YY/T 0487-2010: Sterile, single-use hydrocephalus shunts and components

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Scope

This Standard specifies safety and performance requirements for sterile, single-use
non-active hydrocephalus shunts and components. This includes the components
used in shunts, like valves, tubes and reservoirs.
This Standard gives no recommendation concerning the superiority of a certain type
of valve.
For manufacturing, it defines the mechanical and technical requirements. This
Standard defines the technical information of the valve, to be given by the manufacturer.
In respect to the different principles of the valve types, specific characteristics are
defined for each group as declared by the manufacturer.
The benefit of this Standard for the surgeon and the patient is to understand the
information given by the manufacturer and to obtain standardized information about
the performance of a well working product with new design characteristics. The benefit
for the manufacturer is to define the important requirements for shunts as a basis for
investigations during development as well as for quality control during manufacture.
This Standard does not apply to active implants for the treatment of hydrocephalus.

Basic Data

Standard ID	YY/T 0487-2010 (YY/T0487-2010)
Description (Translated English)	Sterile, single-use hydrocephalus shunts and components
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C48
Classification of International Standard	11.040.40
Word Count Estimation	11,119
Date of Issue	2010-12-27
Date of Implementation	2012-06-01
Older Standard (superseded by this standard)	YY 0487-2004
Quoted Standard	YY 0334; YY/T 0640-2008; ASTM F2503-2005
Adopted Standard	ISO 7197-2006, MOD
Regulation (derived from)	State Food and Drug Administration Notice 2010 No. 97
Issuing agency(ies)	State Food and Drug Administration
Summary	This standard specifies the use of sterile disposable hydrocephalus shunts and components of safety and performance requirements. Including shunts used in components such as valves, piping and reservoir. This standard provides for the production of mechanical and technical requirements, and gives the valve manufacturer's technical information. Manufacturer to be based on various types of valve working principle, given the special characteristics of various types of valves. This standard does not apply to the treatment of hydrocephalus active implantable devices.