YY/T 0450.3-2016: Accessory devices for sterile single-use intravascular catheters - Part 3: Inflation devices for balloon of balloon dilatation catheters

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Scope

This Part of YY/T 0450 specifies the requirements for the single-use intravascular
manual inflation devices for balloon dilatation catheters (referred to as "inflation
devices"). This product is suitable for balloon compression of balloon dilatation
catheters specified in YY 0285.4, making it expand to achieve the purpose of dilating
blood vessels or releasing stents.
The release device of intravascular embolism and the inflation device of the balloon
occlusion catheter have a similar structure to the inflation device specified in this Part.
This standard does not apply to these devices.

Basic Data

Standard ID	YY/T 0450.3-2016 (YY/T0450.3-2016)
Description (Translated English)	Accessory devices for sterile single-use intravascular catheters - Part 3: Inflation devices for balloon of balloon dilatation catheters
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C31
Word Count Estimation	17,153
Date of Issue	2016-07-29
Date of Implementation	2017-06-01
Older Standard (superseded by this standard)	YY 0450.3-2007
Quoted Standard	GB/T 1962.2; GB 15810; GB/T 16886.1; GB/T 19633.1-2015; YY 0505; YY/T 0615.1; GB 9706.1; GB 9706.2; GB 9706.3; GB 9706.4; GB 9706.5; GB 9706.6; GB 9706.7; GB 9706.8; GB 9706.9; GB 9706.10; GB 9706.11; GB 9706.12; GB 9706.13; GB 9706.14; GB 9706.15; GB 970
Regulation (derived from)	State Food and Drug Administration Notice 2016 (No.129)
Issuing agency(ies)	State Food and Drug Administration
Summary	This standard specifies the requirement for a one-time use of a manual pressurized device (referred to as "pressurized device") for intravascular balloon dilatation catheters, which is suitable for suppressing the balloon of balloon dilatation catheters as defined by YY 0285.4 Its expansion so as to achieve the purpose of dilating blood vessels or the release of stents. An endotracheal embolization device and a balloon-blocking catheter have a structure similar to that of the charging device as defined in this standard. This standard does not apply to these devices.