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YY 0285.1-2004 English PDF

YY 0285.1-2004 English PDF

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YY 0285.1-2004: Sterile, single-use intravascular catheters. Part 1: General requirements

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Scope

This Part of YY 0285 specifies general requirements for intravascular
catheters, supplied in the sterile condition and intended for single use, for any
application.
It does not apply to intravascular catheter accessories, which will be covered
by a separate standard.
NOTE Requirements for accessories are specified in YY 0450.

Basic Data

Standard ID YY 0285.1-2004 (YY0285.1-2004)
Description (Translated English) Sterile, single-use intravascular catheters. Part 1: General requirements
Sector / Industry Medical Device and Pharmaceutical Industry Standard
Classification of Chinese Standard C31
Classification of International Standard 11.040.20
Word Count Estimation 12,115
Date of Issue 2004-07-16
Date of Implementation 2005-08-01
Older Standard (superseded by this standard) YY 0285.1-1999
Adopted Standard ISO 10555-1-1995, IDT; ISO 10555-1/Amd 1-1999, IDT
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies the state of supply and sterile single-use intravascular catheters for various uses generic requirements. YY 0285 does not apply to this part of intravascular catheter accessories.


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