YY 0477-2016_English: PDF (YY0477-2016)
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Rigid gas permeable contact lenses for orthokeratology
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Rigid gas permeable contact lenses for orthokeratology [Replaced by YY 0477-2016]
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| Standard ID | YY 0477-2016 (YY0477-2016) | | Description (Translated English) | Rigid gas permeable contact lenses for orthokeratology | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C40 | | Classification of International Standard | 11.040.70 | | Word Count Estimation | 9,943 | | Date of Issue | 3/23/2016 | | Date of Implementation | 2018-01-01 | | Older Standard (superseded by this standard) | YY 0477-2004 | | Quoted Standard | GB/T 2829; GB/T 11417.1-2012; GB 11477.2-2012; YY/T 0316; YY/T 0466.1 | | Drafting Organization | The State Food and Drug Administration, Hangzhou Medical Device Quality Supervision and Inspection Center, Zhejiang Medical Device Testing is responsible for drafting | | Administrative Organization | National Standardization Subcommittee on Medical Optics and Instruments (SAC/TC 103/SC 1) | | Regulation (derived from) | Notice of the General Administration of Food and Drug Administration (No. 74 of 2016) | | Proposing organization | State Food and Drug Administration | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the terms and definitions, requirements, test methods, sampling and inspection rules, marking, labeling and accompanying documentation, packaging, etc. of rigid contact lenses for orthokeratology (hereinafter referred to as orthokeratology). Orthokeratology is expected to temporarily change the shape of the cornea in order to achieve the purpose of temporary correction of refractive errors. | | Standard ID | YY 0477-2004 (YY0477-2004) | | Description (Translated English) | Rigid gas permeable contact lenses for orthokeratology [Replaced by YY 0477-2016] | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C40 | | Classification of International Standard | 11.040.99 | | Word Count Estimation | 33,347 | | Date of Issue | 2004-03-23 | | Date of Implementation | 2005-01-01 | | Quoted Standard | SFDA [ 2004 ] No. 86 | | Adopted Standard | ISO 8320-1, NEQ; ISO 8321-1, NEQ; ISO 8599, NEQ; ISO 9337-1, NEQ; ISO 9338, NEQ; ISO 9339-1, NEQ; ISO 9340, NEQ | | Drafting Organization | Hangzhou, the State Food and Drug Administration Medical Device Quality Supervision and Inspection Center | | Administrative Organization | National Standardization Technical Committee of Medical optics and instruments | | Regulation (derived from) | SFDA [2004] No. 86 | | Proposing organization | State Food and Drug Administration | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the orthokeratology with rigid gas permeable contact lens terminology, classification, technical requirements, test methods, inspection rules, packaging requirements and recommendations of the fitting procedure. |
YY 0477-2016
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
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
3. No action is required - Full-copy of this standard will be automatically &
immediately delivered to your EMAIL address in 0~60 minutes.
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;
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.
4.2.1 Rear vertex, cylinder power and cylindrical axis
The rear vertex and/or prescription cylinder mirror and cylinder axis nominal
values of orthokeratology lenses shall be marked on the small packaging
container’s label or in the accompanying technical documentation. Its
tolerance shall be consistent with the provisions of Table 1 in GB
11417.2-2012.
4.2.2 Light transmission performance
The requirements for the visible light transmittance, color vision requirements
and UV transmittance of orthokeratology lenses shall comply with the
provisions of 4.2.4 in GB 11417.2-2012.
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.
The design values shall be marked according to the requirements for small
packaging container label or accompanying technical documentation. The
geometric parameters shall be marked according to the requirements in
Annex A of GB/T 11417.1-2012. It tolerance shall meet requirements for
permeable materials in Table 4 of GB 11417.2-2012. The structural dimension
tolerance of alignment curve zone shall be confirmed by the manufacturer.
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
4.4.1 Material description
The manufacturer shall indicate that the materials for orthokeratology lenses
shall be classified and marked according to the requirements of GB/T
11417.1-2012. Each manufacturer shall provide the names, contents of all
compositions of materials for orthokeratology lenses, the main chemical
molecular structure and characteristic peaks of testing IR spectra. Meanwhile,
it shall state the test methods and conditions. Carry out the test via infrared
spectrometer. The testing sample shall meet requirements for material
4.4.3.2 The intake and release of preservatives (if applicable) shall comply
with the provisions of 4.4.3.2 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
4.7.1 The radiation aging test shall comply with the provisions of 4.7.1 in GB
11417.2-2017.
4.7.2 The validity requirements shall comply with the provisions of 4.7.2 in
GB 11417.2-2017.
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.
4.8.2 Edge contour. observe under the 7~10 times magnifier. The edges of
orthokeratology lenses shall be smooth, bright and clean. Its shape shall be
consistent with the quality characteristics described by the manufacturer. The
transition between the peripheral curves and the base curve zone shall be
smooth, bright and clean. The transition shall be uniform, consistent.
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. The test or test method
provided shall consider as much as possible to simulate the practical
application of the human eyes, including the treatment (e.g., the balance in
the standard salt solution). The reproducibility of the detection method shall
be better than half of the specified tolerance limit.
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
n) manufacturer’s name.
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.
In addition to the nominal value of the accompanying documentation provided
in Clause 5, the instructions for use shall include at least the following
information.
a) main performance, structure and scope of application.
1) product name and model;
2) structure and principle of orthokeratology lenses;
3) material description;
4) main technical parameters;
5) physical properties of the lenses...
......
YY 0477-2004
ICS 11.040.99
C 40
INDUSTRY STANDARD
OF THE PEOPLE’S 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 & 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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