YY/T 0031-2008: Silicone tubes and elastomeric parts for infusion and transfusion

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Scope

This Standard specifies the general requirements and test methods for silicone
tubes for infusion and transfusion (hereinafter referred to as “the tubes”) and
elastomeric parts.
The products to which this Standard is applicable include (but are not limited
to):
-- Reusable in vitro transfer lines for intravenous infusion;
-- Disposable silicone rubber elastic parts in blood treatment products, such
as pump tubing, valves or seals for flow control devices, injection parts;
-- Silicone rubber elastic parts for disposable infusion apparatus, such as
silicone rubber reservoirs for injection parts and infusion pumps;
-- Pump tubes, valves, and injection parts in disposable pressure infusion
lines.
This Standard does not include silicone rubber catheters and artificial heart-
lung machine pump tubes inserted or implanted in the human body.

Basic Data

Standard ID	YY/T 0031-2008 (YY/T0031-2008)
Description (Translated English)	Silicone tubes and elastomeric parts for infusion and transfusion
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	G45
Classification of International Standard	11.040.20
Word Count Estimation	11,183
Date of Issue	2008-10-17
Date of Implementation	2010-01-01
Older Standard (superseded by this standard)	YY 0031-1990
Quoted Standard	GB/T 528; GB/T 529; GB/T 531; GB/T 3512; GB/T 16886.1; YY/T 0313; YY 0466
Regulation (derived from)	SFDA [2008] No. 605
Issuing agency(ies)	State Food and Drug Administration
Summary	This standard specifies the infusion, transfusion with silicone rubber tubing (hereinafter referred to as "piping") and the elastic member General requirements and test methods. This standard applies to products include (but not limited to): repetitive use of intravenous infusion of liquid transfer lines in vitro, disposable blood processing products silicone rubber elastic member, such as tubing, valves or flow control device seals, injection parts, etc., Disposable infusion set with silicone rubber elastic member, such as injection parts, infusion pumps and other silicone rubber storage sac, disposable pressure infusion pump tubing piping, valves, injection parts. This standard does not inserted or implanted in the body, including silicone rubber catheters and artificial heart-lung pump tube.