YY 0484-2004: Implants for surgery. Two-part addition-cure silicone elastomers

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Scope

This Standard specifies the characteristics of, and corresponding test methods
for, the two-part addition-cure high consistency or liquid silicone elastomer for
use in the manufacture (partially or totally) of surgical implants.

Basic Data

Standard ID	YY 0484-2004 (YY0484-2004)
Description (Translated English)	Implants for surgery. Two-part addition-cure silicone elastomers
Sector / Industry	Medical Device and Pharmaceutical Industry Standard
Classification of Chinese Standard	C48
Classification of International Standard	11.040.40
Word Count Estimation	15,179
Date of Issue	2004-07-16
Date of Implementation	2005-08-01
Adopted Standard	ISO 14949-2001, IDT
Issuing agency(ies)	State Food and Drug Administration
Summary	This standard specifies the production of (some or all) surgical implants or forming curing two-component liquid silicone rubber or high viscous properties and the corresponding test methods.