This Standard specifies the classification, requirements, inspection rules, marks and packaging of medical sodium hyaluronate gel. This Standard is applicable to medical sodium hyaluronate gel. The application of medical sodium hyaluronate gel includes viscoelastic agents for eye surgery, lubricants for intra-articular injection and barriers for surgical operation.
Basic Data
Standard ID
YY/T 0308-2015 (YY/T0308-2015)
Description (Translated English)
Medical sodium hyaluronate gel
Sector / Industry
Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard
C48
Classification of International Standard
11.120.20
Word Count Estimation
17,195
Date of Issue
2015-03-02
Date of Implementation
2016-01-01
Older Standard (superseded by this standard)
YY 0308-2004
Quoted Standard
GB/T 16886.1
Regulation (derived from)
The State Food and Drug Administration Announcement 2015 No. 8
Issuing agency(ies)
State Food and Drug Administration
Summary
This Standard specifies the classification of medical sodium hyaluronate gel, requirements, inspection rules, signs and packaging. This Standard applies to medical sodium hyaluronate gel. Medical sodium hyaluronate gel scope includes a viscoelastic ophthalmic surgery, intra-articular injection of lubricant and surgical blocking agent.
