusion pump for ambulatory use
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C31
Classification of International Standard	11.040.20
Word Count Estimation	16,153
Date of Issue	2016-01-26
Date of Implementation	2017-01-01
Quoted Standard	GB/T 1962.1-2005; GB/T 1962.2-2001; GB 9706.1-2007; GB 9706.27-2005; GB/T 14233.1-2008; GB/T 14233.2-2005; GB/T 14710-2009; GB/T 16886.10; GB/T 16886.12; GB/T 16886.13; GB/T 16886.14; GB/T 16886.15; GB/T 16886.17; GB/T 16886.3; GB/T 16886.4; GB/T 16886.5
Regulation (derived from)	China Food and Drug Administration Bulletin 2016 No.25
Issuing agency(ies)	State Food and Drug Administration
Summary	This standard specifies the definition, basic requirements and corresponding test methods for portable electric infusion pumps (hereinafter referred to as portable infusion pumps). This standard applies to portable electric infusion pumps for use in medical care environments; the intended use of the product is intravenous or epidural analgesic administration. The portable infusion pump is mainly composed of a driving device, a liquid storage device and an infusion line; the liquid storage device and the infusion line are disposable parts. This standard does not apply to the following equipment: - equipment specifically for diagnostic or similar use (eg high pressure syringes); - gastrointestinal feeding pumps; - equipment for blood extracorporeal circulation; - insulin pumps and similar clinical applications Pumps - Portable infusion pumps with special requirements for infusion accuracy.