YY 0477-2016Rigid gas permeable contact lenses for orthokeratology (English PDF)
角膜塑形用硬性透气接触镜
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
March 23, 2016
Implementation date
January 1, 2018
Scope
YY 0477-2016 is the English-translated version of 角膜塑形用硬性透气接触镜.
YY 0477-2016 is the Chinese pharmaceutical industry standard for the rigid gas permeable contact lens used in orthokeratology, the lens worn to reshape the cornea and so reduce refractive error.
It specifies the terms and definitions, the requirements, the test methods, the sampling and inspection rules, the marks, the labels and the accompanying data and the packaging, covering the geometry of the back surface and the dimensions and their tolerances, the optical power and the light transmittance, the oxygen permeability of the material, the surface quality and the biological evaluation. Issued on 23 March 2016, it applies from 1 January 2018.
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Document preview — YY 0477-2016
National Standard of the People's Republic of China
- Replacing
- YY 0477-2004
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword3
- 1 Scope5
- 2 Normative references5
- 3 Terms and definitions5
- 4 Requirements7
- 5 Test methods10
- 6 Sampling and inspection rules11
- 7 Marks, labels and accompanying information12
- 8 Packaging14
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;
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.
4.3 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.
4.8 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.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 23 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 2829Sampling procedures and tables for periodic inspection by attributes
- GB/T 11417.1-2012Ophthalmic optics - Contact lenses - Part 1: Vocabulary, classification and recommendations for labelling specifications
- GB 11417.2-2012Ophthalmic optics - Contact lenses - Part 2: Rigid contact lenses
- YY/T 0316Medical devices-Application of risk management to medical devices
- YY/T 0466.1Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
Similar standards
Editions of YY 0477
| Edition | Title | Revision | Status |
|---|---|---|---|
| YY 0477-2016 | Rigid gas permeable contact lenses for orthokeratology | current edition | Current |
| YY 0477-2004 | Rigid gas permeable contact lenses for orthokeratology | previous edition | Superseded |
This page sells the current edition, YY 0477-2016. Earlier editions are listed for reference only.
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Related Standards
GB 11417.2-2012 — Ophthalmic optics - Contact lenses - Part 2: Rigid contact lenses specification
GB/T 11417.1-2012 — Ophthalmic optics - Contact lenses - Part 1: Vocabulary, classification and recommendations for labelling specifications
GB/T 2829-2025 — Sampling procedures and tables for periodic inspection by attributes
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YY 0477-2016
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