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YY 0477-2004 English PDF (YY0477-2004)

YY 0477-2004 English PDF (YY0477-2004)

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YY 0477-2004: Rigid gas permeable contact lenses for orthokeratology [Replaced by YY 0477-2016]

This Standard specifies the classification, technical requirements, testing methods, inspection rules, packing requirements and the recommended fitting program of the rigid gas permeable contact lenses for orthokeratology.
YY 0477-2004
ICS 11.040.99
C 40
INDUSTRY STANDARD
OF THE PEOPLE REPUBLIC OF CHINA
YY 0477?€?2004
Rigid gas permeable contact lenses for
orthokeratology
ISSUED ON. MARCH 23, 2004
IMPLEMENTED ON. JANUARY 01, 2005
Issued by. the State Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 5
2 Normative References ... 5
3 Terms and Definitions ... 5
4 Classification ... 9
5 Requirements ... 9
6 Sampling ... 12
7 Testing Method ... 13
8 Signs, Labels and Instruction for Use ... 31
9 Packaging, Transport and Storage ... 33
Annex A (Normative) Invitro Cytotoxicity Testing of Orthokeratology Contact Lens Material... 34 Annex B (Normative) Rabbit Eye Biocompatibility Test of Orthokeratology Contact Lens Materials .. 39 Annex C (Informative) Recommended Orthokeratology Contact Lens Fitting Procedures ... 47 References and Original Chinese Documents ... 54
Foreword
This Standard is not equivalent to international standard, it is drafted by referencing to the technical contents of the relevant international and domestic standards; and the relevant contents of the foreign and domestic law and regulations, mainly including.
ISO 8320-1 Ophthalmic Optics -- Vocabulary of Contact Lenses and Care Products -- Basic Requirements
ISO 8321-1 Optics and Optic Instruments -- Contact Lenses -- Part 1. Rigid Gas Permeable Contact Lens
ISO 8599 Ophthalmic Optics -- Contact Lenses -- Spectral Transmittance Test ISO 9337-1 Ophthalmic Optics -- Contact Lenses -- Back Vertex Dioptrie Test -- Part 1. Lensometer ISO 9338 Ophthalmic Optics -- Contact Lenses -- Diameter Measurement
ISO 9339-1 Ophthalmic Optics -- Contact Lenses -- Thickness Measurement -- Part 1. Rigid Contact Lenses
ISO 9340 Ophthalmic Optics -- Contact Lenses -- Stress Test of Rigid Contact Lenses ISO 9341 Ophthalmic Optics -- Contact Lenses -- Tests for Inherent Quality and Surface Defect of Rigid Contact Lenses
ISO 9363-1 Ophthalmic Optics -- Contact Lenses -- Biological Compatibility of Contact Lenses -- Evaluation on Cytotoxicity Test -- Part 1. Agar Overlay Test and Growth Inhibition Test ISO 9394 Ophthalmic Optics -- Evaluation on Material Biocompatibility of Contact Lenses -- Test of Contact Lenses in Rabbits' Eyes
ISO 9913-1 Ophthalmic Optics -- Contact Lenses -- Polarographic Oxygen Permeability Measurement ISO 9913-2 Ophthalmic Optics -- Contact Lenses -- Measurement of Oxygen Permeability through Coulomb
ISO 9914 Ophthalmic Optics - Contact Lenses - Measurements for Refractive Index -- Materials -- Contact Lenses
ISO 10338 Ophthalmic Optics -- Contact Lenses -- Curvature Measurement
ISO 10334 Ophthalmic Optics -- Contact Lenses -- Salt Solution Used in the Test of Contact Lenses ISO 10340 Ophthalmic Optics -- Contact Lenses -- Methods for Measurement of Extractable Materials ISO 11539 Ophthalmic Optics -- Contact Lenses -- Methods for the Classification of Care Products for Contact Lenses and Corneal Contact Lenses
ISO 14534 Ophthalmic Optics -- Vocabulary of Contact Lenses and Care Products -- Basic Requirements
?€?Administrative regulations of the Provisions on the Supervision and Administration of Orthokeratology Operation?€? issued by the State Food and Drug Administration.
?€?Technical document of the Listing Guide for Rigid Gas Permeable Contact Lenses for Orthokeratology?€? issued by the FDA of USA.
This Standard is related to the technical and safety performance of medical devices and products, and is a mandatory standard.
Annex A and Annex B of this Standard are the normative annexes. At the same time, in consideration of the actual situation of rigid gas permeable contact lenses for orthokeratology in the implementation of orthokeratology, the quality of the rigid gas permeable contact lenses for orthokeratology is only one aspect of its efficacy and safety in clinical application, and proper fitting is another important aspect. For this reason, in Annex C of this Standard, the recommended standardized fitting program is proposed as the informative annex of this Standard.
This Standard is proposed by the State Food and Drug Administration.
This Standard is under the jurisdiction of the National Technical Committee on Optics and Optic Instruments of Standardization Administration of China.
This Standard is drafted by Hangzhou Medical Device Quality Supervision and Inspection Center of State Food and Drug Administration.
Main Drafters of this Standard. He Tao, Jia Xiaohang, Chen Xianhua, Jiang Xiaolu and Wen Yan. Rigid Gas Permeable Contact Lenses for
Orthokeratology
1 Scope
This Standard specifies the classification, technical requirements, testing method, inspection rules, packing requirement and the recommended fitting program of the rigid gas permeable contact lenses for orthokeratology.
2 Normative References
The articles contained in the following documents have become part of this Standard when they are quoted herein. For the dated documents so quoted, all the modifications (excluding corrections) or revisions made thereafter shall not be applicable to this Standard. For the undated documents so quoted, the latest edition shall be applicable to this Standard.
GB/T 14233.2 Test Methods for Infusion, Transfusion, Injection Equipments for Medical Use Part 2. Biological Test Methods
GB/T 17341 Optics and Optical Instruments Lensometer
GB/T 16886.5 Biological Evaluation of Medical Devices Part 5. Tests for in vitro Cytotoxicity GB/T 16886.10 Biological Evaluation of Medical Devices Part 10. Eye Irritation and Sensitization Tests GB/T 16886.11 Biological Evaluation of Medical Devices Part 11. Tests for Systemic Toxicity ISO 10334 Ophthalmic Optics -- Contact Lenses -- Salt Solution Used in the Test of Contact Lenses Pharmacopeia of the People's Republic of China (2000 edition)
3 Terms and Definitions
For the purpose of this Standard, the following terms and definitions apply. 3.1
Contact Lenses
Any lens designed to be worn on the front surface of the cornea.
Note. The definition of contact lenses includes the myopic lenses, hyperopia lenses and trial (diagnostic) lenses.
3.2
Rigid Gas Permeable Contact Lenses
The contact lenses made of rigid gas permeable material, usually the polymeric material used for contact lenses contains the organic silicone and organic fluorine.
3.3
Rigid Gas Permeable Contact Lenses for Orthokeratology
The rigid gas permeable contact lenses for orthokeratology (hereinafter referred to as orthokeratology contact lenses) that are used to correct the refractive errors of eyes through the corneal refractive therapy in order to change the shape of cornea.
3.4
Oxygen Permeability (Dk value)
Arithmetic product of the gas dissolution coefficient and the diffusion coefficient. Note 1. This is one of the most commonly used parameters of materials of the contact lenses. Note 2. Unit in or . The Dk value
obtained through the hPa is multiplied by 1.333 22, to get the Dk value in unit of mmhg. Note 3. Oxygen Permeability Coefficient. oxygen flux of the contact lens material of the unit-thickness, under certain conditions and under the unit gas pressure difference.
Gas Volume (cm3) X Thickness (cm)
Oxygen Permeability Coefficient = ---------------------------------------------------------------------- Area (cm2) X Time (s) X Pressure Difference (hPa)
3.5
Oxygen Transmissibility (Dk/t value)
The oxygen permeability coefficient divided by the average thickness of the measured material. 3.6
Trial (diagnostic) Lens
The lens only used by researcher or wearer to confirm or assist to confirm the specifications of the lens of the potential contact lens wearer.
3.7
Wetting Angle
The included angle of the interface tangential lines formed between the standard salt solution, inspected material and air.
3.8
Modulus
The stress generated when specific strain occurs to the tested material, in unit MPa. 3.9
Total Extractable
The percentage of the total content of the monomer molecular polymer and other extractable AND the original mass.
3.10
Total Diameters
7.7.1.3 Testing
The testing chamber is opened, lubricating oil is applied on the circular base of the sample tested, the tested sample is placed, the circular sealing rubber ring is placed on the laboratory sample, then the testing chamber is closed, and the bolts are fastened, to enable the f...

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