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YY/T 0719.6-2020 PDF English

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YY/T 0719.6-2020: Ophthalmic optics - Contact lens care products - Part 6: Guidelines for determination of shelf-life
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YY/T 0719.6: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] deliveryName of Chinese StandardStatus
YY/T 0719.6-2020English185 Add to Cart 0-9 seconds. Auto-delivery Ophthalmic optics - Contact lens care products - Part 6: Guidelines for determination of shelf-life Valid
YY 0719.6-2010English180 Add to Cart 0-9 seconds. Auto-delivery Ophthalmic optics. Contact lens care products. Part 6: Guidelines for determination of shelf-life Obsolete

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YY/T 0719.6-2020: Ophthalmic optics - Contact lens care products - Part 6: Guidelines for determination of shelf-life


---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT0719.6-2020
YY PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.040.70 C 40 YY/T 0719.6-2020 / ISO 13212:2014 Replacing YY/T 0716.9-2010 Ophthalmic Optics - Contact Lens Care Products - Part 6: Guidelines for Determination of Shelf-Life (ISO 13212:2014 Ophthalmic Optics - Contact Lens Care Products - Guidelines for Determination of Shelf-Life, IDT) ISSUED ON: JUNE 30, 2020 IMPLEMENTED ON: JUNE 01, 2021 Issued by: National Medical Products Administration

Table of Contents

Foreword ... 3 1 Scope ... 5 2 Normative References ... 5 3 Terms and Definitions ... 5 4 General Requirements ... 5 5 Determination of Finished Product Stability ... 6 Annex A (informative) Example of a Stability Testing Plan for the Finished Contact Lens Care Product ... 12 Bibliography ... 13

Foreword

Ophthalmic Optics – Contact Lens Care Products may be divided into the following 11 parts: --- Part 1: Vocabulary; --- Part 2: Fundamental Requirements; --- Part 3: Microbiological Requirements and Test Methods for Products and Regiments for Hygienic Management of Contact; --- Part 4: Antimicrobial Preservative Efficacy Testing and Determining Discard Date; --- Part 5: Determination of Physical Compatibility of Contact Lens Care Products with Contact Lens; --- Part 6: Guidelines for Determination of Shelf-Life; --- Part 7: Biological Evaluation Test Methods. --- Part 8: Test Method for Detergent; --- Part 9: Test Method for Sequestrant; --- Part 10: Test Method for Disinfectant; --- Part 11: Test Method for Moisturizing Lubricant. This Part is Part 6 of Ophthalmic Optics – Contact Lens Care Products. This Part was drafted as per the rules specified in GB/T 1.1-2009. This Part replaced YY/T 0719.6-2010 Ophthalmic Optics – Contact Lens Care Products – Part 6: Guidelines for Determination of Shelf-Life (ISO 13212:1999, IDT). Compared with YY/T 0719.6-2010, this Part has the major technical changes as follows besides the editorial modifications: --- Modify the Normative References (see Clause 2 of this Edition; Clause 2 of 2010 Edition); --- Modify the real-time study (see 5.2.2 of this Edition; 5.2.2 of 2010 Edition); --- Modify the studies under varying storage conditions (see 5.2.3 of this Edition; 5.2.3 of 2010 Edition); --- Modify the number and nature of the test sample (see 5.3.1 of this Edition; 5.3.1 of 2010 Edition); --- Modify the Annex A (see Annex A of this Edition; Annex A of 2010 Edition). This Part equivalently adopts ISO 13212:2014 Ophthalmic Optics – Contact Lens Care Products – Guidelines for Determination of Shelf-Life. The Chinese documents that have a consistent correspondence with the international documents cited in this Part are as follows: --- YY/T 0719.3-2009 Ophthalmic Optics – Contact Lens Care Products – Part 3: Microbiological Requirements and Test Methods for Products and Regiments for Hygienic Management of Contact (ISO 14729:2001, MOD); --- YY/T 0719.4-2009 Ophthalmic Optics – Contact Lens Care Products – Part 4: Antimicrobial Preservative Efficacy Testing and Determining Discard Date (ISO 14730:2000, IDT); --- GB/T 11417.1-2012 Ophthalmic Optics - Contact Lenses - Part 1: Vocabulary, Classification System and Recommendations for Labeling Specifications (ISO 18369-1:2006, MOD). Please note some contents of this document may involve the patents. The issuing agency of this document shall not assume the responsibility to identify these patents. This Part was proposed by National Medical Products Administration. This Part shall be under the jurisdiction of National Technical Subcommittee for Standardization of Medical Optics & Instruments (SAC/TC 103/SC 1). Drafting organization of this Part: Zhejiang Institute for the Control of Medical Device. Chief drafting staffs of this Part: Chen Jingyun, Zhang Li, He Tao, Qi Weiming, Lu Xin, Ding Yichen, and Hu Meili. The historical edition replaced by this Standard is as follows: --- YY/T 0719.6-2010. Ophthalmic Optics - Contact Lens Care Products - Part 6: Guidelines for Determination of Shelf-Life

1 Scope

This Part of Ophthalmic Optics – Contact Lens Care Products provides guidance on the design of stability studies for use in gathering information to enable determination of the shelf-life of contact lens care products. This International Standard does not address studies designed to obtain information to establish the in-use stability (i.e.: discard date) of contact lens care products.

2 Normative References

The following documents are essential to the application of this document. For the dated documents, only the versions with the dates indicated are applicable to this document; for the undated documents, only the latest version (including all the amendments) is applicable to this document. ISO 14729 Ophthalmic Optics – Contact Lens Care Products – Microbiological Requirements and Test Methods for Products and Regimens for Hygienic Management of Contact Lenses ISO 14730 Ophthalmic Optics – Contact Lens Care Products – Antimicrobial Preservative Efficacy Testing and Guidance on Determining Discard Date ISO 18369-1 Ophthalmic Optics – Contact Lenses – Part 1: Vocabulary, Classification System and Recommendations for Labeling Specifications

3 Terms and Definitions

For the purposes of this document, the terms and definitions given in ISO 18369-1 apply.

4 General Requirements

4.1 The specified shelf-life of the contact lens care product shall be based on the ......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.


      

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