YY 0450.1-2020: Accessory devices for sterile single-use intravascular catheters - Part 1: Introducers

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Scope

This Part of YY 0450 specifies the requirements for single-use introducer needles,
introducer catheters, sheath introducers, guidewires and dilators supplied in the sterile
condition and used in conjunction with intravascular catheters specified in YY 0285.
This Standard is applicable to single-use introducer needles, introducer catheters,
sheath introducers, guidewires and dilators supplied in the sterile condition and used
in conjunction with intravascular catheters specified in YY 0285.

Basic Data

Standard ID	YY 0450.1-2020 (YY0450.1-2020)
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	C31
Classification of International Standard	11.040.25
Word Count Estimation	29,220
Date of Issue	2020
Date of Implementation	2021-08-01
Issuing agency(ies)	State Drug Administration
Summary	This standard specifies the requirements for single-use puncture needles, guide cannulas, catheter sheaths, guide wires and dilators supplied in a sterile state for use with intravascular catheters that meet the requirements of YY 0285. This standard applies to single-use puncture needles, guide cannulas, catheter sheaths, guide wires and dilators supplied in a sterile state for use with intravascular catheters that meet the requirements of the YY 0285 standard. This standard replaces YY 0450.1-2003 "Disposable Sterile Intravascular Catheter Accessories Part 1: Guiding Devices".