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YY 0477-2016 PDF English

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YY 0477-2016: Rigid gas permeable contact lenses for orthokeratology
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YY 0477: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] deliveryName of Chinese StandardStatus
YY 0477-2016English140 Add to Cart 0-9 seconds. Auto-delivery Rigid gas permeable contact lenses for orthokeratology Valid
YY 0477-2004English330 Add to Cart 0-9 seconds. Auto-delivery Rigid gas permeable contact lenses for orthokeratology [Replaced by YY 0477-2016] Obsolete

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YY 0477-2016: Rigid gas permeable contact lenses for orthokeratology

---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/YY0477-2016
YY PHARMACEUTICAL INDUSTRY STANDARD ICS 11.040.70 C 40 Replacing YY 0477-2004 Rigid gas permeable contact lenses for orthokeratology Issued on. MARCH 23, 2016 Implemented on. JANUARY 1, 2018 Issued by. China Food and Drug Administration

Table of Contents

Foreword... 3 1 Scope... 5 2 Normative references... 5 3 Terms and definitions... 5 4 Requirements... 7 5 Test methods... 10 6 Sampling and inspection rules... 11 7 Marks, labels and accompanying information... 12 8 Packaging... 14

Foreword

4.4.3.2, 4.7.1 of this Standard are recommendatory; the rest are mandatory. This Standard was drafted in accordance with the rules given in GB/T 1.1-2009. This Standard replaces YY 0477-2004 Rigid gas permeable contact lenses for orthokeratology. The main technical differences between this Standard and YY 0477-2004 are as follows. - added the purpose of use of Clause 1; - modified Clause 3 Terms and definitions; - added alignment curve zone (3.4), aide curve zone (3.5); - supplemented the definition of complex reverse geometry design for orthokeratology (3.6); - deleted the classification requirements in Clause 4; - deleted Table 1 Geometric parameter range values and tolerances and Table 2 Optical parameters and tolerances of orthokeratology lenses in Clause 5; directly referred to the requirements for gas permeable materials in GB 11417.2-2012; deleted the requirements for stress, try lenses, lens color; - added general requirements, intake and release of preservatives, radiation aging test, validity requirements, material requirements; - transmissibility, physical properties of materials, chemical properties, biocompatibility evaluation, microbiological requirements, impurities and surface flaws, etc., refer to the requirements in GB 11417.2-2012; - supplemented the requirements for design size, edge contour; - deleted specific test methods; test methods referred to the test methods specified in GB 11417.2-2012; - supplemented a standard test method for infrared spectral analysis of materials; - added the contents of the information provided by the manufacturer to the optometrists; - deleted the transport and storage conditions; - deleted Annex A; - deleted Annex B; - deleted Annex C. Attention is drawn to the possibility that some of the elements of this Standard may be the subject of patent rights. The issuing authority shall not be held responsible for identifying any or all such patent rights. This Standard was proposed by China Food and Drug Administration. This Standard shall be under the jurisdiction of Subcommittee of National Technical Committee on Medical Optics and Instruments of Standardization Administration of China (SAC/TC 103/SC1). The drafting organizations of this Standard. China Food and Drug Administration Hangzhou Medical Device Quality Supervision and Inspection Center, Zhejiang Medical Devices Laboratory. Main drafters of this Standard. He Tao, Jia Xiaohang, Wen Yan, Zhang Li, Zheng Jian. This Standard was issued on March 2004. Rigid gas permeable contact lenses for orthokeratology

1 Scope

This Standard specifies the terms and definitions, requirements, test methods, sampling and inspection rules, marks, labels and accompanying data, packaging for rigid gas permeable contact lenses for orthokeratology (hereinafter referred to as orthokeratology lenses). Orthokeratology lenses are expected to be used by temporarily altering corneal morphology in order to achieve temporary correction of refractive errors.

2 Normative references

The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. GB/T 2829, Sampling procedures and tables for periodic inspection by attributes (Apply to inspection of process stability) GB/T 11417.1-2012, Ophthalmic optics - Contact lenses - Part 1. Vocabulary, classification system and recommendations for labeling specifications GB 11417.2-2012, Ophthalmic optics - Contact lenses - Part 2.Rigid contact lenses specification YY/T 0316, Medical devices - Application of risk management to medical devices YY/T 0466.1, Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1.General requirements

3 Terms and definitions

For the purposes of this document, the terms and definitions defined in GB/T 11417.1-2012 and the followings apply. 3.1 rigid gas permeable contact lenses for orthokeratology rigid gas permeable contact lenses that use the shaping method to temporarily change the corneal morphology so as to achieve temporary correction of refractive error as the intended purpose 3.2 base curve zone rear surface central area of orthokeratology lenses, used for the shape the central area of the cornea 3.4 alignment curve zone rear cambered surface of orthokeratology lenses that closes to reverse curve, flatter than the reverse curve, playing a positioning role with cornea adaption during wearing lenses 3.5 aide curve zone the most marginal rear cambered surface of orthokeratology lenses for moderate movement of lenses, good for the exchange between tears under the lenses and the outside world

4 Requirements

4.1 General The safety and performance of orthokeratology lenses shall pass the preclinical evaluation and the clinical evaluation, including the appropriate risk analysis carried out according to YY/T 0316. 4.2 Optical performance 4.3 Geometric dimensions 4.3.1 Design size The manufacturer shall provide the design pattern for orthokeratology lenses, confirm the radius or vector height of base curve zone, total diameter, center thickness, base curve zone diameter, reverse curve curvature radius and diameter, alignment curve zone curvature radius and dimeter if applicable, or geometric parameter design values of structure size of alignment curve zone. 4.3.2 Additional size If applicable, the geometric size of micro-pore shall be marked on the small packaging container’s label. The difference between the actual measured value and the nominal value shall not exceed 10% of the nominal value. 4.4 Materials 4.4.2 Physical properties of materials 4.4.2.3 Material hardness The material hardness of orthokeratology lenses shall comply with the provisions of 4.4.2.3 in GB 11417.2-2012. 4.4.2.4 Contact angle The material contact angle of orthokeratology lenses shall comply with the provisions of 4.4.2.4 in GB 11417.2-2012. 4.4.3 Material chemical properties 4.4.3.1 The extraction test shall comply with the provisions of 4.4.3.1 in GB 11417.2-2012. 4.5 Biocompatibility evaluation The biocompatibility evaluation shall comply with the provisions of 4.5 in GB 11417.2-2012. 4.6 Microbiological requirements The microbiological requirements shall comply with the provisions of 4.6 in GB 11417.2-2012. 4.7 Stability 4.8 Intrinsic quality and surface defects 4.8.1 Impurities and surface flaws, microporous shall comply with the provisions of 4.8.1, 4.8.2 in GB 11417.2-2017.

5 Test methods

5.1 For the requirements in Clause 4, except 5.2, the rest shall be detected or tested according to the methods listed in Annex A of GB 11417.2-2012.If Annex A of GB 11417.2-2012 does not have a suitable method, the manufacturer shall provide an applicable method. 5.2 Analysis test of infrared spectra of material composition. take the finished product of orthokeratology lenses as testing sample. Use Fourier transform infrared spectrometer to carry out the test. The characteristic peak of the infrared spectrum of the test sample shall meet the main chemical molecular characteristic peak of the material.

6 Sampling and inspection rules

6.1 Exit-factory inspection The exit-factory inspection rules shall be confirmed by the manufacturer. It shall inspect one by one.

7 Marks, labels and accompanying information

7.1 Marks, labels 7.1.1 Marks The orthokeratology lenses shall be designed as two colors for lenses wore by the left and right eyes, so as to make the wearing patients and ophthalmologists easily identify the left and right lenses. The manufacturer shall indicate in the accompanying file. 7.2 Accompanying information NOTE. The manufacturer shall provide the instructions to the patient, the information to the optometrists according to the following requirements. 7.2.1 Instructions for use provided by the manufacturer to the patient The manufacturer shall require the fitting personnel to provide the instructions to the patient.

8 Packaging

8.1 The small packaging for orthokeratology lenses, under the normal conditions of storage, transport and treatment, shall be able to protect the product from any foreseeable damage and shall not negatively affect its function, safety or characteristics. ......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.


      

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