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YY 0308-2004 English PDF

YY 0308-2004 English PDF

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YY 0308-2004: Medical sodium hyaluronate gel

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Scope

This Standard specifies classification, requirements, rules for inspection,
packing and marking of medical sodium hyaluronate gel.
This Standard applies to medical sodium hyaluronate gel. The applicable
scope of medical sodium hyaluronate gel includes the fillers of eye-surgeries,
lubricants of intra-articular injections and blockers of surgeries.

Basic Data

Standard ID YY 0308-2004 (YY0308-2004)
Description (Translated English) Medical sodium hyaluronate gel
Sector / Industry Medical Device and Pharmaceutical Industry Standard
Classification of Chinese Standard C48
Classification of International Standard 11.120.20
Word Count Estimation 14,113
Date of Issue 2004-11-08
Date of Implementation 2005-11-01
Older Standard (superseded by this standard) YY 0308-1998
Regulation (derived from) 2005 Bulletin No. 2 industry standard
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies the classification of medical sodium hyaluronate gel, requirements, inspection rules, marking and packaging. This standard applies to medical sodium hyaluronate gel. Medical sodium hyaluronate gel for ophthalmic surgery include fillers, lubricants and intraarticular surgery blocking agent.


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