YY 0450.1-2003: Accessory devices for sterile single-use intravascular catheters. Part 1: Introducers

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Scope

This Part of YY 0450 specifies requirements for introducer needles,
introducer catheters, sheath introducers, guide wires and dilators supplied in
the sterile condition, and intended for single use in conjunction with
intravascular catheters specified in YY 0285.
NOTE Guidance on materials and design of accessory devices is given in Annex A.

Basic Data

Standard ID	YY 0450.1-2003 (YY0450.1-2003)
Description (Translated English)	Accessory devices for sterile single-use intravascular catheters. Part 1: Introducers
Sector / Industry	Medical Device and Pharmaceutical Industry Standard
Classification of Chinese Standard	C48
Classification of International Standard	11.120.30
Word Count Estimation	19,195
Date of Issue	2003-02-09
Date of Implementation	2003-09-01
Adopted Standard	ISO 11070-1998, IDT
Issuing agency(ies)	State Drug Administration
Summary	This standard specifies the requirements and compliance standards YY 0285 intravascular catheters used together to supply disposable sterile needle, guide tube, catheter sheath, guidewire and dilator requirements.