YY 0719.6-2010: Ophthalmic optics. Contact lens care products. Part 6: Guidelines for determination of shelf-life

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Scope

This Part of YY 0719 provides guidance on the design of stability studies to use in
gathering information to allow determination of shelf-life of contact lens care products.
This Part does not address studies designed to obtain information to establish the in-
use stability (i.e.. discard statement) of contact lens care products.

Basic Data

Standard ID	YY 0719.6-2010 (YY0719.6-2010)
Description (Translated English)	Ophthalmic optics. Contact lens care products. Part 6: Guidelines for determination of shelf-life
Sector / Industry	Medical Device and Pharmaceutical Industry Standard
Classification of Chinese Standard	C40
Classification of International Standard	11.040.70
Word Count Estimation	9,943
Date of Issue	2010-12-27
Date of Implementation	2012-06-01
Quoted Standard	YY 0719.1; YY 0719.2; YY 0719.3; YY 0719.4; YY 0719.5
Adopted Standard	ISO 13212-1999, IDT
Regulation (derived from)	State Food and Drug Administration Notice 2010 No. 97
Issuing agency(ies)	State Food and Drug Administration
Summary	This standard applies to the stability study design, stability data collected is used to determine the validity of contact lens care products. This section does not involve the study design of the data used to determine the contact lens care products in use stability (ie, discard statement).