GB 11417.2-2012_English: PDF (GB11417.2-2012)
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Ophthalmic optics -- Contact lenses -- Part 2: Rigid contact lenses specification
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GB 11417.2-2012
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Standards related to: GB 11417.2-2012
| Standard ID | GB 11417.2-2012 (GB11417.2-2012) | | Description (Translated English) | Ophthalmic optics - Contact lenses - Part 2: Rigid contact lenses specification | | Sector / Industry | National Standard | | Classification of Chinese Standard | C40 | | Classification of International Standard | 11.040.70 | | Word Count Estimation | 12,198 | | Older Standard (superseded by this standard) | GB 11417.1-1989 | | Quoted Standard | GB/T 2829-2002; GB/T 3978-2008; GB/T 5702-2003; GB/T 11417.1-2012; GB/T 16886.5; GB/T 16886.10; GB/T 16886.11; GB/T 19973.1; YY/T 0297; YY/T 0316; YY/T 0466.1; Chinese Pharmacopoeia 2010 edition two | | Drafting Organization | Hangzhou, the State Food and Drug Administration Medical Device Quality Supervision and Inspection Center | | Administrative Organization | Optics and Photonics National Standardization Technical Committee of Medical optics and instruments at the Technical Committee | | Regulation (derived from) | National Standards Bulletin No. 41 of 2012 | | Proposing organization | State Food and Drug Administration | | Issuing agency(ies) | General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China | | Summary | This Chinese standard provides rigid contact lens scope, terms and definitions, requirements, test methods, sampling and inspection rules, labeling, marking and accompanying information requirements. This standard applies to rigid corneal and scleral cont | GB 11417.2‐2012
GB
ICS 11.040.70
C 40
NATIONAL STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
Replacing GB 11417.1-1989
Ophthalmic optics - Contact lenses -
Part 2. Rigid contact lenses specification
眼科光学 接触镜
ISSUED ON. DECEMBER 31, 2012
IMPLEMENTED ON. DECEMBER 1, 2013
Issued by. General Administration of Quality Supervision, Inspection and
Quarantine of the People's Republic of China;
Committee of Standardization Administration of the People's
Republic of China
Table of Contents
Foreword ... 3
1 Scope ... 5
2 Normative references ... 5
3 Terms and definitions ... 6
4 Requirements ... 6
5 Test methods ... 13
6 Sampling and inspection rules ... 13
7 Label, mark and accompanying information ... 14
Appendix A ... 16
Foreword
Sections 4.3.3.2 and 4.7.1 are recommendatory. The rest are mandatory.
“Ophthalmic Optics - Contact Lenses”, GB/T28539 “Ophthalmic Optics - Contact
Lenses and Contact Lens Care Products - Guidelines for Determination of
Preservative Uptake and Release” and GB/T28538 “Ophthalmic Optics - Contact
Lenses and Contact Lens Care Products - Determination of Biocompatibility by Ocular
Study with Rabbit Eyes” jointly constitute the national standards of contact lenses.
“Ophthalmic Optics – Contact lenses” is divided into 9 parts as follows.
— Part 1. Vocabulary, Classification System and Recommendations for Labeling
Specifications (GB/T 11417.1);
— Part 2. Rigid contact lenses (GB 11417.2);
— Part 3. Soft contact lenses (GB 11417.3);
— Part 4. Standard salt solution for test (GB/T 11417.4);
— Part 5. Test methods for optical properties (GB/T 11417.5);
— Part 6. Mechanical properties test methods (GB/T 11417.6);
— Part 7. Physicochemical properties test methods (GB/T 11417.7);
— Part 8. Determination of shelf-life (GB/T 11417.8);
— Part 9. Ageing by exposure to UV and visible radiation (in vitro method) (GB/T
11417.9).
This Part is Part 2.
This Part is drafted according to the rules specified in GB/T 1.1-2009.
This Part replaces GB 11417.1-1989 “Rigid corneal contact lenses” and the
Corrigendum No. 1 in 1997.
Except editorial amendment, the change of technical content of this Part, GB
11417.1-1989 and Corrigendum No. 1 in 1997 are as follows.
— Amend the requirements of biological compatibility, refractive index, optical
deviation, geometric dimensioning, impurities, surface defects, fenestration,
limbic shape, luminous transmittance, and spectral transmittance;
— Modify the test methods (Chapter 6);
— Modify the sampling and inspection rules (Chapter 7);
— Modify the contents of signs (Chapter 8);
— Delete the requirements for the stress and lens shape;
— Delete the wear requirements (Chapter 9);
— Supplement the requirements of ultraviolet spectrum performance, amount of
oxygen permeability, coefficient of oxygen permeability, mechanical property,
physicochemical properties of materials, microorganism, and stability.
This Part is redrafted and compiled by referring to ISO 14534.2002 “Ophthalmic
Optics-Contact Lenses and Contact Lens Care Products - Fundamental
Requirements”, ISO18369.2006 “Ophthalmic Optics - Contact Lenses”, and ANSI
Z80.20 “Ophthalmic Optics - Contact Lenses - Terminology, Tolerances,
Measurement Methods and Physicochemical Properties”.
Please note that some contents in this document may involve patents. The issuing
organization of this document is not responsible to identify these patents.
This Part was proposed by the China Food and Drug Administration.
This Part shall be administered by Technical Subcommittee of Medical Optics and
Instrument of National Optics and Photonics Technical Committee for Standardization
(SAC/TC 103/SC1).
The drafting organizations of the Part. China Food and Drug Administration -
Hangzhou Medical Device Quality, Supervising and Testing Center, and Zhejiang
Medical Device Inspection Institute.
Main drafters of this Part. He Tao, Jia Xiaohang, Wen Yan, Ma Li, Jiang Xiaolu, Chen
Xianhua, Zheng Jian, Qi Weiming, Li Jiazhong, and Chen Jingyun.
The previous versions replaced by the Part are.
— GB 11417.1-1989, and Corrigendum No. 1 in 1997.
Ophthalmic optics - Contact lenses -
Part 2. Rigid contact lenses specification
1 Scope
This Part of GB 11417 specifies the scope, terminology, definition, requirements, test
method, sampling, inspection regulations, label, mark, and accompanying information
of rigid contact lenses (hereinafter referred to as contact lenses).
This Part applies to rigid cornea and scleral contact lenses.
2 Normative references
The articles contained in the following documents have become part of this document
when they are quoted herein. For the dated documents so quoted, all the
modifications (Including all corrections) or revisions made thereafter shall be
applicable to this document.
GB/T 2829-2002 Sampling procedures and tables for periodic inspection by
attributes (Applicable to inspection of process stability)
GB/T 3978-2008 Standard illuminants and geometric conditions
GB/T 5702-2003 Methods of measuring the color of light sources
GB/T 11417.1-2012 Ophthalmic optics - Contact lenses - Part 1. Vocabulary,
classification system and recommendations for labeling specifications
GB/T 16886.5 Biological evaluation of medical devices - Part 5. Test for in vitro
cytotoxicity
GB/T 16886.10 Biological evaluation of medical devices - Part 10. Tests for
irritation and delayed-type hypersensitivity
GB/T 16886.11 Biological evaluation of medical devices - Part 11. Tests for
systemic toxicity
GB/T 19973.1 Sterilization of medical devices - Microbiological methods - Part 1.
Estimation of population of microorganisms on products
YY/T 0297 Clinical investigation of medical devices
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
Pharmacopoeia of the People's Republic of China, Edition II, 2010
3 Terms and definitions
For the purpose of this standard, the following terms and definitions defined in GB/T
11417.1-2012 apply to this document.
4 Requirements
4.1 General provisions
The contact lenses shall be under the pre-clinical and clinical evaluation in terms of its
safety and property, including proper risk analysis according to YY/T 0316. In addition
to the following requirements, if there are other additional properties declared by the
manufacturer, it shall give detailed description, applicable requirements and test
methods.
4.2 Optical property
4.2.1 General provisions
If accompanying information and marks have distinct description on the contact
lenses for special medical purpose instead of having optical property, the following
optical property requirements may not be applicable.
4.2.2 Back vertex power, cylindrical power and cylindrical axis
For back vertex power, prescription cylindrical power and cylindrical axis (if any), the
nominal values shall be marked on the labels on the small packaging container. The
tolerance of nominal values shall comply with the provisions in Table 1.
After tested on aging by ultraviolet light and visible radiation, materials of contact
lenses shall be remained stable, in accordance with requirements of 4.1 and 4.3.
4.7.2 Validity period
Contact lens manufacturer shall conduct stability test to determine the storage period
and shall mark on the small package.
4.8 Internal quality and surface defect
4.8.1 Impurities and surface flaws
When observed with a 7x-10x magnifier, contact lenses shall be free of internal
impurities and surface flaws affecting the normal usage. Impurities in the materials.
bubbles, stripes and residue. Surface flaws. cracks, edge gaps, scratches and
roughness.
4.8.2 Fenestration
When observed with a 7x-10x magnifier, the front and back limbic shape of
fenestration shall be consistent with the shape described by manufacturers.
4.8.3 Edge profile
When observed with a 7x-10x magnifier, the edge of contact lens shall be smooth,
clean, and bright. Its shape shall be in accordance with the quality properties
described by manufacturers.
5 Test methods
All requirements in Chapter 4 of this standard can be carried out for detection or test
according to Appendix A. If there is no suitable method and standard in Appendix A,
the manufacturer shall provide suitable methods. Inspection or test methods provided
shall consider the actual application of simulation eye as much as possible, including
treatment (for example, keep balance in standard salt solution). The reproducibility of
detection methods shall be better than half of the specified tolerance limit.
6 Sampling and inspection rules
6.1 Ex-factory test
Ex-factory inspection rules are determined by the manufacturer.
6.2 Type test
It shall be divided into general type test and special type test, as shown in Table 5.
7.2 Accompanying information provided by the manufacturer
7.2.1 Operation inst...
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