YY 0581.2-2011: Infusion access adapter. Part 2: Needleless access adapters

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Scope

This Part of YY 0581 specifies the requirements and test methods for single-use self-
closing access adapters (hereinafter referred to as access adapters) in the form of non-
puncture use.
For products that are integrated with intravascular indwelling devices (such as venous
indwelling needles) and supplied as one piece, it can refer to this Part.
Backflow prevention valves specified in YY 0286.6 are not included in the scope of this
Part.
Switches specified in YY 0585.2 are not included in the scope of this Part.

Basic Data

Standard ID	YY 0581.2-2011 (YY0581.2-2011)
Description (Translated English)	Infusion access adapter. Part 2: Needleless access adapters
Sector / Industry	Medical Device and Pharmaceutical Industry Standard
Classification of Chinese Standard	C31
Classification of International Standard	11.040.20
Word Count Estimation	13,180
Date of Issue	2011-12-31
Date of Implementation	2013-06-01
Quoted Standard	GB/T 1962.2; GB 8368; GB 15810; GB 15811; YY/T 0466.1
Regulation (derived from)	State Food and Drug Administration Notice 2011 No. 106; industry standard filing Notice 2013 No. 6 (No. 162 overall)
Issuing agency(ies)	State Food and Drug Administration
Summary	This standard provides for the use of non-piercing form of single-use self-closing type connections (hereinafter: the connector) requirements and test methods. Connections with indwelling intravascular devices (eg intravenous catheter) are integrated supply products, you can refer to the implementation of this section. YY 0286. 6 specified backflow preventer is not included within the scope of this section. YY 0585. 2 switch as specified in this section are not included in the range.